MDedge Neurology

New research provides strong evidence of an association between abdominal fat and reduced brain volumes, particularly those involved with cognitive function.

In a large study of healthy middle-aged adults, greater visceral and subcutaneous abdominal fat on abdominal MRI predicted brain atrophy on imaging, especially in women.

“The study shows that excess fat is bad for the brain and worse in women, including in Alzheimer’s disease risk regions,” lead author Cyrus Raji, MD, PhD, with the Mallinckrodt Institute of Radiology, Washington University, St. Louis, Mo., said in an interview.

The study was published online in the journal Aging and Disease
 

Modifiable risk factor

Multiple studies have suggested a connection between body fat accumulation and increased dementia risk. But few have examined the relationship between types of fat (visceral and subcutaneous) and brain volume.

For the new study, 10,000 healthy adults aged 20-80 years (mean age, 52.9 years; 53% men) underwent a short whole-body MRI protocol. Regression analyses of abdominal fat types and normalized brain volumes were evaluated, controlling for age and sex.

The research team found that higher amounts of both visceral and subcutaneous abdominal fat predicted lower total gray and white matter volume, as well as lower volume in the hippocampus, frontal cortex, and temporal, parietal, and occipital lobes.

“The findings are quite dramatic,” Dr. Raji told this news organization. “Overall, we found that both subcutaneous and visceral fat has similar levels of negative relationships with brain volumes.”

Women had a higher burden of brain atrophy with increased visceral fat than men. However, it’s difficult to place the sex differences in context because of the lack of prior work specifically investigating visceral fat, brain volume loss, and sex differences, the researchers caution.

They also note that while statistically significant relationships were observed between visceral fat levels and gray matter volume changes, their effect sizes were generally small. 

“Thus, the statistical significance of this work is influenced by the large sample size and less so by large effect size in any given set of regions,” the investigators write.

Other limitations include the cross-sectional nature of the study, which precludes conclusions about causality. The analysis also did not account for other lifestyle factors such as physical activity, diet, and genetic variables.

The researchers call for further investigation “to better elucidate underlying mechanisms and discover possible interventions targeting abdominal fat reduction as a strategy to maintain brain health.”
 

‘Helpful addition to the literature’

In a comment, Claire Sexton, DPhil, Alzheimer’s Association senior director of scientific programs and outreach, noted that “previous studies have linked obesity with cognitive decline and increased risk of dementia. Rather than using BMI as a proxy for body fat, the current study examined visceral and subcutaneous fat directly using imaging techniques.”

Dr. Sexton, who was not associated with this study, said the finding that increased body fat was associated with reduced brain volumes suggests “a possible mechanism to explain the previously reported associations between obesity and cognition.”

“Though some degree of atrophy and brain shrinkage is common with old age, awareness of this association is important because reduced brain volume may be associated with problems with thinking, memory, and performing everyday tasks, and because rates of obesity continue to rise in the United States, along with obesity-related conditions including heart disease, stroke, type 2 diabetes and certain types of cancer,” she added.

“While a helpful addition to the literature, the study does have important limitations. As an observational study, it cannot establish whether higher levels of body fat directly causes reduced brain volumes,” Dr. Sexton cautioned.

In addition, the study did not take into account important related factors like physical activity and diet, which may influence any relationship between body fat and brain volumes, she noted. “Overall, it is not just one factor that is important to consider when considering risk for cognitive decline and dementia, but multiple factors.

“Obesity and the location of body fat must be considered in combination with one’s total lived experience and habits, including physical activity, education, head injury, sleep, mental health, and the health of your heart/cardiovascular system and other key bodily systems,” Dr. Sexton said.

The Alzheimer’s Association is leading a 2-year clinical trial known as U.S. POINTER to see whether combining physical activity, healthy nutrition, social and intellectual challenges, and improved self-management of medical conditions can protect cognitive function in older adults who are at increased risk for cognitive decline.

This work was supported in part by Providence St. Joseph Health in Seattle; Saint John’s Health Center Foundation; Pacific Neuroscience Institute and Foundation; Will and Cary Singleton; and the McLoughlin family. Dr. Raji is a consultant for Brainreader, Apollo Health, Voxelwise, Neurevolution, Pacific Neuroscience Institute Foundation, and Icometrix. Dr. Sexton reports no relevant financial relationships.

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

New research provides strong evidence of an association between abdominal fat and reduced brain volumes, particularly those involved with cognitive function.

In a large study of healthy middle-aged adults, greater visceral and subcutaneous abdominal fat on abdominal MRI predicted brain atrophy on imaging, especially in women.

“The study shows that excess fat is bad for the brain and worse in women, including in Alzheimer’s disease risk regions,” lead author Cyrus Raji, MD, PhD, with the Mallinckrodt Institute of Radiology, Washington University, St. Louis, Mo., said in an interview.

The study was published online in the journal Aging and Disease
 

Modifiable risk factor

Multiple studies have suggested a connection between body fat accumulation and increased dementia risk. But few have examined the relationship between types of fat (visceral and subcutaneous) and brain volume.

For the new study, 10,000 healthy adults aged 20-80 years (mean age, 52.9 years; 53% men) underwent a short whole-body MRI protocol. Regression analyses of abdominal fat types and normalized brain volumes were evaluated, controlling for age and sex.

The research team found that higher amounts of both visceral and subcutaneous abdominal fat predicted lower total gray and white matter volume, as well as lower volume in the hippocampus, frontal cortex, and temporal, parietal, and occipital lobes.

“The findings are quite dramatic,” Dr. Raji told this news organization. “Overall, we found that both subcutaneous and visceral fat has similar levels of negative relationships with brain volumes.”

Women had a higher burden of brain atrophy with increased visceral fat than men. However, it’s difficult to place the sex differences in context because of the lack of prior work specifically investigating visceral fat, brain volume loss, and sex differences, the researchers caution.

They also note that while statistically significant relationships were observed between visceral fat levels and gray matter volume changes, their effect sizes were generally small. 

“Thus, the statistical significance of this work is influenced by the large sample size and less so by large effect size in any given set of regions,” the investigators write.

Other limitations include the cross-sectional nature of the study, which precludes conclusions about causality. The analysis also did not account for other lifestyle factors such as physical activity, diet, and genetic variables.

The researchers call for further investigation “to better elucidate underlying mechanisms and discover possible interventions targeting abdominal fat reduction as a strategy to maintain brain health.”
 

‘Helpful addition to the literature’

In a comment, Claire Sexton, DPhil, Alzheimer’s Association senior director of scientific programs and outreach, noted that “previous studies have linked obesity with cognitive decline and increased risk of dementia. Rather than using BMI as a proxy for body fat, the current study examined visceral and subcutaneous fat directly using imaging techniques.”

Dr. Sexton, who was not associated with this study, said the finding that increased body fat was associated with reduced brain volumes suggests “a possible mechanism to explain the previously reported associations between obesity and cognition.”

“Though some degree of atrophy and brain shrinkage is common with old age, awareness of this association is important because reduced brain volume may be associated with problems with thinking, memory, and performing everyday tasks, and because rates of obesity continue to rise in the United States, along with obesity-related conditions including heart disease, stroke, type 2 diabetes and certain types of cancer,” she added.

“While a helpful addition to the literature, the study does have important limitations. As an observational study, it cannot establish whether higher levels of body fat directly causes reduced brain volumes,” Dr. Sexton cautioned.

In addition, the study did not take into account important related factors like physical activity and diet, which may influence any relationship between body fat and brain volumes, she noted. “Overall, it is not just one factor that is important to consider when considering risk for cognitive decline and dementia, but multiple factors.

“Obesity and the location of body fat must be considered in combination with one’s total lived experience and habits, including physical activity, education, head injury, sleep, mental health, and the health of your heart/cardiovascular system and other key bodily systems,” Dr. Sexton said.

The Alzheimer’s Association is leading a 2-year clinical trial known as U.S. POINTER to see whether combining physical activity, healthy nutrition, social and intellectual challenges, and improved self-management of medical conditions can protect cognitive function in older adults who are at increased risk for cognitive decline.

This work was supported in part by Providence St. Joseph Health in Seattle; Saint John’s Health Center Foundation; Pacific Neuroscience Institute and Foundation; Will and Cary Singleton; and the McLoughlin family. Dr. Raji is a consultant for Brainreader, Apollo Health, Voxelwise, Neurevolution, Pacific Neuroscience Institute Foundation, and Icometrix. Dr. Sexton reports no relevant financial relationships.

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

New research provides strong evidence of an association between abdominal fat and reduced brain volumes, particularly those involved with cognitive function.

In a large study of healthy middle-aged adults, greater visceral and subcutaneous abdominal fat on abdominal MRI predicted brain atrophy on imaging, especially in women.

“The study shows that excess fat is bad for the brain and worse in women, including in Alzheimer’s disease risk regions,” lead author Cyrus Raji, MD, PhD, with the Mallinckrodt Institute of Radiology, Washington University, St. Louis, Mo., said in an interview.

The study was published online in the journal Aging and Disease
 

Modifiable risk factor

Multiple studies have suggested a connection between body fat accumulation and increased dementia risk. But few have examined the relationship between types of fat (visceral and subcutaneous) and brain volume.

For the new study, 10,000 healthy adults aged 20-80 years (mean age, 52.9 years; 53% men) underwent a short whole-body MRI protocol. Regression analyses of abdominal fat types and normalized brain volumes were evaluated, controlling for age and sex.

The research team found that higher amounts of both visceral and subcutaneous abdominal fat predicted lower total gray and white matter volume, as well as lower volume in the hippocampus, frontal cortex, and temporal, parietal, and occipital lobes.

“The findings are quite dramatic,” Dr. Raji told this news organization. “Overall, we found that both subcutaneous and visceral fat has similar levels of negative relationships with brain volumes.”

Women had a higher burden of brain atrophy with increased visceral fat than men. However, it’s difficult to place the sex differences in context because of the lack of prior work specifically investigating visceral fat, brain volume loss, and sex differences, the researchers caution.

They also note that while statistically significant relationships were observed between visceral fat levels and gray matter volume changes, their effect sizes were generally small. 

“Thus, the statistical significance of this work is influenced by the large sample size and less so by large effect size in any given set of regions,” the investigators write.

Other limitations include the cross-sectional nature of the study, which precludes conclusions about causality. The analysis also did not account for other lifestyle factors such as physical activity, diet, and genetic variables.

The researchers call for further investigation “to better elucidate underlying mechanisms and discover possible interventions targeting abdominal fat reduction as a strategy to maintain brain health.”
 

‘Helpful addition to the literature’

In a comment, Claire Sexton, DPhil, Alzheimer’s Association senior director of scientific programs and outreach, noted that “previous studies have linked obesity with cognitive decline and increased risk of dementia. Rather than using BMI as a proxy for body fat, the current study examined visceral and subcutaneous fat directly using imaging techniques.”

Dr. Sexton, who was not associated with this study, said the finding that increased body fat was associated with reduced brain volumes suggests “a possible mechanism to explain the previously reported associations between obesity and cognition.”

“Though some degree of atrophy and brain shrinkage is common with old age, awareness of this association is important because reduced brain volume may be associated with problems with thinking, memory, and performing everyday tasks, and because rates of obesity continue to rise in the United States, along with obesity-related conditions including heart disease, stroke, type 2 diabetes and certain types of cancer,” she added.

“While a helpful addition to the literature, the study does have important limitations. As an observational study, it cannot establish whether higher levels of body fat directly causes reduced brain volumes,” Dr. Sexton cautioned.

