Feature

Michael Victoroff, MD, described the phone call he received from an attorney asking a thorny ethics question involving a patient’s gift to another physician. Dr. Victoroff, a past member of the ethics committee of the American Academy of Family Physicians, had definite thoughts about it.

“The attorney was representing the daughters of an elderly gentleman who had moved from the East Coast to Colorado to be closer to them,” said Dr. Victoroff, who teaches bioethics in the MBA program at the University of Denver and also practices at the University of Colorado School of Medicine.

“The father visited his new primary care physician frequently because he had multiple health issues.”

The patient was happy with the doctor’s medical care and over time that they developed a friendship. Dr. Victoroff emphasized that no sexual or romantic impropriety ever took place between the patient and his physician.

“But the social relationship went beyond the ordinary doctor-patient boundaries. The patient ultimately named the doctor as his health care proxy in the event that he became unable to make decisions regarding his care. He also mentioned he was going to leave her $100,000 in his will,” says Dr. Victoroff.

The physician did accept the role of proxy, “which raises a whole host of ethical issues,” says Dr. Victoroff. As it happened, she was never called upon to exercise that decision-making authority, since the patient died suddenly and was mentally competent at the time.

After his death, his daughters became aware of the large sum of money he had bequeathed to his doctor. They felt it was unethical for her to accept such a substantial bequest from a patient, and they hired an attorney to contest the will.
 

No law against it

Dennis Hursh, attorney and managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, noted in an interview that, “the problem isn’t legal per se. Rather, the problem is an ethical one.”

Legally speaking, there’s no prohibition against receiving a bequest or other form of gift from a patient. “People are free to dispose of their estates in whatever way they see fit, and no law technically precludes a physician from accepting a bequest,” says Dr. Victoroff. “But this presupposes there is nothing improper going on, such as extortion, deception, coercion, or exercising undue influence.”

The issue of bequeathing money to their physician gained attention in a recent case that took place in Australia. Peter Alexakis, MD, received a whopping bequest of $24 million from a patient. The elderly patient had changed his will to name Dr. Alexakis as the sole beneficiary – after Dr. Alexakis had visited him at home 92 times during the preceding months. The original heirs filed a lawsuit in Australia’s Supreme Court against Dr. Alexakis, contesting the will.

The lawsuit was unsuccessful in court, but Dr. Alexakis was found guilty of malpractice by Australia’s Health Care Complaints Commission after being reported to the HCCC by the palliative care physicians who were treating the patient. They alleged that Dr. Alexakis had interfered with their care of the patient. The more serious allegation was that the doctor had engaged in a deliberate strategy to exploit the relationship for financial gain.

Dr. Alexakis was chastised by the HCCC for engaging in “obtuse” and “suspicious” behavior and for “blurring the boundaries of the doctor-patient relationship.”

There are three domains – legal, ethical, and practical – when it comes to accepting bequests or any gifts from patients, says Dr. Victoroff.

“[In] the legal domain, for example, if you receive a bequest from anyone, patient or otherwise, you have to know your local laws about estates and taxes and so forth and obey them,” he said.

Attorney Hursh pointed out that the Australian doctor wasn’t found guilty of wrongdoing in a court of law but rather of unethical conduct by the Australian medical licensing entity.

Patients giving gifts is often a part of a physician’s life

When Ian Schorr, MD, first started out in practice, he was surprised that patients began bringing him gifts of food to express gratitude for his care.

“I thought it was unethical to accept their gifts, so I turned them down and wouldn’t accept so much as a cookie,” Dr. Schorr, a now-retired ophthalmologist, told this news organization. “But that changed because my office staff told me that some patients were feeling disappointed and insulted. I realized that some people want to express appreciation in ways that go beyond a monetary payment.”

The next time he received a gift from a patient, he “accepted it gracefully.” And he wrote a thank you note, which he continued to do any time he received a gift from a patient.

Kenneth Prager, MD, professor of clinical medicine, director of clinical ethics and chairman of the Medical Ethics Committee at Columbia University Medical Center, New York, says, “I have literally received hundreds of gifts, the vast majority being tokens of patients’ appreciation,” he said. “I’ll get boxes of chocolate or cakes, or sometimes articles of clothing.”

Occasionally, Dr. Prager receives a “somewhat larger gift” – for example, two tickets to a baseball game. “To reject these gifts would be a slap in the face to the patient,” he says, but “where it gets more ethically cloudy is when a gift is very substantial.”

Dr. Prager has never been offered a “substantial” gift or bequest personally. “But a patient whose brother I cared for has indicated that she has left instructions in her will to endow an associate chair of ethics in my honor, and I didn’t decline that,” he said.

The AMA Code of Ethics confirms that accepting gifts offered “as an expression of gratitude or a reflection of the patient’s cultural tradition” can “enhance the patient-physician relationship.” But sometimes gifts “may signal psychological needs that require the physician’s attention.” Accepting such gifts is “likely to damage the patient-physician relationship.”

Potential damage to the therapeutic relationship applies to all physicians but especially for psychiatrists and mental health professionals. “There are more stringent ethical requirements when it comes to these disciplines, where gift-giving gets into the territory of transference or may have particular psychological meaning, and accepting the gift may muddy the therapeutic waters,” Dr. Victoroff said.
 

Impact on the patient’s family and on other patients

The AMA statement encourages physicians to be “sensitive to the gift’s value, relative to the patient’s or physician’s means.” Physicians should decline gifts that are “disproportionately or inappropriately large, or when the physician would be uncomfortable to have colleagues know the gift had been accepted.”

They should also decline a bequest from a patient if they have reason to believe that to accept it “would present an emotional or financial hardship to the patient’s family.”

“If Bill Gates were leaving $100,000 to his doctor, I imagine Melinda would be just fine,” Mr. Hursh said. “But under ordinary circumstances, if the patient’s family might feel the impact of the bequest, it would be unethical to accept it and could be grounds for revocation of the doctor’s license.”

The AMA statement also warns physicians that by offering a gift, some patients may be seeking to “secure or influence care or to secure preferential treatment,” which can “undermine physicians’ obligation to provide services fairly to all patients.”

For this reason, bequests are “sticky,” said Laurel Lyckholm, MD, professor of hematology and oncology at West Virginia University School of Medicine. In the case of institutions where patients or community members donate money, “we know whose names are on the plaques that hang on the hospital walls, so it’s a delicate balance. What if there’s only one bed or one ventilator? Will the wife of the donor get preferential treatment?”
 

Follow institutional policy

A “very small gift, such as a fruitcake, is fine,” says Dr. Lyckholm, author of an essay on accepting gifts from patients. She said there’s a dollar amount ($15) that her institution mandates, above which a gift – even food – is considered too expensive to accept. “I was a nurse before I became a physician, and people always tried to give us gifts because we were so close to the minute-by-minute care of the patients,” she said. “We were not allowed to accept money or anything lavish.”

But in the case of small gifts, “the risk-benefit analysis is that there’s much more risk not to take it and to hurt the patient’s feelings.”

Gifts above $15 are given to charity. “I explain to patients that I’m not allowed to take such a large gift, but I’d love to give it to the hospital’s Rosenbaum Family House that provides patients and their relatives with lodging, or to the homeless shelter in Morgantown.”

Dr. Lyckholm, who serves on the ethics committee at J.W. Ruby Memorial Hospital, once was offered expensive tickets and said to the patient, “This is so incredibly thoughtful and kind, but I can’t accept them. I would like to give the tickets to a charity that can auction them off.”

She advises physicians to find out their institution’s policies. Many institutions have policies about what gifts their staff – whether physicians, nurses, or other health care professionals – can accept.
 

Passing the ‘smell test’

Accepting a large gift from a patient could potentially make it look like you might have exercised undue influence.

“That concern brings us to the third domain, which is very practical and all about appearances and perceptions,” Dr. Victoroff said.

He noted that there is “an inherent power differential between a physician and a patient. The very nature of the relationship can create a risk of ‘undue influence’ on the doctor’s part, even if it’s not apparent to the doctor.” For this reason, it’s necessary to be utterly transparent about how the bequest came about.

He suggests that if a patient informs you that he or she would like to leave money to you, it might be wise to suggest a meeting with the patient’s family, thus establishing some transparency.

It may not be possible to meet with the patient’s family for logistical reasons or because the patient would prefer not to involve their family in their estate planning. But in any case, it’s advisable to document any conversation in the patient’s chart, Dr. Victoroff advised.

“You should make a contemporaneous note that the patient initiated the suggestion and that you counseled them about the implications, no differently than you would with an interaction of a clinical nature,” he suggests. That way, if money has been left to you and is disputed, there’s a clear record that you didn’t solicit it or use any undue influence to bring it about.

He also recommended getting advice from a trusted colleague or a member of your institution’s ethics committee. “Taking time to get a second opinion about an ethical question is a safeguard, like having a chaperone in the room during an examination.”

Ultimately, “there is no human relationship without potential conflicts of interest. Our job is to manage those as best as we can, and sunlight is the best antidote to bad appearances,” Dr. Victoroff said.

A version of this article appeared on Medscape.com.

Michael Victoroff, MD, described the phone call he received from an attorney asking a thorny ethics question involving a patient’s gift to another physician. Dr. Victoroff, a past member of the ethics committee of the American Academy of Family Physicians, had definite thoughts about it.

“The attorney was representing the daughters of an elderly gentleman who had moved from the East Coast to Colorado to be closer to them,” said Dr. Victoroff, who teaches bioethics in the MBA program at the University of Denver and also practices at the University of Colorado School of Medicine.

“The father visited his new primary care physician frequently because he had multiple health issues.”

The patient was happy with the doctor’s medical care and over time that they developed a friendship. Dr. Victoroff emphasized that no sexual or romantic impropriety ever took place between the patient and his physician.

“But the social relationship went beyond the ordinary doctor-patient boundaries. The patient ultimately named the doctor as his health care proxy in the event that he became unable to make decisions regarding his care. He also mentioned he was going to leave her $100,000 in his will,” says Dr. Victoroff.

The physician did accept the role of proxy, “which raises a whole host of ethical issues,” says Dr. Victoroff. As it happened, she was never called upon to exercise that decision-making authority, since the patient died suddenly and was mentally competent at the time.

After his death, his daughters became aware of the large sum of money he had bequeathed to his doctor. They felt it was unethical for her to accept such a substantial bequest from a patient, and they hired an attorney to contest the will.
 

No law against it

Dennis Hursh, attorney and managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, noted in an interview that, “the problem isn’t legal per se. Rather, the problem is an ethical one.”

Legally speaking, there’s no prohibition against receiving a bequest or other form of gift from a patient. “People are free to dispose of their estates in whatever way they see fit, and no law technically precludes a physician from accepting a bequest,” says Dr. Victoroff. “But this presupposes there is nothing improper going on, such as extortion, deception, coercion, or exercising undue influence.”

The issue of bequeathing money to their physician gained attention in a recent case that took place in Australia. Peter Alexakis, MD, received a whopping bequest of $24 million from a patient. The elderly patient had changed his will to name Dr. Alexakis as the sole beneficiary – after Dr. Alexakis had visited him at home 92 times during the preceding months. The original heirs filed a lawsuit in Australia’s Supreme Court against Dr. Alexakis, contesting the will.

The lawsuit was unsuccessful in court, but Dr. Alexakis was found guilty of malpractice by Australia’s Health Care Complaints Commission after being reported to the HCCC by the palliative care physicians who were treating the patient. They alleged that Dr. Alexakis had interfered with their care of the patient. The more serious allegation was that the doctor had engaged in a deliberate strategy to exploit the relationship for financial gain.

Dr. Alexakis was chastised by the HCCC for engaging in “obtuse” and “suspicious” behavior and for “blurring the boundaries of the doctor-patient relationship.”

There are three domains – legal, ethical, and practical – when it comes to accepting bequests or any gifts from patients, says Dr. Victoroff.

“[In] the legal domain, for example, if you receive a bequest from anyone, patient or otherwise, you have to know your local laws about estates and taxes and so forth and obey them,” he said.

Attorney Hursh pointed out that the Australian doctor wasn’t found guilty of wrongdoing in a court of law but rather of unethical conduct by the Australian medical licensing entity.

Patients giving gifts is often a part of a physician’s life

When Ian Schorr, MD, first started out in practice, he was surprised that patients began bringing him gifts of food to express gratitude for his care.

“I thought it was unethical to accept their gifts, so I turned them down and wouldn’t accept so much as a cookie,” Dr. Schorr, a now-retired ophthalmologist, told this news organization. “But that changed because my office staff told me that some patients were feeling disappointed and insulted. I realized that some people want to express appreciation in ways that go beyond a monetary payment.”

The next time he received a gift from a patient, he “accepted it gracefully.” And he wrote a thank you note, which he continued to do any time he received a gift from a patient.

