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The leading independent newspaper covering dermatology news and commentary.
Going into solo practice? An expert shares tips
SAN DIEGO – When the Boston-based cosmetic dermatology practice that employed Catherine M. DiGiorgio, MD, MS, was sold to a private equity firm a few years ago, she found herself at a crossroads: Stay and work for a large corporation, or open a solo practice?
She opted to start her own practice in Boston, “because I didn’t want to work for a large corporation, and I want to provide the best care for my patients in a more intimate manner,” Dr. DiGiorgio, a board-certified laser and cosmetic dermatologist, said at the annual Masters of Aesthetics Symposium.
The decision also tested her mettle. “I spoke to several colleagues and friends, and I was terrified,” she said. “I was like: ‘I don’t even know where to start.’ ”
On the heels of opening a new office in a matter of weeks, she offered the following tips and questions to consider when launching a solo dermatology practice:
Select a location. “That’s your first decision,” she said. “Where in the city are you going to open? Are you going to a new city, or are you moving back home? Don’t be afraid to start from scratch, and don’t be afraid to start a [solo] practice if you already have a patient base.”
Will you lease or purchase your space? After she secured a bank loan, Dr. DiGiorgio chose to lease the space for her new practice, “because you can kind of see where things go, get all the kinks out and figure out how to build things in a space that you don’t own. Then, when you’re ready and you have grown, you can invest more into your practice.”
Will you accept insurance? She built her practice around the direct specialty care model, which emphasizes the patient-physician relationship and removes third-party payors. “It’s not a concierge practice, but it’s a transparent, reasonable fee schedule for medical dermatology,” she explained. “I’ve done 100% cosmetics for about 5 years now, [but] I do medical dermatology for a fee. On my website I have a full price list on how much a full skin check is, [and] how much biopsies are. It’s completely transparent. Patients can submit to their insurance for reimbursement, but we don’t guarantee that they’re going to be reimbursed.”
Where will your patients come from? Will you advertise? Do you have physicians in the area who will refer to you if you’re a board-certified dermatologist? She emphasized the importance of “learning how to present yourself” on a website dedicated to your own practice. “Instagram, Facebook, and social media are great, but you don’t own those pages,” noted Dr. DiGiorgio, who served as the program cochair of the 2023 annual meeting of the American Society for Laser Medicine and Surgery and was recently elected to serve on the board of directors for the American Society for Dermatology Surgery. “You don’t own one of those pictures that are posted on your social media page. They can disappear in a second. If that happens, how are people going to find you?”
Are you going to hire more physicians in the future? That will influence the size of the new office and the floor plan.
Lawyer up. Hiring a health care attorney can “help you navigate transitioning from whatever position you’re in to opening up your own practice, as well as setting up the regulatory paperwork necessary for your new practice. You’ll also need a real estate attorney to help once you have selected a place, to help you navigate through that process,” she said, such as figuring out if the elevator in the building meets the Americans With Disabilities Act (ADA) requirements.
Create a mission statement. That way, “you know why you’re doing this, and it stays with you as you’re getting through the hard roadblocks.”
Find an architect, contractor, or designer. “If you’re building out a space from scratch, you’re going to need an architect,” she said. “Along with that architect will come a full-on contracting firm. I ended up hiring everyone individually, because I’m trying to spend as little money as possible.” She also hired a designer to help select furnishings and create the office atmosphere.
Secure a building permit ASAP. “It’s almost better to have the city permit before you sign the lease, because the permits can take a year, and you don’t want to pay rent on an empty space for a year if you don’t have a permit or if there are other hoops to go through,” Dr. DiGiorgio said.
Find an agent to help you set up medical malpractice insurance, liability insurance, and worker’s compensation insurance. “Make sure you read all the paperwork, because it can be very intricate,” she said.
Find an accountant. That person can help set up a bookkeeping process.
What equipment and devices will you need? That depends largely on the patient population a physician serves. Dr. DiGiorgio noted that eligible small businesses may take a tax credit of up to $5,000 per year for accommodations made to comply with the ADA. “That’s a nice feature, so that you can purchase ADA compliant items like a larger exam chair and custom reception areas.”
Dr. DiGiorgio reported having no relevant disclosures.
SAN DIEGO – When the Boston-based cosmetic dermatology practice that employed Catherine M. DiGiorgio, MD, MS, was sold to a private equity firm a few years ago, she found herself at a crossroads: Stay and work for a large corporation, or open a solo practice?
She opted to start her own practice in Boston, “because I didn’t want to work for a large corporation, and I want to provide the best care for my patients in a more intimate manner,” Dr. DiGiorgio, a board-certified laser and cosmetic dermatologist, said at the annual Masters of Aesthetics Symposium.
The decision also tested her mettle. “I spoke to several colleagues and friends, and I was terrified,” she said. “I was like: ‘I don’t even know where to start.’ ”
On the heels of opening a new office in a matter of weeks, she offered the following tips and questions to consider when launching a solo dermatology practice:
Select a location. “That’s your first decision,” she said. “Where in the city are you going to open? Are you going to a new city, or are you moving back home? Don’t be afraid to start from scratch, and don’t be afraid to start a [solo] practice if you already have a patient base.”
Will you lease or purchase your space? After she secured a bank loan, Dr. DiGiorgio chose to lease the space for her new practice, “because you can kind of see where things go, get all the kinks out and figure out how to build things in a space that you don’t own. Then, when you’re ready and you have grown, you can invest more into your practice.”
Will you accept insurance? She built her practice around the direct specialty care model, which emphasizes the patient-physician relationship and removes third-party payors. “It’s not a concierge practice, but it’s a transparent, reasonable fee schedule for medical dermatology,” she explained. “I’ve done 100% cosmetics for about 5 years now, [but] I do medical dermatology for a fee. On my website I have a full price list on how much a full skin check is, [and] how much biopsies are. It’s completely transparent. Patients can submit to their insurance for reimbursement, but we don’t guarantee that they’re going to be reimbursed.”
Where will your patients come from? Will you advertise? Do you have physicians in the area who will refer to you if you’re a board-certified dermatologist? She emphasized the importance of “learning how to present yourself” on a website dedicated to your own practice. “Instagram, Facebook, and social media are great, but you don’t own those pages,” noted Dr. DiGiorgio, who served as the program cochair of the 2023 annual meeting of the American Society for Laser Medicine and Surgery and was recently elected to serve on the board of directors for the American Society for Dermatology Surgery. “You don’t own one of those pictures that are posted on your social media page. They can disappear in a second. If that happens, how are people going to find you?”
Are you going to hire more physicians in the future? That will influence the size of the new office and the floor plan.
Lawyer up. Hiring a health care attorney can “help you navigate transitioning from whatever position you’re in to opening up your own practice, as well as setting up the regulatory paperwork necessary for your new practice. You’ll also need a real estate attorney to help once you have selected a place, to help you navigate through that process,” she said, such as figuring out if the elevator in the building meets the Americans With Disabilities Act (ADA) requirements.
Create a mission statement. That way, “you know why you’re doing this, and it stays with you as you’re getting through the hard roadblocks.”
Find an architect, contractor, or designer. “If you’re building out a space from scratch, you’re going to need an architect,” she said. “Along with that architect will come a full-on contracting firm. I ended up hiring everyone individually, because I’m trying to spend as little money as possible.” She also hired a designer to help select furnishings and create the office atmosphere.
Secure a building permit ASAP. “It’s almost better to have the city permit before you sign the lease, because the permits can take a year, and you don’t want to pay rent on an empty space for a year if you don’t have a permit or if there are other hoops to go through,” Dr. DiGiorgio said.
Find an agent to help you set up medical malpractice insurance, liability insurance, and worker’s compensation insurance. “Make sure you read all the paperwork, because it can be very intricate,” she said.
Find an accountant. That person can help set up a bookkeeping process.
What equipment and devices will you need? That depends largely on the patient population a physician serves. Dr. DiGiorgio noted that eligible small businesses may take a tax credit of up to $5,000 per year for accommodations made to comply with the ADA. “That’s a nice feature, so that you can purchase ADA compliant items like a larger exam chair and custom reception areas.”
Dr. DiGiorgio reported having no relevant disclosures.
SAN DIEGO – When the Boston-based cosmetic dermatology practice that employed Catherine M. DiGiorgio, MD, MS, was sold to a private equity firm a few years ago, she found herself at a crossroads: Stay and work for a large corporation, or open a solo practice?
She opted to start her own practice in Boston, “because I didn’t want to work for a large corporation, and I want to provide the best care for my patients in a more intimate manner,” Dr. DiGiorgio, a board-certified laser and cosmetic dermatologist, said at the annual Masters of Aesthetics Symposium.
The decision also tested her mettle. “I spoke to several colleagues and friends, and I was terrified,” she said. “I was like: ‘I don’t even know where to start.’ ”
On the heels of opening a new office in a matter of weeks, she offered the following tips and questions to consider when launching a solo dermatology practice:
Select a location. “That’s your first decision,” she said. “Where in the city are you going to open? Are you going to a new city, or are you moving back home? Don’t be afraid to start from scratch, and don’t be afraid to start a [solo] practice if you already have a patient base.”
Will you lease or purchase your space? After she secured a bank loan, Dr. DiGiorgio chose to lease the space for her new practice, “because you can kind of see where things go, get all the kinks out and figure out how to build things in a space that you don’t own. Then, when you’re ready and you have grown, you can invest more into your practice.”
Will you accept insurance? She built her practice around the direct specialty care model, which emphasizes the patient-physician relationship and removes third-party payors. “It’s not a concierge practice, but it’s a transparent, reasonable fee schedule for medical dermatology,” she explained. “I’ve done 100% cosmetics for about 5 years now, [but] I do medical dermatology for a fee. On my website I have a full price list on how much a full skin check is, [and] how much biopsies are. It’s completely transparent. Patients can submit to their insurance for reimbursement, but we don’t guarantee that they’re going to be reimbursed.”
Where will your patients come from? Will you advertise? Do you have physicians in the area who will refer to you if you’re a board-certified dermatologist? She emphasized the importance of “learning how to present yourself” on a website dedicated to your own practice. “Instagram, Facebook, and social media are great, but you don’t own those pages,” noted Dr. DiGiorgio, who served as the program cochair of the 2023 annual meeting of the American Society for Laser Medicine and Surgery and was recently elected to serve on the board of directors for the American Society for Dermatology Surgery. “You don’t own one of those pictures that are posted on your social media page. They can disappear in a second. If that happens, how are people going to find you?”
Are you going to hire more physicians in the future? That will influence the size of the new office and the floor plan.
Lawyer up. Hiring a health care attorney can “help you navigate transitioning from whatever position you’re in to opening up your own practice, as well as setting up the regulatory paperwork necessary for your new practice. You’ll also need a real estate attorney to help once you have selected a place, to help you navigate through that process,” she said, such as figuring out if the elevator in the building meets the Americans With Disabilities Act (ADA) requirements.
Create a mission statement. That way, “you know why you’re doing this, and it stays with you as you’re getting through the hard roadblocks.”
Find an architect, contractor, or designer. “If you’re building out a space from scratch, you’re going to need an architect,” she said. “Along with that architect will come a full-on contracting firm. I ended up hiring everyone individually, because I’m trying to spend as little money as possible.” She also hired a designer to help select furnishings and create the office atmosphere.
Secure a building permit ASAP. “It’s almost better to have the city permit before you sign the lease, because the permits can take a year, and you don’t want to pay rent on an empty space for a year if you don’t have a permit or if there are other hoops to go through,” Dr. DiGiorgio said.
Find an agent to help you set up medical malpractice insurance, liability insurance, and worker’s compensation insurance. “Make sure you read all the paperwork, because it can be very intricate,” she said.
Find an accountant. That person can help set up a bookkeeping process.
What equipment and devices will you need? That depends largely on the patient population a physician serves. Dr. DiGiorgio noted that eligible small businesses may take a tax credit of up to $5,000 per year for accommodations made to comply with the ADA. “That’s a nice feature, so that you can purchase ADA compliant items like a larger exam chair and custom reception areas.”
Dr. DiGiorgio reported having no relevant disclosures.
AT MOAS 2023
Domestic violence in health care is real and underreported
To protect survivors’ identities, some names have been changed or shortened.
Natasha Abadilla, MD, met the man who would become her abuser while working abroad for a public health nonprofit. When he began emotionally and physically abusing her, she did everything she could to hide it.
“My coworkers knew nothing of the abuse. I became an expert in applying makeup to hide the bruises,” recalls Dr. Abadilla, now a second-year resident and pediatric neurologist at Lucile Packard Children’s Hospital at Stanford.
Dr. Abadilla says she strongly identifies as a hard worker and – to this day – hopes her work did not falter despite her partner’s constant drain on her. But the impact of the abuse continued to affect her for years. Like many survivors of domestic violence, she struggled with PTSD and depression.
Health care workers are often the first point of contact for survivors of domestic violence. Experts and advocates continue to push for more training for clinicians to identify and respond to signs among their patients. Often missing from this conversation is the reality that those tasked with screening can also be victims of intimate partner violence themselves.
What’s more: The very strengths that medical professionals often pride themselves on – perfectionism, empathy, grit – can make it harder for them to identify abuse in their own relationships and push through humiliation and shame to seek help.
Dr. Abadilla is exceptional among survivors in the medical field. Rather than keep her experience quiet, she has shared it publicly.
Awareness, she believes, can save lives.
An understudied problem in an underserved group
The majority of research on health care workers in this area has focused on workplace violence, which 62% experience worldwide. But intimate partner violence remains understudied and underdiscussed. Some medical professionals are even saddled with a “double burden,” facing trauma at work and at home, note the authors of a 2022 meta-analysis published in the journal Trauma, Violence, & Abuse.
The problem has had dire consequences. In recent years, many health care workers have been killed by their abusers:
- In 2016, Casey M. Drawert, MD, a Texas-based critical care anesthesiologist, was fatally shot by her husband in a murder-suicide.
- In 2018, Tamara O’Neal, MD, an ER physician, and Dayna Less, a first-year pharmacy resident, were killed by Dr. O’Neal’s ex-fiancé at Mercy Hospital in Chicago.
- In 2019, Sarah Hawley, MD, a first-year University of Utah resident, was fatally shot by her boyfriend in a murder-suicide.
- In 2021, Moria Kinsey, a nurse practitioner in Tahlequah, Okla., was murdered by a physician.
- In July of 2023, Gwendolyn Lavonne Riddick, DO, an ob.gyn. in North Carolina, was fatally shot by the father of her 3-year-old son.
There are others.
In the wake of these tragedies, calls for health care workers to screen each other as well as patients have grown. But for an untold number of survivors, breaking the silence is still not possible due to concerns about their reputation, professional consequences, the threat of harassment from abusers who are often in the same field, a medical culture of selfless endurance, and a lack of appropriate resources.
While the vast majority have stayed silent, those who have spoken out say there’s a need for targeted interventions to educate medical professionals as well as more supportive policies throughout the health care system.
Are health care workers more at risk?
Although more studies are needed, research indicates health care workers experience domestic violence at rates comparable to those of other populations, whereas some data suggest rates may be higher.
In the United States, more than one in three women and one in four men experience some form of intimate partner violence in their lifetime. Similarly, a 2020 study found that 24% of 400 physicians responding to a survey reported a history of domestic violence, with 15% reporting verbal abuse, 8% reporting physical violence, 4% reporting sexual abuse, and 4% reporting stalking.
Meanwhile, in an anonymous survey completed by 882 practicing surgeons and trainees in the United States from late 2018 to early 2019, more than 60% reported experiencing some type of intimate partner violence, most commonly emotional abuse.
Recent studies in the United Kingdom, Australia, and elsewhere show that significant numbers of medical professionals are fighting this battle. A 2019 study of more than 2,000 nurses, midwives, and health care assistants in the United Kingdom found that nurses were three times more likely to experience domestic violence than the average person.
What would help solve this problem: More study of health care worker-survivors as a unique group with unique risk factors. In general, domestic violence is most prevalent among women and people in marginalized groups. But young adults, such as medical students and trainees, can face an increased risk due to economic strain. Major life changes, such as relocating for residency, can also drive up stress and fray social connections, further isolating victims.
Why it’s so much harder for medical professionals to reveal abuse
For medical professionals accustomed to being strong and forging on, identifying as a victim of abuse can seem like a personal contradiction. It can feel easier to separate their personal and professional lives rather than face a complex reality.
In a personal essay on KevinMD.com, medical student Chloe N. L. Lee describes this emotional turmoil. “As an aspiring psychiatrist, I questioned my character judgment (how did I end up with a misogynistic abuser?) and wondered if I ought to have known better. I worried that my colleagues would deem me unfit to care for patients. And I thought that this was not supposed to happen to women like me,” Ms. Lee writes.
Kimberly, a licensed therapist, experienced a similar pattern of self-blame when her partner began exhibiting violent behavior. “For a long time, I felt guilty because I said to myself, You’re a therapist. You’re supposed to know this,” she recalls. At the same time, she felt driven to help him and sought couples therapy as his violence escalated.
Whitney, a pharmacist, recognized the “hallmarks” of abuse in her relationship, but she coped by compartmentalizing. Whitney says she was vulnerable to her abuser as a young college student who struggled financially. As he showered her with gifts, she found herself waving away red flags like aggressiveness or overprotectiveness.
After Whitney graduated, her partner’s emotional manipulation escalated into frequent physical assaults. When he gave her a black eye, she could not bring herself to go into work. She quit her job without notice. Despite a spotless record, none of her coworkers ever reached out to investigate her sudden departure.
It would take 8 years for Whitney to acknowledge the abuse and seize a moment to escape. She fled with just her purse and started over in a new city, rebuilding her life in the midst of harassment and threats from her ex. She says she’s grateful to be alive.
An imperfect system doesn’t help
Health care workers rarely ask for support or disclose abuse at work. Some have cited stigma, a lack of confidentiality (especially when the abuser is also in health care), fears about colleagues’ judgment, and a culture that doesn’t prioritize self-care.
Sometimes policies get in the way: In a 2021 qualitative study of interviews with 21 female physician-survivors in the United Kingdom, many said that despite the intense stress of abuse and recovery, they were unable to take any time off.
Of 180 UK-based midwife-survivors interviewed in a 2018 study, only 60 sought support at work and 30 received it. Many said their supervisors pressured them to report the abuse and get back to work, called social services behind their back, or reported them to their professional regulator. “I was treated like the perpetrator,” one said. Barbara Hernandez, PhD, a researcher who studies physician-survivors and director of physician vitality at Loma Linda University in southern California, says workplace violence and mistreatment from patients or colleagues – and a poor institutional response – can make those in health care feel like they have to “shut up and put up,” priming them to also tolerate abuse at home.
When survivors do reach out, there can be a disconnect between the resources they need and those they’re offered, Dr. Hernandez adds. In a recent survey of 400 physicians she conducted, respondents typically said they would advise a physician-survivor to “get to a shelter quickly.” But when roles were reversed, they admitted going to a shelter was the least feasible option. Support groups can also be problematic in smaller communities where physicians might be recognized or see their own patients.
Complicating matters further, the violence often comes from within the medical community. This can lead to particularly malicious abuse tactics like sending false accusations to a victim’s regulatory college or board; prolonged court and custody battles to drain them of all resources and their ability to hold a job; or even sabotage, harassment, or violence at work. The sheen of the abuser’s public persona, on the other hand, can guard them from any accountability.
For example, one physician-survivor said her ex-partner, a psychiatrist, coerced her into believing she was mentally ill, claimed she was “psychotic” in order to take back their children after she left, and had numerous colleagues serve as character witnesses in court for him, “saying he couldn’t have done any of these things, how great he is, and what a wonderful father he is.”
Slow progress is still progress
After Sherilyn M. Gordon-Burroughs, MD, a Texas-based transplant surgeon, mother, and educator, was killed by her husband in a murder-suicide in 2017, her friends Barbara Lee Bass, MD, president of the American College of Surgeons, and Patricia L. Turner, MD, were spurred into action. Together, they founded the ACS Intimate Partner Violence Task Force. Their mission is to educate surgeons to identify the signs of intimate partner violence (IPV) in themselves and their colleagues and connect them with resources.
“There is a concerted effort to close that gap,” says D’Andrea K. Joseph, MD, cochair of the task force and chief of trauma and acute care surgery at NYU Langone in New York. In the future, Dr. Joseph predicts, “making this a part of the curriculum, that it’s standardized for residents and trainees, that there is a safe place for victims ... and that we can band together and really recognize and assist our colleagues who are in trouble.”