In addition, the study did not take into account important related factors like physical activity and diet, which may influence any relationship between body fat and brain volumes, she noted. “Overall, it is not just one factor that is important to consider when considering risk for cognitive decline and dementia, but multiple factors.

“Obesity and the location of body fat must be considered in combination with one’s total lived experience and habits, including physical activity, education, head injury, sleep, mental health, and the health of your heart/cardiovascular system and other key bodily systems,” Dr. Sexton said.

The Alzheimer’s Association is leading a 2-year clinical trial known as U.S. POINTER to see whether combining physical activity, healthy nutrition, social and intellectual challenges, and improved self-management of medical conditions can protect cognitive function in older adults who are at increased risk for cognitive decline.

This work was supported in part by Providence St. Joseph Health in Seattle; Saint John’s Health Center Foundation; Pacific Neuroscience Institute and Foundation; Will and Cary Singleton; and the McLoughlin family. Dr. Raji is a consultant for Brainreader, Apollo Health, Voxelwise, Neurevolution, Pacific Neuroscience Institute Foundation, and Icometrix. Dr. Sexton reports no relevant financial relationships.

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

I’m really going to miss Jimmy Buffett.

I’ve liked his music as far back as I can remember, and was lucky enough to see him in person in the mid-90s.

I’ve written about music before, but its affect on us never fails to amaze me. Songs can be background noise conducive to getting things done. They can also be in the foreground, serving as a mental vacation (or accompanying a real one). They can transport you to another place, briefly clearing your head from the daily goings-on around you. Even if it’s just during the drive home, it’s a welcome escape to a virtual beach and tropical drink.

Songs can bring back memories of certain events or people that we link them to. My dad loved anything by Neil Diamond, and nothing brings back thoughts of Dad more than when my iTunes randomly picks “I Am ... I Said.” Or John Williams’ Star Wars theme, taking me back to the summer of 1977 when I sat, spellbound, by this incredible movie whose magic is still going strong two generations later.

It’s amazing how our brain tries to make music out of nothing. Even in silence we have ear worms, the songs stuck in our head for hours to days (recently I’ve had “I Sing the Body Electric” from the 1980 movie Fame playing in there).

My office is over an MRI scanner, so I can always hear the chiller pumps softly running in the background. Sometimes my brain will turn their rhythmic chirping into a song, altering the pace of the song to fit them. The soft clicking of the ceiling fan, in my home office, does the same thing (for some reason my brain usually tries to fit “Yellow Submarine” to that one, no idea why).

Music is a part of that mysterious essence that makes us human. It touches all of us in some way, which varies between people, songs, and artists.

Jimmy Buffet’s music has a vacation vibe. Songs of the Caribbean & Keys, beaches, bars, boats, and tropical drinks. The 4:12 running time of his most well-known song, “Margaritaville,” gives a brief respite from my day when it comes on.

He passes into the beyond, to the sadness of his family, friends, and fans. But, unlike people, music can be immortal, and so he lives on through his creations. Like, Bach, Lennon, Bowie, Joplin, Sousa, and too many others to count, his work – and the enjoyment we get from it – are a gift left behind for the future.

Tight lines, Jimmy.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

I’m really going to miss Jimmy Buffett.

I’ve liked his music as far back as I can remember, and was lucky enough to see him in person in the mid-90s.

I’ve written about music before, but its affect on us never fails to amaze me. Songs can be background noise conducive to getting things done. They can also be in the foreground, serving as a mental vacation (or accompanying a real one). They can transport you to another place, briefly clearing your head from the daily goings-on around you. Even if it’s just during the drive home, it’s a welcome escape to a virtual beach and tropical drink.

Songs can bring back memories of certain events or people that we link them to. My dad loved anything by Neil Diamond, and nothing brings back thoughts of Dad more than when my iTunes randomly picks “I Am ... I Said.” Or John Williams’ Star Wars theme, taking me back to the summer of 1977 when I sat, spellbound, by this incredible movie whose magic is still going strong two generations later.

It’s amazing how our brain tries to make music out of nothing. Even in silence we have ear worms, the songs stuck in our head for hours to days (recently I’ve had “I Sing the Body Electric” from the 1980 movie Fame playing in there).

My office is over an MRI scanner, so I can always hear the chiller pumps softly running in the background. Sometimes my brain will turn their rhythmic chirping into a song, altering the pace of the song to fit them. The soft clicking of the ceiling fan, in my home office, does the same thing (for some reason my brain usually tries to fit “Yellow Submarine” to that one, no idea why).

Music is a part of that mysterious essence that makes us human. It touches all of us in some way, which varies between people, songs, and artists.

Jimmy Buffet’s music has a vacation vibe. Songs of the Caribbean & Keys, beaches, bars, boats, and tropical drinks. The 4:12 running time of his most well-known song, “Margaritaville,” gives a brief respite from my day when it comes on.

He passes into the beyond, to the sadness of his family, friends, and fans. But, unlike people, music can be immortal, and so he lives on through his creations. Like, Bach, Lennon, Bowie, Joplin, Sousa, and too many others to count, his work – and the enjoyment we get from it – are a gift left behind for the future.

Tight lines, Jimmy.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

I’m really going to miss Jimmy Buffett.

I’ve liked his music as far back as I can remember, and was lucky enough to see him in person in the mid-90s.

I’ve written about music before, but its affect on us never fails to amaze me. Songs can be background noise conducive to getting things done. They can also be in the foreground, serving as a mental vacation (or accompanying a real one). They can transport you to another place, briefly clearing your head from the daily goings-on around you. Even if it’s just during the drive home, it’s a welcome escape to a virtual beach and tropical drink.

Songs can bring back memories of certain events or people that we link them to. My dad loved anything by Neil Diamond, and nothing brings back thoughts of Dad more than when my iTunes randomly picks “I Am ... I Said.” Or John Williams’ Star Wars theme, taking me back to the summer of 1977 when I sat, spellbound, by this incredible movie whose magic is still going strong two generations later.

It’s amazing how our brain tries to make music out of nothing. Even in silence we have ear worms, the songs stuck in our head for hours to days (recently I’ve had “I Sing the Body Electric” from the 1980 movie Fame playing in there).

My office is over an MRI scanner, so I can always hear the chiller pumps softly running in the background. Sometimes my brain will turn their rhythmic chirping into a song, altering the pace of the song to fit them. The soft clicking of the ceiling fan, in my home office, does the same thing (for some reason my brain usually tries to fit “Yellow Submarine” to that one, no idea why).

Music is a part of that mysterious essence that makes us human. It touches all of us in some way, which varies between people, songs, and artists.

Jimmy Buffet’s music has a vacation vibe. Songs of the Caribbean & Keys, beaches, bars, boats, and tropical drinks. The 4:12 running time of his most well-known song, “Margaritaville,” gives a brief respite from my day when it comes on.

He passes into the beyond, to the sadness of his family, friends, and fans. But, unlike people, music can be immortal, and so he lives on through his creations. Like, Bach, Lennon, Bowie, Joplin, Sousa, and too many others to count, his work – and the enjoyment we get from it – are a gift left behind for the future.

Tight lines, Jimmy.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

AURORA, COLO. – Several drugs for multiple sclerosis (MS) that are contraindicated during pregnancy nevertheless have not shown concerning safety signals in a series of small studies presented as posters at the annual meeting of the Consortium of Multiple Sclerosis Centers. The industry-sponsored research included an assessment of pregnancy and infant outcomes for cladribine, ocrelizumab, ofatumumab, and ozanimod, all of which are not recommended during pregnancy based primarily on minimal data that suggests, but does not confirm, possible teratogenicity.

“When these new medications hit the market, maternal-fetal medicine physicians and obstetricians are left with very scant data on how to counsel patients, and it’s often based on theory, case reports, or animal studies,” said Teodora Kolarova, MD, a maternal-fetal medicine physician at the University of Washington, Seattle, who was not involved in any of the research. “Although these sample sizes seem small, the population they are sampling from – patients with MS who take immunomodulators who then experience a pregnancy – is much smaller than all pregnant patients.”

Taken together, the findings suggest no increased risk of miscarriage or congenital malformation, compared with baseline risk, Dr. Kolarova said.

“As a whole, these studies are overall reassuring with, of course, some caveats, including timing of medication exposure, limited sample size, and limited outcome data,” Dr. Kolarova said. She noted that embryonic organ formation is complete by 10 weeks gestation, by which time an unplanned pregnancy may not have been recognized yet. “In the subset of patients in the studies that were exposed during the first trimester, there was no increase in congenital malformations from a baseline risk of about 2%-3% in the general population, which is helpful for patient counseling.”
 

Counseling during the childbearing years

That kind of counseling is important yet absent for many people capable of pregnancy, suggests separate research also presented at the conference by Suma Shah, MD, an associate professor of neurology at Duke University, Durham, N.C. Dr. Shah gave 13-question surveys to female MS patients of all ages at her institution and presented an analysis of data from 38 completed surveys. Among those taking disease-modifying therapies, their medications included ocrelizumab, rituximab, teriflunomide, fingolimod, fumarates, interferons, natalizumab, and cladribine.

“MS disproportionately impacts women among 20 to 40 years, and that’s a really big part of their childbearing years when there are big decisions being made about whether they’re going to choose to grow family or not,” said Dr. Shah. The average age of those who completed the survey was 44. Dr. Shah noted that a lot of research has looked at the safety of older disease-modifying agents in pregnancy, but that information doesn’t appear to be filtering down to patients. “What I really wanted to look at is what do our parent patients understand about whether or not they can even think about pregnancy – and there’s a lot of work to be done.”

Just under a third of survey respondents said they did not have as many children as they would like, and a quarter said they were told they couldn’t have children if they had a diagnosis of MS.

“That was a little heartbreaking to hear because that’s not the truth,” Dr. Shah said. She said it’s necessary to have a more detailed conversation looking at tailored decisions for patients. “Both of those things – patients not being able to grow their family to the number that they desire, and not feeling like they can grow a family – I would think in 2023 we would have come farther than that, and there’s still a lot of room there to improve.”

She advised clinicians not to assume that MS patients know what their options are regarding family planning. “There’s still a lot of room for conversations,” she said. She also explicitly recommends discussing family planning and pregnancy planning with every patient, no matter their gender, early and often.
 

Cladribine shows no miscarriage, malformations

Dr. Kolarova noted that one of the studies, on cladribine, had a fairly robust sample size with its 180 pregnancy exposures. In that study, led by Kerstin Hellwig, MD, of Ruhr University in Bochum, Germany, data came from the global surveillance program MAPLE-MS, established to assess cladribine effects on pregnancy and infant outcomes. The researchers analyzed data from 76 mothers and 9 fathers who, at any time from 2017 to 2022, were taking cladribine during pregnancy or up to 6 months before pregnancy. Outcomes included live birth, miscarriage, stillbirth, elective abortion, ectopic pregnancy, and major congenital anomalies.

Just over half the mothers (53.9%) were exposed before pregnancy, and about a quarter (26.3%) were exposed during the first trimester. The timing was unknown for most of the other mothers (18.4%). Among the fathers, two-thirds (66.7%) were exposed before pregnancy, and one-third had unknown timing.

Among the 180 pregnancies in the maternal cohort, 42.2% had known outcomes. Nearly half the women (48.7%) taking cladribine had live births, 28.9% had elective abortions, and 21.1% had miscarriages. Only 9 of the 22 pregnancies in the paternal cohort had known outcomes, which included 88.9% live births and 11.1% miscarriages. None of the pregnancies resulted in stillbirth or in a live birth with major congenital anomalies.