Kenneth Prager, MD, professor of clinical medicine, director of clinical ethics and chairman of the Medical Ethics Committee at Columbia University Medical Center, New York, says, “I have literally received hundreds of gifts, the vast majority being tokens of patients’ appreciation,” he said. “I’ll get boxes of chocolate or cakes, or sometimes articles of clothing.”

Occasionally, Dr. Prager receives a “somewhat larger gift” – for example, two tickets to a baseball game. “To reject these gifts would be a slap in the face to the patient,” he says, but “where it gets more ethically cloudy is when a gift is very substantial.”

Dr. Prager has never been offered a “substantial” gift or bequest personally. “But a patient whose brother I cared for has indicated that she has left instructions in her will to endow an associate chair of ethics in my honor, and I didn’t decline that,” he said.

The AMA Code of Ethics confirms that accepting gifts offered “as an expression of gratitude or a reflection of the patient’s cultural tradition” can “enhance the patient-physician relationship.” But sometimes gifts “may signal psychological needs that require the physician’s attention.” Accepting such gifts is “likely to damage the patient-physician relationship.”

Potential damage to the therapeutic relationship applies to all physicians but especially for psychiatrists and mental health professionals. “There are more stringent ethical requirements when it comes to these disciplines, where gift-giving gets into the territory of transference or may have particular psychological meaning, and accepting the gift may muddy the therapeutic waters,” Dr. Victoroff said.
 

Impact on the patient’s family and on other patients

The AMA statement encourages physicians to be “sensitive to the gift’s value, relative to the patient’s or physician’s means.” Physicians should decline gifts that are “disproportionately or inappropriately large, or when the physician would be uncomfortable to have colleagues know the gift had been accepted.”

They should also decline a bequest from a patient if they have reason to believe that to accept it “would present an emotional or financial hardship to the patient’s family.”

“If Bill Gates were leaving $100,000 to his doctor, I imagine Melinda would be just fine,” Mr. Hursh said. “But under ordinary circumstances, if the patient’s family might feel the impact of the bequest, it would be unethical to accept it and could be grounds for revocation of the doctor’s license.”

The AMA statement also warns physicians that by offering a gift, some patients may be seeking to “secure or influence care or to secure preferential treatment,” which can “undermine physicians’ obligation to provide services fairly to all patients.”

For this reason, bequests are “sticky,” said Laurel Lyckholm, MD, professor of hematology and oncology at West Virginia University School of Medicine. In the case of institutions where patients or community members donate money, “we know whose names are on the plaques that hang on the hospital walls, so it’s a delicate balance. What if there’s only one bed or one ventilator? Will the wife of the donor get preferential treatment?”
 

Follow institutional policy

A “very small gift, such as a fruitcake, is fine,” says Dr. Lyckholm, author of an essay on accepting gifts from patients. She said there’s a dollar amount ($15) that her institution mandates, above which a gift – even food – is considered too expensive to accept. “I was a nurse before I became a physician, and people always tried to give us gifts because we were so close to the minute-by-minute care of the patients,” she said. “We were not allowed to accept money or anything lavish.”

But in the case of small gifts, “the risk-benefit analysis is that there’s much more risk not to take it and to hurt the patient’s feelings.”

Gifts above $15 are given to charity. “I explain to patients that I’m not allowed to take such a large gift, but I’d love to give it to the hospital’s Rosenbaum Family House that provides patients and their relatives with lodging, or to the homeless shelter in Morgantown.”

Dr. Lyckholm, who serves on the ethics committee at J.W. Ruby Memorial Hospital, once was offered expensive tickets and said to the patient, “This is so incredibly thoughtful and kind, but I can’t accept them. I would like to give the tickets to a charity that can auction them off.”

She advises physicians to find out their institution’s policies. Many institutions have policies about what gifts their staff – whether physicians, nurses, or other health care professionals – can accept.
 

Passing the ‘smell test’

Accepting a large gift from a patient could potentially make it look like you might have exercised undue influence.

“That concern brings us to the third domain, which is very practical and all about appearances and perceptions,” Dr. Victoroff said.

He noted that there is “an inherent power differential between a physician and a patient. The very nature of the relationship can create a risk of ‘undue influence’ on the doctor’s part, even if it’s not apparent to the doctor.” For this reason, it’s necessary to be utterly transparent about how the bequest came about.

He suggests that if a patient informs you that he or she would like to leave money to you, it might be wise to suggest a meeting with the patient’s family, thus establishing some transparency.

It may not be possible to meet with the patient’s family for logistical reasons or because the patient would prefer not to involve their family in their estate planning. But in any case, it’s advisable to document any conversation in the patient’s chart, Dr. Victoroff advised.

“You should make a contemporaneous note that the patient initiated the suggestion and that you counseled them about the implications, no differently than you would with an interaction of a clinical nature,” he suggests. That way, if money has been left to you and is disputed, there’s a clear record that you didn’t solicit it or use any undue influence to bring it about.

He also recommended getting advice from a trusted colleague or a member of your institution’s ethics committee. “Taking time to get a second opinion about an ethical question is a safeguard, like having a chaperone in the room during an examination.”

Ultimately, “there is no human relationship without potential conflicts of interest. Our job is to manage those as best as we can, and sunlight is the best antidote to bad appearances,” Dr. Victoroff said.

A version of this article appeared on Medscape.com.

Michael Victoroff, MD, described the phone call he received from an attorney asking a thorny ethics question involving a patient’s gift to another physician. Dr. Victoroff, a past member of the ethics committee of the American Academy of Family Physicians, had definite thoughts about it.

“The attorney was representing the daughters of an elderly gentleman who had moved from the East Coast to Colorado to be closer to them,” said Dr. Victoroff, who teaches bioethics in the MBA program at the University of Denver and also practices at the University of Colorado School of Medicine.

“The father visited his new primary care physician frequently because he had multiple health issues.”

The patient was happy with the doctor’s medical care and over time that they developed a friendship. Dr. Victoroff emphasized that no sexual or romantic impropriety ever took place between the patient and his physician.

“But the social relationship went beyond the ordinary doctor-patient boundaries. The patient ultimately named the doctor as his health care proxy in the event that he became unable to make decisions regarding his care. He also mentioned he was going to leave her $100,000 in his will,” says Dr. Victoroff.

The physician did accept the role of proxy, “which raises a whole host of ethical issues,” says Dr. Victoroff. As it happened, she was never called upon to exercise that decision-making authority, since the patient died suddenly and was mentally competent at the time.

After his death, his daughters became aware of the large sum of money he had bequeathed to his doctor. They felt it was unethical for her to accept such a substantial bequest from a patient, and they hired an attorney to contest the will.
 

No law against it

Dennis Hursh, attorney and managing partner of Physician Agreements Health Law, a Pennsylvania-based law firm that represents physicians, noted in an interview that, “the problem isn’t legal per se. Rather, the problem is an ethical one.”

Legally speaking, there’s no prohibition against receiving a bequest or other form of gift from a patient. “People are free to dispose of their estates in whatever way they see fit, and no law technically precludes a physician from accepting a bequest,” says Dr. Victoroff. “But this presupposes there is nothing improper going on, such as extortion, deception, coercion, or exercising undue influence.”

The issue of bequeathing money to their physician gained attention in a recent case that took place in Australia. Peter Alexakis, MD, received a whopping bequest of $24 million from a patient. The elderly patient had changed his will to name Dr. Alexakis as the sole beneficiary – after Dr. Alexakis had visited him at home 92 times during the preceding months. The original heirs filed a lawsuit in Australia’s Supreme Court against Dr. Alexakis, contesting the will.

The lawsuit was unsuccessful in court, but Dr. Alexakis was found guilty of malpractice by Australia’s Health Care Complaints Commission after being reported to the HCCC by the palliative care physicians who were treating the patient. They alleged that Dr. Alexakis had interfered with their care of the patient. The more serious allegation was that the doctor had engaged in a deliberate strategy to exploit the relationship for financial gain.

Dr. Alexakis was chastised by the HCCC for engaging in “obtuse” and “suspicious” behavior and for “blurring the boundaries of the doctor-patient relationship.”

There are three domains – legal, ethical, and practical – when it comes to accepting bequests or any gifts from patients, says Dr. Victoroff.

“[In] the legal domain, for example, if you receive a bequest from anyone, patient or otherwise, you have to know your local laws about estates and taxes and so forth and obey them,” he said.

Attorney Hursh pointed out that the Australian doctor wasn’t found guilty of wrongdoing in a court of law but rather of unethical conduct by the Australian medical licensing entity.

Patients giving gifts is often a part of a physician’s life

When Ian Schorr, MD, first started out in practice, he was surprised that patients began bringing him gifts of food to express gratitude for his care.

“I thought it was unethical to accept their gifts, so I turned them down and wouldn’t accept so much as a cookie,” Dr. Schorr, a now-retired ophthalmologist, told this news organization. “But that changed because my office staff told me that some patients were feeling disappointed and insulted. I realized that some people want to express appreciation in ways that go beyond a monetary payment.”

The next time he received a gift from a patient, he “accepted it gracefully.” And he wrote a thank you note, which he continued to do any time he received a gift from a patient.

Kenneth Prager, MD, professor of clinical medicine, director of clinical ethics and chairman of the Medical Ethics Committee at Columbia University Medical Center, New York, says, “I have literally received hundreds of gifts, the vast majority being tokens of patients’ appreciation,” he said. “I’ll get boxes of chocolate or cakes, or sometimes articles of clothing.”

Occasionally, Dr. Prager receives a “somewhat larger gift” – for example, two tickets to a baseball game. “To reject these gifts would be a slap in the face to the patient,” he says, but “where it gets more ethically cloudy is when a gift is very substantial.”

Dr. Prager has never been offered a “substantial” gift or bequest personally. “But a patient whose brother I cared for has indicated that she has left instructions in her will to endow an associate chair of ethics in my honor, and I didn’t decline that,” he said.

The AMA Code of Ethics confirms that accepting gifts offered “as an expression of gratitude or a reflection of the patient’s cultural tradition” can “enhance the patient-physician relationship.” But sometimes gifts “may signal psychological needs that require the physician’s attention.” Accepting such gifts is “likely to damage the patient-physician relationship.”

Potential damage to the therapeutic relationship applies to all physicians but especially for psychiatrists and mental health professionals. “There are more stringent ethical requirements when it comes to these disciplines, where gift-giving gets into the territory of transference or may have particular psychological meaning, and accepting the gift may muddy the therapeutic waters,” Dr. Victoroff said.
 

Impact on the patient’s family and on other patients

The AMA statement encourages physicians to be “sensitive to the gift’s value, relative to the patient’s or physician’s means.” Physicians should decline gifts that are “disproportionately or inappropriately large, or when the physician would be uncomfortable to have colleagues know the gift had been accepted.”

They should also decline a bequest from a patient if they have reason to believe that to accept it “would present an emotional or financial hardship to the patient’s family.”

“If Bill Gates were leaving $100,000 to his doctor, I imagine Melinda would be just fine,” Mr. Hursh said. “But under ordinary circumstances, if the patient’s family might feel the impact of the bequest, it would be unethical to accept it and could be grounds for revocation of the doctor’s license.”

The AMA statement also warns physicians that by offering a gift, some patients may be seeking to “secure or influence care or to secure preferential treatment,” which can “undermine physicians’ obligation to provide services fairly to all patients.”

For this reason, bequests are “sticky,” said Laurel Lyckholm, MD, professor of hematology and oncology at West Virginia University School of Medicine. In the case of institutions where patients or community members donate money, “we know whose names are on the plaques that hang on the hospital walls, so it’s a delicate balance. What if there’s only one bed or one ventilator? Will the wife of the donor get preferential treatment?”
 

Follow institutional policy

A “very small gift, such as a fruitcake, is fine,” says Dr. Lyckholm, author of an essay on accepting gifts from patients. She said there’s a dollar amount ($15) that her institution mandates, above which a gift – even food – is considered too expensive to accept. “I was a nurse before I became a physician, and people always tried to give us gifts because we were so close to the minute-by-minute care of the patients,” she said. “We were not allowed to accept money or anything lavish.”

But in the case of small gifts, “the risk-benefit analysis is that there’s much more risk not to take it and to hurt the patient’s feelings.”

Gifts above $15 are given to charity. “I explain to patients that I’m not allowed to take such a large gift, but I’d love to give it to the hospital’s Rosenbaum Family House that provides patients and their relatives with lodging, or to the homeless shelter in Morgantown.”

Dr. Lyckholm, who serves on the ethics committee at J.W. Ruby Memorial Hospital, once was offered expensive tickets and said to the patient, “This is so incredibly thoughtful and kind, but I can’t accept them. I would like to give the tickets to a charity that can auction them off.”