Resources created by the ACS IPV task force, such as the toolkit and curriculum, provide a model for other health care leaders. But there have been few similar initiatives aimed at increasing IPV intervention within the medical system.
What you can do in your workplace
In her essay, Ms. Lee explains that a major turning point came when a physician friend explicitly asked if she was experiencing abuse. He then gently confirmed she was, and asked without judgment how he could support her, an approach that mirrors advice from the National Domestic Violence Hotline.
“Having a physician validate that this was, indeed, an abusive situation helped enormously ... I believe it may have saved my life,” she writes.
That validation can be crucial, and Dr. Abadilla urges other physicians to regularly check in with colleagues, especially those who seem particularly positive with a go-getter attitude and yet may not seem themselves. That was how she presented when she was struggling the most.
Supporting systemic changes within your organization and beyond is also important. The authors of the 2022 meta-analysis stress the need for domestic violence training, legislative changes, paid leave, and union support.
Finding strength in recovery
Over a decade after escaping her abuser, Whitney says she’s only just begun to share her experience, but what she’s learned has made her a better pharmacist. She says she’s more attuned to subtle signs something could be off with patients and coworkers. When someone makes comments about feeling anxious or that they can’t do anything right, it’s important to ask why, she says.
Recently, Kimberly has opened up to her mentor and other therapists, many of whom have shared that they’re also survivors.
“The last thing I said to [my abuser] is you think you’ve won and you’re hurting me, but what you’ve done to me – I’m going to utilize this and I’m going to help other people,” Kimberly says. “This pain that I have will go away, and I’m going to save the lives of others.”
A version of this article first appeared on Medscape.com.
To protect survivors’ identities, some names have been changed or shortened.
Natasha Abadilla, MD, met the man who would become her abuser while working abroad for a public health nonprofit. When he began emotionally and physically abusing her, she did everything she could to hide it.
“My coworkers knew nothing of the abuse. I became an expert in applying makeup to hide the bruises,” recalls Dr. Abadilla, now a second-year resident and pediatric neurologist at Lucile Packard Children’s Hospital at Stanford.
Dr. Abadilla says she strongly identifies as a hard worker and – to this day – hopes her work did not falter despite her partner’s constant drain on her. But the impact of the abuse continued to affect her for years. Like many survivors of domestic violence, she struggled with PTSD and depression.
Health care workers are often the first point of contact for survivors of domestic violence. Experts and advocates continue to push for more training for clinicians to identify and respond to signs among their patients. Often missing from this conversation is the reality that those tasked with screening can also be victims of intimate partner violence themselves.
What’s more: The very strengths that medical professionals often pride themselves on – perfectionism, empathy, grit – can make it harder for them to identify abuse in their own relationships and push through humiliation and shame to seek help.
Dr. Abadilla is exceptional among survivors in the medical field. Rather than keep her experience quiet, she has shared it publicly.
Awareness, she believes, can save lives.
An understudied problem in an underserved group
The majority of research on health care workers in this area has focused on workplace violence, which 62% experience worldwide. But intimate partner violence remains understudied and underdiscussed. Some medical professionals are even saddled with a “double burden,” facing trauma at work and at home, note the authors of a 2022 meta-analysis published in the journal Trauma, Violence, & Abuse.
The problem has had dire consequences. In recent years, many health care workers have been killed by their abusers:
- In 2016, Casey M. Drawert, MD, a Texas-based critical care anesthesiologist, was fatally shot by her husband in a murder-suicide.
- In 2018, Tamara O’Neal, MD, an ER physician, and Dayna Less, a first-year pharmacy resident, were killed by Dr. O’Neal’s ex-fiancé at Mercy Hospital in Chicago.
- In 2019, Sarah Hawley, MD, a first-year University of Utah resident, was fatally shot by her boyfriend in a murder-suicide.
- In 2021, Moria Kinsey, a nurse practitioner in Tahlequah, Okla., was murdered by a physician.
- In July of 2023, Gwendolyn Lavonne Riddick, DO, an ob.gyn. in North Carolina, was fatally shot by the father of her 3-year-old son.
There are others.
In the wake of these tragedies, calls for health care workers to screen each other as well as patients have grown. But for an untold number of survivors, breaking the silence is still not possible due to concerns about their reputation, professional consequences, the threat of harassment from abusers who are often in the same field, a medical culture of selfless endurance, and a lack of appropriate resources.
While the vast majority have stayed silent, those who have spoken out say there’s a need for targeted interventions to educate medical professionals as well as more supportive policies throughout the health care system.
Are health care workers more at risk?
Although more studies are needed, research indicates health care workers experience domestic violence at rates comparable to those of other populations, whereas some data suggest rates may be higher.
In the United States, more than one in three women and one in four men experience some form of intimate partner violence in their lifetime. Similarly, a 2020 study found that 24% of 400 physicians responding to a survey reported a history of domestic violence, with 15% reporting verbal abuse, 8% reporting physical violence, 4% reporting sexual abuse, and 4% reporting stalking.
Meanwhile, in an anonymous survey completed by 882 practicing surgeons and trainees in the United States from late 2018 to early 2019, more than 60% reported experiencing some type of intimate partner violence, most commonly emotional abuse.
Recent studies in the United Kingdom, Australia, and elsewhere show that significant numbers of medical professionals are fighting this battle. A 2019 study of more than 2,000 nurses, midwives, and health care assistants in the United Kingdom found that nurses were three times more likely to experience domestic violence than the average person.
What would help solve this problem: More study of health care worker-survivors as a unique group with unique risk factors. In general, domestic violence is most prevalent among women and people in marginalized groups. But young adults, such as medical students and trainees, can face an increased risk due to economic strain. Major life changes, such as relocating for residency, can also drive up stress and fray social connections, further isolating victims.
Why it’s so much harder for medical professionals to reveal abuse
For medical professionals accustomed to being strong and forging on, identifying as a victim of abuse can seem like a personal contradiction. It can feel easier to separate their personal and professional lives rather than face a complex reality.
In a personal essay on KevinMD.com, medical student Chloe N. L. Lee describes this emotional turmoil. “As an aspiring psychiatrist, I questioned my character judgment (how did I end up with a misogynistic abuser?) and wondered if I ought to have known better. I worried that my colleagues would deem me unfit to care for patients. And I thought that this was not supposed to happen to women like me,” Ms. Lee writes.
Kimberly, a licensed therapist, experienced a similar pattern of self-blame when her partner began exhibiting violent behavior. “For a long time, I felt guilty because I said to myself, You’re a therapist. You’re supposed to know this,” she recalls. At the same time, she felt driven to help him and sought couples therapy as his violence escalated.
Whitney, a pharmacist, recognized the “hallmarks” of abuse in her relationship, but she coped by compartmentalizing. Whitney says she was vulnerable to her abuser as a young college student who struggled financially. As he showered her with gifts, she found herself waving away red flags like aggressiveness or overprotectiveness.
After Whitney graduated, her partner’s emotional manipulation escalated into frequent physical assaults. When he gave her a black eye, she could not bring herself to go into work. She quit her job without notice. Despite a spotless record, none of her coworkers ever reached out to investigate her sudden departure.
It would take 8 years for Whitney to acknowledge the abuse and seize a moment to escape. She fled with just her purse and started over in a new city, rebuilding her life in the midst of harassment and threats from her ex. She says she’s grateful to be alive.
An imperfect system doesn’t help
Health care workers rarely ask for support or disclose abuse at work. Some have cited stigma, a lack of confidentiality (especially when the abuser is also in health care), fears about colleagues’ judgment, and a culture that doesn’t prioritize self-care.
Sometimes policies get in the way: In a 2021 qualitative study of interviews with 21 female physician-survivors in the United Kingdom, many said that despite the intense stress of abuse and recovery, they were unable to take any time off.
Of 180 UK-based midwife-survivors interviewed in a 2018 study, only 60 sought support at work and 30 received it. Many said their supervisors pressured them to report the abuse and get back to work, called social services behind their back, or reported them to their professional regulator. “I was treated like the perpetrator,” one said. Barbara Hernandez, PhD, a researcher who studies physician-survivors and director of physician vitality at Loma Linda University in southern California, says workplace violence and mistreatment from patients or colleagues – and a poor institutional response – can make those in health care feel like they have to “shut up and put up,” priming them to also tolerate abuse at home.
When survivors do reach out, there can be a disconnect between the resources they need and those they’re offered, Dr. Hernandez adds. In a recent survey of 400 physicians she conducted, respondents typically said they would advise a physician-survivor to “get to a shelter quickly.” But when roles were reversed, they admitted going to a shelter was the least feasible option. Support groups can also be problematic in smaller communities where physicians might be recognized or see their own patients.
Complicating matters further, the violence often comes from within the medical community. This can lead to particularly malicious abuse tactics like sending false accusations to a victim’s regulatory college or board; prolonged court and custody battles to drain them of all resources and their ability to hold a job; or even sabotage, harassment, or violence at work. The sheen of the abuser’s public persona, on the other hand, can guard them from any accountability.
For example, one physician-survivor said her ex-partner, a psychiatrist, coerced her into believing she was mentally ill, claimed she was “psychotic” in order to take back their children after she left, and had numerous colleagues serve as character witnesses in court for him, “saying he couldn’t have done any of these things, how great he is, and what a wonderful father he is.”
Slow progress is still progress
After Sherilyn M. Gordon-Burroughs, MD, a Texas-based transplant surgeon, mother, and educator, was killed by her husband in a murder-suicide in 2017, her friends Barbara Lee Bass, MD, president of the American College of Surgeons, and Patricia L. Turner, MD, were spurred into action. Together, they founded the ACS Intimate Partner Violence Task Force. Their mission is to educate surgeons to identify the signs of intimate partner violence (IPV) in themselves and their colleagues and connect them with resources.
“There is a concerted effort to close that gap,” says D’Andrea K. Joseph, MD, cochair of the task force and chief of trauma and acute care surgery at NYU Langone in New York. In the future, Dr. Joseph predicts, “making this a part of the curriculum, that it’s standardized for residents and trainees, that there is a safe place for victims ... and that we can band together and really recognize and assist our colleagues who are in trouble.”
Resources created by the ACS IPV task force, such as the toolkit and curriculum, provide a model for other health care leaders. But there have been few similar initiatives aimed at increasing IPV intervention within the medical system.
What you can do in your workplace
In her essay, Ms. Lee explains that a major turning point came when a physician friend explicitly asked if she was experiencing abuse. He then gently confirmed she was, and asked without judgment how he could support her, an approach that mirrors advice from the National Domestic Violence Hotline.
“Having a physician validate that this was, indeed, an abusive situation helped enormously ... I believe it may have saved my life,” she writes.
That validation can be crucial, and Dr. Abadilla urges other physicians to regularly check in with colleagues, especially those who seem particularly positive with a go-getter attitude and yet may not seem themselves. That was how she presented when she was struggling the most.
Supporting systemic changes within your organization and beyond is also important. The authors of the 2022 meta-analysis stress the need for domestic violence training, legislative changes, paid leave, and union support.
Finding strength in recovery
Over a decade after escaping her abuser, Whitney says she’s only just begun to share her experience, but what she’s learned has made her a better pharmacist. She says she’s more attuned to subtle signs something could be off with patients and coworkers. When someone makes comments about feeling anxious or that they can’t do anything right, it’s important to ask why, she says.
Recently, Kimberly has opened up to her mentor and other therapists, many of whom have shared that they’re also survivors.
“The last thing I said to [my abuser] is you think you’ve won and you’re hurting me, but what you’ve done to me – I’m going to utilize this and I’m going to help other people,” Kimberly says. “This pain that I have will go away, and I’m going to save the lives of others.”
A version of this article first appeared on Medscape.com.
To protect survivors’ identities, some names have been changed or shortened.
Natasha Abadilla, MD, met the man who would become her abuser while working abroad for a public health nonprofit. When he began emotionally and physically abusing her, she did everything she could to hide it.
“My coworkers knew nothing of the abuse. I became an expert in applying makeup to hide the bruises,” recalls Dr. Abadilla, now a second-year resident and pediatric neurologist at Lucile Packard Children’s Hospital at Stanford.
Dr. Abadilla says she strongly identifies as a hard worker and – to this day – hopes her work did not falter despite her partner’s constant drain on her. But the impact of the abuse continued to affect her for years. Like many survivors of domestic violence, she struggled with PTSD and depression.
Health care workers are often the first point of contact for survivors of domestic violence. Experts and advocates continue to push for more training for clinicians to identify and respond to signs among their patients. Often missing from this conversation is the reality that those tasked with screening can also be victims of intimate partner violence themselves.
What’s more: The very strengths that medical professionals often pride themselves on – perfectionism, empathy, grit – can make it harder for them to identify abuse in their own relationships and push through humiliation and shame to seek help.
Dr. Abadilla is exceptional among survivors in the medical field. Rather than keep her experience quiet, she has shared it publicly.
Awareness, she believes, can save lives.
An understudied problem in an underserved group
The majority of research on health care workers in this area has focused on workplace violence, which 62% experience worldwide. But intimate partner violence remains understudied and underdiscussed. Some medical professionals are even saddled with a “double burden,” facing trauma at work and at home, note the authors of a 2022 meta-analysis published in the journal Trauma, Violence, & Abuse.
The problem has had dire consequences. In recent years, many health care workers have been killed by their abusers:
- In 2016, Casey M. Drawert, MD, a Texas-based critical care anesthesiologist, was fatally shot by her husband in a murder-suicide.
- In 2018, Tamara O’Neal, MD, an ER physician, and Dayna Less, a first-year pharmacy resident, were killed by Dr. O’Neal’s ex-fiancé at Mercy Hospital in Chicago.
- In 2019, Sarah Hawley, MD, a first-year University of Utah resident, was fatally shot by her boyfriend in a murder-suicide.
- In 2021, Moria Kinsey, a nurse practitioner in Tahlequah, Okla., was murdered by a physician.
- In July of 2023, Gwendolyn Lavonne Riddick, DO, an ob.gyn. in North Carolina, was fatally shot by the father of her 3-year-old son.
There are others.
In the wake of these tragedies, calls for health care workers to screen each other as well as patients have grown. But for an untold number of survivors, breaking the silence is still not possible due to concerns about their reputation, professional consequences, the threat of harassment from abusers who are often in the same field, a medical culture of selfless endurance, and a lack of appropriate resources.
While the vast majority have stayed silent, those who have spoken out say there’s a need for targeted interventions to educate medical professionals as well as more supportive policies throughout the health care system.
Are health care workers more at risk?
Although more studies are needed, research indicates health care workers experience domestic violence at rates comparable to those of other populations, whereas some data suggest rates may be higher.
In the United States, more than one in three women and one in four men experience some form of intimate partner violence in their lifetime. Similarly, a 2020 study found that 24% of 400 physicians responding to a survey reported a history of domestic violence, with 15% reporting verbal abuse, 8% reporting physical violence, 4% reporting sexual abuse, and 4% reporting stalking.
Meanwhile, in an anonymous survey completed by 882 practicing surgeons and trainees in the United States from late 2018 to early 2019, more than 60% reported experiencing some type of intimate partner violence, most commonly emotional abuse.
Recent studies in the United Kingdom, Australia, and elsewhere show that significant numbers of medical professionals are fighting this battle. A 2019 study of more than 2,000 nurses, midwives, and health care assistants in the United Kingdom found that nurses were three times more likely to experience domestic violence than the average person.
What would help solve this problem: More study of health care worker-survivors as a unique group with unique risk factors. In general, domestic violence is most prevalent among women and people in marginalized groups. But young adults, such as medical students and trainees, can face an increased risk due to economic strain. Major life changes, such as relocating for residency, can also drive up stress and fray social connections, further isolating victims.
Why it’s so much harder for medical professionals to reveal abuse
For medical professionals accustomed to being strong and forging on, identifying as a victim of abuse can seem like a personal contradiction. It can feel easier to separate their personal and professional lives rather than face a complex reality.
In a personal essay on KevinMD.com, medical student Chloe N. L. Lee describes this emotional turmoil. “As an aspiring psychiatrist, I questioned my character judgment (how did I end up with a misogynistic abuser?) and wondered if I ought to have known better. I worried that my colleagues would deem me unfit to care for patients. And I thought that this was not supposed to happen to women like me,” Ms. Lee writes.
Kimberly, a licensed therapist, experienced a similar pattern of self-blame when her partner began exhibiting violent behavior. “For a long time, I felt guilty because I said to myself, You’re a therapist. You’re supposed to know this,” she recalls. At the same time, she felt driven to help him and sought couples therapy as his violence escalated.
Whitney, a pharmacist, recognized the “hallmarks” of abuse in her relationship, but she coped by compartmentalizing. Whitney says she was vulnerable to her abuser as a young college student who struggled financially. As he showered her with gifts, she found herself waving away red flags like aggressiveness or overprotectiveness.
After Whitney graduated, her partner’s emotional manipulation escalated into frequent physical assaults. When he gave her a black eye, she could not bring herself to go into work. She quit her job without notice. Despite a spotless record, none of her coworkers ever reached out to investigate her sudden departure.
It would take 8 years for Whitney to acknowledge the abuse and seize a moment to escape. She fled with just her purse and started over in a new city, rebuilding her life in the midst of harassment and threats from her ex. She says she’s grateful to be alive.
An imperfect system doesn’t help
Health care workers rarely ask for support or disclose abuse at work. Some have cited stigma, a lack of confidentiality (especially when the abuser is also in health care), fears about colleagues’ judgment, and a culture that doesn’t prioritize self-care.
Sometimes policies get in the way: In a 2021 qualitative study of interviews with 21 female physician-survivors in the United Kingdom, many said that despite the intense stress of abuse and recovery, they were unable to take any time off.
Of 180 UK-based midwife-survivors interviewed in a 2018 study, only 60 sought support at work and 30 received it. Many said their supervisors pressured them to report the abuse and get back to work, called social services behind their back, or reported them to their professional regulator. “I was treated like the perpetrator,” one said. Barbara Hernandez, PhD, a researcher who studies physician-survivors and director of physician vitality at Loma Linda University in southern California, says workplace violence and mistreatment from patients or colleagues – and a poor institutional response – can make those in health care feel like they have to “shut up and put up,” priming them to also tolerate abuse at home.
When survivors do reach out, there can be a disconnect between the resources they need and those they’re offered, Dr. Hernandez adds. In a recent survey of 400 physicians she conducted, respondents typically said they would advise a physician-survivor to “get to a shelter quickly.” But when roles were reversed, they admitted going to a shelter was the least feasible option. Support groups can also be problematic in smaller communities where physicians might be recognized or see their own patients.
Complicating matters further, the violence often comes from within the medical community. This can lead to particularly malicious abuse tactics like sending false accusations to a victim’s regulatory college or board; prolonged court and custody battles to drain them of all resources and their ability to hold a job; or even sabotage, harassment, or violence at work. The sheen of the abuser’s public persona, on the other hand, can guard them from any accountability.
For example, one physician-survivor said her ex-partner, a psychiatrist, coerced her into believing she was mentally ill, claimed she was “psychotic” in order to take back their children after she left, and had numerous colleagues serve as character witnesses in court for him, “saying he couldn’t have done any of these things, how great he is, and what a wonderful father he is.”
Slow progress is still progress
After Sherilyn M. Gordon-Burroughs, MD, a Texas-based transplant surgeon, mother, and educator, was killed by her husband in a murder-suicide in 2017, her friends Barbara Lee Bass, MD, president of the American College of Surgeons, and Patricia L. Turner, MD, were spurred into action. Together, they founded the ACS Intimate Partner Violence Task Force. Their mission is to educate surgeons to identify the signs of intimate partner violence (IPV) in themselves and their colleagues and connect them with resources.
“There is a concerted effort to close that gap,” says D’Andrea K. Joseph, MD, cochair of the task force and chief of trauma and acute care surgery at NYU Langone in New York. In the future, Dr. Joseph predicts, “making this a part of the curriculum, that it’s standardized for residents and trainees, that there is a safe place for victims ... and that we can band together and really recognize and assist our colleagues who are in trouble.”
Resources created by the ACS IPV task force, such as the toolkit and curriculum, provide a model for other health care leaders. But there have been few similar initiatives aimed at increasing IPV intervention within the medical system.
What you can do in your workplace
In her essay, Ms. Lee explains that a major turning point came when a physician friend explicitly asked if she was experiencing abuse. He then gently confirmed she was, and asked without judgment how he could support her, an approach that mirrors advice from the National Domestic Violence Hotline.