”Robust conclusions cannot be made about the risks of adverse pregnancy outcomes with cladribine tablets, but no increase has been signaled thus far,” the researchers reported. ”It is necessary to counsel patients to prevent pregnancy and to use effective contraception during cladribine tablets intake and for at least 6 months after the last cladribine tablet intake in each treatment year.”

Emily Evans, MD, MBE, medical director at U.S. Neurology and Immunology in Rockland, Mass., speaking on behalf of the findings, said they were fairly encouraging.

“Of course, we don’t encourage patients to get pregnant within 6 months of their last dose of cladribine tablets,” Dr. Evans said, but “within those individuals who have gotten pregnant within 6 months of their last dose of cladribine, or who have fathered a child within 6 months of their last dose of cladribine tablets, we’re seeing overall encouraging outcomes. We’re specifically not seeing any differences in the rates of spontaneous abortions, and we’re not seeing any differences in the rates of congenital malformations.”
 

Ocrelizumab and ofatumumab: No infections so far

Current recommendations for ocrelizumab are to avoid pregnancy for 6 months after the last infusion and stop any breastfeeding during therapy. Yet these recommendations are only because of insufficient data rather than evidence of risk, according to Lana Zhovtis Ryerson, MD, of the NYU Multiple Sclerosis Comprehensive Care Center in New York. She and her colleagues identified all women of childbearing age who had received ocrelizumab within 1 year of pregnancy at their NYU institution. A retrospective chart review found 18 women, with an average age of 35, an average 11 years of an MS diagnosis, and an average 11 months taking ocrelizumab.

Among the 18 pregnancies, four women had a first trimester miscarriage, one had a second trimester miscarriage, and one had an abortion. The miscarriage rate could have been partly influenced by the older maternal population, the authors noted. Of the remaining 12 live births, one infant was premature at 34 weeks, and three infants stayed in NICU but were discharged within 2 weeks.

One patient experienced an MS relapse postpartum, despite receiving ocrelizumab within 45 days of delivery. Of the 16 women who agreed to participate in a Pregnancy Assessment Monitoring System (PRAMS) developed by the CDC, two women chose to breastfeed, and seven said their neurologist recommended against breastfeeding. None of the children’s pediatricians advised delaying vaccinations.

“This small sample observational study has not identified a potential additional risk with ocrelizumab for an adverse pregnancy outcome,” the authors concluded, but they added that ongoing studies, MINORE and SOPRANINO, can help guide future recommendations.

Though still limited, slightly more data exists on ofatumumab during pregnancy, including transient B-cell depletion and lymphopenia in infants whose mothers received anti-CD20 antibodies during pregnancy. However, research has found minimal IgG transfer in the first trimester, though it begins rising in the second trimester, and in utero ofatumumab exposure did not lead to any maternal toxicity or adverse prenatal or postnatal developmental effects in cynomolgus monkeys.

Riley Love, MD, of the University of California, San Francisco, Weill Institute for Neuroscience, and her colleagues both prospectively and retrospectively examined pregnancy and infant outcomes for up to 1 year post partum in women with MS who took ofatumumab during pregnancy or in the 6 months leading up to pregnancy. Their population included 104 prospective cases, most of which (84%) included first trimester exposure, and 14 retrospective cases. One in five of the prospective cases occurred during a clinical trial, while the remaining 80% occurred in postmarketing surveillance.

The prospectively followed women were an average 32 years old and were an average 7 weeks pregnant at the time of reporting. Among the 106 fetuses (including two twin pregnancies), only 30 outcomes had data at the cutoff time, including 16 live births, 9 abortions, and 5 miscarriages. None of the live births had congenital anomalies or serious infections. Another 30 pregnancies were lost to follow-up, and 46 were ongoing.

In the 14 retrospective cases, 57% of women were exposed in the first trimester, and 43% were exposed leading up to pregnancy. Half the cases occurred during clinical trials, and half in postmarketing surveillance. The women were an average 32 years old and were an average 10 weeks pregnant at reporting. Among the 14 pregnancies, nine were miscarriages, one was aborted, and four were born live with no congenital anomalies.

The authors did not draw any conclusions from the findings; they cited too little data and an ongoing study by Novartis to investigate ofatumumab in pregnancy.

“Therapies such as ofatumumab and ocrelizumab can lead to increased risk of infection due to transient B-cell depletion in neonates, but the two studies looking at this did not demonstrate increased infectious morbidity for these infants,” Dr. Kolarova said. “As with all poster presentations, I look forward to reading the full papers once they are published as they will often include a lot more detail about when during pregnancy medication exposure occurred and more detailed outcome data that was assessed.”
 

Ozanimod outcomes within general population’s ‘expected ranges’

The final study looked at outcomes of pregnancies in people taking ozanimod and in the partners of people taking ozanimod in a clinical trial setting. The findings show low rates of miscarriage, preterm birth, and congenital anomalies that the authors concluded were within the typical range expected for the general population.

“While pregnancy should be avoided when taking and for 3 months after stopping ozanimod to allow for drug elimination, there is no evidence to date of increased occurrence of adverse pregnancy outcomes with ozanimod exposure during early pregnancy,” wrote Anthony Krakovich, of Bristol Myers Squibb in Princeton, N.J., and his associates.

Ozanimod is an oral sphingosine 1-phosphate (S1P) receptor 1 and 5 modulator whose therapeutic mechanism is not fully understood “but may involve the reduction of lymphocyte migration into the central nervous system and intestine,” the authors wrote. S1P receptors are involved in vascular formation during embryogenesis, and animal studies in rats and rabbits have shown toxicity to the embryo and fetus from S1P receptor modulators, including death and malformations. S1P receptor modulator labels therefore note potential fetal risk and the need for effective contraception while taking the drug.

The study prospectively tracked clinical trial participants taking ozanimod as healthy volunteers or for relapsing MS, ulcerative colitis, or Crohn’s disease. Most of the participants who became pregnant (73%) had relapsing MS, while 18% had ulcerative colitis and 8% had Crohn’s disease.

In female patients receiving ozanimod, 78 pregnancies resulted in 12 miscarriages (including one twin), 15 abortions, and 42 live births, with 6 pregnancies ongoing at the time of reporting and no data available for the remaining 4 pregnancies. Among the 42 live births, 4 were premature but otherwise healthy, 1 had a duplex kidney, and the other 37 infants were typical with no apparent health concerns. These rates of miscarriage, preterm birth, and congenital anomalies were within the expected ranges for the general population, the researchers wrote.

The researchers also assessed pregnancy outcomes for partners of male participants taking ozanimod. The 29 partner pregnancies resulted in 21 live births and one miscarriage, with one pregnancy ongoing and no information available for the other seven. The live births included 5 premature infants (including twins), 13 typical and healthy infants, 1 with Hirschsprung’s disease, 1 with a congenital hydrocele, and 1 with a partial atrioventricular septal defect. Again, the researchers concluded that these rates were within the typical range for the general population and that “no teratogenicity was observed.”

“We often encourage patients with MS, regardless of disease activity and therapies, to seek preconception evaluations with Maternal-Fetal Medicine and their neurologists in order to make plans for pregnancy and postpartum care,” Dr. Kolarova said. “That being said, access to subspecialized health care is not available to all, and pregnancy prior to such consultation does occur. These studies provide novel information that we have not had access to in the past and can improve patient counseling regarding their risks and options.”

The study on cladribine was funded by Merck KGaA, at which two authors are employed. Dr. Hellwig reported consulting, speaker, and/or research support from Bayer, Biogen, Teva, Novartis, Roche, Sanofi, Schering Healthcare, Serono, and Merck, and one author is a former employee of EMD Serono. The study on ocrelizumab was funded by Genentech. Dr. Zhovtis Ryerson reported personal fees from Biogen, Genentech, and Novartis, and research grants from Biogen, Genentech, and CMSC. The other authors had no disclosures. The study on ofatumumab was funded by Novartis. Dr. Bove has received research funds from Biogen, Novartis, and Roche Genentech, and consulting fees from EMD Serono, Horizon, Janssen, and TG Therapeutics; she has an ownership interest in Global Consult MD. Five authors are Novartis employees. Her coauthors, including Dr. Hellwig, reported advisory, consulting, research, speaking, or traveling fees from Alexion, Bayer, Biogen, Celgene BMS, EMD Serono, Horizon, Janssen, Lundbeck, Merck, Pfizer, Roche Genentech, Sanofi Genzyme, Schering Healthcare, Teva, TG Therapeutics, and Novartis. The study on ozanimod was funded by Bristol Myers Squibb. Dr. Krakovich and another author are employees and/or shareholders of Bristol Myers Squibb. The other authors reported consulting, speaking, advisory board, and/or research fees from AbbVie, Almirall, Arena, Biogen, Boehringer Ingelhei, Celgene, Celltrion, EXCEMED, Falk Benelux, Ferring, Forward Pharma, Genentech, Genzyme, Gilead, Janssen, Lilly, Merck, Novartis, Ono Pharma, Pfizer, Prometheus Labs, Protagonist, Roche, Sanofi, Synthon, Takeda, and Teva. Dr. Kolarova had no disclosures. Dr. Shah has received research support from Biogen and VeraSci.
 

AURORA, COLO. – Several drugs for multiple sclerosis (MS) that are contraindicated during pregnancy nevertheless have not shown concerning safety signals in a series of small studies presented as posters at the annual meeting of the Consortium of Multiple Sclerosis Centers. The industry-sponsored research included an assessment of pregnancy and infant outcomes for cladribine, ocrelizumab, ofatumumab, and ozanimod, all of which are not recommended during pregnancy based primarily on minimal data that suggests, but does not confirm, possible teratogenicity.

“When these new medications hit the market, maternal-fetal medicine physicians and obstetricians are left with very scant data on how to counsel patients, and it’s often based on theory, case reports, or animal studies,” said Teodora Kolarova, MD, a maternal-fetal medicine physician at the University of Washington, Seattle, who was not involved in any of the research. “Although these sample sizes seem small, the population they are sampling from – patients with MS who take immunomodulators who then experience a pregnancy – is much smaller than all pregnant patients.”

Taken together, the findings suggest no increased risk of miscarriage or congenital malformation, compared with baseline risk, Dr. Kolarova said.

“As a whole, these studies are overall reassuring with, of course, some caveats, including timing of medication exposure, limited sample size, and limited outcome data,” Dr. Kolarova said. She noted that embryonic organ formation is complete by 10 weeks gestation, by which time an unplanned pregnancy may not have been recognized yet. “In the subset of patients in the studies that were exposed during the first trimester, there was no increase in congenital malformations from a baseline risk of about 2%-3% in the general population, which is helpful for patient counseling.”
 

Counseling during the childbearing years

That kind of counseling is important yet absent for many people capable of pregnancy, suggests separate research also presented at the conference by Suma Shah, MD, an associate professor of neurology at Duke University, Durham, N.C. Dr. Shah gave 13-question surveys to female MS patients of all ages at her institution and presented an analysis of data from 38 completed surveys. Among those taking disease-modifying therapies, their medications included ocrelizumab, rituximab, teriflunomide, fingolimod, fumarates, interferons, natalizumab, and cladribine.

“MS disproportionately impacts women among 20 to 40 years, and that’s a really big part of their childbearing years when there are big decisions being made about whether they’re going to choose to grow family or not,” said Dr. Shah. The average age of those who completed the survey was 44. Dr. Shah noted that a lot of research has looked at the safety of older disease-modifying agents in pregnancy, but that information doesn’t appear to be filtering down to patients. “What I really wanted to look at is what do our parent patients understand about whether or not they can even think about pregnancy – and there’s a lot of work to be done.”