She advises physicians to find out their institution’s policies. Many institutions have policies about what gifts their staff – whether physicians, nurses, or other health care professionals – can accept.
 

Passing the ‘smell test’

Accepting a large gift from a patient could potentially make it look like you might have exercised undue influence.

“That concern brings us to the third domain, which is very practical and all about appearances and perceptions,” Dr. Victoroff said.

He noted that there is “an inherent power differential between a physician and a patient. The very nature of the relationship can create a risk of ‘undue influence’ on the doctor’s part, even if it’s not apparent to the doctor.” For this reason, it’s necessary to be utterly transparent about how the bequest came about.

He suggests that if a patient informs you that he or she would like to leave money to you, it might be wise to suggest a meeting with the patient’s family, thus establishing some transparency.

It may not be possible to meet with the patient’s family for logistical reasons or because the patient would prefer not to involve their family in their estate planning. But in any case, it’s advisable to document any conversation in the patient’s chart, Dr. Victoroff advised.

“You should make a contemporaneous note that the patient initiated the suggestion and that you counseled them about the implications, no differently than you would with an interaction of a clinical nature,” he suggests. That way, if money has been left to you and is disputed, there’s a clear record that you didn’t solicit it or use any undue influence to bring it about.

He also recommended getting advice from a trusted colleague or a member of your institution’s ethics committee. “Taking time to get a second opinion about an ethical question is a safeguard, like having a chaperone in the room during an examination.”

Ultimately, “there is no human relationship without potential conflicts of interest. Our job is to manage those as best as we can, and sunlight is the best antidote to bad appearances,” Dr. Victoroff said.

A version of this article appeared on Medscape.com.

An alarming gap bedevils menopause care in the United States – thanks to enduring myths about hormone replacement therapy and flaws in how new doctors are trained. The result: Countless women grapple with the physical and emotional toll of this life transition.

These shortcomings have led to an influx of doctors moving from traditional practice to virtual startups that focus on women’s health issues, treating patients who come to them desperate and frustrated after years of unresolved issues.

The solution is often so simple it is almost maddening, specialists say: vaginal creams containing low-dose estrogen which can address the symptoms of menopause, from vaginal dryness to recurrent urinary tract infections. 

“Hands down, this is one of the most meaningful interventions I’ve ever offered to a patient and yet it is underutilized,” said Ashley Winter, MD, chief medical officer and urologist at Odela Health, a digital women’s health clinic. “A lot of companies are blossoming in this menopause space because it is underserved by traditional health care – your gynecologist typically deals with reproduction, and typically when women are done with child-bearing, they’re kind of discharged from the care of their gynecologist.”

More than 1 million women in the United States go through menopause each year. According to a 2022 survey, 4 in 10 women report menopause symptoms that have been disruptive enough to interfere with their work performance on at least a weekly basis. 

And yet, many women are not getting appropriate treatment.

Partially to blame is the harmful legacy of faulty data, doctors say. The early results of the federally funded Women’s Health Initiative, released in 2002, showed that hormone therapy (HT) led to increased risk for heart attacks, strokes, and breast cancer. But further analysis showed the opposite: Hormonal therapies have a helpful effect on cardiovascular and bone health and generally reduce risk of death in younger women or those in the early postmenopausal period.

Hormone therapy delivers estrogen, sometimes with progesterone, to the body through gels, creams, patches, pills, suppositories, or a device fitted inside the uterus. Systemic HT sends hormones into the bloodstream, while local HT – like vaginal estrogen cream – specifically treats vaginal symptoms of menopause. 

Myths about the health risks linked to systemic and topical HT have long been debunked, and research on topical HT in particular shows it poses no risk for cancer or other chronic diseases. 

Yet while 2 decades have passed since the misinformation first started to spread, people remain woefully uninformed about hormone treatments. 

The FDA still requires that estrogen products carry a black-box warning on the early data, even though it has since been proven false. 

“This is one of the most damaging PR misadventures of modern medicine in my opinion,” Dr. Winter said. “It has literally killed women, and it’s made them miserable.”

The public has a glaring lack of knowledge about menopause management, said Stephanie Faubion, MD, medical director for the North American Menopause Society and director of Mayo Clinic’s Center for Women’s Health.

Pegasus Health Justice Center

UCLA

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

An alarming gap bedevils menopause care in the United States – thanks to enduring myths about hormone replacement therapy and flaws in how new doctors are trained. The result: Countless women grapple with the physical and emotional toll of this life transition.

These shortcomings have led to an influx of doctors moving from traditional practice to virtual startups that focus on women’s health issues, treating patients who come to them desperate and frustrated after years of unresolved issues.

The solution is often so simple it is almost maddening, specialists say: vaginal creams containing low-dose estrogen which can address the symptoms of menopause, from vaginal dryness to recurrent urinary tract infections. 

“Hands down, this is one of the most meaningful interventions I’ve ever offered to a patient and yet it is underutilized,” said Ashley Winter, MD, chief medical officer and urologist at Odela Health, a digital women’s health clinic. “A lot of companies are blossoming in this menopause space because it is underserved by traditional health care – your gynecologist typically deals with reproduction, and typically when women are done with child-bearing, they’re kind of discharged from the care of their gynecologist.”

More than 1 million women in the United States go through menopause each year. According to a 2022 survey, 4 in 10 women report menopause symptoms that have been disruptive enough to interfere with their work performance on at least a weekly basis. 

And yet, many women are not getting appropriate treatment.

Partially to blame is the harmful legacy of faulty data, doctors say. The early results of the federally funded Women’s Health Initiative, released in 2002, showed that hormone therapy (HT) led to increased risk for heart attacks, strokes, and breast cancer. But further analysis showed the opposite: Hormonal therapies have a helpful effect on cardiovascular and bone health and generally reduce risk of death in younger women or those in the early postmenopausal period.

Hormone therapy delivers estrogen, sometimes with progesterone, to the body through gels, creams, patches, pills, suppositories, or a device fitted inside the uterus. Systemic HT sends hormones into the bloodstream, while local HT – like vaginal estrogen cream – specifically treats vaginal symptoms of menopause. 

Myths about the health risks linked to systemic and topical HT have long been debunked, and research on topical HT in particular shows it poses no risk for cancer or other chronic diseases. 

Yet while 2 decades have passed since the misinformation first started to spread, people remain woefully uninformed about hormone treatments. 

The FDA still requires that estrogen products carry a black-box warning on the early data, even though it has since been proven false. 

“This is one of the most damaging PR misadventures of modern medicine in my opinion,” Dr. Winter said. “It has literally killed women, and it’s made them miserable.”

The public has a glaring lack of knowledge about menopause management, said Stephanie Faubion, MD, medical director for the North American Menopause Society and director of Mayo Clinic’s Center for Women’s Health.

Pegasus Health Justice Center

UCLA

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

An alarming gap bedevils menopause care in the United States – thanks to enduring myths about hormone replacement therapy and flaws in how new doctors are trained. The result: Countless women grapple with the physical and emotional toll of this life transition.

These shortcomings have led to an influx of doctors moving from traditional practice to virtual startups that focus on women’s health issues, treating patients who come to them desperate and frustrated after years of unresolved issues.

The solution is often so simple it is almost maddening, specialists say: vaginal creams containing low-dose estrogen which can address the symptoms of menopause, from vaginal dryness to recurrent urinary tract infections. 

“Hands down, this is one of the most meaningful interventions I’ve ever offered to a patient and yet it is underutilized,” said Ashley Winter, MD, chief medical officer and urologist at Odela Health, a digital women’s health clinic. “A lot of companies are blossoming in this menopause space because it is underserved by traditional health care – your gynecologist typically deals with reproduction, and typically when women are done with child-bearing, they’re kind of discharged from the care of their gynecologist.”

More than 1 million women in the United States go through menopause each year. According to a 2022 survey, 4 in 10 women report menopause symptoms that have been disruptive enough to interfere with their work performance on at least a weekly basis. 

And yet, many women are not getting appropriate treatment.

Partially to blame is the harmful legacy of faulty data, doctors say. The early results of the federally funded Women’s Health Initiative, released in 2002, showed that hormone therapy (HT) led to increased risk for heart attacks, strokes, and breast cancer. But further analysis showed the opposite: Hormonal therapies have a helpful effect on cardiovascular and bone health and generally reduce risk of death in younger women or those in the early postmenopausal period.

Hormone therapy delivers estrogen, sometimes with progesterone, to the body through gels, creams, patches, pills, suppositories, or a device fitted inside the uterus. Systemic HT sends hormones into the bloodstream, while local HT – like vaginal estrogen cream – specifically treats vaginal symptoms of menopause. 

Myths about the health risks linked to systemic and topical HT have long been debunked, and research on topical HT in particular shows it poses no risk for cancer or other chronic diseases. 

Yet while 2 decades have passed since the misinformation first started to spread, people remain woefully uninformed about hormone treatments. 

The FDA still requires that estrogen products carry a black-box warning on the early data, even though it has since been proven false. 

“This is one of the most damaging PR misadventures of modern medicine in my opinion,” Dr. Winter said. “It has literally killed women, and it’s made them miserable.”

The public has a glaring lack of knowledge about menopause management, said Stephanie Faubion, MD, medical director for the North American Menopause Society and director of Mayo Clinic’s Center for Women’s Health.

Pegasus Health Justice Center

UCLA

A version of this article first appeared on WebMD.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.

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.

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.

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.

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.

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.

A year after celebrating the approval of the first treatment for repigmentation of vitiligo, dermatologists describe how topical ruxolitinib has advanced the outlook for patients with the disease and what’s next in the pipeline.

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.

Dr. Chovatiya

“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.

NYU Langone Health

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.

A year after celebrating the approval of the first treatment for repigmentation of vitiligo, dermatologists describe how topical ruxolitinib has advanced the outlook for patients with the disease and what’s next in the pipeline.

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.

Dr. Chovatiya

“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.

NYU Langone Health

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.

A year after celebrating the approval of the first treatment for repigmentation of vitiligo, dermatologists describe how topical ruxolitinib has advanced the outlook for patients with the disease and what’s next in the pipeline.

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.

Dr. Chovatiya

“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.

NYU Langone Health

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.

Several new clinical trials in prostate cancer have opened in recent months. Maybe one of your patients is eligible to participate?

Prostate cancer at high risk for biochemical recurrence following radical prostatectomy and/or radiation therapy. Adult patients with this diagnosis can join a randomized, double-blind, placebo-controlled, phase 3 study evaluating darolutamide (Nubeqa) plus androgen deprivation therapy against ADT alone. For up to 2 years, one group of participants will take twice-daily tablets of darolutamide, a nonsteroidal antiandrogen approved in 2019, in combination with ADT. A second group will take placebo plus ADT. Sites in California, Colorado, and worldwide started recruiting for 750 participants in April 2023; study centers across 19 other states in the US are gearing up. The primary outcome measure is radiological progression-free survival (PFS). Overall survival and quality of life (QoL) are secondary measures. More details at clinicaltrials.gov.

Commenting on the study, Marc Garnick, MD, professor of medicine, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, said the trial “addresses an important question regarding intensification of androgen deprivation therapy with darolutamide” – specifically, whether this intensified approach is useful for a large proportion of men who experience biochemical recurrence (BCR) – rising PSA levels – after definitive localized therapy.

Dr. Garnick cautioned, however, that “it will be very important for the study investigators to stratify the many characteristics of BCR – and not treat this population as a homogeneous one since initial Gleason Score, time to BCR, and PSA doubling time all may impact the outcomes.”

Metastatic castration-sensitive prostate cancer. Adults with this type of cancer can join a randomized, open-label, phase 3 trial evaluating the nonsteroidal antiandrogen apalutamide (Erleada). Apalutamide, the first treatment approved for nonmetastatic castration-resistant prostate cancer, has also been approved for patients with metastatic castration-sensitive prostate cancer. This new trial will assess an intermittent approach to providing ADT alongside apalutamide in patients with metastatic disease.

All participants will take daily apalutamide tablets plus physician’s choice of ADT for 6 months. Everyone whose PSA falls below 0.2 ng/mL will either receive apalutamide with intermittent ADT per protocol or continue to receive apalutamide plus ADT for a further 18 months or until the patient discontinues the study, whichever happens first. Recruitment of 333 participants is planned for sites in Colorado, New York, Ohio, Utah, and Germany starting in August 2023. Radiographic PFS and hot flash score are the primary endpoints. QoL and overall survival are secondary outcomes. See more details at clinicaltrials.gov.

This study “should add to our knowledge of optimal treatment” for metastatic castrate-sensitive prostate cancer,” Dr. Garnick said. However, “this is a very heterogeneous population of patients and how they get to the [diagnosis] of metastatic castrate-sensitive prostate cancer is important. The sample size and stratifications need to be well studied for this study to provide any meaningful data.”