“Having a physician validate that this was, indeed, an abusive situation helped enormously ... I believe it may have saved my life,” she writes.
That validation can be crucial, and Dr. Abadilla urges other physicians to regularly check in with colleagues, especially those who seem particularly positive with a go-getter attitude and yet may not seem themselves. That was how she presented when she was struggling the most.
Supporting systemic changes within your organization and beyond is also important. The authors of the 2022 meta-analysis stress the need for domestic violence training, legislative changes, paid leave, and union support.
Finding strength in recovery
Over a decade after escaping her abuser, Whitney says she’s only just begun to share her experience, but what she’s learned has made her a better pharmacist. She says she’s more attuned to subtle signs something could be off with patients and coworkers. When someone makes comments about feeling anxious or that they can’t do anything right, it’s important to ask why, she says.
Recently, Kimberly has opened up to her mentor and other therapists, many of whom have shared that they’re also survivors.
“The last thing I said to [my abuser] is you think you’ve won and you’re hurting me, but what you’ve done to me – I’m going to utilize this and I’m going to help other people,” Kimberly says. “This pain that I have will go away, and I’m going to save the lives of others.”
A version of this article first appeared on Medscape.com.
One in five doctors with long COVID can no longer work: Survey
Crippling symptoms, lost careers, and eroded incomes: This is the harsh reality for doctors suffering with long COVID, according to the first major survey of physicians with the condition.
The survey, conducted by the British Medical Association and the Long COVID Doctors for Action support group, sheds light on the lingering effects of long COVID on more than 600 chronically ill and disabled doctors with the condition. It also spotlights what they describe as a lack of medical and financial support from their government and employers at the National Health Service.
“We feel betrayed and abandoned,” said Kelly Fearnley, MBChB, chair and cofounder of Long COVID Doctors for Action. “At a time of national crisis, when health care workers were asked to step up, we did. When the nation needed us, we stepped up. We put our lives on the line. We put our families’ lives on the line. And now that we are injured after knowingly being unprotected and deliberately and repeatedly exposed to a level 3 biohazard, we now find ourselves in this position.”
Dr. Fearnley fell ill while working in a hospital’s COVID ward in November 2020. She is one of an estimated 2 million people in the United Kingdom – including thousands of NHS employees – with long COVID. She hasn’t been able to return to work in nearly 3 years.
Long COVID affects more than 65 million people worldwide. It is estimated that 1 in 10 people infected with the virus develop long-term symptoms. In the United Kingdom, health care and social care workers are seven times more likely to have had severe COVID-19 than other types of employees.
Doctors responding to the BMA survey reported a wide range of long COVID symptoms, including fatigue, headaches, muscular pain, nerve damage, joint pain, and respiratory problems.
Among the survey’s key findings, 60% of doctors said long COVID has affected their ability to carry out day-to-day tasks on a regular basis. Almost one in five (18%) said they were no longer able to work, while fewer than one in three (31%) were working full time. This compares with more than half (57%) of respondents working full time before the onset of their COVID illness – a decline of 46%.
Nearly half (48%) of respondents said they have experienced some form of loss of earnings as a result of long COVID, and almost half of the doctors were never referred to an NHS long COVID clinic. The survey included the following first-person accounts from doctors living with the condition.
- One doctor said: “I nearly lost my life, my home, my partner and my career. I have received little support to help keep these. The impact on my mental health nearly cost [me] my life again.”
- A senior consulting physician commented: “Life is absolutely miserable. Every day is a struggle. I wake up exhausted, the insomnia and night terrors are horrendous as I live through my worst fears every night. Any activity such as eating meals, washing, etc., will mean I have to go to bed for a few hours. I am unable to look after myself or my child, exercise or maintain social relationships. I have no financial security. Long COVID has totally destroyed my life.”
- A salaried general practitioner said: “I can no longer work, finances are ruined. I didn’t have employment protection so am now unemployed and penniless.”
Calls for action from the BMA include the following:
- Financial support for doctors and health care staff with long COVID.
- The recognition of long COVID as an occupational disease among health care workers, along with a definition of the condition that covers all of the debilitating disease’s symptoms.
- Improved access to physical and mental health services to help comprehensive assessment, investigations, and treatment.
- Greater workplace protection for health care staff who risk their lives for others.
- Better support for long COVID sufferers to return to work safely if they can, including a flexible approach to the use of workplace adjustments.
“One would think, given the circumstances under which we fell ill and current workforce shortages, NHS employers would be eager to do everything to facilitate the return to work of people with long COVID,” said Dr. Fearnley. “However, NHS employers are legally required to implement only ‘reasonable adjustments,’ and so things such as extended phased return or adjustments to shift patterns are not always being facilitated. Instead, an increasing number of employers are choosing to terminate contracts.”
Raymond Agius, the BMA’s occupational medicine committee cochair, also put the blame on inadequate safety measures for doctors. Those inadequate measures persist to this day, inasmuch as U.K. hospitals have dropped masking requirements.
“During the COVID-19 pandemic, doctors were left exposed and unprotected at work,” he said in a BMA press release. “They often did not have access to the right PPE. ... Too many risk assessments of workplaces and especially of vulnerable doctors were not undertaken.”
A small minority of doctors who were surveyed said they had access to respiratory protective equipment about the time they contracted COVID-19. Only 11% had access to an FFP2 respirator (the equivalent of an N95 mask); 16% had an FFP3 respirator (the equivalent of an N99 mask).
To date, the British government hasn’t issued much of a response to the survey, saying only that it has invested more than ₤50 million to better understand long COVID.
A version of this article first appeared on Medscape.com.
Crippling symptoms, lost careers, and eroded incomes: This is the harsh reality for doctors suffering with long COVID, according to the first major survey of physicians with the condition.
The survey, conducted by the British Medical Association and the Long COVID Doctors for Action support group, sheds light on the lingering effects of long COVID on more than 600 chronically ill and disabled doctors with the condition. It also spotlights what they describe as a lack of medical and financial support from their government and employers at the National Health Service.
“We feel betrayed and abandoned,” said Kelly Fearnley, MBChB, chair and cofounder of Long COVID Doctors for Action. “At a time of national crisis, when health care workers were asked to step up, we did. When the nation needed us, we stepped up. We put our lives on the line. We put our families’ lives on the line. And now that we are injured after knowingly being unprotected and deliberately and repeatedly exposed to a level 3 biohazard, we now find ourselves in this position.”
Dr. Fearnley fell ill while working in a hospital’s COVID ward in November 2020. She is one of an estimated 2 million people in the United Kingdom – including thousands of NHS employees – with long COVID. She hasn’t been able to return to work in nearly 3 years.
Long COVID affects more than 65 million people worldwide. It is estimated that 1 in 10 people infected with the virus develop long-term symptoms. In the United Kingdom, health care and social care workers are seven times more likely to have had severe COVID-19 than other types of employees.
Doctors responding to the BMA survey reported a wide range of long COVID symptoms, including fatigue, headaches, muscular pain, nerve damage, joint pain, and respiratory problems.
Among the survey’s key findings, 60% of doctors said long COVID has affected their ability to carry out day-to-day tasks on a regular basis. Almost one in five (18%) said they were no longer able to work, while fewer than one in three (31%) were working full time. This compares with more than half (57%) of respondents working full time before the onset of their COVID illness – a decline of 46%.
Nearly half (48%) of respondents said they have experienced some form of loss of earnings as a result of long COVID, and almost half of the doctors were never referred to an NHS long COVID clinic. The survey included the following first-person accounts from doctors living with the condition.
- One doctor said: “I nearly lost my life, my home, my partner and my career. I have received little support to help keep these. The impact on my mental health nearly cost [me] my life again.”
- A senior consulting physician commented: “Life is absolutely miserable. Every day is a struggle. I wake up exhausted, the insomnia and night terrors are horrendous as I live through my worst fears every night. Any activity such as eating meals, washing, etc., will mean I have to go to bed for a few hours. I am unable to look after myself or my child, exercise or maintain social relationships. I have no financial security. Long COVID has totally destroyed my life.”
- A salaried general practitioner said: “I can no longer work, finances are ruined. I didn’t have employment protection so am now unemployed and penniless.”
Calls for action from the BMA include the following:
- Financial support for doctors and health care staff with long COVID.
- The recognition of long COVID as an occupational disease among health care workers, along with a definition of the condition that covers all of the debilitating disease’s symptoms.
- Improved access to physical and mental health services to help comprehensive assessment, investigations, and treatment.
- Greater workplace protection for health care staff who risk their lives for others.
- Better support for long COVID sufferers to return to work safely if they can, including a flexible approach to the use of workplace adjustments.
“One would think, given the circumstances under which we fell ill and current workforce shortages, NHS employers would be eager to do everything to facilitate the return to work of people with long COVID,” said Dr. Fearnley. “However, NHS employers are legally required to implement only ‘reasonable adjustments,’ and so things such as extended phased return or adjustments to shift patterns are not always being facilitated. Instead, an increasing number of employers are choosing to terminate contracts.”
Raymond Agius, the BMA’s occupational medicine committee cochair, also put the blame on inadequate safety measures for doctors. Those inadequate measures persist to this day, inasmuch as U.K. hospitals have dropped masking requirements.
“During the COVID-19 pandemic, doctors were left exposed and unprotected at work,” he said in a BMA press release. “They often did not have access to the right PPE. ... Too many risk assessments of workplaces and especially of vulnerable doctors were not undertaken.”
A small minority of doctors who were surveyed said they had access to respiratory protective equipment about the time they contracted COVID-19. Only 11% had access to an FFP2 respirator (the equivalent of an N95 mask); 16% had an FFP3 respirator (the equivalent of an N99 mask).
To date, the British government hasn’t issued much of a response to the survey, saying only that it has invested more than ₤50 million to better understand long COVID.
A version of this article first appeared on Medscape.com.
Crippling symptoms, lost careers, and eroded incomes: This is the harsh reality for doctors suffering with long COVID, according to the first major survey of physicians with the condition.
The survey, conducted by the British Medical Association and the Long COVID Doctors for Action support group, sheds light on the lingering effects of long COVID on more than 600 chronically ill and disabled doctors with the condition. It also spotlights what they describe as a lack of medical and financial support from their government and employers at the National Health Service.
“We feel betrayed and abandoned,” said Kelly Fearnley, MBChB, chair and cofounder of Long COVID Doctors for Action. “At a time of national crisis, when health care workers were asked to step up, we did. When the nation needed us, we stepped up. We put our lives on the line. We put our families’ lives on the line. And now that we are injured after knowingly being unprotected and deliberately and repeatedly exposed to a level 3 biohazard, we now find ourselves in this position.”
Dr. Fearnley fell ill while working in a hospital’s COVID ward in November 2020. She is one of an estimated 2 million people in the United Kingdom – including thousands of NHS employees – with long COVID. She hasn’t been able to return to work in nearly 3 years.
Long COVID affects more than 65 million people worldwide. It is estimated that 1 in 10 people infected with the virus develop long-term symptoms. In the United Kingdom, health care and social care workers are seven times more likely to have had severe COVID-19 than other types of employees.
Doctors responding to the BMA survey reported a wide range of long COVID symptoms, including fatigue, headaches, muscular pain, nerve damage, joint pain, and respiratory problems.
Among the survey’s key findings, 60% of doctors said long COVID has affected their ability to carry out day-to-day tasks on a regular basis. Almost one in five (18%) said they were no longer able to work, while fewer than one in three (31%) were working full time. This compares with more than half (57%) of respondents working full time before the onset of their COVID illness – a decline of 46%.
Nearly half (48%) of respondents said they have experienced some form of loss of earnings as a result of long COVID, and almost half of the doctors were never referred to an NHS long COVID clinic. The survey included the following first-person accounts from doctors living with the condition.
- One doctor said: “I nearly lost my life, my home, my partner and my career. I have received little support to help keep these. The impact on my mental health nearly cost [me] my life again.”
- A senior consulting physician commented: “Life is absolutely miserable. Every day is a struggle. I wake up exhausted, the insomnia and night terrors are horrendous as I live through my worst fears every night. Any activity such as eating meals, washing, etc., will mean I have to go to bed for a few hours. I am unable to look after myself or my child, exercise or maintain social relationships. I have no financial security. Long COVID has totally destroyed my life.”
- A salaried general practitioner said: “I can no longer work, finances are ruined. I didn’t have employment protection so am now unemployed and penniless.”
Calls for action from the BMA include the following:
- Financial support for doctors and health care staff with long COVID.
- The recognition of long COVID as an occupational disease among health care workers, along with a definition of the condition that covers all of the debilitating disease’s symptoms.
- Improved access to physical and mental health services to help comprehensive assessment, investigations, and treatment.
- Greater workplace protection for health care staff who risk their lives for others.
- Better support for long COVID sufferers to return to work safely if they can, including a flexible approach to the use of workplace adjustments.
“One would think, given the circumstances under which we fell ill and current workforce shortages, NHS employers would be eager to do everything to facilitate the return to work of people with long COVID,” said Dr. Fearnley. “However, NHS employers are legally required to implement only ‘reasonable adjustments,’ and so things such as extended phased return or adjustments to shift patterns are not always being facilitated. Instead, an increasing number of employers are choosing to terminate contracts.”
Raymond Agius, the BMA’s occupational medicine committee cochair, also put the blame on inadequate safety measures for doctors. Those inadequate measures persist to this day, inasmuch as U.K. hospitals have dropped masking requirements.
“During the COVID-19 pandemic, doctors were left exposed and unprotected at work,” he said in a BMA press release. “They often did not have access to the right PPE. ... Too many risk assessments of workplaces and especially of vulnerable doctors were not undertaken.”
A small minority of doctors who were surveyed said they had access to respiratory protective equipment about the time they contracted COVID-19. Only 11% had access to an FFP2 respirator (the equivalent of an N95 mask); 16% had an FFP3 respirator (the equivalent of an N99 mask).
To date, the British government hasn’t issued much of a response to the survey, saying only that it has invested more than ₤50 million to better understand long COVID.
A version of this article first appeared on Medscape.com.
Resident creates AI alternative to U.S. News med school ranking
For decades, pre-med students depended on the annual medical school rankings by U.S. News and World Report to decide where to apply for physician education. But after several prominent med schools pulled out of the rankings, one resident began experimenting with artificial intelligence (AI) to create an alternative.
Brandon Turner MD, MSc, a radiation oncology resident at Massachusetts General Hospital in Boston, developed a free do-it-yourself tool using AI that allows prospective students to rank medical schools based on considerations that are most important to them. His research was published online in JAMA Network Open.
“One of the flaws with conventional ranking systems is that the metrics used in these tools are weighted based on the preferences and views of the people who developed these rankings, but those may not work for everyone,” Dr. Turner told this news organization.
He explained that there are different types of metrics used in the U.S. News ranking: one for research and the other for primary care. “The research rankings carry the most prestige and are the ones that most people know about,” he explained. These metrics take into account factors such as how many grant dollars the medical school receives and the average size of those grants per faculty member, Dr. Turner said.
Admission metrics are also included – for example, the median grade point average or MCAT scores of students who have been accepted. “These don’t tell you anything about the research output of the school, only about how selective the school is,” he said.
Primary care metrics might focus on how many graduates of a given school go into primary care, or how other schools rate the quality of primary care training at a given school – a process called peer assessment, Dr. Turner said.
But even though these might be helpful, students may be more interested in the cost of attendance, average debt, representation of minorities, and how many graduates pass their boards, he said. “U.S. News metrics don’t capture these things, but I included them in my algorithm.”
A U.S. News spokesperson said that the publication continues to help students and their families make decisions about their future education. The spokesperson cited U.S. News’ explanation of how it calculates its rankings. “A school’s overall Best Medical Schools rank should be one consideration and not the lone determinant in where a student applies and accepts,” the article states.
Dr. Turner agreed ranking systems are a good starting point when researching med schools, “but the values reflected in the ranking may not reflect an individual’s goals.”
Tyra-Lee Brett, a premed student at the University of South Florida, Tampa, believes an additional tool for students to evaluate medical schools is needed – and she could potentially see herself using Dr. Turner’s creation.
Still, Ms. Brett, a premed trustee of the American Medical Student Association, doesn’t regard any ranking tool as the “be all and end all.” Rather, she feels that the most effective tool would be based on students’ lived experiences. The AMSA is developing a scorecard in which students grade schools based on their opinions about such issues as housing, family planning, and environmental health, she said.
No prior judgments
To develop his algorithm, Dr. Turner used a branch of AI called “unsupervised learning.” It doesn’t make a prior judgment about what the data should look like, Dr. Turner explained.
“You’re just analyzing natural trends within the data.”
The algorithm tries to find and discover clusters or patterns within the data. “It’s like saying to the algorithm: ‘I want you to tell me what schools you think should be grouped together based on the data I feed you,’ which is the data that the user selects based on his or her personal preferences.”
U.S. News has been transparent about the metrics it uses, Dr. Turner notes. “When I started looking into how rankings are developed, I saw that there was transparency, and the reasoning for choosing the metrics used to develop the ranking was pretty sound,” he said.
“But I didn’t see any justification as to why they chose the particular metrics and weighted them in the way that they did.”
Dr. Turner extracted data from the 2023 U.S. News report, which ranked 109 allopathic medical schools, and applied several scenarios to the results to create his alternative ranking system.
In one scenario, he used the same research metrics used by U.S. News, such as a peer research assessment, median federal research activity per full-time faculty member, median GPA, median MCAT, acceptance rate, and faculty-student ratio.
In another scenario, he included four additional metrics: debt, in-state cost of attendance, USMLE Step 1 passing rate, and percentage of underrepresented students with minority race or ethnicity at the school.
For example, a user can rank the importance of the diversity of the class, amount of debt students expect to incur, and amount of research funding the medical school receives. After selecting those factors, the tool generates tiered results displayed in a circle, a shape chosen to avoid the appearance of the hierarchy associated with traditional rankings, Dr. Turner said.
“A prospective student might not care about acceptance rates and MCAT scores, and instead cares about diversity and debt,” Dr. Turner said. He looks forward to extending this approach to the ranking of colleges as well.
‘Imperfect measures’
“The model and interesting online tool that Dr. Turner created allows a premed [student] to generate custom rankings that are in line with their own priorities,” said Christopher Worsham, MD, MPH, a critical care physician in Mass General’s division of pulmonary and critical care medicine.
But Dr. Worsham, also a teaching associate at Harvard Medical School’s department of health care policy, expressed concern that factors figuring into the rankings by U.S. News and Dr. Turner’s alternative “are imperfect measures of medical school quality.”
For example, a student interested in research might favor federal research funding in their customized rankings with Dr. Turner’s model. “But higher research funding doesn’t necessarily translate into a better education for students, particularly when differentiating between two major research systems,” Dr. Worsham noted.
Dr. Worsham added that neither ranking system accurately predicts the quality of doctors graduating from the schools. Instead, he’d like to see ranking systems based on which schools’ graduates deliver the best patient outcomes, whether that’s through direct patient care, impactful research, or leadership within the health care system.
Michael Sauder, PhD, professor of sociology at the University of Iowa, Iowa City, said the model could offer a valuable alternative to the U.S. News ranking system. It might help users develop their own criteria for determining the ranking of medical schools, which is a big improvement over a “one-size-fits-all” approach, Dr. Sauder said.
And Hanna Stotland, an admission consultant based in Chicago, noted that most students rely on rankings because they “don’t have the luxury of advisers who know the ins and outs of different medical schools.” Given the role that rankings play, Ms. Stotland expects that every new ranking tool will have some influence on students.
This tool in particular “has the potential to be useful for students who have identified values they want their medical school to share.” For example, students who care about racial diversity “could use it to easily identify schools that are successful on that metric,” Ms. Stotland said.
Sujay Ratna, a 2nd-year med student at Icahn School of Medicine at Mount Sinai in New York, said he considered the U.S. News ranking his “go-to tool” when he was applying to med school.
But after reading Dr. Turner’s article, the AMSA membership vice president tried the algorithm. “I definitely would have used it had it existed when I was thinking of what schools to apply to and what [schools] to attend.”
The study had no specific funding. Dr. Turner, Dr. Worsham, Dr. Sauder, Ms. Stotland, Ms. Brett, and Mr. Ratna report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
For decades, pre-med students depended on the annual medical school rankings by U.S. News and World Report to decide where to apply for physician education. But after several prominent med schools pulled out of the rankings, one resident began experimenting with artificial intelligence (AI) to create an alternative.