Just under a third of survey respondents said they did not have as many children as they would like, and a quarter said they were told they couldn’t have children if they had a diagnosis of MS.

“That was a little heartbreaking to hear because that’s not the truth,” Dr. Shah said. She said it’s necessary to have a more detailed conversation looking at tailored decisions for patients. “Both of those things – patients not being able to grow their family to the number that they desire, and not feeling like they can grow a family – I would think in 2023 we would have come farther than that, and there’s still a lot of room there to improve.”

She advised clinicians not to assume that MS patients know what their options are regarding family planning. “There’s still a lot of room for conversations,” she said. She also explicitly recommends discussing family planning and pregnancy planning with every patient, no matter their gender, early and often.
 

Cladribine shows no miscarriage, malformations

Dr. Kolarova noted that one of the studies, on cladribine, had a fairly robust sample size with its 180 pregnancy exposures. In that study, led by Kerstin Hellwig, MD, of Ruhr University in Bochum, Germany, data came from the global surveillance program MAPLE-MS, established to assess cladribine effects on pregnancy and infant outcomes. The researchers analyzed data from 76 mothers and 9 fathers who, at any time from 2017 to 2022, were taking cladribine during pregnancy or up to 6 months before pregnancy. Outcomes included live birth, miscarriage, stillbirth, elective abortion, ectopic pregnancy, and major congenital anomalies.

Just over half the mothers (53.9%) were exposed before pregnancy, and about a quarter (26.3%) were exposed during the first trimester. The timing was unknown for most of the other mothers (18.4%). Among the fathers, two-thirds (66.7%) were exposed before pregnancy, and one-third had unknown timing.

Among the 180 pregnancies in the maternal cohort, 42.2% had known outcomes. Nearly half the women (48.7%) taking cladribine had live births, 28.9% had elective abortions, and 21.1% had miscarriages. Only 9 of the 22 pregnancies in the paternal cohort had known outcomes, which included 88.9% live births and 11.1% miscarriages. None of the pregnancies resulted in stillbirth or in a live birth with major congenital anomalies.

”Robust conclusions cannot be made about the risks of adverse pregnancy outcomes with cladribine tablets, but no increase has been signaled thus far,” the researchers reported. ”It is necessary to counsel patients to prevent pregnancy and to use effective contraception during cladribine tablets intake and for at least 6 months after the last cladribine tablet intake in each treatment year.”

Emily Evans, MD, MBE, medical director at U.S. Neurology and Immunology in Rockland, Mass., speaking on behalf of the findings, said they were fairly encouraging.

“Of course, we don’t encourage patients to get pregnant within 6 months of their last dose of cladribine tablets,” Dr. Evans said, but “within those individuals who have gotten pregnant within 6 months of their last dose of cladribine, or who have fathered a child within 6 months of their last dose of cladribine tablets, we’re seeing overall encouraging outcomes. We’re specifically not seeing any differences in the rates of spontaneous abortions, and we’re not seeing any differences in the rates of congenital malformations.”
 

Ocrelizumab and ofatumumab: No infections so far

Current recommendations for ocrelizumab are to avoid pregnancy for 6 months after the last infusion and stop any breastfeeding during therapy. Yet these recommendations are only because of insufficient data rather than evidence of risk, according to Lana Zhovtis Ryerson, MD, of the NYU Multiple Sclerosis Comprehensive Care Center in New York. She and her colleagues identified all women of childbearing age who had received ocrelizumab within 1 year of pregnancy at their NYU institution. A retrospective chart review found 18 women, with an average age of 35, an average 11 years of an MS diagnosis, and an average 11 months taking ocrelizumab.

Among the 18 pregnancies, four women had a first trimester miscarriage, one had a second trimester miscarriage, and one had an abortion. The miscarriage rate could have been partly influenced by the older maternal population, the authors noted. Of the remaining 12 live births, one infant was premature at 34 weeks, and three infants stayed in NICU but were discharged within 2 weeks.

One patient experienced an MS relapse postpartum, despite receiving ocrelizumab within 45 days of delivery. Of the 16 women who agreed to participate in a Pregnancy Assessment Monitoring System (PRAMS) developed by the CDC, two women chose to breastfeed, and seven said their neurologist recommended against breastfeeding. None of the children’s pediatricians advised delaying vaccinations.

“This small sample observational study has not identified a potential additional risk with ocrelizumab for an adverse pregnancy outcome,” the authors concluded, but they added that ongoing studies, MINORE and SOPRANINO, can help guide future recommendations.

Though still limited, slightly more data exists on ofatumumab during pregnancy, including transient B-cell depletion and lymphopenia in infants whose mothers received anti-CD20 antibodies during pregnancy. However, research has found minimal IgG transfer in the first trimester, though it begins rising in the second trimester, and in utero ofatumumab exposure did not lead to any maternal toxicity or adverse prenatal or postnatal developmental effects in cynomolgus monkeys.

Riley Love, MD, of the University of California, San Francisco, Weill Institute for Neuroscience, and her colleagues both prospectively and retrospectively examined pregnancy and infant outcomes for up to 1 year post partum in women with MS who took ofatumumab during pregnancy or in the 6 months leading up to pregnancy. Their population included 104 prospective cases, most of which (84%) included first trimester exposure, and 14 retrospective cases. One in five of the prospective cases occurred during a clinical trial, while the remaining 80% occurred in postmarketing surveillance.

The prospectively followed women were an average 32 years old and were an average 7 weeks pregnant at the time of reporting. Among the 106 fetuses (including two twin pregnancies), only 30 outcomes had data at the cutoff time, including 16 live births, 9 abortions, and 5 miscarriages. None of the live births had congenital anomalies or serious infections. Another 30 pregnancies were lost to follow-up, and 46 were ongoing.

In the 14 retrospective cases, 57% of women were exposed in the first trimester, and 43% were exposed leading up to pregnancy. Half the cases occurred during clinical trials, and half in postmarketing surveillance. The women were an average 32 years old and were an average 10 weeks pregnant at reporting. Among the 14 pregnancies, nine were miscarriages, one was aborted, and four were born live with no congenital anomalies.

The authors did not draw any conclusions from the findings; they cited too little data and an ongoing study by Novartis to investigate ofatumumab in pregnancy.

“Therapies such as ofatumumab and ocrelizumab can lead to increased risk of infection due to transient B-cell depletion in neonates, but the two studies looking at this did not demonstrate increased infectious morbidity for these infants,” Dr. Kolarova said. “As with all poster presentations, I look forward to reading the full papers once they are published as they will often include a lot more detail about when during pregnancy medication exposure occurred and more detailed outcome data that was assessed.”
 

Ozanimod outcomes within general population’s ‘expected ranges’

The final study looked at outcomes of pregnancies in people taking ozanimod and in the partners of people taking ozanimod in a clinical trial setting. The findings show low rates of miscarriage, preterm birth, and congenital anomalies that the authors concluded were within the typical range expected for the general population.

“While pregnancy should be avoided when taking and for 3 months after stopping ozanimod to allow for drug elimination, there is no evidence to date of increased occurrence of adverse pregnancy outcomes with ozanimod exposure during early pregnancy,” wrote Anthony Krakovich, of Bristol Myers Squibb in Princeton, N.J., and his associates.

Ozanimod is an oral sphingosine 1-phosphate (S1P) receptor 1 and 5 modulator whose therapeutic mechanism is not fully understood “but may involve the reduction of lymphocyte migration into the central nervous system and intestine,” the authors wrote. S1P receptors are involved in vascular formation during embryogenesis, and animal studies in rats and rabbits have shown toxicity to the embryo and fetus from S1P receptor modulators, including death and malformations. S1P receptor modulator labels therefore note potential fetal risk and the need for effective contraception while taking the drug.

The study prospectively tracked clinical trial participants taking ozanimod as healthy volunteers or for relapsing MS, ulcerative colitis, or Crohn’s disease. Most of the participants who became pregnant (73%) had relapsing MS, while 18% had ulcerative colitis and 8% had Crohn’s disease.

In female patients receiving ozanimod, 78 pregnancies resulted in 12 miscarriages (including one twin), 15 abortions, and 42 live births, with 6 pregnancies ongoing at the time of reporting and no data available for the remaining 4 pregnancies. Among the 42 live births, 4 were premature but otherwise healthy, 1 had a duplex kidney, and the other 37 infants were typical with no apparent health concerns. These rates of miscarriage, preterm birth, and congenital anomalies were within the expected ranges for the general population, the researchers wrote.

The researchers also assessed pregnancy outcomes for partners of male participants taking ozanimod. The 29 partner pregnancies resulted in 21 live births and one miscarriage, with one pregnancy ongoing and no information available for the other seven. The live births included 5 premature infants (including twins), 13 typical and healthy infants, 1 with Hirschsprung’s disease, 1 with a congenital hydrocele, and 1 with a partial atrioventricular septal defect. Again, the researchers concluded that these rates were within the typical range for the general population and that “no teratogenicity was observed.”

“We often encourage patients with MS, regardless of disease activity and therapies, to seek preconception evaluations with Maternal-Fetal Medicine and their neurologists in order to make plans for pregnancy and postpartum care,” Dr. Kolarova said. “That being said, access to subspecialized health care is not available to all, and pregnancy prior to such consultation does occur. These studies provide novel information that we have not had access to in the past and can improve patient counseling regarding their risks and options.”

The study on cladribine was funded by Merck KGaA, at which two authors are employed. Dr. Hellwig reported consulting, speaker, and/or research support from Bayer, Biogen, Teva, Novartis, Roche, Sanofi, Schering Healthcare, Serono, and Merck, and one author is a former employee of EMD Serono. The study on ocrelizumab was funded by Genentech. Dr. Zhovtis Ryerson reported personal fees from Biogen, Genentech, and Novartis, and research grants from Biogen, Genentech, and CMSC. The other authors had no disclosures. The study on ofatumumab was funded by Novartis. Dr. Bove has received research funds from Biogen, Novartis, and Roche Genentech, and consulting fees from EMD Serono, Horizon, Janssen, and TG Therapeutics; she has an ownership interest in Global Consult MD. Five authors are Novartis employees. Her coauthors, including Dr. Hellwig, reported advisory, consulting, research, speaking, or traveling fees from Alexion, Bayer, Biogen, Celgene BMS, EMD Serono, Horizon, Janssen, Lundbeck, Merck, Pfizer, Roche Genentech, Sanofi Genzyme, Schering Healthcare, Teva, TG Therapeutics, and Novartis. The study on ozanimod was funded by Bristol Myers Squibb. Dr. Krakovich and another author are employees and/or shareholders of Bristol Myers Squibb. The other authors reported consulting, speaking, advisory board, and/or research fees from AbbVie, Almirall, Arena, Biogen, Boehringer Ingelhei, Celgene, Celltrion, EXCEMED, Falk Benelux, Ferring, Forward Pharma, Genentech, Genzyme, Gilead, Janssen, Lilly, Merck, Novartis, Ono Pharma, Pfizer, Prometheus Labs, Protagonist, Roche, Sanofi, Synthon, Takeda, and Teva. Dr. Kolarova had no disclosures. Dr. Shah has received research support from Biogen and VeraSci.
 