Localized intermediate- or high-risk prostate cancer. People with one of these clinical scenarios who have not yet had stereotactic body radiation therapy (SBRT) or a prostatectomy are eligible for a randomized, open-label, phase 2 study. This National Cancer Institute (NCI) trial is looking at whether the experimental immunocytokine M9241 can enhance the effectiveness of SBRT. M9241 is designed to assist the immune system to fight cancer by boosting the activity of T cells at necrotic sites in the tumor.

All participants will receive standard of care ADT. One group of people will also receive three subcutaneous injections of M9241 at 4-weekly intervals in deescalating doses, then 10 days of standard SBRT, followed by another three injections of M9241 at the highest tolerable dose. A second group will only undergo SBRT. The National Institutes of Health Clinical Center in Bethesda, Maryland, started recruiting the trial’s 65 participants in June 2023. The primary endpoints are the doses of M9241 in combination with ADT that are safe and tolerable, and T-cell clonality (a measure of immunologic activity). Overall survival and QoL will not be tracked. More details are available at clinicaltrials.gov.

“The M9241 study is very important,” said Dr. Garnick, explaining that he hopes the trial will add to the growing knowledge about the interactions of radiation and its effects on the immune system.

Confirmed prostate cancer. People with prostate cancer eligible for triplet or doublet ADT combination therapy can join a randomized, single-masked, phase 2 NCI investigation of bright white light therapy for ADT-associated fatigue and depression. All participants will receive standard of care ADT combination therapy for up to a year. One group of participants will use AYOpro glasses, a commercial bright white light therapy, daily as ADT starts (“immediate” therapy). A second set of people will start using the glasses after 6 months of ADT therapy (“delayed” therapy). The City of Hope Medical Center, Duarte, Calif., planned to start welcoming the trial’s 210 participants in August 2023. Fatigue is the primary endpoint, QoL is a secondary endpoint, and overall survival will not be recorded. More details are available at clinicaltrials.gov.

“Fatigue is an important feature of cancer therapies in general and any approach to lessen the impact of fatigue should be welcome,” Dr. Garnick said. However, “it would have been helpful” if the official description of the trial had provided more information on the rationale for testing bright white light therapy in prostate cancer.

Metastatic castration-resistant prostate cancer. Adults with this diagnosis who have been treated with one prior androgen receptor axis-targeted therapy (ARAT) can enter a randomized, open-label, phase 2 trial to determine the best dose of the antibody-drug conjugate vobramitamab duocarmazine (MacroGenics). This experimental drug is designed to deliver an alkylating agent that promotes cell death in solid tumors expressing B7-H3. The B7-H3 protein rarely appears in normal tissues but is expressed at high frequency in 60% of cancers.

For approximately 2 years, participants will receive one of two doses of intravenous vobramitamab duocarmazine every 4 weeks. The trial opened in June 2023, looking to recruit 100 participants across nine states in the United States and eight other countries. The primary outcome measure is radiographic PFS. Overall survival and QoL will not be assessed. More details at clinicaltrials.gov.

Localized or biochemically recurrent prostate cancer. Adults in this position who have not received prior GnRH agonist or antagonist therapy are being recruited for a randomized, single-masked, phase 2 study comparing QoL among patients taking ADTs relugolix (Orgovyx, Relumina) and leuprolide acetate for depot suspension (Lupron Depot). For up to 1 year, people in the trial will either take daily tablets of relugolix or receive injections of leuprolide every 3 months. Three study sites in Massachusetts are due to open their doors in August 2023, seeking 110 participants. The study will assess various measures of QoL. Overall survival will not be measured. More details at clinicaltrials.gov.

This study is “sort of plain vanilla,” Dr. Garnick said. Although “the objectives of the study are important, the study number is small and unlikely to show any meaningful differences,” even if differences do exist.

All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov). Dr. Garnick reported no relevant financial relationships. He is editor-in-chief of the Harvard Medical School Annual Report on Prostate Diseases, for which he receives an honorarium. 

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

Several new clinical trials in prostate cancer have opened in recent months. Maybe one of your patients is eligible to participate?

Prostate cancer at high risk for biochemical recurrence following radical prostatectomy and/or radiation therapy. Adult patients with this diagnosis can join a randomized, double-blind, placebo-controlled, phase 3 study evaluating darolutamide (Nubeqa) plus androgen deprivation therapy against ADT alone. For up to 2 years, one group of participants will take twice-daily tablets of darolutamide, a nonsteroidal antiandrogen approved in 2019, in combination with ADT. A second group will take placebo plus ADT. Sites in California, Colorado, and worldwide started recruiting for 750 participants in April 2023; study centers across 19 other states in the US are gearing up. The primary outcome measure is radiological progression-free survival (PFS). Overall survival and quality of life (QoL) are secondary measures. More details at clinicaltrials.gov.

Commenting on the study, Marc Garnick, MD, professor of medicine, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, said the trial “addresses an important question regarding intensification of androgen deprivation therapy with darolutamide” – specifically, whether this intensified approach is useful for a large proportion of men who experience biochemical recurrence (BCR) – rising PSA levels – after definitive localized therapy.

Dr. Garnick cautioned, however, that “it will be very important for the study investigators to stratify the many characteristics of BCR – and not treat this population as a homogeneous one since initial Gleason Score, time to BCR, and PSA doubling time all may impact the outcomes.”

Metastatic castration-sensitive prostate cancer. Adults with this type of cancer can join a randomized, open-label, phase 3 trial evaluating the nonsteroidal antiandrogen apalutamide (Erleada). Apalutamide, the first treatment approved for nonmetastatic castration-resistant prostate cancer, has also been approved for patients with metastatic castration-sensitive prostate cancer. This new trial will assess an intermittent approach to providing ADT alongside apalutamide in patients with metastatic disease.

All participants will take daily apalutamide tablets plus physician’s choice of ADT for 6 months. Everyone whose PSA falls below 0.2 ng/mL will either receive apalutamide with intermittent ADT per protocol or continue to receive apalutamide plus ADT for a further 18 months or until the patient discontinues the study, whichever happens first. Recruitment of 333 participants is planned for sites in Colorado, New York, Ohio, Utah, and Germany starting in August 2023. Radiographic PFS and hot flash score are the primary endpoints. QoL and overall survival are secondary outcomes. See more details at clinicaltrials.gov.

This study “should add to our knowledge of optimal treatment” for metastatic castrate-sensitive prostate cancer,” Dr. Garnick said. However, “this is a very heterogeneous population of patients and how they get to the [diagnosis] of metastatic castrate-sensitive prostate cancer is important. The sample size and stratifications need to be well studied for this study to provide any meaningful data.”

Localized intermediate- or high-risk prostate cancer. People with one of these clinical scenarios who have not yet had stereotactic body radiation therapy (SBRT) or a prostatectomy are eligible for a randomized, open-label, phase 2 study. This National Cancer Institute (NCI) trial is looking at whether the experimental immunocytokine M9241 can enhance the effectiveness of SBRT. M9241 is designed to assist the immune system to fight cancer by boosting the activity of T cells at necrotic sites in the tumor.

All participants will receive standard of care ADT. One group of people will also receive three subcutaneous injections of M9241 at 4-weekly intervals in deescalating doses, then 10 days of standard SBRT, followed by another three injections of M9241 at the highest tolerable dose. A second group will only undergo SBRT. The National Institutes of Health Clinical Center in Bethesda, Maryland, started recruiting the trial’s 65 participants in June 2023. The primary endpoints are the doses of M9241 in combination with ADT that are safe and tolerable, and T-cell clonality (a measure of immunologic activity). Overall survival and QoL will not be tracked. More details are available at clinicaltrials.gov.

“The M9241 study is very important,” said Dr. Garnick, explaining that he hopes the trial will add to the growing knowledge about the interactions of radiation and its effects on the immune system.

Confirmed prostate cancer. People with prostate cancer eligible for triplet or doublet ADT combination therapy can join a randomized, single-masked, phase 2 NCI investigation of bright white light therapy for ADT-associated fatigue and depression. All participants will receive standard of care ADT combination therapy for up to a year. One group of participants will use AYOpro glasses, a commercial bright white light therapy, daily as ADT starts (“immediate” therapy). A second set of people will start using the glasses after 6 months of ADT therapy (“delayed” therapy). The City of Hope Medical Center, Duarte, Calif., planned to start welcoming the trial’s 210 participants in August 2023. Fatigue is the primary endpoint, QoL is a secondary endpoint, and overall survival will not be recorded. More details are available at clinicaltrials.gov.

“Fatigue is an important feature of cancer therapies in general and any approach to lessen the impact of fatigue should be welcome,” Dr. Garnick said. However, “it would have been helpful” if the official description of the trial had provided more information on the rationale for testing bright white light therapy in prostate cancer.

Metastatic castration-resistant prostate cancer. Adults with this diagnosis who have been treated with one prior androgen receptor axis-targeted therapy (ARAT) can enter a randomized, open-label, phase 2 trial to determine the best dose of the antibody-drug conjugate vobramitamab duocarmazine (MacroGenics). This experimental drug is designed to deliver an alkylating agent that promotes cell death in solid tumors expressing B7-H3. The B7-H3 protein rarely appears in normal tissues but is expressed at high frequency in 60% of cancers.

For approximately 2 years, participants will receive one of two doses of intravenous vobramitamab duocarmazine every 4 weeks. The trial opened in June 2023, looking to recruit 100 participants across nine states in the United States and eight other countries. The primary outcome measure is radiographic PFS. Overall survival and QoL will not be assessed. More details at clinicaltrials.gov.

Localized or biochemically recurrent prostate cancer. Adults in this position who have not received prior GnRH agonist or antagonist therapy are being recruited for a randomized, single-masked, phase 2 study comparing QoL among patients taking ADTs relugolix (Orgovyx, Relumina) and leuprolide acetate for depot suspension (Lupron Depot). For up to 1 year, people in the trial will either take daily tablets of relugolix or receive injections of leuprolide every 3 months. Three study sites in Massachusetts are due to open their doors in August 2023, seeking 110 participants. The study will assess various measures of QoL. Overall survival will not be measured. More details at clinicaltrials.gov.

This study is “sort of plain vanilla,” Dr. Garnick said. Although “the objectives of the study are important, the study number is small and unlikely to show any meaningful differences,” even if differences do exist.

All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov). Dr. Garnick reported no relevant financial relationships. He is editor-in-chief of the Harvard Medical School Annual Report on Prostate Diseases, for which he receives an honorarium. 

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

Several new clinical trials in prostate cancer have opened in recent months. Maybe one of your patients is eligible to participate?

Prostate cancer at high risk for biochemical recurrence following radical prostatectomy and/or radiation therapy. Adult patients with this diagnosis can join a randomized, double-blind, placebo-controlled, phase 3 study evaluating darolutamide (Nubeqa) plus androgen deprivation therapy against ADT alone. For up to 2 years, one group of participants will take twice-daily tablets of darolutamide, a nonsteroidal antiandrogen approved in 2019, in combination with ADT. A second group will take placebo plus ADT. Sites in California, Colorado, and worldwide started recruiting for 750 participants in April 2023; study centers across 19 other states in the US are gearing up. The primary outcome measure is radiological progression-free survival (PFS). Overall survival and quality of life (QoL) are secondary measures. More details at clinicaltrials.gov.

Commenting on the study, Marc Garnick, MD, professor of medicine, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, said the trial “addresses an important question regarding intensification of androgen deprivation therapy with darolutamide” – specifically, whether this intensified approach is useful for a large proportion of men who experience biochemical recurrence (BCR) – rising PSA levels – after definitive localized therapy.

Dr. Garnick cautioned, however, that “it will be very important for the study investigators to stratify the many characteristics of BCR – and not treat this population as a homogeneous one since initial Gleason Score, time to BCR, and PSA doubling time all may impact the outcomes.”

Metastatic castration-sensitive prostate cancer. Adults with this type of cancer can join a randomized, open-label, phase 3 trial evaluating the nonsteroidal antiandrogen apalutamide (Erleada). Apalutamide, the first treatment approved for nonmetastatic castration-resistant prostate cancer, has also been approved for patients with metastatic castration-sensitive prostate cancer. This new trial will assess an intermittent approach to providing ADT alongside apalutamide in patients with metastatic disease.

All participants will take daily apalutamide tablets plus physician’s choice of ADT for 6 months. Everyone whose PSA falls below 0.2 ng/mL will either receive apalutamide with intermittent ADT per protocol or continue to receive apalutamide plus ADT for a further 18 months or until the patient discontinues the study, whichever happens first. Recruitment of 333 participants is planned for sites in Colorado, New York, Ohio, Utah, and Germany starting in August 2023. Radiographic PFS and hot flash score are the primary endpoints. QoL and overall survival are secondary outcomes. See more details at clinicaltrials.gov.