Brandon Turner MD, MSc, a radiation oncology resident at Massachusetts General Hospital in Boston, developed a free do-it-yourself tool using AI that allows prospective students to rank medical schools based on considerations that are most important to them. His research was published online in JAMA Network Open.
“One of the flaws with conventional ranking systems is that the metrics used in these tools are weighted based on the preferences and views of the people who developed these rankings, but those may not work for everyone,” Dr. Turner told this news organization.
He explained that there are different types of metrics used in the U.S. News ranking: one for research and the other for primary care. “The research rankings carry the most prestige and are the ones that most people know about,” he explained. These metrics take into account factors such as how many grant dollars the medical school receives and the average size of those grants per faculty member, Dr. Turner said.
Admission metrics are also included – for example, the median grade point average or MCAT scores of students who have been accepted. “These don’t tell you anything about the research output of the school, only about how selective the school is,” he said.
Primary care metrics might focus on how many graduates of a given school go into primary care, or how other schools rate the quality of primary care training at a given school – a process called peer assessment, Dr. Turner said.
But even though these might be helpful, students may be more interested in the cost of attendance, average debt, representation of minorities, and how many graduates pass their boards, he said. “U.S. News metrics don’t capture these things, but I included them in my algorithm.”
A U.S. News spokesperson said that the publication continues to help students and their families make decisions about their future education. The spokesperson cited U.S. News’ explanation of how it calculates its rankings. “A school’s overall Best Medical Schools rank should be one consideration and not the lone determinant in where a student applies and accepts,” the article states.
Dr. Turner agreed ranking systems are a good starting point when researching med schools, “but the values reflected in the ranking may not reflect an individual’s goals.”
Tyra-Lee Brett, a premed student at the University of South Florida, Tampa, believes an additional tool for students to evaluate medical schools is needed – and she could potentially see herself using Dr. Turner’s creation.
Still, Ms. Brett, a premed trustee of the American Medical Student Association, doesn’t regard any ranking tool as the “be all and end all.” Rather, she feels that the most effective tool would be based on students’ lived experiences. The AMSA is developing a scorecard in which students grade schools based on their opinions about such issues as housing, family planning, and environmental health, she said.
No prior judgments
To develop his algorithm, Dr. Turner used a branch of AI called “unsupervised learning.” It doesn’t make a prior judgment about what the data should look like, Dr. Turner explained.
“You’re just analyzing natural trends within the data.”
The algorithm tries to find and discover clusters or patterns within the data. “It’s like saying to the algorithm: ‘I want you to tell me what schools you think should be grouped together based on the data I feed you,’ which is the data that the user selects based on his or her personal preferences.”
U.S. News has been transparent about the metrics it uses, Dr. Turner notes. “When I started looking into how rankings are developed, I saw that there was transparency, and the reasoning for choosing the metrics used to develop the ranking was pretty sound,” he said.
“But I didn’t see any justification as to why they chose the particular metrics and weighted them in the way that they did.”
Dr. Turner extracted data from the 2023 U.S. News report, which ranked 109 allopathic medical schools, and applied several scenarios to the results to create his alternative ranking system.
In one scenario, he used the same research metrics used by U.S. News, such as a peer research assessment, median federal research activity per full-time faculty member, median GPA, median MCAT, acceptance rate, and faculty-student ratio.
In another scenario, he included four additional metrics: debt, in-state cost of attendance, USMLE Step 1 passing rate, and percentage of underrepresented students with minority race or ethnicity at the school.
For example, a user can rank the importance of the diversity of the class, amount of debt students expect to incur, and amount of research funding the medical school receives. After selecting those factors, the tool generates tiered results displayed in a circle, a shape chosen to avoid the appearance of the hierarchy associated with traditional rankings, Dr. Turner said.
“A prospective student might not care about acceptance rates and MCAT scores, and instead cares about diversity and debt,” Dr. Turner said. He looks forward to extending this approach to the ranking of colleges as well.
‘Imperfect measures’
“The model and interesting online tool that Dr. Turner created allows a premed [student] to generate custom rankings that are in line with their own priorities,” said Christopher Worsham, MD, MPH, a critical care physician in Mass General’s division of pulmonary and critical care medicine.
But Dr. Worsham, also a teaching associate at Harvard Medical School’s department of health care policy, expressed concern that factors figuring into the rankings by U.S. News and Dr. Turner’s alternative “are imperfect measures of medical school quality.”
For example, a student interested in research might favor federal research funding in their customized rankings with Dr. Turner’s model. “But higher research funding doesn’t necessarily translate into a better education for students, particularly when differentiating between two major research systems,” Dr. Worsham noted.
Dr. Worsham added that neither ranking system accurately predicts the quality of doctors graduating from the schools. Instead, he’d like to see ranking systems based on which schools’ graduates deliver the best patient outcomes, whether that’s through direct patient care, impactful research, or leadership within the health care system.
Michael Sauder, PhD, professor of sociology at the University of Iowa, Iowa City, said the model could offer a valuable alternative to the U.S. News ranking system. It might help users develop their own criteria for determining the ranking of medical schools, which is a big improvement over a “one-size-fits-all” approach, Dr. Sauder said.
And Hanna Stotland, an admission consultant based in Chicago, noted that most students rely on rankings because they “don’t have the luxury of advisers who know the ins and outs of different medical schools.” Given the role that rankings play, Ms. Stotland expects that every new ranking tool will have some influence on students.
This tool in particular “has the potential to be useful for students who have identified values they want their medical school to share.” For example, students who care about racial diversity “could use it to easily identify schools that are successful on that metric,” Ms. Stotland said.
Sujay Ratna, a 2nd-year med student at Icahn School of Medicine at Mount Sinai in New York, said he considered the U.S. News ranking his “go-to tool” when he was applying to med school.
But after reading Dr. Turner’s article, the AMSA membership vice president tried the algorithm. “I definitely would have used it had it existed when I was thinking of what schools to apply to and what [schools] to attend.”
The study had no specific funding. Dr. Turner, Dr. Worsham, Dr. Sauder, Ms. Stotland, Ms. Brett, and Mr. Ratna report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
For decades, pre-med students depended on the annual medical school rankings by U.S. News and World Report to decide where to apply for physician education. But after several prominent med schools pulled out of the rankings, one resident began experimenting with artificial intelligence (AI) to create an alternative.
Brandon Turner MD, MSc, a radiation oncology resident at Massachusetts General Hospital in Boston, developed a free do-it-yourself tool using AI that allows prospective students to rank medical schools based on considerations that are most important to them. His research was published online in JAMA Network Open.
“One of the flaws with conventional ranking systems is that the metrics used in these tools are weighted based on the preferences and views of the people who developed these rankings, but those may not work for everyone,” Dr. Turner told this news organization.
He explained that there are different types of metrics used in the U.S. News ranking: one for research and the other for primary care. “The research rankings carry the most prestige and are the ones that most people know about,” he explained. These metrics take into account factors such as how many grant dollars the medical school receives and the average size of those grants per faculty member, Dr. Turner said.
Admission metrics are also included – for example, the median grade point average or MCAT scores of students who have been accepted. “These don’t tell you anything about the research output of the school, only about how selective the school is,” he said.
Primary care metrics might focus on how many graduates of a given school go into primary care, or how other schools rate the quality of primary care training at a given school – a process called peer assessment, Dr. Turner said.
But even though these might be helpful, students may be more interested in the cost of attendance, average debt, representation of minorities, and how many graduates pass their boards, he said. “U.S. News metrics don’t capture these things, but I included them in my algorithm.”
A U.S. News spokesperson said that the publication continues to help students and their families make decisions about their future education. The spokesperson cited U.S. News’ explanation of how it calculates its rankings. “A school’s overall Best Medical Schools rank should be one consideration and not the lone determinant in where a student applies and accepts,” the article states.
Dr. Turner agreed ranking systems are a good starting point when researching med schools, “but the values reflected in the ranking may not reflect an individual’s goals.”
Tyra-Lee Brett, a premed student at the University of South Florida, Tampa, believes an additional tool for students to evaluate medical schools is needed – and she could potentially see herself using Dr. Turner’s creation.
Still, Ms. Brett, a premed trustee of the American Medical Student Association, doesn’t regard any ranking tool as the “be all and end all.” Rather, she feels that the most effective tool would be based on students’ lived experiences. The AMSA is developing a scorecard in which students grade schools based on their opinions about such issues as housing, family planning, and environmental health, she said.
No prior judgments
To develop his algorithm, Dr. Turner used a branch of AI called “unsupervised learning.” It doesn’t make a prior judgment about what the data should look like, Dr. Turner explained.
“You’re just analyzing natural trends within the data.”
The algorithm tries to find and discover clusters or patterns within the data. “It’s like saying to the algorithm: ‘I want you to tell me what schools you think should be grouped together based on the data I feed you,’ which is the data that the user selects based on his or her personal preferences.”
U.S. News has been transparent about the metrics it uses, Dr. Turner notes. “When I started looking into how rankings are developed, I saw that there was transparency, and the reasoning for choosing the metrics used to develop the ranking was pretty sound,” he said.
“But I didn’t see any justification as to why they chose the particular metrics and weighted them in the way that they did.”
Dr. Turner extracted data from the 2023 U.S. News report, which ranked 109 allopathic medical schools, and applied several scenarios to the results to create his alternative ranking system.
In one scenario, he used the same research metrics used by U.S. News, such as a peer research assessment, median federal research activity per full-time faculty member, median GPA, median MCAT, acceptance rate, and faculty-student ratio.
In another scenario, he included four additional metrics: debt, in-state cost of attendance, USMLE Step 1 passing rate, and percentage of underrepresented students with minority race or ethnicity at the school.
For example, a user can rank the importance of the diversity of the class, amount of debt students expect to incur, and amount of research funding the medical school receives. After selecting those factors, the tool generates tiered results displayed in a circle, a shape chosen to avoid the appearance of the hierarchy associated with traditional rankings, Dr. Turner said.
“A prospective student might not care about acceptance rates and MCAT scores, and instead cares about diversity and debt,” Dr. Turner said. He looks forward to extending this approach to the ranking of colleges as well.
‘Imperfect measures’
“The model and interesting online tool that Dr. Turner created allows a premed [student] to generate custom rankings that are in line with their own priorities,” said Christopher Worsham, MD, MPH, a critical care physician in Mass General’s division of pulmonary and critical care medicine.
But Dr. Worsham, also a teaching associate at Harvard Medical School’s department of health care policy, expressed concern that factors figuring into the rankings by U.S. News and Dr. Turner’s alternative “are imperfect measures of medical school quality.”
For example, a student interested in research might favor federal research funding in their customized rankings with Dr. Turner’s model. “But higher research funding doesn’t necessarily translate into a better education for students, particularly when differentiating between two major research systems,” Dr. Worsham noted.
Dr. Worsham added that neither ranking system accurately predicts the quality of doctors graduating from the schools. Instead, he’d like to see ranking systems based on which schools’ graduates deliver the best patient outcomes, whether that’s through direct patient care, impactful research, or leadership within the health care system.
Michael Sauder, PhD, professor of sociology at the University of Iowa, Iowa City, said the model could offer a valuable alternative to the U.S. News ranking system. It might help users develop their own criteria for determining the ranking of medical schools, which is a big improvement over a “one-size-fits-all” approach, Dr. Sauder said.
And Hanna Stotland, an admission consultant based in Chicago, noted that most students rely on rankings because they “don’t have the luxury of advisers who know the ins and outs of different medical schools.” Given the role that rankings play, Ms. Stotland expects that every new ranking tool will have some influence on students.
This tool in particular “has the potential to be useful for students who have identified values they want their medical school to share.” For example, students who care about racial diversity “could use it to easily identify schools that are successful on that metric,” Ms. Stotland said.
Sujay Ratna, a 2nd-year med student at Icahn School of Medicine at Mount Sinai in New York, said he considered the U.S. News ranking his “go-to tool” when he was applying to med school.
But after reading Dr. Turner’s article, the AMSA membership vice president tried the algorithm. “I definitely would have used it had it existed when I was thinking of what schools to apply to and what [schools] to attend.”
The study had no specific funding. Dr. Turner, Dr. Worsham, Dr. Sauder, Ms. Stotland, Ms. Brett, and Mr. Ratna report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Q&A: What to know about the new BA 2.86 COVID variant
The Centers for Disease Control and Prevention and the World Health Organization have dubbed the BA 2.86 variant of COVID-19 as a variant to watch.
So far, only 26 cases of “Pirola,” as the new variant is being called, have been identified: 10 in Denmark, four each in Sweden and the United States, three in South Africa, two in Portugal, and one each the United Kingdom, Israel, and Canada. BA 2.86 is a subvariant of Omicron, but according to reports from the CDC, the strain has many more mutations than the ones that came before it.
With so many facts still unknown about this new variant, this news organization asked experts what people need to be aware of as it continues to spread.
What is unique about the BA 2.86 variant?
“It is unique in that it has more than three mutations on the spike protein,” said Purvi S. Parikh, MD, an infectious disease expert at New York University’s Langone Health. The virus uses the spike proteins to enter our cells.
This “may mean it will be more transmissible, cause more severe disease, and/or our vaccines and treatments may not work as well, as compared to other variants,” she said.
What do we need to watch with BA 2.86 going forward?
“We don’t know if this variant will be associated with a change in the disease severity. We currently see increased numbers of cases in general, even though we don’t yet see the BA.2.86 in our system,” said Heba Mostafa, PhD, director of the molecular virology laboratory at Johns Hopkins Hospital in Baltimore.
“It is important to monitor BA.2.86 (and other variants) and understand how its evolution impacts the number of cases and disease outcomes,” she said. “We should all be aware of the current increase in cases, though, and try to get tested and be treated as soon as possible, as antivirals should be effective against the circulating variants.”
What should doctors know?
Dr. Parikh said doctors should generally expect more COVID cases in their clinics and make sure to screen patients even if their symptoms are mild.
“We have tools that can be used – antivirals like Paxlovid are still efficacious with current dominant strains such as EG.5,” she said. “And encourage your patients to get their boosters, mask, wash hands, and social distance.”
How well can our vaccines fight BA 2.86?
“Vaccine coverage for the BA.2.86 is an area of uncertainty right now,” said Dr. Mostafa.
In its report, the CDC said scientists are still figuring out how well the updated COVID vaccine works. It’s expected to be available in the fall, and for now, they believe the new shot will still make infections less severe, new variants and all.
Prior vaccinations and infections have created antibodies in many people, and that will likely provide some protection, Dr. Mostafa said. “When we experienced the Omicron wave in December 2021, even though the variant was distant from what circulated before its emergence and was associated with a very large increase in the number of cases, vaccinations were still protective against severe disease.”
What is the most important thing to keep track of when it comes to this variant?
According to Dr. Parikh, “it’s most important to monitor how transmissible [BA 2.86] is, how severe it is, and if our current treatments and vaccines work.”
Dr. Mostafa said how well the new variants escape existing antibody protection should also be studied and watched closely.
What does this stage of the virus mutation tell us about where we are in the pandemic?
The history of the coronavirus over the past few years shows that variants with many changes evolve and can spread very quickly, Dr. Mostafa said. “Now that the virus is endemic, it is essential to monitor, update vaccinations if necessary, diagnose, treat, and implement infection control measures when necessary.”
With the limited data we have so far, experts seem to agree that while the variant’s makeup raises some red flags, it is too soon to jump to any conclusions about how easy it is to catch it and the ways it may change how the virus impacts those who contract it.
A version of this article first appeared on WebMD.com.
The Centers for Disease Control and Prevention and the World Health Organization have dubbed the BA 2.86 variant of COVID-19 as a variant to watch.
So far, only 26 cases of “Pirola,” as the new variant is being called, have been identified: 10 in Denmark, four each in Sweden and the United States, three in South Africa, two in Portugal, and one each the United Kingdom, Israel, and Canada. BA 2.86 is a subvariant of Omicron, but according to reports from the CDC, the strain has many more mutations than the ones that came before it.
With so many facts still unknown about this new variant, this news organization asked experts what people need to be aware of as it continues to spread.
What is unique about the BA 2.86 variant?
“It is unique in that it has more than three mutations on the spike protein,” said Purvi S. Parikh, MD, an infectious disease expert at New York University’s Langone Health. The virus uses the spike proteins to enter our cells.
This “may mean it will be more transmissible, cause more severe disease, and/or our vaccines and treatments may not work as well, as compared to other variants,” she said.
What do we need to watch with BA 2.86 going forward?
“We don’t know if this variant will be associated with a change in the disease severity. We currently see increased numbers of cases in general, even though we don’t yet see the BA.2.86 in our system,” said Heba Mostafa, PhD, director of the molecular virology laboratory at Johns Hopkins Hospital in Baltimore.
“It is important to monitor BA.2.86 (and other variants) and understand how its evolution impacts the number of cases and disease outcomes,” she said. “We should all be aware of the current increase in cases, though, and try to get tested and be treated as soon as possible, as antivirals should be effective against the circulating variants.”
What should doctors know?
Dr. Parikh said doctors should generally expect more COVID cases in their clinics and make sure to screen patients even if their symptoms are mild.
“We have tools that can be used – antivirals like Paxlovid are still efficacious with current dominant strains such as EG.5,” she said. “And encourage your patients to get their boosters, mask, wash hands, and social distance.”
How well can our vaccines fight BA 2.86?
“Vaccine coverage for the BA.2.86 is an area of uncertainty right now,” said Dr. Mostafa.
In its report, the CDC said scientists are still figuring out how well the updated COVID vaccine works. It’s expected to be available in the fall, and for now, they believe the new shot will still make infections less severe, new variants and all.
Prior vaccinations and infections have created antibodies in many people, and that will likely provide some protection, Dr. Mostafa said. “When we experienced the Omicron wave in December 2021, even though the variant was distant from what circulated before its emergence and was associated with a very large increase in the number of cases, vaccinations were still protective against severe disease.”
What is the most important thing to keep track of when it comes to this variant?
According to Dr. Parikh, “it’s most important to monitor how transmissible [BA 2.86] is, how severe it is, and if our current treatments and vaccines work.”
Dr. Mostafa said how well the new variants escape existing antibody protection should also be studied and watched closely.
What does this stage of the virus mutation tell us about where we are in the pandemic?
The history of the coronavirus over the past few years shows that variants with many changes evolve and can spread very quickly, Dr. Mostafa said. “Now that the virus is endemic, it is essential to monitor, update vaccinations if necessary, diagnose, treat, and implement infection control measures when necessary.”
With the limited data we have so far, experts seem to agree that while the variant’s makeup raises some red flags, it is too soon to jump to any conclusions about how easy it is to catch it and the ways it may change how the virus impacts those who contract it.
A version of this article first appeared on WebMD.com.
The Centers for Disease Control and Prevention and the World Health Organization have dubbed the BA 2.86 variant of COVID-19 as a variant to watch.
So far, only 26 cases of “Pirola,” as the new variant is being called, have been identified: 10 in Denmark, four each in Sweden and the United States, three in South Africa, two in Portugal, and one each the United Kingdom, Israel, and Canada. BA 2.86 is a subvariant of Omicron, but according to reports from the CDC, the strain has many more mutations than the ones that came before it.
With so many facts still unknown about this new variant, this news organization asked experts what people need to be aware of as it continues to spread.
What is unique about the BA 2.86 variant?
“It is unique in that it has more than three mutations on the spike protein,” said Purvi S. Parikh, MD, an infectious disease expert at New York University’s Langone Health. The virus uses the spike proteins to enter our cells.
This “may mean it will be more transmissible, cause more severe disease, and/or our vaccines and treatments may not work as well, as compared to other variants,” she said.
What do we need to watch with BA 2.86 going forward?
“We don’t know if this variant will be associated with a change in the disease severity. We currently see increased numbers of cases in general, even though we don’t yet see the BA.2.86 in our system,” said Heba Mostafa, PhD, director of the molecular virology laboratory at Johns Hopkins Hospital in Baltimore.
“It is important to monitor BA.2.86 (and other variants) and understand how its evolution impacts the number of cases and disease outcomes,” she said. “We should all be aware of the current increase in cases, though, and try to get tested and be treated as soon as possible, as antivirals should be effective against the circulating variants.”
What should doctors know?
Dr. Parikh said doctors should generally expect more COVID cases in their clinics and make sure to screen patients even if their symptoms are mild.