AURORA, COLO. – Several drugs for multiple sclerosis (MS) that are contraindicated during pregnancy nevertheless have not shown concerning safety signals in a series of small studies presented as posters at the annual meeting of the Consortium of Multiple Sclerosis Centers. The industry-sponsored research included an assessment of pregnancy and infant outcomes for cladribine, ocrelizumab, ofatumumab, and ozanimod, all of which are not recommended during pregnancy based primarily on minimal data that suggests, but does not confirm, possible teratogenicity.

“When these new medications hit the market, maternal-fetal medicine physicians and obstetricians are left with very scant data on how to counsel patients, and it’s often based on theory, case reports, or animal studies,” said Teodora Kolarova, MD, a maternal-fetal medicine physician at the University of Washington, Seattle, who was not involved in any of the research. “Although these sample sizes seem small, the population they are sampling from – patients with MS who take immunomodulators who then experience a pregnancy – is much smaller than all pregnant patients.”

Taken together, the findings suggest no increased risk of miscarriage or congenital malformation, compared with baseline risk, Dr. Kolarova said.

“As a whole, these studies are overall reassuring with, of course, some caveats, including timing of medication exposure, limited sample size, and limited outcome data,” Dr. Kolarova said. She noted that embryonic organ formation is complete by 10 weeks gestation, by which time an unplanned pregnancy may not have been recognized yet. “In the subset of patients in the studies that were exposed during the first trimester, there was no increase in congenital malformations from a baseline risk of about 2%-3% in the general population, which is helpful for patient counseling.”
 

Counseling during the childbearing years

That kind of counseling is important yet absent for many people capable of pregnancy, suggests separate research also presented at the conference by Suma Shah, MD, an associate professor of neurology at Duke University, Durham, N.C. Dr. Shah gave 13-question surveys to female MS patients of all ages at her institution and presented an analysis of data from 38 completed surveys. Among those taking disease-modifying therapies, their medications included ocrelizumab, rituximab, teriflunomide, fingolimod, fumarates, interferons, natalizumab, and cladribine.

“MS disproportionately impacts women among 20 to 40 years, and that’s a really big part of their childbearing years when there are big decisions being made about whether they’re going to choose to grow family or not,” said Dr. Shah. The average age of those who completed the survey was 44. Dr. Shah noted that a lot of research has looked at the safety of older disease-modifying agents in pregnancy, but that information doesn’t appear to be filtering down to patients. “What I really wanted to look at is what do our parent patients understand about whether or not they can even think about pregnancy – and there’s a lot of work to be done.”

Just under a third of survey respondents said they did not have as many children as they would like, and a quarter said they were told they couldn’t have children if they had a diagnosis of MS.

“That was a little heartbreaking to hear because that’s not the truth,” Dr. Shah said. She said it’s necessary to have a more detailed conversation looking at tailored decisions for patients. “Both of those things – patients not being able to grow their family to the number that they desire, and not feeling like they can grow a family – I would think in 2023 we would have come farther than that, and there’s still a lot of room there to improve.”

She advised clinicians not to assume that MS patients know what their options are regarding family planning. “There’s still a lot of room for conversations,” she said. She also explicitly recommends discussing family planning and pregnancy planning with every patient, no matter their gender, early and often.
 

Cladribine shows no miscarriage, malformations

Dr. Kolarova noted that one of the studies, on cladribine, had a fairly robust sample size with its 180 pregnancy exposures. In that study, led by Kerstin Hellwig, MD, of Ruhr University in Bochum, Germany, data came from the global surveillance program MAPLE-MS, established to assess cladribine effects on pregnancy and infant outcomes. The researchers analyzed data from 76 mothers and 9 fathers who, at any time from 2017 to 2022, were taking cladribine during pregnancy or up to 6 months before pregnancy. Outcomes included live birth, miscarriage, stillbirth, elective abortion, ectopic pregnancy, and major congenital anomalies.

Just over half the mothers (53.9%) were exposed before pregnancy, and about a quarter (26.3%) were exposed during the first trimester. The timing was unknown for most of the other mothers (18.4%). Among the fathers, two-thirds (66.7%) were exposed before pregnancy, and one-third had unknown timing.

Among the 180 pregnancies in the maternal cohort, 42.2% had known outcomes. Nearly half the women (48.7%) taking cladribine had live births, 28.9% had elective abortions, and 21.1% had miscarriages. Only 9 of the 22 pregnancies in the paternal cohort had known outcomes, which included 88.9% live births and 11.1% miscarriages. None of the pregnancies resulted in stillbirth or in a live birth with major congenital anomalies.

”Robust conclusions cannot be made about the risks of adverse pregnancy outcomes with cladribine tablets, but no increase has been signaled thus far,” the researchers reported. ”It is necessary to counsel patients to prevent pregnancy and to use effective contraception during cladribine tablets intake and for at least 6 months after the last cladribine tablet intake in each treatment year.”

Emily Evans, MD, MBE, medical director at U.S. Neurology and Immunology in Rockland, Mass., speaking on behalf of the findings, said they were fairly encouraging.

“Of course, we don’t encourage patients to get pregnant within 6 months of their last dose of cladribine tablets,” Dr. Evans said, but “within those individuals who have gotten pregnant within 6 months of their last dose of cladribine, or who have fathered a child within 6 months of their last dose of cladribine tablets, we’re seeing overall encouraging outcomes. We’re specifically not seeing any differences in the rates of spontaneous abortions, and we’re not seeing any differences in the rates of congenital malformations.”
 

Ocrelizumab and ofatumumab: No infections so far

Current recommendations for ocrelizumab are to avoid pregnancy for 6 months after the last infusion and stop any breastfeeding during therapy. Yet these recommendations are only because of insufficient data rather than evidence of risk, according to Lana Zhovtis Ryerson, MD, of the NYU Multiple Sclerosis Comprehensive Care Center in New York. She and her colleagues identified all women of childbearing age who had received ocrelizumab within 1 year of pregnancy at their NYU institution. A retrospective chart review found 18 women, with an average age of 35, an average 11 years of an MS diagnosis, and an average 11 months taking ocrelizumab.

Among the 18 pregnancies, four women had a first trimester miscarriage, one had a second trimester miscarriage, and one had an abortion. The miscarriage rate could have been partly influenced by the older maternal population, the authors noted. Of the remaining 12 live births, one infant was premature at 34 weeks, and three infants stayed in NICU but were discharged within 2 weeks.

One patient experienced an MS relapse postpartum, despite receiving ocrelizumab within 45 days of delivery. Of the 16 women who agreed to participate in a Pregnancy Assessment Monitoring System (PRAMS) developed by the CDC, two women chose to breastfeed, and seven said their neurologist recommended against breastfeeding. None of the children’s pediatricians advised delaying vaccinations.

“This small sample observational study has not identified a potential additional risk with ocrelizumab for an adverse pregnancy outcome,” the authors concluded, but they added that ongoing studies, MINORE and SOPRANINO, can help guide future recommendations.

Though still limited, slightly more data exists on ofatumumab during pregnancy, including transient B-cell depletion and lymphopenia in infants whose mothers received anti-CD20 antibodies during pregnancy. However, research has found minimal IgG transfer in the first trimester, though it begins rising in the second trimester, and in utero ofatumumab exposure did not lead to any maternal toxicity or adverse prenatal or postnatal developmental effects in cynomolgus monkeys.

Riley Love, MD, of the University of California, San Francisco, Weill Institute for Neuroscience, and her colleagues both prospectively and retrospectively examined pregnancy and infant outcomes for up to 1 year post partum in women with MS who took ofatumumab during pregnancy or in the 6 months leading up to pregnancy. Their population included 104 prospective cases, most of which (84%) included first trimester exposure, and 14 retrospective cases. One in five of the prospective cases occurred during a clinical trial, while the remaining 80% occurred in postmarketing surveillance.

The prospectively followed women were an average 32 years old and were an average 7 weeks pregnant at the time of reporting. Among the 106 fetuses (including two twin pregnancies), only 30 outcomes had data at the cutoff time, including 16 live births, 9 abortions, and 5 miscarriages. None of the live births had congenital anomalies or serious infections. Another 30 pregnancies were lost to follow-up, and 46 were ongoing.

In the 14 retrospective cases, 57% of women were exposed in the first trimester, and 43% were exposed leading up to pregnancy. Half the cases occurred during clinical trials, and half in postmarketing surveillance. The women were an average 32 years old and were an average 10 weeks pregnant at reporting. Among the 14 pregnancies, nine were miscarriages, one was aborted, and four were born live with no congenital anomalies.

The authors did not draw any conclusions from the findings; they cited too little data and an ongoing study by Novartis to investigate ofatumumab in pregnancy.

“Therapies such as ofatumumab and ocrelizumab can lead to increased risk of infection due to transient B-cell depletion in neonates, but the two studies looking at this did not demonstrate increased infectious morbidity for these infants,” Dr. Kolarova said. “As with all poster presentations, I look forward to reading the full papers once they are published as they will often include a lot more detail about when during pregnancy medication exposure occurred and more detailed outcome data that was assessed.”
 

Ozanimod outcomes within general population’s ‘expected ranges’

The final study looked at outcomes of pregnancies in people taking ozanimod and in the partners of people taking ozanimod in a clinical trial setting. The findings show low rates of miscarriage, preterm birth, and congenital anomalies that the authors concluded were within the typical range expected for the general population.

“While pregnancy should be avoided when taking and for 3 months after stopping ozanimod to allow for drug elimination, there is no evidence to date of increased occurrence of adverse pregnancy outcomes with ozanimod exposure during early pregnancy,” wrote Anthony Krakovich, of Bristol Myers Squibb in Princeton, N.J., and his associates.

Ozanimod is an oral sphingosine 1-phosphate (S1P) receptor 1 and 5 modulator whose therapeutic mechanism is not fully understood “but may involve the reduction of lymphocyte migration into the central nervous system and intestine,” the authors wrote. S1P receptors are involved in vascular formation during embryogenesis, and animal studies in rats and rabbits have shown toxicity to the embryo and fetus from S1P receptor modulators, including death and malformations. S1P receptor modulator labels therefore note potential fetal risk and the need for effective contraception while taking the drug.

The study prospectively tracked clinical trial participants taking ozanimod as healthy volunteers or for relapsing MS, ulcerative colitis, or Crohn’s disease. Most of the participants who became pregnant (73%) had relapsing MS, while 18% had ulcerative colitis and 8% had Crohn’s disease.

In female patients receiving ozanimod, 78 pregnancies resulted in 12 miscarriages (including one twin), 15 abortions, and 42 live births, with 6 pregnancies ongoing at the time of reporting and no data available for the remaining 4 pregnancies. Among the 42 live births, 4 were premature but otherwise healthy, 1 had a duplex kidney, and the other 37 infants were typical with no apparent health concerns. These rates of miscarriage, preterm birth, and congenital anomalies were within the expected ranges for the general population, the researchers wrote.

The researchers also assessed pregnancy outcomes for partners of male participants taking ozanimod. The 29 partner pregnancies resulted in 21 live births and one miscarriage, with one pregnancy ongoing and no information available for the other seven. The live births included 5 premature infants (including twins), 13 typical and healthy infants, 1 with Hirschsprung’s disease, 1 with a congenital hydrocele, and 1 with a partial atrioventricular septal defect. Again, the researchers concluded that these rates were within the typical range for the general population and that “no teratogenicity was observed.”

“We often encourage patients with MS, regardless of disease activity and therapies, to seek preconception evaluations with Maternal-Fetal Medicine and their neurologists in order to make plans for pregnancy and postpartum care,” Dr. Kolarova said. “That being said, access to subspecialized health care is not available to all, and pregnancy prior to such consultation does occur. These studies provide novel information that we have not had access to in the past and can improve patient counseling regarding their risks and options.”