This study “should add to our knowledge of optimal treatment” for metastatic castrate-sensitive prostate cancer,” Dr. Garnick said. However, “this is a very heterogeneous population of patients and how they get to the [diagnosis] of metastatic castrate-sensitive prostate cancer is important. The sample size and stratifications need to be well studied for this study to provide any meaningful data.”

Localized intermediate- or high-risk prostate cancer. People with one of these clinical scenarios who have not yet had stereotactic body radiation therapy (SBRT) or a prostatectomy are eligible for a randomized, open-label, phase 2 study. This National Cancer Institute (NCI) trial is looking at whether the experimental immunocytokine M9241 can enhance the effectiveness of SBRT. M9241 is designed to assist the immune system to fight cancer by boosting the activity of T cells at necrotic sites in the tumor.

All participants will receive standard of care ADT. One group of people will also receive three subcutaneous injections of M9241 at 4-weekly intervals in deescalating doses, then 10 days of standard SBRT, followed by another three injections of M9241 at the highest tolerable dose. A second group will only undergo SBRT. The National Institutes of Health Clinical Center in Bethesda, Maryland, started recruiting the trial’s 65 participants in June 2023. The primary endpoints are the doses of M9241 in combination with ADT that are safe and tolerable, and T-cell clonality (a measure of immunologic activity). Overall survival and QoL will not be tracked. More details are available at clinicaltrials.gov.

“The M9241 study is very important,” said Dr. Garnick, explaining that he hopes the trial will add to the growing knowledge about the interactions of radiation and its effects on the immune system.

Confirmed prostate cancer. People with prostate cancer eligible for triplet or doublet ADT combination therapy can join a randomized, single-masked, phase 2 NCI investigation of bright white light therapy for ADT-associated fatigue and depression. All participants will receive standard of care ADT combination therapy for up to a year. One group of participants will use AYOpro glasses, a commercial bright white light therapy, daily as ADT starts (“immediate” therapy). A second set of people will start using the glasses after 6 months of ADT therapy (“delayed” therapy). The City of Hope Medical Center, Duarte, Calif., planned to start welcoming the trial’s 210 participants in August 2023. Fatigue is the primary endpoint, QoL is a secondary endpoint, and overall survival will not be recorded. More details are available at clinicaltrials.gov.

“Fatigue is an important feature of cancer therapies in general and any approach to lessen the impact of fatigue should be welcome,” Dr. Garnick said. However, “it would have been helpful” if the official description of the trial had provided more information on the rationale for testing bright white light therapy in prostate cancer.

Metastatic castration-resistant prostate cancer. Adults with this diagnosis who have been treated with one prior androgen receptor axis-targeted therapy (ARAT) can enter a randomized, open-label, phase 2 trial to determine the best dose of the antibody-drug conjugate vobramitamab duocarmazine (MacroGenics). This experimental drug is designed to deliver an alkylating agent that promotes cell death in solid tumors expressing B7-H3. The B7-H3 protein rarely appears in normal tissues but is expressed at high frequency in 60% of cancers.

For approximately 2 years, participants will receive one of two doses of intravenous vobramitamab duocarmazine every 4 weeks. The trial opened in June 2023, looking to recruit 100 participants across nine states in the United States and eight other countries. The primary outcome measure is radiographic PFS. Overall survival and QoL will not be assessed. More details at clinicaltrials.gov.

Localized or biochemically recurrent prostate cancer. Adults in this position who have not received prior GnRH agonist or antagonist therapy are being recruited for a randomized, single-masked, phase 2 study comparing QoL among patients taking ADTs relugolix (Orgovyx, Relumina) and leuprolide acetate for depot suspension (Lupron Depot). For up to 1 year, people in the trial will either take daily tablets of relugolix or receive injections of leuprolide every 3 months. Three study sites in Massachusetts are due to open their doors in August 2023, seeking 110 participants. The study will assess various measures of QoL. Overall survival will not be measured. More details at clinicaltrials.gov.

This study is “sort of plain vanilla,” Dr. Garnick said. Although “the objectives of the study are important, the study number is small and unlikely to show any meaningful differences,” even if differences do exist.

All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov). Dr. Garnick reported no relevant financial relationships. He is editor-in-chief of the Harvard Medical School Annual Report on Prostate Diseases, for which he receives an honorarium. 

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

Early in his career as a pain researcher, Daniel Whibley, PhD, was struck by an article that drew parallels between methods of torture and the experiences of patients with insomnia and chronic pain.

The author of that article, Nicole Tang, DPhil, observed that two methods used by torturers – pain infliction and sleep deprivation – harm people in ways that also are experienced by many patients with pain and sleep conditions.

Patients are “essentially living in this perpetually undesirable, at best, situation where both of these features are playing out in their lives,” said Dr. Whibley, a research assistant professor of physical medicine and rehabilitation at the University of Michigan, Ann Arbor.

The problems create a “kind of vicious circle,” he said. Pain disrupts sleep. Insufficient sleep worsens pain.

Studies have established important relationships between the conditions, but investigators are still trying to clarify the mechanisms that connect them and the best ways to intervene to improve patient outcomes.

To that end, Dr. Whibley has developed an intervention known as Move & Snooze to benefit patients with pain associated with osteoarthritis.

The program includes remote exercise coaching and an automated 6-week course of digital cognitive-behavioral therapy for insomnia (CBT-I). Dr. Whibley’s hypothesis is that addressing sleep disturbances will help patients stay engaged with the physical activity component of the program and help with pain management.

He and his colleagues have tested the intervention in a feasibility study and are in the process of securing grant funding to test it in a large, nationwide trial.
 

Losing sleep for science

Michael Smith, PhD, is examining the sleep-pain connection from a different angle.

Dr. Smith, the director of the Behavioral Medicine Research Laboratory at Johns Hopkins University, Baltimore, is recruiting healthy adults to endure restless nights and painful stimuli.

His team is conducting a study known as Sleep-MOR that aims to reveal how different types of sleep disturbances influence pain and a person’s response to opioids.

Nearly three dozen participants have completed the study so far, Dr. Smith said, out of what he hopes will be 200 in all.

Participants are randomly assigned to sleep normally or to undergo an experimental condition that is designed to mimic the sleep disturbances of insomnia or obstructive sleep apnea (OSA).

In a “forced awakening” group, participants are awakened for 20-minute intervals every hour and for a full hour-long window during the night. In this condition, they could sleep for about four hours in all. Forced awakening is intended to represent insomnia

A “sleep fragmentation” group is meant to represent patients with OSA. About 30 times per hour, tones and tactile buzzers rouse sleeping participants without fully waking them up. Although the experiment involves brief arousals such as those experienced by patients with OSA, it does not capture another important feature of sleep apnea – the cessation of breathing, Dr. Smith noted.

The next day, researchers perform pain testing and brain imaging and see how opioid receptors respond to pain medication.

“Some of the forms of sleep loss that we are studying may actually alter the efficacy of the binding of those receptors, and that might then require you to have higher doses of an opioid to get the same effect,” Dr. Smith said. “That’s our hypothesis.”

If that bears out, disturbed sleep may play a role in the development of opioid use disorder and have implications for patients who receive opioids after surgery, he said.

In the lab, researchers examine pain thresholds using techniques such as thermal pain testing, in which a thermode attached to a participant’s arm heats up. The temperature “slowly goes up and the patient just says: ‘Ouch,’ when it first hurts. Then we have their pain threshold,” Dr. Smith said.
 

A bidirectional relationship

Epidemiologic studies have found that, if you follow women who do not have pain, those with complaints about sleep are more than twice as likely to develop fibromyalgia.

Dr. Smith’s group and others have shown that if you deprive a healthy person of sleep, they become more sensitive to pain.

Inflammation could be one possible reason for this effect. In one study, participants who experienced forced awakening experienced less slow-wave sleep, which was tied to more inflammation in the morning. Increased inflammation was linked to greater pain sensitivity.

“We are starting to piece together some of the pathways. That’s just one,” Dr. Smith said.

A recent study by researchers at Harvard University and elsewhere investigated how sleep disturbances affected three pain pathways. In that study, the results varied by sex. The data indicate that optimal treatment approaches might differ for men and women, the researchers said.
 

Waking up to the problem

Sleep problems can be neglected in medical school and in the clinic. “People just have other things to focus on that they clearly know what they can do about it,” Dr. Smith said.

But clinicians should not hesitate to screen for conditions such as insomnia or OSA and refer patients to a specialist. If a patient has had pain for 6 months and treatments are not working, the chance that they have a treatable sleep disorder “is very high, above 50%,” Dr. Smith said. Many could have more than one sleep disorder, he added.

Continuous positive airway pressure for OSA and CBT for insomnia can improve sleep. Dr. Smith said he expects these measures will improve overall pain management as well.

If treating a sleep disorder fails to help with pain, however, it may still help prevent other sleep-related problems, such as depression, poor glucose control, and heart disease. It also could improve patients’ ability to function day to day, he said.

Evidence on whether treating sleep problems reduces pain has so far been mixed.

“We’ve done some studies showing that if you have CBT-I and you have knee arthritis, improvements in the amount of time you spend awake at night translate into improvements in pain at 6 months. There is a signal there, but it’s not as strong as we would like,” he said. “It may be that it takes longer than anyone would like” to have an effect.

A structured intervention such as CBT-I is likely more beneficial than education about sleep hygiene alone in resolving sleep disturbances, Dr. Whibley said. CBT-I includes active components such as sleep restriction therapy and stimulus control therapy and is recommended by the American Academy of Sleep Medicine as the first-line treatment for chronic insomnia (J Clin Sleep Med. 2008 Oct 15;4[5]:487-504).

Patients should consider the role that sleep may play in their chronic pain condition, he said.

“An increasing number of researchers and clinicians are becoming more interested in this as a foundational pillar of health, alongside activity and diet,” Dr. Whibley said. “Sleep is recognized as just as important but doesn’t seem to get the airtime.”

Clinicians, he added, should regularly assess their patients’ sleep and know where to refer those whom they feel would benefit from more advanced management: “They [should] know that they have at least got it on their radar to check as one of the important pillars of health that you should be able to control.”
 

Sleep trials seeking pain patients

Researchers around the United States are conducting dozens of studies related to sleep and pain. The following trials are recruiting participants, according to ClinicalTrials.gov.

Sleep and Pain Interventions in Women With Fibromyalgia (SPIN-II). Investigators at the University of Missouri–Columbia are examining two cognitive-behavioral treatments for women with fibromyalgia and insomnia. “This trial will yield important information about the roles of sleep, arousal, and brain structure and function in the development and maintenance of chronic pain in women with fibromyalgia,” the researchers say.

Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids (PRESTO). At the University of California, San Diego, researchers are investigating whether patients with chronic pain who use opioids and have sleep-disordered breathing may benefit from treatment with continuous positive airway pressure. They plan to assess the intervention’s effects on sleep quality, pain, and quality of life. They also will see which patients are least likely to benefit from this treatment approach.

Latent Aging Mechanisms in Pain and Sleep (LAMPS). Researchers at the University of Florida are studying the effects of oral gamma-aminobutyric acid in older adults with chronic pain and sleep difficulties.

Sleep and Pain in Sickle Cell Disease. At Johns Hopkins University, investigators are evaluating how behavioral sleep interventions influence pain and brain function in patients with sickle cell disease.

Pain in Long COVID-19: The Role of Sleep. Researchers at Beth Israel Deaconess Medical Center are conducting an observational study of patients with long COVID who have pain and sleep disturbances. The study aims “to understand the role of sleep in the development and persistence of pain symptoms in long COVID.”

Intervention for Sleep and Pain in Youth: A Randomized Controlled Trial (I-SPY-RCT). Adolescents with migraine are being recruited by a team at Seattle Children’s Hospital for a randomized controlled trial. The study will examine the effects of CBT-I as well as the combined effect of CBT-I and pain interventions on reducing insomnia symptoms and headache-related disability in this population.

A version of this article appeared on Medscape.com.

Early in his career as a pain researcher, Daniel Whibley, PhD, was struck by an article that drew parallels between methods of torture and the experiences of patients with insomnia and chronic pain.

The author of that article, Nicole Tang, DPhil, observed that two methods used by torturers – pain infliction and sleep deprivation – harm people in ways that also are experienced by many patients with pain and sleep conditions.

Patients are “essentially living in this perpetually undesirable, at best, situation where both of these features are playing out in their lives,” said Dr. Whibley, a research assistant professor of physical medicine and rehabilitation at the University of Michigan, Ann Arbor.

The problems create a “kind of vicious circle,” he said. Pain disrupts sleep. Insufficient sleep worsens pain.