“We have tools that can be used – antivirals like Paxlovid are still efficacious with current dominant strains such as EG.5,” she said. “And encourage your patients to get their boosters, mask, wash hands, and social distance.”
How well can our vaccines fight BA 2.86?
“Vaccine coverage for the BA.2.86 is an area of uncertainty right now,” said Dr. Mostafa.
In its report, the CDC said scientists are still figuring out how well the updated COVID vaccine works. It’s expected to be available in the fall, and for now, they believe the new shot will still make infections less severe, new variants and all.
Prior vaccinations and infections have created antibodies in many people, and that will likely provide some protection, Dr. Mostafa said. “When we experienced the Omicron wave in December 2021, even though the variant was distant from what circulated before its emergence and was associated with a very large increase in the number of cases, vaccinations were still protective against severe disease.”
What is the most important thing to keep track of when it comes to this variant?
According to Dr. Parikh, “it’s most important to monitor how transmissible [BA 2.86] is, how severe it is, and if our current treatments and vaccines work.”
Dr. Mostafa said how well the new variants escape existing antibody protection should also be studied and watched closely.
What does this stage of the virus mutation tell us about where we are in the pandemic?
The history of the coronavirus over the past few years shows that variants with many changes evolve and can spread very quickly, Dr. Mostafa said. “Now that the virus is endemic, it is essential to monitor, update vaccinations if necessary, diagnose, treat, and implement infection control measures when necessary.”
With the limited data we have so far, experts seem to agree that while the variant’s makeup raises some red flags, it is too soon to jump to any conclusions about how easy it is to catch it and the ways it may change how the virus impacts those who contract it.
A version of this article first appeared on WebMD.com.
Ruxolitinib for vitiligo: Experts share experiences from first year
.
The Food and Drug Administration approved the cream formulation of ruxolitinib (Opzelura), a JAK inhibitor, for repigmentation of nonsegmental vitiligo in July 2022 for people aged 12 years and older.
Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, said that he likes to use ruxolitinib cream in combination with other treatments.
“In the real world with vitiligo patients, we’re oftentimes doing combinatorial therapy anyway. So phototherapy, specifically, narrow-band UVB, is something that we have a lot of clinical evidence for over the years, and it’s a modality that can combine with topical steroids and topical calcineurin inhibitors.”
He said trials to study combinations will yield better guidance on optimal use of ruxolitinib cream. “In general, vitiligo patients can really benefit from phototherapy,” he said in an interview. (Labeling recommends against combination with other JAK inhibitors, biologics, or potent immunosuppressants, such as azathioprine or cyclosporine.)
This first year has shown that ruxolitinib is an effective option, but counseling patients to expect slow improvement is important so that patients stick with it, he noted.
Documenting what treatments patients with vitiligo have used before is important, he said, as is counseling patients that ruxolitinib is approved only for use on up to 10% of a person’s body surface area. (Product labeling recommends that a thin layer be applied twice a day to affected areas up to 10% of body surface area.)
Ruxolitinib has brought a “louder voice” to vitiligo and has opened up options for patients with the disease, Dr. Chovatiya said. “Having the ability to topically treat people who have very extensive disease really gives us a lot more flexibility than we have had before.”
Good experiences with payers at safety-net hospital
Candrice R. Heath, MD, assistant professor of dermatology at Temple University, Philadelphia, said that real-world experience with topical ruxolitinib will be more evident after its been on the market for 18-24 months.
Dr. Heath said she, too, encourages use of narrow-band UVB phototherapy in conjunction with the treatment.
From an insurance reimbursement standpoint, she said that she is glad that there have been fewer hurdles in getting ruxolitinib to patients than she has experienced with other medications.
In her safety-net hospital, she told this news organization, she sees patients with many types of insurance, but most have Medicaid. “So, I’m always expecting the step therapies, denials, pushbacks, etc.,” she said. But the path has been smoother for ruxolitinib coverage, she noted.
Her colleagues are committed to documenting everything the patient has tried, she added, and that helps with prior authorization.
Dr. Heath said that pointing out to insurers that ruxolitinib is the only approved treatment for repigmentation helps facilitate coverage.
“The science is advancing, and I’m happy to be practicing during a time when we actually have something approved for vitiligo,” she said. But she pointed out that phototherapy often is not covered for vitiligo, “which is horrible, when it is readily approved for psoriasis and atopic dermatitis.”
To document progress, Dr. Heath said that she always takes photographs of her patients with vitiligo because “the pictures remind us how far we have come.”
Data spotlight success in adolescents
Data from two trials give a clinical picture of the drug’s safety and efficacy in younger patients.
Adolescents had particularly good results in the first year with ruxolitinib, according to pooled phase 3 data from TRuE-V1 and TRuE-V2, this news organization reported.
The findings, presented at the 25th World Congress of Dermatology in Singapore, indicate that more than half of the participants achieved at least a 50% improvement from baseline in the total Vitiligo Area Scoring Index (T-VASI50) at 52 weeks.
The percentages of young patients aged 12-17 years taking twice-daily ruxolitinib who achieved T-VASI 50 at weeks 12, 24, and 52 were 11.5%, 26.9%, and 57.7%, respectively. The corresponding percentages for all in the study population were 10.7%, 22.7%, and 44.4%, respectively.
At the meeting, the presenter, Julien Seneschal, MD, PhD, professor of dermatology and head of the vitiligo and pigmentary disorders clinic at the University of Bordeaux, France, said, “This suggests that younger patients can respond better to the treatment.” He noted, however, that there were few adolescents in the studies.
New excitement in the field
Daniel Gutierrez, MD, assistant professor of dermatology at New York University, said the treatment has brought new excitement to the field.
“Patients with vitiligo are very motivated to treat their disease,” he said, because it typically is on the face and other highly visual areas, which can affect their overall perception of self.
Previously, he noted in an interview, the only FDA-approved treatment was monobenzone, but that was for depigmentation rather than repigmentation.
Otherwise, treatments were being used off label, and patients were receiving compounded formulations that often weren’t covered by insurance and often had shorter shelf life.
He said that he still occasionally gets denials from payers who consider vitiligo a cosmetic condition.
“I’ve had more luck with insurance, at least in the New York State area.” He added that sometimes payers require use of a topical calcineurin inhibitor for about 12 weeks before they will cover ruxolitinib.
Dr. Gutierrez also recommends using phototherapy with topical ruxolitinib “because they work on slightly different pathways.”
When he starts patients on a new therapy such as ruxolitinib, he asks them to come back in 3 months, and often by then, progress is evident. Facial areas show the most response, he said, while hands and feet are less likely to show significant improvement.
He said that it’s important for physicians and patients to know that improvements can take weeks or months to be noticeable. “I tell patients not to give up,” he added.
Showing the patients pictures from the current appointment and comparing them with pictures from previous appointments can help them better understand their progress, he said.
Lead investigator adds observations
David Rosmarin, MD, chair of the department of dermatology at Indiana University, Indianapolis, was the lead investigator of the pivotal TruE-V1 and TruE-V2 trials for vitiligo. In that role, he has been treating vitiligo patients with topical ruxolitinib since 2015.
In an interview, he said that many patients “don’t hit their optimal results at 3 months, 6 months, even the year mark. With continued use, many can see continued benefit.”
Other patients, he said, don’t respond within the first 6 months but with continued use may eventually respond, he said.
“Unfortunately, we have no way of knowing, based on clinical characteristics or baseline demographics, whether a patient will be a delayed responder or not or an early responder,” Dr. Rosmarin added.
He provided several observations about people who have stopped taking the medication.
“When people stop,” he said, “some maintain their response, but some start to depigment again. Again, we have no way of predicting who will be in which category.”
He said that once patients have hit their desired response, he usually advises them to taper down to maybe twice a week or to stop treatment, but if they see any recurrence, they should start reusing the medicine.
“We have some patients who have gone 6 or 7 years now before they had a recurrence, but others may start to depigment again in 2 to 3 months,” Dr. Rosmarin said.
As for phototherapy, he said, the combination with topical ruxolitinib is being studied.
“We think the combination is synergistic and better than either alone, but we’re still waiting for data to prove that,” he said.
In his practice, he offers patients the option either to use just ruxolitinib cream or the combination early on. Many patients, because of convenience, say they’ll first try the cream to see if that works.
“The challenge with light [therapy] is that it can be very inconvenient,” he said. Patients have to live close to a phototherapy unit to receive therapy 2-3 times a week or have a phototherapy product in their home.
Next in the pipeline
Experts say the progress doesn’t stop with ruxolitinib cream. Current trials of several medications show there’s more to come for patients with vitiligo.
Dr. Chovatiya said that next up may be oral ritlecitinib (Litfulo), a JAK inhibitor that was approved for severe alopecia areata in June for people aged 12 years and older. Phase 2 results have been published for its use with vitiligo.
“This would be an oral medication that may be able to help people with much more extensive disease as far as vitiligo goes,” he said, adding that he expects approval for a vitiligo indication within a few years.
He pointed out that longer-term safety data will be available because it is already on the market for alopecia.
Upadacitinib (Rinvoq), an oral JAK inhibitor, is approved for atopic dermatitis but is being studied for vitiligo as well, he noted. “I’m very excited to see what that holds for patients as well,” Dr. Chovatiya said.
Dr. Gutierrez said that he is excited about oral JAK inhibitors but sees potential in finding new ways to transplant melanocytes into areas where there are none.
The pigmentation field has seen new energy since last year’s approval, he said, particularly among people of color.
“We have new options for vitiligo that were lacking compared with other conditions, such as atopic dermatitis and psoriasis,” he said. “Hopefully, there will be more promising breakthroughs.”
Dr. Rosmarin is the chief investigator for the pivotal trials that led to FDA approval of ruxolitinib. He disclosed ties with AbbVie, Abcuro, AltruBio, Amgen, Arena, Boehringer Ingelheim, Bristol-Meyers Squibb, Celgene, Concert, CSL Behring, Dermavant, Dermira, Galderma, Incyte, Janssen, Kyowa Kirin, Lilly, Merck, Novartis, Pfizer, Regeneron, Revolo Biotherapeutics, Sanofi, Sun Pharmaceuticals, UCB, and Viela Bio. Dr. Chovatiya disclosed ties with AbbVie, Arcutis, Arena, Argenx, Beiersdorf, Bristol-Myers Squibb, Dermavant, Eli Lilly, EPI Health, Incyte, LEO Pharma, L’Oréal, National Eczema Association, Pfizer, Regeneron, Sanofi, and UCB. Dr. Heath and Dr. Gutierrez report no relevant financial relationships.
A version of this article appeared on Medscape.com.
.
The Food and Drug Administration approved the cream formulation of ruxolitinib (Opzelura), a JAK inhibitor, for repigmentation of nonsegmental vitiligo in July 2022 for people aged 12 years and older.
Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, said that he likes to use ruxolitinib cream in combination with other treatments.
“In the real world with vitiligo patients, we’re oftentimes doing combinatorial therapy anyway. So phototherapy, specifically, narrow-band UVB, is something that we have a lot of clinical evidence for over the years, and it’s a modality that can combine with topical steroids and topical calcineurin inhibitors.”
He said trials to study combinations will yield better guidance on optimal use of ruxolitinib cream. “In general, vitiligo patients can really benefit from phototherapy,” he said in an interview. (Labeling recommends against combination with other JAK inhibitors, biologics, or potent immunosuppressants, such as azathioprine or cyclosporine.)
This first year has shown that ruxolitinib is an effective option, but counseling patients to expect slow improvement is important so that patients stick with it, he noted.
Documenting what treatments patients with vitiligo have used before is important, he said, as is counseling patients that ruxolitinib is approved only for use on up to 10% of a person’s body surface area. (Product labeling recommends that a thin layer be applied twice a day to affected areas up to 10% of body surface area.)
Ruxolitinib has brought a “louder voice” to vitiligo and has opened up options for patients with the disease, Dr. Chovatiya said. “Having the ability to topically treat people who have very extensive disease really gives us a lot more flexibility than we have had before.”
Good experiences with payers at safety-net hospital
Candrice R. Heath, MD, assistant professor of dermatology at Temple University, Philadelphia, said that real-world experience with topical ruxolitinib will be more evident after its been on the market for 18-24 months.
Dr. Heath said she, too, encourages use of narrow-band UVB phototherapy in conjunction with the treatment.
From an insurance reimbursement standpoint, she said that she is glad that there have been fewer hurdles in getting ruxolitinib to patients than she has experienced with other medications.
In her safety-net hospital, she told this news organization, she sees patients with many types of insurance, but most have Medicaid. “So, I’m always expecting the step therapies, denials, pushbacks, etc.,” she said. But the path has been smoother for ruxolitinib coverage, she noted.
Her colleagues are committed to documenting everything the patient has tried, she added, and that helps with prior authorization.
Dr. Heath said that pointing out to insurers that ruxolitinib is the only approved treatment for repigmentation helps facilitate coverage.
“The science is advancing, and I’m happy to be practicing during a time when we actually have something approved for vitiligo,” she said. But she pointed out that phototherapy often is not covered for vitiligo, “which is horrible, when it is readily approved for psoriasis and atopic dermatitis.”
To document progress, Dr. Heath said that she always takes photographs of her patients with vitiligo because “the pictures remind us how far we have come.”
Data spotlight success in adolescents
Data from two trials give a clinical picture of the drug’s safety and efficacy in younger patients.
Adolescents had particularly good results in the first year with ruxolitinib, according to pooled phase 3 data from TRuE-V1 and TRuE-V2, this news organization reported.
The findings, presented at the 25th World Congress of Dermatology in Singapore, indicate that more than half of the participants achieved at least a 50% improvement from baseline in the total Vitiligo Area Scoring Index (T-VASI50) at 52 weeks.
The percentages of young patients aged 12-17 years taking twice-daily ruxolitinib who achieved T-VASI 50 at weeks 12, 24, and 52 were 11.5%, 26.9%, and 57.7%, respectively. The corresponding percentages for all in the study population were 10.7%, 22.7%, and 44.4%, respectively.
At the meeting, the presenter, Julien Seneschal, MD, PhD, professor of dermatology and head of the vitiligo and pigmentary disorders clinic at the University of Bordeaux, France, said, “This suggests that younger patients can respond better to the treatment.” He noted, however, that there were few adolescents in the studies.
New excitement in the field
Daniel Gutierrez, MD, assistant professor of dermatology at New York University, said the treatment has brought new excitement to the field.
“Patients with vitiligo are very motivated to treat their disease,” he said, because it typically is on the face and other highly visual areas, which can affect their overall perception of self.
Previously, he noted in an interview, the only FDA-approved treatment was monobenzone, but that was for depigmentation rather than repigmentation.
Otherwise, treatments were being used off label, and patients were receiving compounded formulations that often weren’t covered by insurance and often had shorter shelf life.
He said that he still occasionally gets denials from payers who consider vitiligo a cosmetic condition.
“I’ve had more luck with insurance, at least in the New York State area.” He added that sometimes payers require use of a topical calcineurin inhibitor for about 12 weeks before they will cover ruxolitinib.
Dr. Gutierrez also recommends using phototherapy with topical ruxolitinib “because they work on slightly different pathways.”
When he starts patients on a new therapy such as ruxolitinib, he asks them to come back in 3 months, and often by then, progress is evident. Facial areas show the most response, he said, while hands and feet are less likely to show significant improvement.
He said that it’s important for physicians and patients to know that improvements can take weeks or months to be noticeable. “I tell patients not to give up,” he added.
Showing the patients pictures from the current appointment and comparing them with pictures from previous appointments can help them better understand their progress, he said.
Lead investigator adds observations
David Rosmarin, MD, chair of the department of dermatology at Indiana University, Indianapolis, was the lead investigator of the pivotal TruE-V1 and TruE-V2 trials for vitiligo. In that role, he has been treating vitiligo patients with topical ruxolitinib since 2015.
In an interview, he said that many patients “don’t hit their optimal results at 3 months, 6 months, even the year mark. With continued use, many can see continued benefit.”
Other patients, he said, don’t respond within the first 6 months but with continued use may eventually respond, he said.
“Unfortunately, we have no way of knowing, based on clinical characteristics or baseline demographics, whether a patient will be a delayed responder or not or an early responder,” Dr. Rosmarin added.
He provided several observations about people who have stopped taking the medication.
“When people stop,” he said, “some maintain their response, but some start to depigment again. Again, we have no way of predicting who will be in which category.”
He said that once patients have hit their desired response, he usually advises them to taper down to maybe twice a week or to stop treatment, but if they see any recurrence, they should start reusing the medicine.
“We have some patients who have gone 6 or 7 years now before they had a recurrence, but others may start to depigment again in 2 to 3 months,” Dr. Rosmarin said.
As for phototherapy, he said, the combination with topical ruxolitinib is being studied.
“We think the combination is synergistic and better than either alone, but we’re still waiting for data to prove that,” he said.
In his practice, he offers patients the option either to use just ruxolitinib cream or the combination early on. Many patients, because of convenience, say they’ll first try the cream to see if that works.
“The challenge with light [therapy] is that it can be very inconvenient,” he said. Patients have to live close to a phototherapy unit to receive therapy 2-3 times a week or have a phototherapy product in their home.
Next in the pipeline
Experts say the progress doesn’t stop with ruxolitinib cream. Current trials of several medications show there’s more to come for patients with vitiligo.
Dr. Chovatiya said that next up may be oral ritlecitinib (Litfulo), a JAK inhibitor that was approved for severe alopecia areata in June for people aged 12 years and older. Phase 2 results have been published for its use with vitiligo.
“This would be an oral medication that may be able to help people with much more extensive disease as far as vitiligo goes,” he said, adding that he expects approval for a vitiligo indication within a few years.
He pointed out that longer-term safety data will be available because it is already on the market for alopecia.
Upadacitinib (Rinvoq), an oral JAK inhibitor, is approved for atopic dermatitis but is being studied for vitiligo as well, he noted. “I’m very excited to see what that holds for patients as well,” Dr. Chovatiya said.
Dr. Gutierrez said that he is excited about oral JAK inhibitors but sees potential in finding new ways to transplant melanocytes into areas where there are none.
The pigmentation field has seen new energy since last year’s approval, he said, particularly among people of color.
“We have new options for vitiligo that were lacking compared with other conditions, such as atopic dermatitis and psoriasis,” he said. “Hopefully, there will be more promising breakthroughs.”
Dr. Rosmarin is the chief investigator for the pivotal trials that led to FDA approval of ruxolitinib. He disclosed ties with AbbVie, Abcuro, AltruBio, Amgen, Arena, Boehringer Ingelheim, Bristol-Meyers Squibb, Celgene, Concert, CSL Behring, Dermavant, Dermira, Galderma, Incyte, Janssen, Kyowa Kirin, Lilly, Merck, Novartis, Pfizer, Regeneron, Revolo Biotherapeutics, Sanofi, Sun Pharmaceuticals, UCB, and Viela Bio. Dr. Chovatiya disclosed ties with AbbVie, Arcutis, Arena, Argenx, Beiersdorf, Bristol-Myers Squibb, Dermavant, Eli Lilly, EPI Health, Incyte, LEO Pharma, L’Oréal, National Eczema Association, Pfizer, Regeneron, Sanofi, and UCB. Dr. Heath and Dr. Gutierrez report no relevant financial relationships.
A version of this article appeared on Medscape.com.
.
The Food and Drug Administration approved the cream formulation of ruxolitinib (Opzelura), a JAK inhibitor, for repigmentation of nonsegmental vitiligo in July 2022 for people aged 12 years and older.
Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, said that he likes to use ruxolitinib cream in combination with other treatments.
“In the real world with vitiligo patients, we’re oftentimes doing combinatorial therapy anyway. So phototherapy, specifically, narrow-band UVB, is something that we have a lot of clinical evidence for over the years, and it’s a modality that can combine with topical steroids and topical calcineurin inhibitors.”
He said trials to study combinations will yield better guidance on optimal use of ruxolitinib cream. “In general, vitiligo patients can really benefit from phototherapy,” he said in an interview. (Labeling recommends against combination with other JAK inhibitors, biologics, or potent immunosuppressants, such as azathioprine or cyclosporine.)
This first year has shown that ruxolitinib is an effective option, but counseling patients to expect slow improvement is important so that patients stick with it, he noted.
Documenting what treatments patients with vitiligo have used before is important, he said, as is counseling patients that ruxolitinib is approved only for use on up to 10% of a person’s body surface area. (Product labeling recommends that a thin layer be applied twice a day to affected areas up to 10% of body surface area.)