The study on cladribine was funded by Merck KGaA, at which two authors are employed. Dr. Hellwig reported consulting, speaker, and/or research support from Bayer, Biogen, Teva, Novartis, Roche, Sanofi, Schering Healthcare, Serono, and Merck, and one author is a former employee of EMD Serono. The study on ocrelizumab was funded by Genentech. Dr. Zhovtis Ryerson reported personal fees from Biogen, Genentech, and Novartis, and research grants from Biogen, Genentech, and CMSC. The other authors had no disclosures. The study on ofatumumab was funded by Novartis. Dr. Bove has received research funds from Biogen, Novartis, and Roche Genentech, and consulting fees from EMD Serono, Horizon, Janssen, and TG Therapeutics; she has an ownership interest in Global Consult MD. Five authors are Novartis employees. Her coauthors, including Dr. Hellwig, reported advisory, consulting, research, speaking, or traveling fees from Alexion, Bayer, Biogen, Celgene BMS, EMD Serono, Horizon, Janssen, Lundbeck, Merck, Pfizer, Roche Genentech, Sanofi Genzyme, Schering Healthcare, Teva, TG Therapeutics, and Novartis. The study on ozanimod was funded by Bristol Myers Squibb. Dr. Krakovich and another author are employees and/or shareholders of Bristol Myers Squibb. The other authors reported consulting, speaking, advisory board, and/or research fees from AbbVie, Almirall, Arena, Biogen, Boehringer Ingelhei, Celgene, Celltrion, EXCEMED, Falk Benelux, Ferring, Forward Pharma, Genentech, Genzyme, Gilead, Janssen, Lilly, Merck, Novartis, Ono Pharma, Pfizer, Prometheus Labs, Protagonist, Roche, Sanofi, Synthon, Takeda, and Teva. Dr. Kolarova had no disclosures. Dr. Shah has received research support from Biogen and VeraSci.
 

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.

For decades, pre-med students depended on the annual medical school rankings by U.S. News and World Report to decide where to apply for physician education. But after several prominent med schools pulled out of the rankings, one resident began experimenting with artificial intelligence (AI) to create an alternative.

Brandon Turner MD, MSc, a radiation oncology resident at Massachusetts General Hospital in Boston, developed a free do-it-yourself tool using AI that allows prospective students to rank medical schools based on considerations that are most important to them. His research was published online in JAMA Network Open.

“One of the flaws with conventional ranking systems is that the metrics used in these tools are weighted based on the preferences and views of the people who developed these rankings, but those may not work for everyone,” Dr. Turner told this news organization.

He explained that there are different types of metrics used in the U.S. News ranking: one for research and the other for primary care. “The research rankings carry the most prestige and are the ones that most people know about,” he explained. These metrics take into account factors such as how many grant dollars the medical school receives and the average size of those grants per faculty member, Dr. Turner said.

Admission metrics are also included – for example, the median grade point average or MCAT scores of students who have been accepted. “These don’t tell you anything about the research output of the school, only about how selective the school is,” he said.

Primary care metrics might focus on how many graduates of a given school go into primary care, or how other schools rate the quality of primary care training at a given school – a process called peer assessment, Dr. Turner said.

But even though these might be helpful, students may be more interested in the cost of attendance, average debt, representation of minorities, and how many graduates pass their boards, he said. “U.S. News metrics don’t capture these things, but I included them in my algorithm.”

A U.S. News spokesperson said that the publication continues to help students and their families make decisions about their future education. The spokesperson cited U.S. News’ explanation of how it calculates its rankings. “A school’s overall Best Medical Schools rank should be one consideration and not the lone determinant in where a student applies and accepts,” the article states.

Dr. Turner agreed ranking systems are a good starting point when researching med schools, “but the values reflected in the ranking may not reflect an individual’s goals.”

Tyra-Lee Brett, a premed student at the University of South Florida, Tampa, believes an additional tool for students to evaluate medical schools is needed – and she could potentially see herself using Dr. Turner’s creation.

Still, Ms. Brett, a premed trustee of the American Medical Student Association, doesn’t regard any ranking tool as the “be all and end all.” Rather, she feels that the most effective tool would be based on students’ lived experiences. The AMSA is developing a scorecard in which students grade schools based on their opinions about such issues as housing, family planning, and environmental health, she said.
 

No prior judgments

To develop his algorithm, Dr. Turner used a branch of AI called “unsupervised learning.” It doesn’t make a prior judgment about what the data should look like, Dr. Turner explained.

“You’re just analyzing natural trends within the data.”

The algorithm tries to find and discover clusters or patterns within the data. “It’s like saying to the algorithm: ‘I want you to tell me what schools you think should be grouped together based on the data I feed you,’ which is the data that the user selects based on his or her personal preferences.”

U.S. News has been transparent about the metrics it uses, Dr. Turner notes. “When I started looking into how rankings are developed, I saw that there was transparency, and the reasoning for choosing the metrics used to develop the ranking was pretty sound,” he said.

“But I didn’t see any justification as to why they chose the particular metrics and weighted them in the way that they did.”

Dr. Turner extracted data from the 2023 U.S. News report, which ranked 109 allopathic medical schools, and applied several scenarios to the results to create his alternative ranking system.

In one scenario, he used the same research metrics used by U.S. News, such as a peer research assessment, median federal research activity per full-time faculty member, median GPA, median MCAT, acceptance rate, and faculty-student ratio.

In another scenario, he included four additional metrics: debt, in-state cost of attendance, USMLE Step 1 passing rate, and percentage of underrepresented students with minority race or ethnicity at the school.

For example, a user can rank the importance of the diversity of the class, amount of debt students expect to incur, and amount of research funding the medical school receives. After selecting those factors, the tool generates tiered results displayed in a circle, a shape chosen to avoid the appearance of the hierarchy associated with traditional rankings, Dr. Turner said.

“A prospective student might not care about acceptance rates and MCAT scores, and instead cares about diversity and debt,” Dr. Turner said. He looks forward to extending this approach to the ranking of colleges as well.
 

‘Imperfect measures’

“The model and interesting online tool that Dr. Turner created allows a premed [student] to generate custom rankings that are in line with their own priorities,” said Christopher Worsham, MD, MPH, a critical care physician in Mass General’s division of pulmonary and critical care medicine.

But Dr. Worsham, also a teaching associate at Harvard Medical School’s department of health care policy, expressed concern that factors figuring into the rankings by U.S. News and Dr. Turner’s alternative “are imperfect measures of medical school quality.”

For example, a student interested in research might favor federal research funding in their customized rankings with Dr. Turner’s model. “But higher research funding doesn’t necessarily translate into a better education for students, particularly when differentiating between two major research systems,” Dr. Worsham noted.

Dr. Worsham added that neither ranking system accurately predicts the quality of doctors graduating from the schools. Instead, he’d like to see ranking systems based on which schools’ graduates deliver the best patient outcomes, whether that’s through direct patient care, impactful research, or leadership within the health care system.

Michael Sauder, PhD, professor of sociology at the University of Iowa, Iowa City, said the model could offer a valuable alternative to the U.S. News ranking system. It might help users develop their own criteria for determining the ranking of medical schools, which is a big improvement over a “one-size-fits-all” approach, Dr. Sauder said.

And Hanna Stotland, an admission consultant based in Chicago, noted that most students rely on rankings because they “don’t have the luxury of advisers who know the ins and outs of different medical schools.” Given the role that rankings play, Ms. Stotland expects that every new ranking tool will have some influence on students.

This tool in particular “has the potential to be useful for students who have identified values they want their medical school to share.” For example, students who care about racial diversity “could use it to easily identify schools that are successful on that metric,” Ms. Stotland said.

Sujay Ratna, a 2nd-year med student at Icahn School of Medicine at Mount Sinai in New York, said he considered the U.S. News ranking his “go-to tool” when he was applying to med school.

But after reading Dr. Turner’s article, the AMSA membership vice president tried the algorithm. “I definitely would have used it had it existed when I was thinking of what schools to apply to and what [schools] to attend.”

The study had no specific funding. Dr. Turner, Dr. Worsham, Dr. Sauder, Ms. Stotland, Ms. Brett, and Mr. Ratna report no relevant financial relationships.

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

For decades, pre-med students depended on the annual medical school rankings by U.S. News and World Report to decide where to apply for physician education. But after several prominent med schools pulled out of the rankings, one resident began experimenting with artificial intelligence (AI) to create an alternative.

Brandon Turner MD, MSc, a radiation oncology resident at Massachusetts General Hospital in Boston, developed a free do-it-yourself tool using AI that allows prospective students to rank medical schools based on considerations that are most important to them. His research was published online in JAMA Network Open.

“One of the flaws with conventional ranking systems is that the metrics used in these tools are weighted based on the preferences and views of the people who developed these rankings, but those may not work for everyone,” Dr. Turner told this news organization.

He explained that there are different types of metrics used in the U.S. News ranking: one for research and the other for primary care. “The research rankings carry the most prestige and are the ones that most people know about,” he explained. These metrics take into account factors such as how many grant dollars the medical school receives and the average size of those grants per faculty member, Dr. Turner said.

Admission metrics are also included – for example, the median grade point average or MCAT scores of students who have been accepted. “These don’t tell you anything about the research output of the school, only about how selective the school is,” he said.

Primary care metrics might focus on how many graduates of a given school go into primary care, or how other schools rate the quality of primary care training at a given school – a process called peer assessment, Dr. Turner said.

But even though these might be helpful, students may be more interested in the cost of attendance, average debt, representation of minorities, and how many graduates pass their boards, he said. “U.S. News metrics don’t capture these things, but I included them in my algorithm.”

A U.S. News spokesperson said that the publication continues to help students and their families make decisions about their future education. The spokesperson cited U.S. News’ explanation of how it calculates its rankings. “A school’s overall Best Medical Schools rank should be one consideration and not the lone determinant in where a student applies and accepts,” the article states.

Dr. Turner agreed ranking systems are a good starting point when researching med schools, “but the values reflected in the ranking may not reflect an individual’s goals.”

Tyra-Lee Brett, a premed student at the University of South Florida, Tampa, believes an additional tool for students to evaluate medical schools is needed – and she could potentially see herself using Dr. Turner’s creation.

Still, Ms. Brett, a premed trustee of the American Medical Student Association, doesn’t regard any ranking tool as the “be all and end all.” Rather, she feels that the most effective tool would be based on students’ lived experiences. The AMSA is developing a scorecard in which students grade schools based on their opinions about such issues as housing, family planning, and environmental health, she said.
 

No prior judgments

To develop his algorithm, Dr. Turner used a branch of AI called “unsupervised learning.” It doesn’t make a prior judgment about what the data should look like, Dr. Turner explained.

“You’re just analyzing natural trends within the data.”

The algorithm tries to find and discover clusters or patterns within the data. “It’s like saying to the algorithm: ‘I want you to tell me what schools you think should be grouped together based on the data I feed you,’ which is the data that the user selects based on his or her personal preferences.”

U.S. News has been transparent about the metrics it uses, Dr. Turner notes. “When I started looking into how rankings are developed, I saw that there was transparency, and the reasoning for choosing the metrics used to develop the ranking was pretty sound,” he said.

“But I didn’t see any justification as to why they chose the particular metrics and weighted them in the way that they did.”

Dr. Turner extracted data from the 2023 U.S. News report, which ranked 109 allopathic medical schools, and applied several scenarios to the results to create his alternative ranking system.