Studies have established important relationships between the conditions, but investigators are still trying to clarify the mechanisms that connect them and the best ways to intervene to improve patient outcomes.

To that end, Dr. Whibley has developed an intervention known as Move & Snooze to benefit patients with pain associated with osteoarthritis.

The program includes remote exercise coaching and an automated 6-week course of digital cognitive-behavioral therapy for insomnia (CBT-I). Dr. Whibley’s hypothesis is that addressing sleep disturbances will help patients stay engaged with the physical activity component of the program and help with pain management.

He and his colleagues have tested the intervention in a feasibility study and are in the process of securing grant funding to test it in a large, nationwide trial.
 

Losing sleep for science

Michael Smith, PhD, is examining the sleep-pain connection from a different angle.

Dr. Smith, the director of the Behavioral Medicine Research Laboratory at Johns Hopkins University, Baltimore, is recruiting healthy adults to endure restless nights and painful stimuli.

His team is conducting a study known as Sleep-MOR that aims to reveal how different types of sleep disturbances influence pain and a person’s response to opioids.

Nearly three dozen participants have completed the study so far, Dr. Smith said, out of what he hopes will be 200 in all.

Participants are randomly assigned to sleep normally or to undergo an experimental condition that is designed to mimic the sleep disturbances of insomnia or obstructive sleep apnea (OSA).

In a “forced awakening” group, participants are awakened for 20-minute intervals every hour and for a full hour-long window during the night. In this condition, they could sleep for about four hours in all. Forced awakening is intended to represent insomnia

A “sleep fragmentation” group is meant to represent patients with OSA. About 30 times per hour, tones and tactile buzzers rouse sleeping participants without fully waking them up. Although the experiment involves brief arousals such as those experienced by patients with OSA, it does not capture another important feature of sleep apnea – the cessation of breathing, Dr. Smith noted.

The next day, researchers perform pain testing and brain imaging and see how opioid receptors respond to pain medication.

“Some of the forms of sleep loss that we are studying may actually alter the efficacy of the binding of those receptors, and that might then require you to have higher doses of an opioid to get the same effect,” Dr. Smith said. “That’s our hypothesis.”

If that bears out, disturbed sleep may play a role in the development of opioid use disorder and have implications for patients who receive opioids after surgery, he said.

In the lab, researchers examine pain thresholds using techniques such as thermal pain testing, in which a thermode attached to a participant’s arm heats up. The temperature “slowly goes up and the patient just says: ‘Ouch,’ when it first hurts. Then we have their pain threshold,” Dr. Smith said.
 

A bidirectional relationship

Epidemiologic studies have found that, if you follow women who do not have pain, those with complaints about sleep are more than twice as likely to develop fibromyalgia.

Dr. Smith’s group and others have shown that if you deprive a healthy person of sleep, they become more sensitive to pain.

Inflammation could be one possible reason for this effect. In one study, participants who experienced forced awakening experienced less slow-wave sleep, which was tied to more inflammation in the morning. Increased inflammation was linked to greater pain sensitivity.

“We are starting to piece together some of the pathways. That’s just one,” Dr. Smith said.

A recent study by researchers at Harvard University and elsewhere investigated how sleep disturbances affected three pain pathways. In that study, the results varied by sex. The data indicate that optimal treatment approaches might differ for men and women, the researchers said.
 

Waking up to the problem

Sleep problems can be neglected in medical school and in the clinic. “People just have other things to focus on that they clearly know what they can do about it,” Dr. Smith said.

But clinicians should not hesitate to screen for conditions such as insomnia or OSA and refer patients to a specialist. If a patient has had pain for 6 months and treatments are not working, the chance that they have a treatable sleep disorder “is very high, above 50%,” Dr. Smith said. Many could have more than one sleep disorder, he added.

Continuous positive airway pressure for OSA and CBT for insomnia can improve sleep. Dr. Smith said he expects these measures will improve overall pain management as well.

If treating a sleep disorder fails to help with pain, however, it may still help prevent other sleep-related problems, such as depression, poor glucose control, and heart disease. It also could improve patients’ ability to function day to day, he said.

Evidence on whether treating sleep problems reduces pain has so far been mixed.

“We’ve done some studies showing that if you have CBT-I and you have knee arthritis, improvements in the amount of time you spend awake at night translate into improvements in pain at 6 months. There is a signal there, but it’s not as strong as we would like,” he said. “It may be that it takes longer than anyone would like” to have an effect.

A structured intervention such as CBT-I is likely more beneficial than education about sleep hygiene alone in resolving sleep disturbances, Dr. Whibley said. CBT-I includes active components such as sleep restriction therapy and stimulus control therapy and is recommended by the American Academy of Sleep Medicine as the first-line treatment for chronic insomnia (J Clin Sleep Med. 2008 Oct 15;4[5]:487-504).

Patients should consider the role that sleep may play in their chronic pain condition, he said.

“An increasing number of researchers and clinicians are becoming more interested in this as a foundational pillar of health, alongside activity and diet,” Dr. Whibley said. “Sleep is recognized as just as important but doesn’t seem to get the airtime.”

Clinicians, he added, should regularly assess their patients’ sleep and know where to refer those whom they feel would benefit from more advanced management: “They [should] know that they have at least got it on their radar to check as one of the important pillars of health that you should be able to control.”
 

Sleep trials seeking pain patients

Researchers around the United States are conducting dozens of studies related to sleep and pain. The following trials are recruiting participants, according to ClinicalTrials.gov.

Sleep and Pain Interventions in Women With Fibromyalgia (SPIN-II). Investigators at the University of Missouri–Columbia are examining two cognitive-behavioral treatments for women with fibromyalgia and insomnia. “This trial will yield important information about the roles of sleep, arousal, and brain structure and function in the development and maintenance of chronic pain in women with fibromyalgia,” the researchers say.

Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids (PRESTO). At the University of California, San Diego, researchers are investigating whether patients with chronic pain who use opioids and have sleep-disordered breathing may benefit from treatment with continuous positive airway pressure. They plan to assess the intervention’s effects on sleep quality, pain, and quality of life. They also will see which patients are least likely to benefit from this treatment approach.

Latent Aging Mechanisms in Pain and Sleep (LAMPS). Researchers at the University of Florida are studying the effects of oral gamma-aminobutyric acid in older adults with chronic pain and sleep difficulties.

Sleep and Pain in Sickle Cell Disease. At Johns Hopkins University, investigators are evaluating how behavioral sleep interventions influence pain and brain function in patients with sickle cell disease.

Pain in Long COVID-19: The Role of Sleep. Researchers at Beth Israel Deaconess Medical Center are conducting an observational study of patients with long COVID who have pain and sleep disturbances. The study aims “to understand the role of sleep in the development and persistence of pain symptoms in long COVID.”

Intervention for Sleep and Pain in Youth: A Randomized Controlled Trial (I-SPY-RCT). Adolescents with migraine are being recruited by a team at Seattle Children’s Hospital for a randomized controlled trial. The study will examine the effects of CBT-I as well as the combined effect of CBT-I and pain interventions on reducing insomnia symptoms and headache-related disability in this population.

A version of this article appeared on Medscape.com.

Early in his career as a pain researcher, Daniel Whibley, PhD, was struck by an article that drew parallels between methods of torture and the experiences of patients with insomnia and chronic pain.

The author of that article, Nicole Tang, DPhil, observed that two methods used by torturers – pain infliction and sleep deprivation – harm people in ways that also are experienced by many patients with pain and sleep conditions.

Patients are “essentially living in this perpetually undesirable, at best, situation where both of these features are playing out in their lives,” said Dr. Whibley, a research assistant professor of physical medicine and rehabilitation at the University of Michigan, Ann Arbor.

The problems create a “kind of vicious circle,” he said. Pain disrupts sleep. Insufficient sleep worsens pain.

Studies have established important relationships between the conditions, but investigators are still trying to clarify the mechanisms that connect them and the best ways to intervene to improve patient outcomes.

To that end, Dr. Whibley has developed an intervention known as Move & Snooze to benefit patients with pain associated with osteoarthritis.

The program includes remote exercise coaching and an automated 6-week course of digital cognitive-behavioral therapy for insomnia (CBT-I). Dr. Whibley’s hypothesis is that addressing sleep disturbances will help patients stay engaged with the physical activity component of the program and help with pain management.

He and his colleagues have tested the intervention in a feasibility study and are in the process of securing grant funding to test it in a large, nationwide trial.
 

Losing sleep for science

Michael Smith, PhD, is examining the sleep-pain connection from a different angle.

Dr. Smith, the director of the Behavioral Medicine Research Laboratory at Johns Hopkins University, Baltimore, is recruiting healthy adults to endure restless nights and painful stimuli.

His team is conducting a study known as Sleep-MOR that aims to reveal how different types of sleep disturbances influence pain and a person’s response to opioids.

Nearly three dozen participants have completed the study so far, Dr. Smith said, out of what he hopes will be 200 in all.

Participants are randomly assigned to sleep normally or to undergo an experimental condition that is designed to mimic the sleep disturbances of insomnia or obstructive sleep apnea (OSA).

In a “forced awakening” group, participants are awakened for 20-minute intervals every hour and for a full hour-long window during the night. In this condition, they could sleep for about four hours in all. Forced awakening is intended to represent insomnia

A “sleep fragmentation” group is meant to represent patients with OSA. About 30 times per hour, tones and tactile buzzers rouse sleeping participants without fully waking them up. Although the experiment involves brief arousals such as those experienced by patients with OSA, it does not capture another important feature of sleep apnea – the cessation of breathing, Dr. Smith noted.

The next day, researchers perform pain testing and brain imaging and see how opioid receptors respond to pain medication.

“Some of the forms of sleep loss that we are studying may actually alter the efficacy of the binding of those receptors, and that might then require you to have higher doses of an opioid to get the same effect,” Dr. Smith said. “That’s our hypothesis.”

If that bears out, disturbed sleep may play a role in the development of opioid use disorder and have implications for patients who receive opioids after surgery, he said.

In the lab, researchers examine pain thresholds using techniques such as thermal pain testing, in which a thermode attached to a participant’s arm heats up. The temperature “slowly goes up and the patient just says: ‘Ouch,’ when it first hurts. Then we have their pain threshold,” Dr. Smith said.
 

A bidirectional relationship

Epidemiologic studies have found that, if you follow women who do not have pain, those with complaints about sleep are more than twice as likely to develop fibromyalgia.

Dr. Smith’s group and others have shown that if you deprive a healthy person of sleep, they become more sensitive to pain.

Inflammation could be one possible reason for this effect. In one study, participants who experienced forced awakening experienced less slow-wave sleep, which was tied to more inflammation in the morning. Increased inflammation was linked to greater pain sensitivity.

“We are starting to piece together some of the pathways. That’s just one,” Dr. Smith said.

A recent study by researchers at Harvard University and elsewhere investigated how sleep disturbances affected three pain pathways. In that study, the results varied by sex. The data indicate that optimal treatment approaches might differ for men and women, the researchers said.
 

Waking up to the problem

Sleep problems can be neglected in medical school and in the clinic. “People just have other things to focus on that they clearly know what they can do about it,” Dr. Smith said.

But clinicians should not hesitate to screen for conditions such as insomnia or OSA and refer patients to a specialist. If a patient has had pain for 6 months and treatments are not working, the chance that they have a treatable sleep disorder “is very high, above 50%,” Dr. Smith said. Many could have more than one sleep disorder, he added.

Continuous positive airway pressure for OSA and CBT for insomnia can improve sleep. Dr. Smith said he expects these measures will improve overall pain management as well.

If treating a sleep disorder fails to help with pain, however, it may still help prevent other sleep-related problems, such as depression, poor glucose control, and heart disease. It also could improve patients’ ability to function day to day, he said.

Evidence on whether treating sleep problems reduces pain has so far been mixed.

“We’ve done some studies showing that if you have CBT-I and you have knee arthritis, improvements in the amount of time you spend awake at night translate into improvements in pain at 6 months. There is a signal there, but it’s not as strong as we would like,” he said. “It may be that it takes longer than anyone would like” to have an effect.

A structured intervention such as CBT-I is likely more beneficial than education about sleep hygiene alone in resolving sleep disturbances, Dr. Whibley said. CBT-I includes active components such as sleep restriction therapy and stimulus control therapy and is recommended by the American Academy of Sleep Medicine as the first-line treatment for chronic insomnia (J Clin Sleep Med. 2008 Oct 15;4[5]:487-504).

Patients should consider the role that sleep may play in their chronic pain condition, he said.

“An increasing number of researchers and clinicians are becoming more interested in this as a foundational pillar of health, alongside activity and diet,” Dr. Whibley said. “Sleep is recognized as just as important but doesn’t seem to get the airtime.”