Ruxolitinib has brought a “louder voice” to vitiligo and has opened up options for patients with the disease, Dr. Chovatiya said. “Having the ability to topically treat people who have very extensive disease really gives us a lot more flexibility than we have had before.”
Good experiences with payers at safety-net hospital
Candrice R. Heath, MD, assistant professor of dermatology at Temple University, Philadelphia, said that real-world experience with topical ruxolitinib will be more evident after its been on the market for 18-24 months.
Dr. Heath said she, too, encourages use of narrow-band UVB phototherapy in conjunction with the treatment.
From an insurance reimbursement standpoint, she said that she is glad that there have been fewer hurdles in getting ruxolitinib to patients than she has experienced with other medications.
In her safety-net hospital, she told this news organization, she sees patients with many types of insurance, but most have Medicaid. “So, I’m always expecting the step therapies, denials, pushbacks, etc.,” she said. But the path has been smoother for ruxolitinib coverage, she noted.
Her colleagues are committed to documenting everything the patient has tried, she added, and that helps with prior authorization.
Dr. Heath said that pointing out to insurers that ruxolitinib is the only approved treatment for repigmentation helps facilitate coverage.
“The science is advancing, and I’m happy to be practicing during a time when we actually have something approved for vitiligo,” she said. But she pointed out that phototherapy often is not covered for vitiligo, “which is horrible, when it is readily approved for psoriasis and atopic dermatitis.”
To document progress, Dr. Heath said that she always takes photographs of her patients with vitiligo because “the pictures remind us how far we have come.”
Data spotlight success in adolescents
Data from two trials give a clinical picture of the drug’s safety and efficacy in younger patients.
Adolescents had particularly good results in the first year with ruxolitinib, according to pooled phase 3 data from TRuE-V1 and TRuE-V2, this news organization reported.
The findings, presented at the 25th World Congress of Dermatology in Singapore, indicate that more than half of the participants achieved at least a 50% improvement from baseline in the total Vitiligo Area Scoring Index (T-VASI50) at 52 weeks.
The percentages of young patients aged 12-17 years taking twice-daily ruxolitinib who achieved T-VASI 50 at weeks 12, 24, and 52 were 11.5%, 26.9%, and 57.7%, respectively. The corresponding percentages for all in the study population were 10.7%, 22.7%, and 44.4%, respectively.
At the meeting, the presenter, Julien Seneschal, MD, PhD, professor of dermatology and head of the vitiligo and pigmentary disorders clinic at the University of Bordeaux, France, said, “This suggests that younger patients can respond better to the treatment.” He noted, however, that there were few adolescents in the studies.
New excitement in the field
Daniel Gutierrez, MD, assistant professor of dermatology at New York University, said the treatment has brought new excitement to the field.
“Patients with vitiligo are very motivated to treat their disease,” he said, because it typically is on the face and other highly visual areas, which can affect their overall perception of self.
Previously, he noted in an interview, the only FDA-approved treatment was monobenzone, but that was for depigmentation rather than repigmentation.
Otherwise, treatments were being used off label, and patients were receiving compounded formulations that often weren’t covered by insurance and often had shorter shelf life.
He said that he still occasionally gets denials from payers who consider vitiligo a cosmetic condition.
“I’ve had more luck with insurance, at least in the New York State area.” He added that sometimes payers require use of a topical calcineurin inhibitor for about 12 weeks before they will cover ruxolitinib.
Dr. Gutierrez also recommends using phototherapy with topical ruxolitinib “because they work on slightly different pathways.”
When he starts patients on a new therapy such as ruxolitinib, he asks them to come back in 3 months, and often by then, progress is evident. Facial areas show the most response, he said, while hands and feet are less likely to show significant improvement.
He said that it’s important for physicians and patients to know that improvements can take weeks or months to be noticeable. “I tell patients not to give up,” he added.
Showing the patients pictures from the current appointment and comparing them with pictures from previous appointments can help them better understand their progress, he said.
Lead investigator adds observations
David Rosmarin, MD, chair of the department of dermatology at Indiana University, Indianapolis, was the lead investigator of the pivotal TruE-V1 and TruE-V2 trials for vitiligo. In that role, he has been treating vitiligo patients with topical ruxolitinib since 2015.
In an interview, he said that many patients “don’t hit their optimal results at 3 months, 6 months, even the year mark. With continued use, many can see continued benefit.”
Other patients, he said, don’t respond within the first 6 months but with continued use may eventually respond, he said.
“Unfortunately, we have no way of knowing, based on clinical characteristics or baseline demographics, whether a patient will be a delayed responder or not or an early responder,” Dr. Rosmarin added.
He provided several observations about people who have stopped taking the medication.
“When people stop,” he said, “some maintain their response, but some start to depigment again. Again, we have no way of predicting who will be in which category.”
He said that once patients have hit their desired response, he usually advises them to taper down to maybe twice a week or to stop treatment, but if they see any recurrence, they should start reusing the medicine.
“We have some patients who have gone 6 or 7 years now before they had a recurrence, but others may start to depigment again in 2 to 3 months,” Dr. Rosmarin said.
As for phototherapy, he said, the combination with topical ruxolitinib is being studied.
“We think the combination is synergistic and better than either alone, but we’re still waiting for data to prove that,” he said.
In his practice, he offers patients the option either to use just ruxolitinib cream or the combination early on. Many patients, because of convenience, say they’ll first try the cream to see if that works.
“The challenge with light [therapy] is that it can be very inconvenient,” he said. Patients have to live close to a phototherapy unit to receive therapy 2-3 times a week or have a phototherapy product in their home.
Next in the pipeline
Experts say the progress doesn’t stop with ruxolitinib cream. Current trials of several medications show there’s more to come for patients with vitiligo.
Dr. Chovatiya said that next up may be oral ritlecitinib (Litfulo), a JAK inhibitor that was approved for severe alopecia areata in June for people aged 12 years and older. Phase 2 results have been published for its use with vitiligo.
“This would be an oral medication that may be able to help people with much more extensive disease as far as vitiligo goes,” he said, adding that he expects approval for a vitiligo indication within a few years.
He pointed out that longer-term safety data will be available because it is already on the market for alopecia.
Upadacitinib (Rinvoq), an oral JAK inhibitor, is approved for atopic dermatitis but is being studied for vitiligo as well, he noted. “I’m very excited to see what that holds for patients as well,” Dr. Chovatiya said.
Dr. Gutierrez said that he is excited about oral JAK inhibitors but sees potential in finding new ways to transplant melanocytes into areas where there are none.
The pigmentation field has seen new energy since last year’s approval, he said, particularly among people of color.
“We have new options for vitiligo that were lacking compared with other conditions, such as atopic dermatitis and psoriasis,” he said. “Hopefully, there will be more promising breakthroughs.”
Dr. Rosmarin is the chief investigator for the pivotal trials that led to FDA approval of ruxolitinib. He disclosed ties with AbbVie, Abcuro, AltruBio, Amgen, Arena, Boehringer Ingelheim, Bristol-Meyers Squibb, Celgene, Concert, CSL Behring, Dermavant, Dermira, Galderma, Incyte, Janssen, Kyowa Kirin, Lilly, Merck, Novartis, Pfizer, Regeneron, Revolo Biotherapeutics, Sanofi, Sun Pharmaceuticals, UCB, and Viela Bio. Dr. Chovatiya disclosed ties with AbbVie, Arcutis, Arena, Argenx, Beiersdorf, Bristol-Myers Squibb, Dermavant, Eli Lilly, EPI Health, Incyte, LEO Pharma, L’Oréal, National Eczema Association, Pfizer, Regeneron, Sanofi, and UCB. Dr. Heath and Dr. Gutierrez report no relevant financial relationships.
A version of this article appeared on Medscape.com.
NPs, PAs, and physicians hope to join doctors’ union in rare alliance
Advanced practice providers (APPs) such as nurse practitioners (NPs) and physician assistants (PAs) have long been at odds with doctor groups over scope of practice issues. But in a rare alliance, in late September. If successful, the Allina group will join the Doctors Council SEIU, Local 10MD.
The Allina health care providers share concerns about their working conditions, such as understaffing and inadequate resources, limited decision-making authority, and health systems valuing productivity and profit over patient care.
Although doctors and APPs have said that they generally work well together, the relationship has been strained in recent years as APPs argue for greater scope of practice. Meanwhile, physician groups, such as the American Medical Association, believe that APPs need more oversight.
An Allina union organizer, Britta V. Kasmarik, CNP, acknowledges the tension between physicians and APPs. But she said in an interview that the union effort helped bond this group of health care providers. “We share common goals of providing high-quality care for patients in a safe way, and we see the same things day in and day out with our patients.”
Matt Hoffman, MD, a primary care physician at Allina, told this news organization that APPs in his specialty perform the same job as doctors “and the working conditions are really identical. In our view, that means we should be unionizing together.”
The decision to hold a union vote follows similar action by nearly 150 Allina Mercy Hospital physicians in March. Allina Health appealed the vote.
In response to a New York Times investigation, the Minnesota Attorney General’s office began reviewing reports of aggressive billing practices and denied care at Allina Health.
The Allina Health system, which reports $4 billion in annual revenue, cut off nonemergency services to patients, including children, if their medical debt exceeded $4,500, according to the New York Times article. For Allina’s physicians and APPs, that meant leaving patients’ illnesses untreated.
Less than a week after the attorney general announced its investigation, the health system ended this practice.
In a prepared statement to this news organization, Allina Health said that its providers are “critical members of our teams. … We deeply value and share their commitment to providing high-quality care to our patients.”
The health system said it planned to make operational improvements, implement new communication tools, and provide additional well-being resources and enhanced employee benefits “to improve the provider experience.” In addition, it hoped to continue to “foster a culture of collaboration with all our employees.”
Having a union will allow health care providers to advocate for their patients and give health care providers more decision-making power instead of corporate leaders maintaining full authority, Ms. Kasmarik told this news organization.
Union organizers are also concerned with changes to the daily practice of medicine. “We don’t want to be spending our time doing paperwork and calling insurance companies and filling out forms,” said Dr. Hoffman. “We want to be in the exam room with a patient.”
The Allina providers organized after multiple requests to corporate managers failed to address their concerns. Their demands include increased staffing and help with nonclinical work so that clinicians can spend more time with their patients.
“What I’m really excited about is that we will be able to work with the other unionized groups to make change ... by being involved in health care policy at a state or national level,” Dr. Hoffman said. For example, that involvement might include challenging insurance company decisions.
Doctors Council bills itself as the largest union for attending physicians in the country, with 3,500 members, according to Joe Crane, national organizing director.
Despite an increase in union efforts since the pandemic, health care workers – particularly doctors – have been slow to join unions. Mr. Crane estimated that only about 3% of U.S. physicians are currently union members. He cited union campaigns in Massachusetts, New York, and Washington, DC. For comparison, a minority of advanced practice registered nurses (APRNs) (9%) report union membership, according to Medscape’s APRN compensation report last year.
Dr. Hoffman is confident the Allina health care providers will have enough votes to win the election to join the union. “We should have done this years ago.”
A version of this article appeared on Medscape.com.
Advanced practice providers (APPs) such as nurse practitioners (NPs) and physician assistants (PAs) have long been at odds with doctor groups over scope of practice issues. But in a rare alliance, in late September. If successful, the Allina group will join the Doctors Council SEIU, Local 10MD.
The Allina health care providers share concerns about their working conditions, such as understaffing and inadequate resources, limited decision-making authority, and health systems valuing productivity and profit over patient care.
Although doctors and APPs have said that they generally work well together, the relationship has been strained in recent years as APPs argue for greater scope of practice. Meanwhile, physician groups, such as the American Medical Association, believe that APPs need more oversight.
An Allina union organizer, Britta V. Kasmarik, CNP, acknowledges the tension between physicians and APPs. But she said in an interview that the union effort helped bond this group of health care providers. “We share common goals of providing high-quality care for patients in a safe way, and we see the same things day in and day out with our patients.”
Matt Hoffman, MD, a primary care physician at Allina, told this news organization that APPs in his specialty perform the same job as doctors “and the working conditions are really identical. In our view, that means we should be unionizing together.”
The decision to hold a union vote follows similar action by nearly 150 Allina Mercy Hospital physicians in March. Allina Health appealed the vote.
In response to a New York Times investigation, the Minnesota Attorney General’s office began reviewing reports of aggressive billing practices and denied care at Allina Health.
The Allina Health system, which reports $4 billion in annual revenue, cut off nonemergency services to patients, including children, if their medical debt exceeded $4,500, according to the New York Times article. For Allina’s physicians and APPs, that meant leaving patients’ illnesses untreated.
Less than a week after the attorney general announced its investigation, the health system ended this practice.
In a prepared statement to this news organization, Allina Health said that its providers are “critical members of our teams. … We deeply value and share their commitment to providing high-quality care to our patients.”
The health system said it planned to make operational improvements, implement new communication tools, and provide additional well-being resources and enhanced employee benefits “to improve the provider experience.” In addition, it hoped to continue to “foster a culture of collaboration with all our employees.”
Having a union will allow health care providers to advocate for their patients and give health care providers more decision-making power instead of corporate leaders maintaining full authority, Ms. Kasmarik told this news organization.
Union organizers are also concerned with changes to the daily practice of medicine. “We don’t want to be spending our time doing paperwork and calling insurance companies and filling out forms,” said Dr. Hoffman. “We want to be in the exam room with a patient.”
The Allina providers organized after multiple requests to corporate managers failed to address their concerns. Their demands include increased staffing and help with nonclinical work so that clinicians can spend more time with their patients.
“What I’m really excited about is that we will be able to work with the other unionized groups to make change ... by being involved in health care policy at a state or national level,” Dr. Hoffman said. For example, that involvement might include challenging insurance company decisions.
Doctors Council bills itself as the largest union for attending physicians in the country, with 3,500 members, according to Joe Crane, national organizing director.
Despite an increase in union efforts since the pandemic, health care workers – particularly doctors – have been slow to join unions. Mr. Crane estimated that only about 3% of U.S. physicians are currently union members. He cited union campaigns in Massachusetts, New York, and Washington, DC. For comparison, a minority of advanced practice registered nurses (APRNs) (9%) report union membership, according to Medscape’s APRN compensation report last year.
Dr. Hoffman is confident the Allina health care providers will have enough votes to win the election to join the union. “We should have done this years ago.”
A version of this article appeared on Medscape.com.
Advanced practice providers (APPs) such as nurse practitioners (NPs) and physician assistants (PAs) have long been at odds with doctor groups over scope of practice issues. But in a rare alliance, in late September. If successful, the Allina group will join the Doctors Council SEIU, Local 10MD.
The Allina health care providers share concerns about their working conditions, such as understaffing and inadequate resources, limited decision-making authority, and health systems valuing productivity and profit over patient care.
Although doctors and APPs have said that they generally work well together, the relationship has been strained in recent years as APPs argue for greater scope of practice. Meanwhile, physician groups, such as the American Medical Association, believe that APPs need more oversight.
An Allina union organizer, Britta V. Kasmarik, CNP, acknowledges the tension between physicians and APPs. But she said in an interview that the union effort helped bond this group of health care providers. “We share common goals of providing high-quality care for patients in a safe way, and we see the same things day in and day out with our patients.”
Matt Hoffman, MD, a primary care physician at Allina, told this news organization that APPs in his specialty perform the same job as doctors “and the working conditions are really identical. In our view, that means we should be unionizing together.”
The decision to hold a union vote follows similar action by nearly 150 Allina Mercy Hospital physicians in March. Allina Health appealed the vote.
In response to a New York Times investigation, the Minnesota Attorney General’s office began reviewing reports of aggressive billing practices and denied care at Allina Health.
The Allina Health system, which reports $4 billion in annual revenue, cut off nonemergency services to patients, including children, if their medical debt exceeded $4,500, according to the New York Times article. For Allina’s physicians and APPs, that meant leaving patients’ illnesses untreated.
Less than a week after the attorney general announced its investigation, the health system ended this practice.
In a prepared statement to this news organization, Allina Health said that its providers are “critical members of our teams. … We deeply value and share their commitment to providing high-quality care to our patients.”
The health system said it planned to make operational improvements, implement new communication tools, and provide additional well-being resources and enhanced employee benefits “to improve the provider experience.” In addition, it hoped to continue to “foster a culture of collaboration with all our employees.”
Having a union will allow health care providers to advocate for their patients and give health care providers more decision-making power instead of corporate leaders maintaining full authority, Ms. Kasmarik told this news organization.
Union organizers are also concerned with changes to the daily practice of medicine. “We don’t want to be spending our time doing paperwork and calling insurance companies and filling out forms,” said Dr. Hoffman. “We want to be in the exam room with a patient.”
The Allina providers organized after multiple requests to corporate managers failed to address their concerns. Their demands include increased staffing and help with nonclinical work so that clinicians can spend more time with their patients.
“What I’m really excited about is that we will be able to work with the other unionized groups to make change ... by being involved in health care policy at a state or national level,” Dr. Hoffman said. For example, that involvement might include challenging insurance company decisions.
Doctors Council bills itself as the largest union for attending physicians in the country, with 3,500 members, according to Joe Crane, national organizing director.
Despite an increase in union efforts since the pandemic, health care workers – particularly doctors – have been slow to join unions. Mr. Crane estimated that only about 3% of U.S. physicians are currently union members. He cited union campaigns in Massachusetts, New York, and Washington, DC. For comparison, a minority of advanced practice registered nurses (APRNs) (9%) report union membership, according to Medscape’s APRN compensation report last year.
Dr. Hoffman is confident the Allina health care providers will have enough votes to win the election to join the union. “We should have done this years ago.”
A version of this article appeared on Medscape.com.
One in five men carries high-risk HPV in international study
Findings from a meta-analysis of 65 studies conducted in 35 countries indicate that These estimates provide further weight to arguments in favor of vaccinating boys against HPV to prevent certain types of cancer.
“Our results support that sexually active men, regardless of age, are an important reservoir of HPV genital infection,” wrote the authors in The Lancet Global Health . “These estimates emphasize the importance of incorporating men into comprehensive HPV prevention strategies to reduce HPV-related morbidity and mortality in men and ultimately achieve elimination of cervical cancer and other HPV-related diseases.”
Literature review
HPV infection is the most common sexually transmitted viral infection worldwide. More than 200 HPV types can be transmitted sexually, and at least 12 types are oncogenic. Previous studies have shown that most sexually active men and women acquire at least one genital HPV infection during their lifetime.
Although most HPV infections are asymptomatic, they can lead to cancer. Indeed, HPV is involved in the development of cervical, vulval, and vaginal cancers, as well as oropharyngeal and anal cancers, which also affect the male population. More than 25% of cancers caused by HPV occur in men.
Despite these observations, fewer epidemiologic studies have assessed HPV infection in men than in women. To determine the prevalence of HPV infection in the male population, Laia Bruni, MD, MPH, PhD, an epidemiologist at the Catalan Institute of Oncology in Barcelona, and her colleagues collated data from 65 studies conducted in 35 countries pertaining to males older than 15 years.
In this literature review, the researchers selected studies that reported infection rates in males without HPV-related symptoms. Studies conducted exclusively in populations that were considered at increased risk for sexually transmitted infections (STIs) were excluded. Overall, the analysis included close to 45,000 men.
Prevalent HPV genotype
Testing for HPV was conducted on samples collected from the anus and genitals. The results show a global pooled prevalence of HPV infection in males older than 15 years of 31% for any HPV and 21% for HR-HPV. One of these viruses, HPV-16, was the most prevalent HPV genotype (5% prevalence).
HPV prevalence was highest among young adults. It stabilized and decreased from age 50 years. Between ages 25 and 29 years, 35% of men are infected with HPV. It should be noted that prevalence is already high in the youngest group, reaching 28% in males between the ages of 15 and 19 years. The variations are similar for HR-HPV infections.
This age-related change is different from rates in women. Among the female population, HPV prevalence peaks soon after first sexual activity and declines with age, with a slight rebound after ages 50–55 years (i.e., often after or around the time of menopause), wrote the researchers.
The results also show country- and region-based disparities. The pooled prevalence for any HPV was highest in Sub-Saharan Africa (37%), followed by Europe and Northern America (36%). The lowest prevalence was in East and Southeast Asia (15%). Here again, the trends are similar with high-risk HPV.
Preventive measures
“Our study draws attention to the high prevalence, ranging from 20% to 30% for HR-HPV in men across most regions, and the need for strengthening HPV prevention within overall STI control efforts,” wrote the authors.