In one scenario, he used the same research metrics used by U.S. News, such as a peer research assessment, median federal research activity per full-time faculty member, median GPA, median MCAT, acceptance rate, and faculty-student ratio.

In another scenario, he included four additional metrics: debt, in-state cost of attendance, USMLE Step 1 passing rate, and percentage of underrepresented students with minority race or ethnicity at the school.

For example, a user can rank the importance of the diversity of the class, amount of debt students expect to incur, and amount of research funding the medical school receives. After selecting those factors, the tool generates tiered results displayed in a circle, a shape chosen to avoid the appearance of the hierarchy associated with traditional rankings, Dr. Turner said.

“A prospective student might not care about acceptance rates and MCAT scores, and instead cares about diversity and debt,” Dr. Turner said. He looks forward to extending this approach to the ranking of colleges as well.
 

‘Imperfect measures’

“The model and interesting online tool that Dr. Turner created allows a premed [student] to generate custom rankings that are in line with their own priorities,” said Christopher Worsham, MD, MPH, a critical care physician in Mass General’s division of pulmonary and critical care medicine.

But Dr. Worsham, also a teaching associate at Harvard Medical School’s department of health care policy, expressed concern that factors figuring into the rankings by U.S. News and Dr. Turner’s alternative “are imperfect measures of medical school quality.”

For example, a student interested in research might favor federal research funding in their customized rankings with Dr. Turner’s model. “But higher research funding doesn’t necessarily translate into a better education for students, particularly when differentiating between two major research systems,” Dr. Worsham noted.

Dr. Worsham added that neither ranking system accurately predicts the quality of doctors graduating from the schools. Instead, he’d like to see ranking systems based on which schools’ graduates deliver the best patient outcomes, whether that’s through direct patient care, impactful research, or leadership within the health care system.

Michael Sauder, PhD, professor of sociology at the University of Iowa, Iowa City, said the model could offer a valuable alternative to the U.S. News ranking system. It might help users develop their own criteria for determining the ranking of medical schools, which is a big improvement over a “one-size-fits-all” approach, Dr. Sauder said.

And Hanna Stotland, an admission consultant based in Chicago, noted that most students rely on rankings because they “don’t have the luxury of advisers who know the ins and outs of different medical schools.” Given the role that rankings play, Ms. Stotland expects that every new ranking tool will have some influence on students.

This tool in particular “has the potential to be useful for students who have identified values they want their medical school to share.” For example, students who care about racial diversity “could use it to easily identify schools that are successful on that metric,” Ms. Stotland said.

Sujay Ratna, a 2nd-year med student at Icahn School of Medicine at Mount Sinai in New York, said he considered the U.S. News ranking his “go-to tool” when he was applying to med school.

But after reading Dr. Turner’s article, the AMSA membership vice president tried the algorithm. “I definitely would have used it had it existed when I was thinking of what schools to apply to and what [schools] to attend.”

The study had no specific funding. Dr. Turner, Dr. Worsham, Dr. Sauder, Ms. Stotland, Ms. Brett, and Mr. Ratna report no relevant financial relationships.

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

For decades, pre-med students depended on the annual medical school rankings by U.S. News and World Report to decide where to apply for physician education. But after several prominent med schools pulled out of the rankings, one resident began experimenting with artificial intelligence (AI) to create an alternative.

Brandon Turner MD, MSc, a radiation oncology resident at Massachusetts General Hospital in Boston, developed a free do-it-yourself tool using AI that allows prospective students to rank medical schools based on considerations that are most important to them. His research was published online in JAMA Network Open.

“One of the flaws with conventional ranking systems is that the metrics used in these tools are weighted based on the preferences and views of the people who developed these rankings, but those may not work for everyone,” Dr. Turner told this news organization.

He explained that there are different types of metrics used in the U.S. News ranking: one for research and the other for primary care. “The research rankings carry the most prestige and are the ones that most people know about,” he explained. These metrics take into account factors such as how many grant dollars the medical school receives and the average size of those grants per faculty member, Dr. Turner said.

Admission metrics are also included – for example, the median grade point average or MCAT scores of students who have been accepted. “These don’t tell you anything about the research output of the school, only about how selective the school is,” he said.

Primary care metrics might focus on how many graduates of a given school go into primary care, or how other schools rate the quality of primary care training at a given school – a process called peer assessment, Dr. Turner said.

But even though these might be helpful, students may be more interested in the cost of attendance, average debt, representation of minorities, and how many graduates pass their boards, he said. “U.S. News metrics don’t capture these things, but I included them in my algorithm.”

A U.S. News spokesperson said that the publication continues to help students and their families make decisions about their future education. The spokesperson cited U.S. News’ explanation of how it calculates its rankings. “A school’s overall Best Medical Schools rank should be one consideration and not the lone determinant in where a student applies and accepts,” the article states.

Dr. Turner agreed ranking systems are a good starting point when researching med schools, “but the values reflected in the ranking may not reflect an individual’s goals.”

Tyra-Lee Brett, a premed student at the University of South Florida, Tampa, believes an additional tool for students to evaluate medical schools is needed – and she could potentially see herself using Dr. Turner’s creation.

Still, Ms. Brett, a premed trustee of the American Medical Student Association, doesn’t regard any ranking tool as the “be all and end all.” Rather, she feels that the most effective tool would be based on students’ lived experiences. The AMSA is developing a scorecard in which students grade schools based on their opinions about such issues as housing, family planning, and environmental health, she said.
 

No prior judgments

To develop his algorithm, Dr. Turner used a branch of AI called “unsupervised learning.” It doesn’t make a prior judgment about what the data should look like, Dr. Turner explained.

“You’re just analyzing natural trends within the data.”

The algorithm tries to find and discover clusters or patterns within the data. “It’s like saying to the algorithm: ‘I want you to tell me what schools you think should be grouped together based on the data I feed you,’ which is the data that the user selects based on his or her personal preferences.”

U.S. News has been transparent about the metrics it uses, Dr. Turner notes. “When I started looking into how rankings are developed, I saw that there was transparency, and the reasoning for choosing the metrics used to develop the ranking was pretty sound,” he said.

“But I didn’t see any justification as to why they chose the particular metrics and weighted them in the way that they did.”

Dr. Turner extracted data from the 2023 U.S. News report, which ranked 109 allopathic medical schools, and applied several scenarios to the results to create his alternative ranking system.

In one scenario, he used the same research metrics used by U.S. News, such as a peer research assessment, median federal research activity per full-time faculty member, median GPA, median MCAT, acceptance rate, and faculty-student ratio.

In another scenario, he included four additional metrics: debt, in-state cost of attendance, USMLE Step 1 passing rate, and percentage of underrepresented students with minority race or ethnicity at the school.

For example, a user can rank the importance of the diversity of the class, amount of debt students expect to incur, and amount of research funding the medical school receives. After selecting those factors, the tool generates tiered results displayed in a circle, a shape chosen to avoid the appearance of the hierarchy associated with traditional rankings, Dr. Turner said.

“A prospective student might not care about acceptance rates and MCAT scores, and instead cares about diversity and debt,” Dr. Turner said. He looks forward to extending this approach to the ranking of colleges as well.
 

‘Imperfect measures’

“The model and interesting online tool that Dr. Turner created allows a premed [student] to generate custom rankings that are in line with their own priorities,” said Christopher Worsham, MD, MPH, a critical care physician in Mass General’s division of pulmonary and critical care medicine.

But Dr. Worsham, also a teaching associate at Harvard Medical School’s department of health care policy, expressed concern that factors figuring into the rankings by U.S. News and Dr. Turner’s alternative “are imperfect measures of medical school quality.”

For example, a student interested in research might favor federal research funding in their customized rankings with Dr. Turner’s model. “But higher research funding doesn’t necessarily translate into a better education for students, particularly when differentiating between two major research systems,” Dr. Worsham noted.

Dr. Worsham added that neither ranking system accurately predicts the quality of doctors graduating from the schools. Instead, he’d like to see ranking systems based on which schools’ graduates deliver the best patient outcomes, whether that’s through direct patient care, impactful research, or leadership within the health care system.

Michael Sauder, PhD, professor of sociology at the University of Iowa, Iowa City, said the model could offer a valuable alternative to the U.S. News ranking system. It might help users develop their own criteria for determining the ranking of medical schools, which is a big improvement over a “one-size-fits-all” approach, Dr. Sauder said.

And Hanna Stotland, an admission consultant based in Chicago, noted that most students rely on rankings because they “don’t have the luxury of advisers who know the ins and outs of different medical schools.” Given the role that rankings play, Ms. Stotland expects that every new ranking tool will have some influence on students.

This tool in particular “has the potential to be useful for students who have identified values they want their medical school to share.” For example, students who care about racial diversity “could use it to easily identify schools that are successful on that metric,” Ms. Stotland said.

Sujay Ratna, a 2nd-year med student at Icahn School of Medicine at Mount Sinai in New York, said he considered the U.S. News ranking his “go-to tool” when he was applying to med school.

But after reading Dr. Turner’s article, the AMSA membership vice president tried the algorithm. “I definitely would have used it had it existed when I was thinking of what schools to apply to and what [schools] to attend.”

The study had no specific funding. Dr. Turner, Dr. Worsham, Dr. Sauder, Ms. Stotland, Ms. Brett, and Mr. Ratna report no relevant financial relationships.

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

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.

Advanced practice providers (APPs) such as nurse practitioners (NPs) and physician assistants (PAs) have long been at odds with doctor groups over scope of practice issues. But in a rare alliance, more than 500 physicians, NPs, and PAs at Allina Health primary care and urgent care clinics in Minneapolis recently filed a petition with the National Labor Relations Board to hold a union election in late September. If successful, the Allina group will join the Doctors Council SEIU, Local 10MD.

The Allina health care providers share concerns about their working conditions, such as understaffing and inadequate resources, limited decision-making authority, and health systems valuing productivity and profit over patient care.

Although doctors and APPs have said that they generally work well together, the relationship has been strained in recent years as APPs argue for greater scope of practice. Meanwhile, physician groups, such as the American Medical Association, believe that APPs need more oversight.

An Allina union organizer, Britta V. Kasmarik, CNP, acknowledges the tension between physicians and APPs. But she said in an interview that the union effort helped bond this group of health care providers. “We share common goals of providing high-quality care for patients in a safe way, and we see the same things day in and day out with our patients.”

Matt Hoffman, MD, a primary care physician at Allina, told this news organization that APPs in his specialty perform the same job as doctors “and the working conditions are really identical. In our view, that means we should be unionizing together.”

The decision to hold a union vote follows similar action by nearly 150 Allina Mercy Hospital physicians in March. Allina Health appealed the vote.

In response to a New York Times investigation, the Minnesota Attorney General’s office began reviewing reports of aggressive billing practices and denied care at Allina Health.

The Allina Health system, which reports $4 billion in annual revenue, cut off nonemergency services to patients, including children, if their medical debt exceeded $4,500, according to the New York Times article. For Allina’s physicians and APPs, that meant leaving patients’ illnesses untreated.

Less than a week after the attorney general announced its investigation, the health system ended this practice.

In a prepared statement to this news organization, Allina Health said that its providers are “critical members of our teams. … We deeply value and share their commitment to providing high-quality care to our patients.”

The health system said it planned to make operational improvements, implement new communication tools, and provide additional well-being resources and enhanced employee benefits “to improve the provider experience.” In addition, it hoped to continue to “foster a culture of collaboration with all our employees.”