Clinicians, he added, should regularly assess their patients’ sleep and know where to refer those whom they feel would benefit from more advanced management: “They [should] know that they have at least got it on their radar to check as one of the important pillars of health that you should be able to control.”
 

Sleep trials seeking pain patients

Researchers around the United States are conducting dozens of studies related to sleep and pain. The following trials are recruiting participants, according to ClinicalTrials.gov.

Sleep and Pain Interventions in Women With Fibromyalgia (SPIN-II). Investigators at the University of Missouri–Columbia are examining two cognitive-behavioral treatments for women with fibromyalgia and insomnia. “This trial will yield important information about the roles of sleep, arousal, and brain structure and function in the development and maintenance of chronic pain in women with fibromyalgia,” the researchers say.

Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids (PRESTO). At the University of California, San Diego, researchers are investigating whether patients with chronic pain who use opioids and have sleep-disordered breathing may benefit from treatment with continuous positive airway pressure. They plan to assess the intervention’s effects on sleep quality, pain, and quality of life. They also will see which patients are least likely to benefit from this treatment approach.

Latent Aging Mechanisms in Pain and Sleep (LAMPS). Researchers at the University of Florida are studying the effects of oral gamma-aminobutyric acid in older adults with chronic pain and sleep difficulties.

Sleep and Pain in Sickle Cell Disease. At Johns Hopkins University, investigators are evaluating how behavioral sleep interventions influence pain and brain function in patients with sickle cell disease.

Pain in Long COVID-19: The Role of Sleep. Researchers at Beth Israel Deaconess Medical Center are conducting an observational study of patients with long COVID who have pain and sleep disturbances. The study aims “to understand the role of sleep in the development and persistence of pain symptoms in long COVID.”

Intervention for Sleep and Pain in Youth: A Randomized Controlled Trial (I-SPY-RCT). Adolescents with migraine are being recruited by a team at Seattle Children’s Hospital for a randomized controlled trial. The study will examine the effects of CBT-I as well as the combined effect of CBT-I and pain interventions on reducing insomnia symptoms and headache-related disability in this population.

A version of this article appeared on Medscape.com.

With COVID-19 hospitalizations up by 22% and deaths up by 8% as of Aug. 12, primary care clinicians are readying to distribute the new COVID-19 booster that is expected to arrive in September.

David Cutler, MD, is hoping to vaccinate as many of his patients who want the shots. He and other primary care clinicians are finally back in the business of prevention after being sidelined during the pandemic.

Most primary care clinicians weren’t provided with the vaccine through the height of the pandemic, when federal officials instead focused their efforts on vaccine distribution through hospital systems and retail pharmacies. The consequence, primary care clinicians say, is that they have no records for patients who need the vaccine; they cannot send patients reminders; and they have no idea if an at-risk patient is ready for a booster.

“The role of primary care is educating people about COVID-19, testing for COVID-19 and other infections, providing access to vaccines and treatment, and sustaining our health care system to provide care, fight disease, and save lives,” said Dr. Cutler, a family physician at Providence Saint John’s Health Center in Santa Monica, Calif.

A study published in Health Affairs confirmed that primary care practices were not included in the federal vaccine strategy. The researchers found that by the end of 2021, 43.1% of 2,000 primary care practices had no records of COVID-19 vaccinations for patients. More than 90% had records for historically routine immunizations, such as influenza and shingles.

“I do believe if PCPs had earlier access to the vaccine, we could have done a better job vaccinating more people,” said Ann Greiner, MCP, president and chief executive officer of the Primary Care Collaborative, a nonprofit organization. “We need to make sure they’re back in that seat, providing the lion’s share of those vaccines.”
 

The roadblocks to vaccines

More than 20,000 primary care clinicians applied to distribute vaccines to patients as of April 2021, according to the Centers for Disease Control and Prevention. A quarter of those received the shots. Fewer than 5% of all vaccine doses were provided to primary care offices during that early stage of rollout.

Natasha Beauvais, MD, MPH, a family physician at Northern Virginia Family Practice in Alexandria, Va., said trying to vaccinate patients back then was a herculean task.

“We were desperate to get the vaccine, like many practices,” Dr. Beauvais said.

It was only by chance – through one of the physician’s work connections – that they got in touch with the city’s health department to request a supply of immunizations.

The requirements for becoming a vaccine provider were stringent: Dr. Beauvais had to show that her practice could appropriately refrigerate or freeze doses at much colder temperatures than most immunizations, monitor the storage unit at all times, and accurately record and schedule every dose. What’s more, most primary care practices lacked the bandwidth to conduct mass vaccinations like larger medical systems.

Robert L. Phillips Jr., MD, MSPH, founding executive director at the American Board of Family Medicine Foundation, said that the decision to sideline primary care practices, along with a poor records system, left clinicians struggling to leverage relationships with patients to boost rates of vaccination.

“Primary care is where most people have trusted health relationships, and it should be more than a footnote in the nation’s epidemic response plans,” said Dr. Phillips, a corresponding author of the Health Affairs study.

The exclusion of primary care has deep roots: These clinicians were mentioned as a footnote in the CDC’s 2017 Pandemic Influenza Plan, according to Dr. Phillips.

“There’s no one in the federal government who wakes up in the morning thinking of primary care,” Dr. Phillips said. “It’s not the only reason the numbers were down, but a big reason.”

Other countries, including Australia, utilized the specialty for vaccine distribution. A 2022 article in Australian Health Review noted that the success of Australia’s COVID-19 vaccine rollout came down to the involvement of primary care.

Dr. Cutler said his clinic also did as much as they could during the early pandemic – from keeping their urgent care clinic open to providing COVID-19 antibody testing and infusions. His practice was able to start vaccinating patients in March 2021, and by that summer, the office had provided the immunization to 4,000 patients. Dr. Cutler was also able to address any health problems these patients reported during their vaccination visit.

“A vaccine is not just a vaccine: It’s an opportunity to have a conversation between a primary care physician and a patient about other health issues, and it encultures people to get important preventive care,” Ms. Greiner said.

The Health Affairs study was supported by the CDC.

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

With COVID-19 hospitalizations up by 22% and deaths up by 8% as of Aug. 12, primary care clinicians are readying to distribute the new COVID-19 booster that is expected to arrive in September.

David Cutler, MD, is hoping to vaccinate as many of his patients who want the shots. He and other primary care clinicians are finally back in the business of prevention after being sidelined during the pandemic.

Most primary care clinicians weren’t provided with the vaccine through the height of the pandemic, when federal officials instead focused their efforts on vaccine distribution through hospital systems and retail pharmacies. The consequence, primary care clinicians say, is that they have no records for patients who need the vaccine; they cannot send patients reminders; and they have no idea if an at-risk patient is ready for a booster.

“The role of primary care is educating people about COVID-19, testing for COVID-19 and other infections, providing access to vaccines and treatment, and sustaining our health care system to provide care, fight disease, and save lives,” said Dr. Cutler, a family physician at Providence Saint John’s Health Center in Santa Monica, Calif.

A study published in Health Affairs confirmed that primary care practices were not included in the federal vaccine strategy. The researchers found that by the end of 2021, 43.1% of 2,000 primary care practices had no records of COVID-19 vaccinations for patients. More than 90% had records for historically routine immunizations, such as influenza and shingles.

“I do believe if PCPs had earlier access to the vaccine, we could have done a better job vaccinating more people,” said Ann Greiner, MCP, president and chief executive officer of the Primary Care Collaborative, a nonprofit organization. “We need to make sure they’re back in that seat, providing the lion’s share of those vaccines.”
 

The roadblocks to vaccines

More than 20,000 primary care clinicians applied to distribute vaccines to patients as of April 2021, according to the Centers for Disease Control and Prevention. A quarter of those received the shots. Fewer than 5% of all vaccine doses were provided to primary care offices during that early stage of rollout.

Natasha Beauvais, MD, MPH, a family physician at Northern Virginia Family Practice in Alexandria, Va., said trying to vaccinate patients back then was a herculean task.

“We were desperate to get the vaccine, like many practices,” Dr. Beauvais said.

It was only by chance – through one of the physician’s work connections – that they got in touch with the city’s health department to request a supply of immunizations.

The requirements for becoming a vaccine provider were stringent: Dr. Beauvais had to show that her practice could appropriately refrigerate or freeze doses at much colder temperatures than most immunizations, monitor the storage unit at all times, and accurately record and schedule every dose. What’s more, most primary care practices lacked the bandwidth to conduct mass vaccinations like larger medical systems.

Robert L. Phillips Jr., MD, MSPH, founding executive director at the American Board of Family Medicine Foundation, said that the decision to sideline primary care practices, along with a poor records system, left clinicians struggling to leverage relationships with patients to boost rates of vaccination.

“Primary care is where most people have trusted health relationships, and it should be more than a footnote in the nation’s epidemic response plans,” said Dr. Phillips, a corresponding author of the Health Affairs study.

The exclusion of primary care has deep roots: These clinicians were mentioned as a footnote in the CDC’s 2017 Pandemic Influenza Plan, according to Dr. Phillips.

“There’s no one in the federal government who wakes up in the morning thinking of primary care,” Dr. Phillips said. “It’s not the only reason the numbers were down, but a big reason.”

Other countries, including Australia, utilized the specialty for vaccine distribution. A 2022 article in Australian Health Review noted that the success of Australia’s COVID-19 vaccine rollout came down to the involvement of primary care.

Dr. Cutler said his clinic also did as much as they could during the early pandemic – from keeping their urgent care clinic open to providing COVID-19 antibody testing and infusions. His practice was able to start vaccinating patients in March 2021, and by that summer, the office had provided the immunization to 4,000 patients. Dr. Cutler was also able to address any health problems these patients reported during their vaccination visit.

“A vaccine is not just a vaccine: It’s an opportunity to have a conversation between a primary care physician and a patient about other health issues, and it encultures people to get important preventive care,” Ms. Greiner said.

The Health Affairs study was supported by the CDC.

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

With COVID-19 hospitalizations up by 22% and deaths up by 8% as of Aug. 12, primary care clinicians are readying to distribute the new COVID-19 booster that is expected to arrive in September.

David Cutler, MD, is hoping to vaccinate as many of his patients who want the shots. He and other primary care clinicians are finally back in the business of prevention after being sidelined during the pandemic.

Most primary care clinicians weren’t provided with the vaccine through the height of the pandemic, when federal officials instead focused their efforts on vaccine distribution through hospital systems and retail pharmacies. The consequence, primary care clinicians say, is that they have no records for patients who need the vaccine; they cannot send patients reminders; and they have no idea if an at-risk patient is ready for a booster.

“The role of primary care is educating people about COVID-19, testing for COVID-19 and other infections, providing access to vaccines and treatment, and sustaining our health care system to provide care, fight disease, and save lives,” said Dr. Cutler, a family physician at Providence Saint John’s Health Center in Santa Monica, Calif.

A study published in Health Affairs confirmed that primary care practices were not included in the federal vaccine strategy. The researchers found that by the end of 2021, 43.1% of 2,000 primary care practices had no records of COVID-19 vaccinations for patients. More than 90% had records for historically routine immunizations, such as influenza and shingles.

“I do believe if PCPs had earlier access to the vaccine, we could have done a better job vaccinating more people,” said Ann Greiner, MCP, president and chief executive officer of the Primary Care Collaborative, a nonprofit organization. “We need to make sure they’re back in that seat, providing the lion’s share of those vaccines.”
 

The roadblocks to vaccines

More than 20,000 primary care clinicians applied to distribute vaccines to patients as of April 2021, according to the Centers for Disease Control and Prevention. A quarter of those received the shots. Fewer than 5% of all vaccine doses were provided to primary care offices during that early stage of rollout.

Natasha Beauvais, MD, MPH, a family physician at Northern Virginia Family Practice in Alexandria, Va., said trying to vaccinate patients back then was a herculean task.

“We were desperate to get the vaccine, like many practices,” Dr. Beauvais said.

It was only by chance – through one of the physician’s work connections – that they got in touch with the city’s health department to request a supply of immunizations.

The requirements for becoming a vaccine provider were stringent: Dr. Beauvais had to show that her practice could appropriately refrigerate or freeze doses at much colder temperatures than most immunizations, monitor the storage unit at all times, and accurately record and schedule every dose. What’s more, most primary care practices lacked the bandwidth to conduct mass vaccinations like larger medical systems.

Robert L. Phillips Jr., MD, MSPH, founding executive director at the American Board of Family Medicine Foundation, said that the decision to sideline primary care practices, along with a poor records system, left clinicians struggling to leverage relationships with patients to boost rates of vaccination.

“Primary care is where most people have trusted health relationships, and it should be more than a footnote in the nation’s epidemic response plans,” said Dr. Phillips, a corresponding author of the Health Affairs study.