“Future epidemiological studies are needed to monitor trends in prevalence in men, especially considering the roll-out of HPV vaccination in girls and young women and that many countries are beginning to vaccinate boys.”
In France, the HPV vaccination program was extended in 2021 to include all boys between the ages of 11 and 14 years (two-dose schedule), with a catch-up course in males up to age 19 years (three-dose schedule). This is the same vaccine program as for girls. It is also recommended for men up to age 26 years who have sex with other men.
The 2023 return to school will see the launch of a general vaccination campaign aimed at seventh-grade students, both boys and girls, with parental consent, to increase vaccine coverage. In 2021, vaccine uptake was 43.6% in girls between the ages of 15 and 18 years and scarcely 6% in boys, according to Public Health France.
Two vaccines are in use: the bivalent Cervarix vaccine, which is effective against HPV-16 and HPV-18, and the nonavalent Gardasil 9, which is effective against types 16, 18, 31, 33, 45, 52, and 58. Both provide protection against HPV-16, the type most common in men, which is responsible for more than half of cases of cervical cancer.
This article was translated from the Medscape French Edition. A version appeared on Medscape.com.
Findings from a meta-analysis of 65 studies conducted in 35 countries indicate that These estimates provide further weight to arguments in favor of vaccinating boys against HPV to prevent certain types of cancer.
“Our results support that sexually active men, regardless of age, are an important reservoir of HPV genital infection,” wrote the authors in The Lancet Global Health . “These estimates emphasize the importance of incorporating men into comprehensive HPV prevention strategies to reduce HPV-related morbidity and mortality in men and ultimately achieve elimination of cervical cancer and other HPV-related diseases.”
Literature review
HPV infection is the most common sexually transmitted viral infection worldwide. More than 200 HPV types can be transmitted sexually, and at least 12 types are oncogenic. Previous studies have shown that most sexually active men and women acquire at least one genital HPV infection during their lifetime.
Although most HPV infections are asymptomatic, they can lead to cancer. Indeed, HPV is involved in the development of cervical, vulval, and vaginal cancers, as well as oropharyngeal and anal cancers, which also affect the male population. More than 25% of cancers caused by HPV occur in men.
Despite these observations, fewer epidemiologic studies have assessed HPV infection in men than in women. To determine the prevalence of HPV infection in the male population, Laia Bruni, MD, MPH, PhD, an epidemiologist at the Catalan Institute of Oncology in Barcelona, and her colleagues collated data from 65 studies conducted in 35 countries pertaining to males older than 15 years.
In this literature review, the researchers selected studies that reported infection rates in males without HPV-related symptoms. Studies conducted exclusively in populations that were considered at increased risk for sexually transmitted infections (STIs) were excluded. Overall, the analysis included close to 45,000 men.
Prevalent HPV genotype
Testing for HPV was conducted on samples collected from the anus and genitals. The results show a global pooled prevalence of HPV infection in males older than 15 years of 31% for any HPV and 21% for HR-HPV. One of these viruses, HPV-16, was the most prevalent HPV genotype (5% prevalence).
HPV prevalence was highest among young adults. It stabilized and decreased from age 50 years. Between ages 25 and 29 years, 35% of men are infected with HPV. It should be noted that prevalence is already high in the youngest group, reaching 28% in males between the ages of 15 and 19 years. The variations are similar for HR-HPV infections.
This age-related change is different from rates in women. Among the female population, HPV prevalence peaks soon after first sexual activity and declines with age, with a slight rebound after ages 50–55 years (i.e., often after or around the time of menopause), wrote the researchers.
The results also show country- and region-based disparities. The pooled prevalence for any HPV was highest in Sub-Saharan Africa (37%), followed by Europe and Northern America (36%). The lowest prevalence was in East and Southeast Asia (15%). Here again, the trends are similar with high-risk HPV.
Preventive measures
“Our study draws attention to the high prevalence, ranging from 20% to 30% for HR-HPV in men across most regions, and the need for strengthening HPV prevention within overall STI control efforts,” wrote the authors.
“Future epidemiological studies are needed to monitor trends in prevalence in men, especially considering the roll-out of HPV vaccination in girls and young women and that many countries are beginning to vaccinate boys.”
In France, the HPV vaccination program was extended in 2021 to include all boys between the ages of 11 and 14 years (two-dose schedule), with a catch-up course in males up to age 19 years (three-dose schedule). This is the same vaccine program as for girls. It is also recommended for men up to age 26 years who have sex with other men.
The 2023 return to school will see the launch of a general vaccination campaign aimed at seventh-grade students, both boys and girls, with parental consent, to increase vaccine coverage. In 2021, vaccine uptake was 43.6% in girls between the ages of 15 and 18 years and scarcely 6% in boys, according to Public Health France.
Two vaccines are in use: the bivalent Cervarix vaccine, which is effective against HPV-16 and HPV-18, and the nonavalent Gardasil 9, which is effective against types 16, 18, 31, 33, 45, 52, and 58. Both provide protection against HPV-16, the type most common in men, which is responsible for more than half of cases of cervical cancer.
This article was translated from the Medscape French Edition. A version appeared on Medscape.com.
Findings from a meta-analysis of 65 studies conducted in 35 countries indicate that These estimates provide further weight to arguments in favor of vaccinating boys against HPV to prevent certain types of cancer.
“Our results support that sexually active men, regardless of age, are an important reservoir of HPV genital infection,” wrote the authors in The Lancet Global Health . “These estimates emphasize the importance of incorporating men into comprehensive HPV prevention strategies to reduce HPV-related morbidity and mortality in men and ultimately achieve elimination of cervical cancer and other HPV-related diseases.”
Literature review
HPV infection is the most common sexually transmitted viral infection worldwide. More than 200 HPV types can be transmitted sexually, and at least 12 types are oncogenic. Previous studies have shown that most sexually active men and women acquire at least one genital HPV infection during their lifetime.
Although most HPV infections are asymptomatic, they can lead to cancer. Indeed, HPV is involved in the development of cervical, vulval, and vaginal cancers, as well as oropharyngeal and anal cancers, which also affect the male population. More than 25% of cancers caused by HPV occur in men.
Despite these observations, fewer epidemiologic studies have assessed HPV infection in men than in women. To determine the prevalence of HPV infection in the male population, Laia Bruni, MD, MPH, PhD, an epidemiologist at the Catalan Institute of Oncology in Barcelona, and her colleagues collated data from 65 studies conducted in 35 countries pertaining to males older than 15 years.
In this literature review, the researchers selected studies that reported infection rates in males without HPV-related symptoms. Studies conducted exclusively in populations that were considered at increased risk for sexually transmitted infections (STIs) were excluded. Overall, the analysis included close to 45,000 men.
Prevalent HPV genotype
Testing for HPV was conducted on samples collected from the anus and genitals. The results show a global pooled prevalence of HPV infection in males older than 15 years of 31% for any HPV and 21% for HR-HPV. One of these viruses, HPV-16, was the most prevalent HPV genotype (5% prevalence).
HPV prevalence was highest among young adults. It stabilized and decreased from age 50 years. Between ages 25 and 29 years, 35% of men are infected with HPV. It should be noted that prevalence is already high in the youngest group, reaching 28% in males between the ages of 15 and 19 years. The variations are similar for HR-HPV infections.
This age-related change is different from rates in women. Among the female population, HPV prevalence peaks soon after first sexual activity and declines with age, with a slight rebound after ages 50–55 years (i.e., often after or around the time of menopause), wrote the researchers.
The results also show country- and region-based disparities. The pooled prevalence for any HPV was highest in Sub-Saharan Africa (37%), followed by Europe and Northern America (36%). The lowest prevalence was in East and Southeast Asia (15%). Here again, the trends are similar with high-risk HPV.
Preventive measures
“Our study draws attention to the high prevalence, ranging from 20% to 30% for HR-HPV in men across most regions, and the need for strengthening HPV prevention within overall STI control efforts,” wrote the authors.
“Future epidemiological studies are needed to monitor trends in prevalence in men, especially considering the roll-out of HPV vaccination in girls and young women and that many countries are beginning to vaccinate boys.”
In France, the HPV vaccination program was extended in 2021 to include all boys between the ages of 11 and 14 years (two-dose schedule), with a catch-up course in males up to age 19 years (three-dose schedule). This is the same vaccine program as for girls. It is also recommended for men up to age 26 years who have sex with other men.
The 2023 return to school will see the launch of a general vaccination campaign aimed at seventh-grade students, both boys and girls, with parental consent, to increase vaccine coverage. In 2021, vaccine uptake was 43.6% in girls between the ages of 15 and 18 years and scarcely 6% in boys, according to Public Health France.
Two vaccines are in use: the bivalent Cervarix vaccine, which is effective against HPV-16 and HPV-18, and the nonavalent Gardasil 9, which is effective against types 16, 18, 31, 33, 45, 52, and 58. Both provide protection against HPV-16, the type most common in men, which is responsible for more than half of cases of cervical cancer.
This article was translated from the Medscape French Edition. A version appeared on Medscape.com.
FROM THE LANCET GLOBAL HEALTH
FDA to step up oversight of cosmetics, assess ‘forever chemicals’
They are also preparing to assess potential risks of so-called forever chemicals in these products.
The Food and Drug Administration last year gained new authority over cosmetics when Congress passed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by adding this bill to a December budget package.
“On average, consumers in the U.S. use six to 12 cosmetics products daily. But, until recently the FDA didn’t have the authority to require manufacturers to submit cosmetic product listings, including a list of ingredients used in these products, or register the facilities where they were produced,” Namandjé Bumpus, PhD, FDA’s chief scientist, said in a press release.
In the statement, the FDA announced the release of a draft guidance document that is intended to help companies comply with the transparency requirements slated to kick in this December. The agency is accepting comments on this draft guidance through Sept. 7.
“Later this year, registration and listing of cosmetic product facilities and products will become a requirement, making information about cosmetic products, including the ingredients used in products and the facilities where they are produced, readily available to the agency,” Dr. Bumpus said.
The products, according to the FDA statement, include makeup, nail polishes, shaving creams, other grooming products, perfumes, face and body cleansers, hair products, moisturizers, and other skin care items.
MoCRA “represents a sea change in how FDA regulates the cosmetics industry,” attorneys Frederick R. Ball, Alyson Walker Lotman, and Kelly A. Bonner, wrote in an article for the Food and Drug Law Institute published in spring 2023.
The FDA has called the MoCRA law “the most significant expansion” of its authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938.
The agency is in the process of expanding its staff to carry out newly authorized duties, including the tracking of adverse events. The FDA budget request for fiscal 2024, which begins Oct. 1, seeks $5 million for work needed to implement MoCRA.
PFAS, or ‘forever chemicals’
Some of the requested FDA funding is intended to prepare the agency to assess the use of per-and polyfluoroalkyl substances (PFAS) in cosmetics.
MoCRA sets a 3-year deadline for the FDA to issue an assessment of the use and potential risks of PFAS in cosmetics products. PFAS are sometimes added as ingredients in some cosmetic products, including lotions, cleansers, nail polish, shaving cream, foundation, lipstick, eyeliner, eyeshadow, and mascara, according to the FDA. Sometimes the presence of PFAS in cosmetics is unintentional and is the result of impurities in raw materials or is due to the breakdown of ingredients, the FDA said.
The FDA’s website says that so far, the available research doesn’t allow for “definitive conclusions about the potential health risks of PFAS in cosmetics.”
The Centers for Disease Control and Prevention has stated that research has suggested potential links between high levels of certain PFAS, in general, with increased cholesterol levels, changes in liver enzyme levels, increased risk of hypertension or preeclampsia in pregnant women, and increased risk of kidney or testicular cancer.
PFAS compounds often are used to resist grease, oil, water, and heat in industrial settings. They are used in thousands of products, from nonstick cookware to firefighting foams and protective gear, because they can reduce friction, according to a National Academies of Sciences, Engineering, and Medicine report on PFAS that was issued last year.
PFAS are known as “forever chemicals” because they contain a carbon-fluorine bond, which does not break naturally. Even when PFAS are transformed in the body, they can assume other forms of PFAS that preserve the troublesome carbon-fluorine bond. With PFAS, the human body is confronted with a substance it doesn’t have the tools to process.
This is in contrast to proteins and carbohydrates, which are in a sense prepackaged for relatively easy disassembly in the human body. Many of these compounds have weak links that enzymes and stomach acid can take apart, such as sulfur-to-sulfur (disulfide) bonds. That’s why protein-based biotech drugs are injected instead of administered as pills. The ultimate goal of this digestion is for the body to gain energy from these compounds.
But with PFAS, the body faces the challenge of carbon-fluorine bonds that are very hard to break down, and there is no payoff for these efforts, Graham F. Peaslee, PhD, professor of physics at the University of Notre Dame (Indiana), told this news organization.
“Nothing will naturally eat it because when you break the bond, it’s like eating celery,” he said. “You use more calories to eat the celery than you gain back from it.”
Interest from a U.S. senator
Dr. Peaslee was one of the authors of a 2021 article about PFAS in cosmetics that appeared in the journal Environmental Science and Technology Letters.
In the article, Dr. Peaslee and colleagues reported on their screening of 231 cosmetic products purchased in the United States and Canada using particle-induced gamma-ray emission spectroscopy. They found cases of undisclosed PFAS in cosmetic products. Foundations, mascaras, and lip products were noted as being especially problematic.
Sen. Susan Collins (R-ME) cited Dr. Peaslee’s article in a 2021 floor speech as she argued for having the FDA ban the intentional addition of PFAS to cosmetics.
“The findings of this study are particularly alarming, as many of these products are subject to direct human exposure,” Sen. Collins said. “For example, lipstick is often inadvertently ingested, and mascara is sometimes absorbed through tear ducts.”
In addition, workers at cosmetics plants may be exposed to PFAS and discarded cosmetics that have these compounds, which could potentially contaminate drinking water, Sen. Collins said. In 2021, she introduced legislation seeking a ban on PFAS that are intentionally added to cosmetics. That legislation did not advance through the Senate.
But the Senate Appropriations Committee, on which Sen. Collins is the ranking Republican, wants the FDA to keep a ban on PFAS in mind.
The Senate Agriculture Appropriations subcommittee, which oversees the FDA’s budget, raised the issue of PFAS and cosmetics in a June report. The FDA should develop a plan outlining research needed to inform “regulatory decision making, including potential development of a proposed rule to ban intentionally added PFAS substances in cosmetics,” the subcommittee said.
A version of this article first appeared on Medscape.com.
They are also preparing to assess potential risks of so-called forever chemicals in these products.
The Food and Drug Administration last year gained new authority over cosmetics when Congress passed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by adding this bill to a December budget package.
“On average, consumers in the U.S. use six to 12 cosmetics products daily. But, until recently the FDA didn’t have the authority to require manufacturers to submit cosmetic product listings, including a list of ingredients used in these products, or register the facilities where they were produced,” Namandjé Bumpus, PhD, FDA’s chief scientist, said in a press release.
In the statement, the FDA announced the release of a draft guidance document that is intended to help companies comply with the transparency requirements slated to kick in this December. The agency is accepting comments on this draft guidance through Sept. 7.
“Later this year, registration and listing of cosmetic product facilities and products will become a requirement, making information about cosmetic products, including the ingredients used in products and the facilities where they are produced, readily available to the agency,” Dr. Bumpus said.
The products, according to the FDA statement, include makeup, nail polishes, shaving creams, other grooming products, perfumes, face and body cleansers, hair products, moisturizers, and other skin care items.
MoCRA “represents a sea change in how FDA regulates the cosmetics industry,” attorneys Frederick R. Ball, Alyson Walker Lotman, and Kelly A. Bonner, wrote in an article for the Food and Drug Law Institute published in spring 2023.
The FDA has called the MoCRA law “the most significant expansion” of its authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938.
The agency is in the process of expanding its staff to carry out newly authorized duties, including the tracking of adverse events. The FDA budget request for fiscal 2024, which begins Oct. 1, seeks $5 million for work needed to implement MoCRA.
PFAS, or ‘forever chemicals’
Some of the requested FDA funding is intended to prepare the agency to assess the use of per-and polyfluoroalkyl substances (PFAS) in cosmetics.
MoCRA sets a 3-year deadline for the FDA to issue an assessment of the use and potential risks of PFAS in cosmetics products. PFAS are sometimes added as ingredients in some cosmetic products, including lotions, cleansers, nail polish, shaving cream, foundation, lipstick, eyeliner, eyeshadow, and mascara, according to the FDA. Sometimes the presence of PFAS in cosmetics is unintentional and is the result of impurities in raw materials or is due to the breakdown of ingredients, the FDA said.
The FDA’s website says that so far, the available research doesn’t allow for “definitive conclusions about the potential health risks of PFAS in cosmetics.”
The Centers for Disease Control and Prevention has stated that research has suggested potential links between high levels of certain PFAS, in general, with increased cholesterol levels, changes in liver enzyme levels, increased risk of hypertension or preeclampsia in pregnant women, and increased risk of kidney or testicular cancer.
PFAS compounds often are used to resist grease, oil, water, and heat in industrial settings. They are used in thousands of products, from nonstick cookware to firefighting foams and protective gear, because they can reduce friction, according to a National Academies of Sciences, Engineering, and Medicine report on PFAS that was issued last year.
PFAS are known as “forever chemicals” because they contain a carbon-fluorine bond, which does not break naturally. Even when PFAS are transformed in the body, they can assume other forms of PFAS that preserve the troublesome carbon-fluorine bond. With PFAS, the human body is confronted with a substance it doesn’t have the tools to process.
This is in contrast to proteins and carbohydrates, which are in a sense prepackaged for relatively easy disassembly in the human body. Many of these compounds have weak links that enzymes and stomach acid can take apart, such as sulfur-to-sulfur (disulfide) bonds. That’s why protein-based biotech drugs are injected instead of administered as pills. The ultimate goal of this digestion is for the body to gain energy from these compounds.
But with PFAS, the body faces the challenge of carbon-fluorine bonds that are very hard to break down, and there is no payoff for these efforts, Graham F. Peaslee, PhD, professor of physics at the University of Notre Dame (Indiana), told this news organization.
“Nothing will naturally eat it because when you break the bond, it’s like eating celery,” he said. “You use more calories to eat the celery than you gain back from it.”
Interest from a U.S. senator
Dr. Peaslee was one of the authors of a 2021 article about PFAS in cosmetics that appeared in the journal Environmental Science and Technology Letters.
In the article, Dr. Peaslee and colleagues reported on their screening of 231 cosmetic products purchased in the United States and Canada using particle-induced gamma-ray emission spectroscopy. They found cases of undisclosed PFAS in cosmetic products. Foundations, mascaras, and lip products were noted as being especially problematic.
Sen. Susan Collins (R-ME) cited Dr. Peaslee’s article in a 2021 floor speech as she argued for having the FDA ban the intentional addition of PFAS to cosmetics.
“The findings of this study are particularly alarming, as many of these products are subject to direct human exposure,” Sen. Collins said. “For example, lipstick is often inadvertently ingested, and mascara is sometimes absorbed through tear ducts.”
In addition, workers at cosmetics plants may be exposed to PFAS and discarded cosmetics that have these compounds, which could potentially contaminate drinking water, Sen. Collins said. In 2021, she introduced legislation seeking a ban on PFAS that are intentionally added to cosmetics. That legislation did not advance through the Senate.
But the Senate Appropriations Committee, on which Sen. Collins is the ranking Republican, wants the FDA to keep a ban on PFAS in mind.
The Senate Agriculture Appropriations subcommittee, which oversees the FDA’s budget, raised the issue of PFAS and cosmetics in a June report. The FDA should develop a plan outlining research needed to inform “regulatory decision making, including potential development of a proposed rule to ban intentionally added PFAS substances in cosmetics,” the subcommittee said.
A version of this article first appeared on Medscape.com.
They are also preparing to assess potential risks of so-called forever chemicals in these products.
The Food and Drug Administration last year gained new authority over cosmetics when Congress passed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by adding this bill to a December budget package.
“On average, consumers in the U.S. use six to 12 cosmetics products daily. But, until recently the FDA didn’t have the authority to require manufacturers to submit cosmetic product listings, including a list of ingredients used in these products, or register the facilities where they were produced,” Namandjé Bumpus, PhD, FDA’s chief scientist, said in a press release.
In the statement, the FDA announced the release of a draft guidance document that is intended to help companies comply with the transparency requirements slated to kick in this December. The agency is accepting comments on this draft guidance through Sept. 7.
“Later this year, registration and listing of cosmetic product facilities and products will become a requirement, making information about cosmetic products, including the ingredients used in products and the facilities where they are produced, readily available to the agency,” Dr. Bumpus said.
The products, according to the FDA statement, include makeup, nail polishes, shaving creams, other grooming products, perfumes, face and body cleansers, hair products, moisturizers, and other skin care items.
MoCRA “represents a sea change in how FDA regulates the cosmetics industry,” attorneys Frederick R. Ball, Alyson Walker Lotman, and Kelly A. Bonner, wrote in an article for the Food and Drug Law Institute published in spring 2023.
The FDA has called the MoCRA law “the most significant expansion” of its authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938.
The agency is in the process of expanding its staff to carry out newly authorized duties, including the tracking of adverse events. The FDA budget request for fiscal 2024, which begins Oct. 1, seeks $5 million for work needed to implement MoCRA.
PFAS, or ‘forever chemicals’
Some of the requested FDA funding is intended to prepare the agency to assess the use of per-and polyfluoroalkyl substances (PFAS) in cosmetics.
MoCRA sets a 3-year deadline for the FDA to issue an assessment of the use and potential risks of PFAS in cosmetics products. PFAS are sometimes added as ingredients in some cosmetic products, including lotions, cleansers, nail polish, shaving cream, foundation, lipstick, eyeliner, eyeshadow, and mascara, according to the FDA. Sometimes the presence of PFAS in cosmetics is unintentional and is the result of impurities in raw materials or is due to the breakdown of ingredients, the FDA said.
The FDA’s website says that so far, the available research doesn’t allow for “definitive conclusions about the potential health risks of PFAS in cosmetics.”
The Centers for Disease Control and Prevention has stated that research has suggested potential links between high levels of certain PFAS, in general, with increased cholesterol levels, changes in liver enzyme levels, increased risk of hypertension or preeclampsia in pregnant women, and increased risk of kidney or testicular cancer.
PFAS compounds often are used to resist grease, oil, water, and heat in industrial settings. They are used in thousands of products, from nonstick cookware to firefighting foams and protective gear, because they can reduce friction, according to a National Academies of Sciences, Engineering, and Medicine report on PFAS that was issued last year.
PFAS are known as “forever chemicals” because they contain a carbon-fluorine bond, which does not break naturally. Even when PFAS are transformed in the body, they can assume other forms of PFAS that preserve the troublesome carbon-fluorine bond. With PFAS, the human body is confronted with a substance it doesn’t have the tools to process.
This is in contrast to proteins and carbohydrates, which are in a sense prepackaged for relatively easy disassembly in the human body. Many of these compounds have weak links that enzymes and stomach acid can take apart, such as sulfur-to-sulfur (disulfide) bonds. That’s why protein-based biotech drugs are injected instead of administered as pills. The ultimate goal of this digestion is for the body to gain energy from these compounds.
But with PFAS, the body faces the challenge of carbon-fluorine bonds that are very hard to break down, and there is no payoff for these efforts, Graham F. Peaslee, PhD, professor of physics at the University of Notre Dame (Indiana), told this news organization.
“Nothing will naturally eat it because when you break the bond, it’s like eating celery,” he said. “You use more calories to eat the celery than you gain back from it.”
Interest from a U.S. senator
Dr. Peaslee was one of the authors of a 2021 article about PFAS in cosmetics that appeared in the journal Environmental Science and Technology Letters.
In the article, Dr. Peaslee and colleagues reported on their screening of 231 cosmetic products purchased in the United States and Canada using particle-induced gamma-ray emission spectroscopy. They found cases of undisclosed PFAS in cosmetic products. Foundations, mascaras, and lip products were noted as being especially problematic.
Sen. Susan Collins (R-ME) cited Dr. Peaslee’s article in a 2021 floor speech as she argued for having the FDA ban the intentional addition of PFAS to cosmetics.
“The findings of this study are particularly alarming, as many of these products are subject to direct human exposure,” Sen. Collins said. “For example, lipstick is often inadvertently ingested, and mascara is sometimes absorbed through tear ducts.”
In addition, workers at cosmetics plants may be exposed to PFAS and discarded cosmetics that have these compounds, which could potentially contaminate drinking water, Sen. Collins said. In 2021, she introduced legislation seeking a ban on PFAS that are intentionally added to cosmetics. That legislation did not advance through the Senate.
But the Senate Appropriations Committee, on which Sen. Collins is the ranking Republican, wants the FDA to keep a ban on PFAS in mind.
The Senate Agriculture Appropriations subcommittee, which oversees the FDA’s budget, raised the issue of PFAS and cosmetics in a June report. The FDA should develop a plan outlining research needed to inform “regulatory decision making, including potential development of a proposed rule to ban intentionally added PFAS substances in cosmetics,” the subcommittee said.
A version of this article first appeared on Medscape.com.
ACR releases guideline for managing ILD in patients with rheumatic disease
The American College of Rheumatology has released a summary of upcoming guidelines on screening, monitoring, and treatment for interstitial lung disease (ILD) in patients with systemic autoimmune rheumatic disease.
The recommendations apply to adults with rheumatic diseases at greater risk for ILD: rheumatoid arthritis, systemic sclerosis (SSc), mixed connective tissue disease (MCTD), Sjögren’s disease (SjD), and idiopathic inflammatory myopathies (IIM).
“Interstitial lung disease is a major cause of morbidity and mortality across several systemic autoimmune rheumatic diseases,” Sindhu R. Johnson, MD, PhD, lead author of the new guidelines and director of the clinical epidemiology and health care research program at the University of Toronto, said in an ACR press release. “Guidance was needed for which tests to use for screening and monitoring this particular disease.”
The two documents are summaries of part of a larger manuscript currently awaiting peer review, according to the ACR, and the final guidelines are anticipated to be published by early 2024.
The recommendations were developed using “the best available evidence and consensus across a range of expert opinions and incorporated patient values and preferences,” according to the press release.
Highlights of recommendations for screening and monitoring ILD are:
- Providers can screen patients at higher risk for ILD with pulmonary function tests (PFTs) and high-resolution CT of the chest.
- PFTs, chest high-resolution CT, and ambulatory desaturation testing are conditionally recommended for monitoring ILD progression.
- It is conditionally recommended that providers do not use 6-minute walk test distance, chest radiography, or bronchoscopy for screening or monitoring disease.
- It is suggested that patients with IIM-ILD and SSc-ILD receive PFTs for monitoring every 3-6 months during the first year, then less frequently once stable.
- It is suggested that patients with RA-ILD, SjD-ILD, and MCTD-ILD receive PFTs every 3-12 months for the first year, then less frequently once stable.
Suggestions on how often to screen for ILD were not present in the summary documents, but will be made available in the larger manuscript, said Elana Bernstein, MD, director of the Columbia University Medical Center/New York–Presbyterian Hospital scleroderma program, New York. She is co–first author of the guidelines.
Nearly all recommendations are conditional, primarily because the certainty of evidence behind many of these recommendations is low or very low, she said in an interview. More clinical data on ILD in patients with rheumatic disease would help strengthen evidence, she said, particularly for best practices in frequency of testing. “We need more research on how often patients should be screened for ILD and how often they should be monitored for ILD progression,” she said. “That would enable us to provide recommendations, rather than just suggestions.”
Highlights of recommendations for ILD treatment are:
- The guidelines strongly recommend against using glucocorticoids for first-line ILD treatment in patients with SSc-ILD.
- Short-term glucocorticoids are conditionally recommended as a first-line ILD treatment for patients with systemic autoimmune rheumatic disease–related ILD (SARD-ILD), excluding SSc-ILD.
- Mycophenolate, azathioprine, rituximab, and cyclophosphamide are all potential first-line ILD treatment options for patients with SARD-ILD.
- It is conditionally recommended that patients with SARD-ILD do not receive leflunomide, methotrexate, tumor necrosis factor inhibitors, or abatacept as first-line ILD treatment.
- If SARD-ILD progresses despite first-line therapy, mycophenolate, rituximab, cyclophosphamide, and nintedanib are potential secondary treatment options.
- If RA-ILD progresses following initial therapy, pirfenidone is a treatment option.
- The guidelines conditionally recommend against pirfenidone as a secondary treatment option for SARD-ILD other than RA-ILD.
These summary guidelines appear “comprehensive,” but there has yet to be information published on the basis of these recommendations, Elizabeth Volkmann, MD, said in an interview.
“It’s important to understand that we don’t know whether most of these recommendations were just driven by expert opinion versus actual evidence from randomized, controlled clinical trials,” said Dr. Volkmann, who codirects the connective tissue disease–related interstitial lung disease program at the University of California, Los Angeles. She was not involved with creating the guidelines.
She expects that many of the recommendations for first- and second-line ILD treatment options were based on expert opinion, as there have been no randomized clinical trials looking at that specific topic, she said. For example, nintedanib is conditionally recommended as a first-line treatment option for SSc-ILD, but as a second-line treatment for SjD-ILD, IIM-ILD, and MCTD-ILD. “There’s no literature to support one or the other – whether nintedanib is first-line or second-line [treatment].”
The decision to publish the summary recommendations online prior to peer review is unusual, she said, as these recommendations could be altered during that process; however, Dr. Bernstein noted that was not likely.
By releasing the summary guideline now, the ACR can “get the needed information to clinicians earlier as the manuscript goes through its remaining stages and is finalized,” an ACR representative explained.
Prior to the expected publication of these guidelines in early 2024, Dr. Volkmann noted that the American Thoracic Society will be publishing guidelines on the treatment of SSc-ILD in the American Journal of Respiratory and Critical Care Medicine in September.
Dr. Bernstein reported grants/contracts with the Department of Defense, the Scleroderma Research Foundation, the National Institutes of Health, Eicos, Boehringer Ingelheim, Kadmon, and Pfizer. Dr. Volkmann has received consulting and speaking fees from Boehringer Ingelheim and GlaxoSmithKline and institutional support for performing studies on systemic sclerosis for Kadmon, Boehringer Ingelheim, Horizon, and Prometheus.
A version of this article first appeared on Medscape.com.
The American College of Rheumatology has released a summary of upcoming guidelines on screening, monitoring, and treatment for interstitial lung disease (ILD) in patients with systemic autoimmune rheumatic disease.
The recommendations apply to adults with rheumatic diseases at greater risk for ILD: rheumatoid arthritis, systemic sclerosis (SSc), mixed connective tissue disease (MCTD), Sjögren’s disease (SjD), and idiopathic inflammatory myopathies (IIM).
“Interstitial lung disease is a major cause of morbidity and mortality across several systemic autoimmune rheumatic diseases,” Sindhu R. Johnson, MD, PhD, lead author of the new guidelines and director of the clinical epidemiology and health care research program at the University of Toronto, said in an ACR press release. “Guidance was needed for which tests to use for screening and monitoring this particular disease.”
The two documents are summaries of part of a larger manuscript currently awaiting peer review, according to the ACR, and the final guidelines are anticipated to be published by early 2024.
The recommendations were developed using “the best available evidence and consensus across a range of expert opinions and incorporated patient values and preferences,” according to the press release.
Highlights of recommendations for screening and monitoring ILD are:
- Providers can screen patients at higher risk for ILD with pulmonary function tests (PFTs) and high-resolution CT of the chest.
- PFTs, chest high-resolution CT, and ambulatory desaturation testing are conditionally recommended for monitoring ILD progression.
- It is conditionally recommended that providers do not use 6-minute walk test distance, chest radiography, or bronchoscopy for screening or monitoring disease.
- It is suggested that patients with IIM-ILD and SSc-ILD receive PFTs for monitoring every 3-6 months during the first year, then less frequently once stable.
- It is suggested that patients with RA-ILD, SjD-ILD, and MCTD-ILD receive PFTs every 3-12 months for the first year, then less frequently once stable.
Suggestions on how often to screen for ILD were not present in the summary documents, but will be made available in the larger manuscript, said Elana Bernstein, MD, director of the Columbia University Medical Center/New York–Presbyterian Hospital scleroderma program, New York. She is co–first author of the guidelines.
Nearly all recommendations are conditional, primarily because the certainty of evidence behind many of these recommendations is low or very low, she said in an interview. More clinical data on ILD in patients with rheumatic disease would help strengthen evidence, she said, particularly for best practices in frequency of testing. “We need more research on how often patients should be screened for ILD and how often they should be monitored for ILD progression,” she said. “That would enable us to provide recommendations, rather than just suggestions.”
Highlights of recommendations for ILD treatment are:
- The guidelines strongly recommend against using glucocorticoids for first-line ILD treatment in patients with SSc-ILD.
- Short-term glucocorticoids are conditionally recommended as a first-line ILD treatment for patients with systemic autoimmune rheumatic disease–related ILD (SARD-ILD), excluding SSc-ILD.
- Mycophenolate, azathioprine, rituximab, and cyclophosphamide are all potential first-line ILD treatment options for patients with SARD-ILD.
- It is conditionally recommended that patients with SARD-ILD do not receive leflunomide, methotrexate, tumor necrosis factor inhibitors, or abatacept as first-line ILD treatment.
- If SARD-ILD progresses despite first-line therapy, mycophenolate, rituximab, cyclophosphamide, and nintedanib are potential secondary treatment options.
- If RA-ILD progresses following initial therapy, pirfenidone is a treatment option.
- The guidelines conditionally recommend against pirfenidone as a secondary treatment option for SARD-ILD other than RA-ILD.
These summary guidelines appear “comprehensive,” but there has yet to be information published on the basis of these recommendations, Elizabeth Volkmann, MD, said in an interview.
“It’s important to understand that we don’t know whether most of these recommendations were just driven by expert opinion versus actual evidence from randomized, controlled clinical trials,” said Dr. Volkmann, who codirects the connective tissue disease–related interstitial lung disease program at the University of California, Los Angeles. She was not involved with creating the guidelines.
She expects that many of the recommendations for first- and second-line ILD treatment options were based on expert opinion, as there have been no randomized clinical trials looking at that specific topic, she said. For example, nintedanib is conditionally recommended as a first-line treatment option for SSc-ILD, but as a second-line treatment for SjD-ILD, IIM-ILD, and MCTD-ILD. “There’s no literature to support one or the other – whether nintedanib is first-line or second-line [treatment].”
The decision to publish the summary recommendations online prior to peer review is unusual, she said, as these recommendations could be altered during that process; however, Dr. Bernstein noted that was not likely.
By releasing the summary guideline now, the ACR can “get the needed information to clinicians earlier as the manuscript goes through its remaining stages and is finalized,” an ACR representative explained.
Prior to the expected publication of these guidelines in early 2024, Dr. Volkmann noted that the American Thoracic Society will be publishing guidelines on the treatment of SSc-ILD in the American Journal of Respiratory and Critical Care Medicine in September.
Dr. Bernstein reported grants/contracts with the Department of Defense, the Scleroderma Research Foundation, the National Institutes of Health, Eicos, Boehringer Ingelheim, Kadmon, and Pfizer. Dr. Volkmann has received consulting and speaking fees from Boehringer Ingelheim and GlaxoSmithKline and institutional support for performing studies on systemic sclerosis for Kadmon, Boehringer Ingelheim, Horizon, and Prometheus.
A version of this article first appeared on Medscape.com.
The American College of Rheumatology has released a summary of upcoming guidelines on screening, monitoring, and treatment for interstitial lung disease (ILD) in patients with systemic autoimmune rheumatic disease.
The recommendations apply to adults with rheumatic diseases at greater risk for ILD: rheumatoid arthritis, systemic sclerosis (SSc), mixed connective tissue disease (MCTD), Sjögren’s disease (SjD), and idiopathic inflammatory myopathies (IIM).
“Interstitial lung disease is a major cause of morbidity and mortality across several systemic autoimmune rheumatic diseases,” Sindhu R. Johnson, MD, PhD, lead author of the new guidelines and director of the clinical epidemiology and health care research program at the University of Toronto, said in an ACR press release. “Guidance was needed for which tests to use for screening and monitoring this particular disease.”
The two documents are summaries of part of a larger manuscript currently awaiting peer review, according to the ACR, and the final guidelines are anticipated to be published by early 2024.
The recommendations were developed using “the best available evidence and consensus across a range of expert opinions and incorporated patient values and preferences,” according to the press release.
Highlights of recommendations for screening and monitoring ILD are:
- Providers can screen patients at higher risk for ILD with pulmonary function tests (PFTs) and high-resolution CT of the chest.
- PFTs, chest high-resolution CT, and ambulatory desaturation testing are conditionally recommended for monitoring ILD progression.
- It is conditionally recommended that providers do not use 6-minute walk test distance, chest radiography, or bronchoscopy for screening or monitoring disease.
- It is suggested that patients with IIM-ILD and SSc-ILD receive PFTs for monitoring every 3-6 months during the first year, then less frequently once stable.
- It is suggested that patients with RA-ILD, SjD-ILD, and MCTD-ILD receive PFTs every 3-12 months for the first year, then less frequently once stable.
Suggestions on how often to screen for ILD were not present in the summary documents, but will be made available in the larger manuscript, said Elana Bernstein, MD, director of the Columbia University Medical Center/New York–Presbyterian Hospital scleroderma program, New York. She is co–first author of the guidelines.
Nearly all recommendations are conditional, primarily because the certainty of evidence behind many of these recommendations is low or very low, she said in an interview. More clinical data on ILD in patients with rheumatic disease would help strengthen evidence, she said, particularly for best practices in frequency of testing. “We need more research on how often patients should be screened for ILD and how often they should be monitored for ILD progression,” she said. “That would enable us to provide recommendations, rather than just suggestions.”
Highlights of recommendations for ILD treatment are:
- The guidelines strongly recommend against using glucocorticoids for first-line ILD treatment in patients with SSc-ILD.
- Short-term glucocorticoids are conditionally recommended as a first-line ILD treatment for patients with systemic autoimmune rheumatic disease–related ILD (SARD-ILD), excluding SSc-ILD.
- Mycophenolate, azathioprine, rituximab, and cyclophosphamide are all potential first-line ILD treatment options for patients with SARD-ILD.
- It is conditionally recommended that patients with SARD-ILD do not receive leflunomide, methotrexate, tumor necrosis factor inhibitors, or abatacept as first-line ILD treatment.
- If SARD-ILD progresses despite first-line therapy, mycophenolate, rituximab, cyclophosphamide, and nintedanib are potential secondary treatment options.
- If RA-ILD progresses following initial therapy, pirfenidone is a treatment option.
- The guidelines conditionally recommend against pirfenidone as a secondary treatment option for SARD-ILD other than RA-ILD.
These summary guidelines appear “comprehensive,” but there has yet to be information published on the basis of these recommendations, Elizabeth Volkmann, MD, said in an interview.
“It’s important to understand that we don’t know whether most of these recommendations were just driven by expert opinion versus actual evidence from randomized, controlled clinical trials,” said Dr. Volkmann, who codirects the connective tissue disease–related interstitial lung disease program at the University of California, Los Angeles. She was not involved with creating the guidelines.
She expects that many of the recommendations for first- and second-line ILD treatment options were based on expert opinion, as there have been no randomized clinical trials looking at that specific topic, she said. For example, nintedanib is conditionally recommended as a first-line treatment option for SSc-ILD, but as a second-line treatment for SjD-ILD, IIM-ILD, and MCTD-ILD. “There’s no literature to support one or the other – whether nintedanib is first-line or second-line [treatment].”
The decision to publish the summary recommendations online prior to peer review is unusual, she said, as these recommendations could be altered during that process; however, Dr. Bernstein noted that was not likely.
By releasing the summary guideline now, the ACR can “get the needed information to clinicians earlier as the manuscript goes through its remaining stages and is finalized,” an ACR representative explained.
Prior to the expected publication of these guidelines in early 2024, Dr. Volkmann noted that the American Thoracic Society will be publishing guidelines on the treatment of SSc-ILD in the American Journal of Respiratory and Critical Care Medicine in September.
Dr. Bernstein reported grants/contracts with the Department of Defense, the Scleroderma Research Foundation, the National Institutes of Health, Eicos, Boehringer Ingelheim, Kadmon, and Pfizer. Dr. Volkmann has received consulting and speaking fees from Boehringer Ingelheim and GlaxoSmithKline and institutional support for performing studies on systemic sclerosis for Kadmon, Boehringer Ingelheim, Horizon, and Prometheus.
A version of this article first appeared on Medscape.com.