The exclusion of primary care has deep roots: These clinicians were mentioned as a footnote in the CDC’s 2017 Pandemic Influenza Plan, according to Dr. Phillips.

“There’s no one in the federal government who wakes up in the morning thinking of primary care,” Dr. Phillips said. “It’s not the only reason the numbers were down, but a big reason.”

Other countries, including Australia, utilized the specialty for vaccine distribution. A 2022 article in Australian Health Review noted that the success of Australia’s COVID-19 vaccine rollout came down to the involvement of primary care.

Dr. Cutler said his clinic also did as much as they could during the early pandemic – from keeping their urgent care clinic open to providing COVID-19 antibody testing and infusions. His practice was able to start vaccinating patients in March 2021, and by that summer, the office had provided the immunization to 4,000 patients. Dr. Cutler was also able to address any health problems these patients reported during their vaccination visit.

“A vaccine is not just a vaccine: It’s an opportunity to have a conversation between a primary care physician and a patient about other health issues, and it encultures people to get important preventive care,” Ms. Greiner said.

The Health Affairs study was supported by the CDC.

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

For the first time in the fall of 2023, families will be offered season-long protection for infants and some children against respiratory syncytial virus (RSV).

The Food and Drug Administration in July approved a prevention called nirsevimab (Beyfortus, AstraZeneca/Sanofi) and it is expected to be widely rolled out in the coming weeks as the RSV season begins.

It’s not a vaccine, but a monoclonal antibody used for prevention. That may cause confusion because a vaccine for RSV was approved just 3 months ago for adults aged 60 and older. And monoclonal antibodies are often used for treatment rather than prevention.

Adding to potential confusion is the fact the Centers for Disease Control and Prevention has included nirsevimab in the Vaccines for Children program, which covers the costs for uninsured kids and makes it more accessible.

Nirsevimab is approved for infants (up to 8 months old) born during or entering their first RSV season, and in children up to 2 years of age who are still vulnerable to severe RSV through their second season.

It’s recommended that all infants get one injection in their first 8 months for prevention instead of the previous monthly shots used to help prevent kids at high risk from getting severe RSV.

If monoclonal antibodies can be used for preventing disease in infants, could they become a viable vaccine alternative for adults?

Specialists say no.

That’s partly because of the difference in body size. Although an injection is an option for a newborn, pediatricians suggest, it would take far too much of the treatment to work as a shot for adults.

Ruth Karron, MD, an expert in pediatric infectious diseases at Johns Hopkins Medicine, Baltimore, said that, while vaccines come in small amounts and activate immune cells, monoclonal antibodies are more like a drug, with the dose based on weight.

“You’d have to give it intravenously,” for larger doses, she explained, which has never been studied before and would also be very expensive. “It really couldn’t be an option for adults.”
 

What’s the difference between vaccines and antibodies?

Monoclonal antibodies are proteins made in a lab to mimic the immune system’s ability to fight pathogens such as viruses.

Dr. Karron explained that a wide variety of monoclonal antibodies have long been used to treat diseases such as cancers and autoimmune disease. In recent years, the antibodies have been used to treat COVID.

Monoclonal antibodies have also been used to treat RSV in children, but the effects don’t last long – they confer passive immunity and “when it’s gone, it’s gone,” Dr. Karron said.

That means kids at high risk for severe RSV have had to get monthly injections.

But with nirsevimab, the mutated antibodies stay in circulation longer so they can last 5 or 6 months, enough to cover the RSV season, Dr. Karron explained. “It’s highly, highly effective.”
 

Vaccines train the body

“The idea with vaccines is that you engage the individual’s immune system. You teach it to make antibodies,” Dr. Karron said. Conversely, “you give an antibody and it’s good for as long as the antibody lasts. It’s not teaching your body anything.”

Frank Esper, MD, a pediatric infectious disease specialist at Cleveland Clinic Children’s Hospital, said monoclonal antibody protection for RSV is particularly welcome. “We’ve been trying to make an RSV vaccine since the 1960s and have done nothing but fail miserably.”

“The best thing is always a vaccine,” Dr. Esper said, explaining that vaccines teach the body to make its own antibodies and confer long-term protection and are “probably more efficacious than anything that’s ever manmade.

“But since we’ve really not done very well for pediatric RSV vaccines, nirsevimab is certainly something I’m looking forward to,” he said.
 

Fast-acting monoclonal antibodies

An advantage for monoclonal antibodies is that they start working almost immediately.

Children can get sick with RSV in the first few months of life so the speed of the monoclonal antibodies to begin protection is important, Dr. Esper said, adding that RSV “is the worst during the first year of life.”

The peak age for babies getting infected enough to require hospitalization is about 2 months, he said.

By 14 months, he said, kids’ immune systems and airways have matured enough “that it’s not nearly as bad.”

To get protection from a vaccine, he added, “usually takes 2-4 weeks from the time you get your shot to the time you see some benefit. With an antibody, you’re bypassing the processing that the body has to do, and it goes straight to ‘protection’ mode,” Dr. Esper said. “You get protected pretty much as soon as you get the antibody.”

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

For the first time in the fall of 2023, families will be offered season-long protection for infants and some children against respiratory syncytial virus (RSV).

The Food and Drug Administration in July approved a prevention called nirsevimab (Beyfortus, AstraZeneca/Sanofi) and it is expected to be widely rolled out in the coming weeks as the RSV season begins.

It’s not a vaccine, but a monoclonal antibody used for prevention. That may cause confusion because a vaccine for RSV was approved just 3 months ago for adults aged 60 and older. And monoclonal antibodies are often used for treatment rather than prevention.

Adding to potential confusion is the fact the Centers for Disease Control and Prevention has included nirsevimab in the Vaccines for Children program, which covers the costs for uninsured kids and makes it more accessible.

Nirsevimab is approved for infants (up to 8 months old) born during or entering their first RSV season, and in children up to 2 years of age who are still vulnerable to severe RSV through their second season.

It’s recommended that all infants get one injection in their first 8 months for prevention instead of the previous monthly shots used to help prevent kids at high risk from getting severe RSV.

If monoclonal antibodies can be used for preventing disease in infants, could they become a viable vaccine alternative for adults?

Specialists say no.

That’s partly because of the difference in body size. Although an injection is an option for a newborn, pediatricians suggest, it would take far too much of the treatment to work as a shot for adults.

Ruth Karron, MD, an expert in pediatric infectious diseases at Johns Hopkins Medicine, Baltimore, said that, while vaccines come in small amounts and activate immune cells, monoclonal antibodies are more like a drug, with the dose based on weight.

“You’d have to give it intravenously,” for larger doses, she explained, which has never been studied before and would also be very expensive. “It really couldn’t be an option for adults.”
 

What’s the difference between vaccines and antibodies?

Monoclonal antibodies are proteins made in a lab to mimic the immune system’s ability to fight pathogens such as viruses.

Dr. Karron explained that a wide variety of monoclonal antibodies have long been used to treat diseases such as cancers and autoimmune disease. In recent years, the antibodies have been used to treat COVID.

Monoclonal antibodies have also been used to treat RSV in children, but the effects don’t last long – they confer passive immunity and “when it’s gone, it’s gone,” Dr. Karron said.

That means kids at high risk for severe RSV have had to get monthly injections.

But with nirsevimab, the mutated antibodies stay in circulation longer so they can last 5 or 6 months, enough to cover the RSV season, Dr. Karron explained. “It’s highly, highly effective.”
 

Vaccines train the body

“The idea with vaccines is that you engage the individual’s immune system. You teach it to make antibodies,” Dr. Karron said. Conversely, “you give an antibody and it’s good for as long as the antibody lasts. It’s not teaching your body anything.”

Frank Esper, MD, a pediatric infectious disease specialist at Cleveland Clinic Children’s Hospital, said monoclonal antibody protection for RSV is particularly welcome. “We’ve been trying to make an RSV vaccine since the 1960s and have done nothing but fail miserably.”

“The best thing is always a vaccine,” Dr. Esper said, explaining that vaccines teach the body to make its own antibodies and confer long-term protection and are “probably more efficacious than anything that’s ever manmade.

“But since we’ve really not done very well for pediatric RSV vaccines, nirsevimab is certainly something I’m looking forward to,” he said.
 

Fast-acting monoclonal antibodies

An advantage for monoclonal antibodies is that they start working almost immediately.

Children can get sick with RSV in the first few months of life so the speed of the monoclonal antibodies to begin protection is important, Dr. Esper said, adding that RSV “is the worst during the first year of life.”

The peak age for babies getting infected enough to require hospitalization is about 2 months, he said.

By 14 months, he said, kids’ immune systems and airways have matured enough “that it’s not nearly as bad.”

To get protection from a vaccine, he added, “usually takes 2-4 weeks from the time you get your shot to the time you see some benefit. With an antibody, you’re bypassing the processing that the body has to do, and it goes straight to ‘protection’ mode,” Dr. Esper said. “You get protected pretty much as soon as you get the antibody.”

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

For the first time in the fall of 2023, families will be offered season-long protection for infants and some children against respiratory syncytial virus (RSV).

The Food and Drug Administration in July approved a prevention called nirsevimab (Beyfortus, AstraZeneca/Sanofi) and it is expected to be widely rolled out in the coming weeks as the RSV season begins.

It’s not a vaccine, but a monoclonal antibody used for prevention. That may cause confusion because a vaccine for RSV was approved just 3 months ago for adults aged 60 and older. And monoclonal antibodies are often used for treatment rather than prevention.

Adding to potential confusion is the fact the Centers for Disease Control and Prevention has included nirsevimab in the Vaccines for Children program, which covers the costs for uninsured kids and makes it more accessible.

Nirsevimab is approved for infants (up to 8 months old) born during or entering their first RSV season, and in children up to 2 years of age who are still vulnerable to severe RSV through their second season.

It’s recommended that all infants get one injection in their first 8 months for prevention instead of the previous monthly shots used to help prevent kids at high risk from getting severe RSV.

If monoclonal antibodies can be used for preventing disease in infants, could they become a viable vaccine alternative for adults?

Specialists say no.

That’s partly because of the difference in body size. Although an injection is an option for a newborn, pediatricians suggest, it would take far too much of the treatment to work as a shot for adults.

Ruth Karron, MD, an expert in pediatric infectious diseases at Johns Hopkins Medicine, Baltimore, said that, while vaccines come in small amounts and activate immune cells, monoclonal antibodies are more like a drug, with the dose based on weight.

“You’d have to give it intravenously,” for larger doses, she explained, which has never been studied before and would also be very expensive. “It really couldn’t be an option for adults.”
 

What’s the difference between vaccines and antibodies?

Monoclonal antibodies are proteins made in a lab to mimic the immune system’s ability to fight pathogens such as viruses.

Dr. Karron explained that a wide variety of monoclonal antibodies have long been used to treat diseases such as cancers and autoimmune disease. In recent years, the antibodies have been used to treat COVID.

Monoclonal antibodies have also been used to treat RSV in children, but the effects don’t last long – they confer passive immunity and “when it’s gone, it’s gone,” Dr. Karron said.

That means kids at high risk for severe RSV have had to get monthly injections.

But with nirsevimab, the mutated antibodies stay in circulation longer so they can last 5 or 6 months, enough to cover the RSV season, Dr. Karron explained. “It’s highly, highly effective.”
 

Vaccines train the body

“The idea with vaccines is that you engage the individual’s immune system. You teach it to make antibodies,” Dr. Karron said. Conversely, “you give an antibody and it’s good for as long as the antibody lasts. It’s not teaching your body anything.”

Frank Esper, MD, a pediatric infectious disease specialist at Cleveland Clinic Children’s Hospital, said monoclonal antibody protection for RSV is particularly welcome. “We’ve been trying to make an RSV vaccine since the 1960s and have done nothing but fail miserably.”

“The best thing is always a vaccine,” Dr. Esper said, explaining that vaccines teach the body to make its own antibodies and confer long-term protection and are “probably more efficacious than anything that’s ever manmade.

“But since we’ve really not done very well for pediatric RSV vaccines, nirsevimab is certainly something I’m looking forward to,” he said.
 

Fast-acting monoclonal antibodies

An advantage for monoclonal antibodies is that they start working almost immediately.

Children can get sick with RSV in the first few months of life so the speed of the monoclonal antibodies to begin protection is important, Dr. Esper said, adding that RSV “is the worst during the first year of life.”

The peak age for babies getting infected enough to require hospitalization is about 2 months, he said.

By 14 months, he said, kids’ immune systems and airways have matured enough “that it’s not nearly as bad.”

To get protection from a vaccine, he added, “usually takes 2-4 weeks from the time you get your shot to the time you see some benefit. With an antibody, you’re bypassing the processing that the body has to do, and it goes straight to ‘protection’ mode,” Dr. Esper said. “You get protected pretty much as soon as you get the antibody.”

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