Having a union will allow health care providers to advocate for their patients and give health care providers more decision-making power instead of corporate leaders maintaining full authority, Ms. Kasmarik told this news organization.

Union organizers are also concerned with changes to the daily practice of medicine. “We don’t want to be spending our time doing paperwork and calling insurance companies and filling out forms,” said Dr. Hoffman. “We want to be in the exam room with a patient.”

The Allina providers organized after multiple requests to corporate managers failed to address their concerns. Their demands include increased staffing and help with nonclinical work so that clinicians can spend more time with their patients.

“What I’m really excited about is that we will be able to work with the other unionized groups to make change ... by being involved in health care policy at a state or national level,” Dr. Hoffman said. For example, that involvement might include challenging insurance company decisions.

Doctors Council bills itself as the largest union for attending physicians in the country, with 3,500 members, according to Joe Crane, national organizing director.

Despite an increase in union efforts since the pandemic, health care workers – particularly doctors – have been slow to join unions. Mr. Crane estimated that only about 3% of U.S. physicians are currently union members. He cited union campaigns in Massachusetts, New York, and Washington, DC. For comparison, a minority of advanced practice registered nurses (APRNs) (9%) report union membership, according to Medscape’s APRN compensation report last year.

Dr. Hoffman is confident the Allina health care providers will have enough votes to win the election to join the union. “We should have done this years ago.”

A version of this article appeared on Medscape.com.

Advanced practice providers (APPs) such as nurse practitioners (NPs) and physician assistants (PAs) have long been at odds with doctor groups over scope of practice issues. But in a rare alliance, more than 500 physicians, NPs, and PAs at Allina Health primary care and urgent care clinics in Minneapolis recently filed a petition with the National Labor Relations Board to hold a union election in late September. If successful, the Allina group will join the Doctors Council SEIU, Local 10MD.

The Allina health care providers share concerns about their working conditions, such as understaffing and inadequate resources, limited decision-making authority, and health systems valuing productivity and profit over patient care.

Although doctors and APPs have said that they generally work well together, the relationship has been strained in recent years as APPs argue for greater scope of practice. Meanwhile, physician groups, such as the American Medical Association, believe that APPs need more oversight.

An Allina union organizer, Britta V. Kasmarik, CNP, acknowledges the tension between physicians and APPs. But she said in an interview that the union effort helped bond this group of health care providers. “We share common goals of providing high-quality care for patients in a safe way, and we see the same things day in and day out with our patients.”

Matt Hoffman, MD, a primary care physician at Allina, told this news organization that APPs in his specialty perform the same job as doctors “and the working conditions are really identical. In our view, that means we should be unionizing together.”

The decision to hold a union vote follows similar action by nearly 150 Allina Mercy Hospital physicians in March. Allina Health appealed the vote.

In response to a New York Times investigation, the Minnesota Attorney General’s office began reviewing reports of aggressive billing practices and denied care at Allina Health.

The Allina Health system, which reports $4 billion in annual revenue, cut off nonemergency services to patients, including children, if their medical debt exceeded $4,500, according to the New York Times article. For Allina’s physicians and APPs, that meant leaving patients’ illnesses untreated.

Less than a week after the attorney general announced its investigation, the health system ended this practice.

In a prepared statement to this news organization, Allina Health said that its providers are “critical members of our teams. … We deeply value and share their commitment to providing high-quality care to our patients.”

The health system said it planned to make operational improvements, implement new communication tools, and provide additional well-being resources and enhanced employee benefits “to improve the provider experience.” In addition, it hoped to continue to “foster a culture of collaboration with all our employees.”

Having a union will allow health care providers to advocate for their patients and give health care providers more decision-making power instead of corporate leaders maintaining full authority, Ms. Kasmarik told this news organization.

Union organizers are also concerned with changes to the daily practice of medicine. “We don’t want to be spending our time doing paperwork and calling insurance companies and filling out forms,” said Dr. Hoffman. “We want to be in the exam room with a patient.”

The Allina providers organized after multiple requests to corporate managers failed to address their concerns. Their demands include increased staffing and help with nonclinical work so that clinicians can spend more time with their patients.

“What I’m really excited about is that we will be able to work with the other unionized groups to make change ... by being involved in health care policy at a state or national level,” Dr. Hoffman said. For example, that involvement might include challenging insurance company decisions.

Doctors Council bills itself as the largest union for attending physicians in the country, with 3,500 members, according to Joe Crane, national organizing director.

Despite an increase in union efforts since the pandemic, health care workers – particularly doctors – have been slow to join unions. Mr. Crane estimated that only about 3% of U.S. physicians are currently union members. He cited union campaigns in Massachusetts, New York, and Washington, DC. For comparison, a minority of advanced practice registered nurses (APRNs) (9%) report union membership, according to Medscape’s APRN compensation report last year.

Dr. Hoffman is confident the Allina health care providers will have enough votes to win the election to join the union. “We should have done this years ago.”

A version of this article appeared on Medscape.com.

Advanced practice providers (APPs) such as nurse practitioners (NPs) and physician assistants (PAs) have long been at odds with doctor groups over scope of practice issues. But in a rare alliance, more than 500 physicians, NPs, and PAs at Allina Health primary care and urgent care clinics in Minneapolis recently filed a petition with the National Labor Relations Board to hold a union election in late September. If successful, the Allina group will join the Doctors Council SEIU, Local 10MD.

The Allina health care providers share concerns about their working conditions, such as understaffing and inadequate resources, limited decision-making authority, and health systems valuing productivity and profit over patient care.

Although doctors and APPs have said that they generally work well together, the relationship has been strained in recent years as APPs argue for greater scope of practice. Meanwhile, physician groups, such as the American Medical Association, believe that APPs need more oversight.

An Allina union organizer, Britta V. Kasmarik, CNP, acknowledges the tension between physicians and APPs. But she said in an interview that the union effort helped bond this group of health care providers. “We share common goals of providing high-quality care for patients in a safe way, and we see the same things day in and day out with our patients.”

Matt Hoffman, MD, a primary care physician at Allina, told this news organization that APPs in his specialty perform the same job as doctors “and the working conditions are really identical. In our view, that means we should be unionizing together.”

The decision to hold a union vote follows similar action by nearly 150 Allina Mercy Hospital physicians in March. Allina Health appealed the vote.

In response to a New York Times investigation, the Minnesota Attorney General’s office began reviewing reports of aggressive billing practices and denied care at Allina Health.

The Allina Health system, which reports $4 billion in annual revenue, cut off nonemergency services to patients, including children, if their medical debt exceeded $4,500, according to the New York Times article. For Allina’s physicians and APPs, that meant leaving patients’ illnesses untreated.

Less than a week after the attorney general announced its investigation, the health system ended this practice.

In a prepared statement to this news organization, Allina Health said that its providers are “critical members of our teams. … We deeply value and share their commitment to providing high-quality care to our patients.”

The health system said it planned to make operational improvements, implement new communication tools, and provide additional well-being resources and enhanced employee benefits “to improve the provider experience.” In addition, it hoped to continue to “foster a culture of collaboration with all our employees.”

Having a union will allow health care providers to advocate for their patients and give health care providers more decision-making power instead of corporate leaders maintaining full authority, Ms. Kasmarik told this news organization.

Union organizers are also concerned with changes to the daily practice of medicine. “We don’t want to be spending our time doing paperwork and calling insurance companies and filling out forms,” said Dr. Hoffman. “We want to be in the exam room with a patient.”

The Allina providers organized after multiple requests to corporate managers failed to address their concerns. Their demands include increased staffing and help with nonclinical work so that clinicians can spend more time with their patients.

“What I’m really excited about is that we will be able to work with the other unionized groups to make change ... by being involved in health care policy at a state or national level,” Dr. Hoffman said. For example, that involvement might include challenging insurance company decisions.

Doctors Council bills itself as the largest union for attending physicians in the country, with 3,500 members, according to Joe Crane, national organizing director.

Despite an increase in union efforts since the pandemic, health care workers – particularly doctors – have been slow to join unions. Mr. Crane estimated that only about 3% of U.S. physicians are currently union members. He cited union campaigns in Massachusetts, New York, and Washington, DC. For comparison, a minority of advanced practice registered nurses (APRNs) (9%) report union membership, according to Medscape’s APRN compensation report last year.

Dr. Hoffman is confident the Allina health care providers will have enough votes to win the election to join the union. “We should have done this years ago.”

A version of this article appeared on Medscape.com.

Dysphagia, gastroparesis, constipation, and irritable bowel syndrome without diarrhea specifically predicted Parkinson’s disease (PD) in a new study.

Early detection of these conditions might help identify patients at risk for PD, potentially prompting preventive strategies, the researchers suggest.

The results of previous experimental studies by the team supported the Braak hypothesis, which states that idiopathic PD originates in the gut in a subset of patients. However, no previous study had investigated a broad range of gastrointestinal symptoms and syndromes that might occur prior to a PD diagnosis.

Given their preclinical work, the authors were not surprised to find that certain GI syndromes were specifically associated with PD, even when compared with Alzheimer’s disease (AD) and cerebrovascular disease (CVD), principal author Pankaj Jay Pasricha, MBBS, MD, of Mayo Clinic Arizona, Scottsdale, said in an interview. However, they were “impressed by the strength of the associations.”

“Experts have known for a very long time that constipation is a potential risk factor for PD, so this study adds to the list of GI conditions that could potentially be risk factors,” he said.

The study was published online in Gut.
 

Studies converge

To determine the incidence of GI syndromes and interventions preceding PD, the investigators performed a combined case-control and cohort study using a U.S.-based nationwide medical record network.

First, they compared 24,624 individuals with new-onset idiopathic PD with the same number of matched negative controls (NCs), as well as 19,046 people with AD and 23,942 with CVD to investigate the presence of preexisting GI conditions, which the researchers referred to as “exposures.” Overall, the mean age was about 70, and about half of those studied were women.

Eighteen conditions covering the entire GI tract were investigated. These included achalasia, dysphagia, gastroesophageal reflux disease, gastroparesis, functional dyspepsia, paralytic ileus, diarrhea, irritable bowel syndrome (IBS) with and without diarrhea, intestinal pseudo-obstruction, fecal incontinence, Crohn’s disease, ulcerative colitis, and microscopic colitis, as well as appendectomy and vagotomy.

All GI syndromes were significantly increased in the PD group, compared with NCs (odds ratio > 1). However, only preexisting dysphagia (OR, 3.58), gastroparesis (OR, 4.64), functional dyspepsia (OR, 3.39), intestinal pseudo-obstruction (OR, 3.01), diarrhea (OR, 2.85), constipation (OR, 3.32), IBS with constipation (OR, 4.11), IBS with diarrhea (OR, 4.31), IBS without diarrhea (OR, 3.53), and fecal incontinence (OR, 3.76) produced ORs that were numerically greater than the upper limit of the negative exposures.

In addition, only gastroparesis, dysphagia, IBS with constipation, IBS without diarrhea, and constipation were specific for PD, compared with the AD and CVD groups (OR > 1). After correction for false discovery rate, though, gastroparesis and constipation did not remain significantly different, compared with the AD and CVD groups.

Other preexisting GI conditions not only were significantly associated with PD but also showed strong associations with the AD and CVD groups.

To validate the case-control analyses, the team set up a complementary cohort study. Eighteen cohorts – each diagnosed with one of the GI conditions in the case-control analysis – were compared with their respective NC cohorts for the prospective risk of developing PD, AD, or CVD within 5 years.

Gastroparesis, dysphagia, IBS without diarrhea, and constipation showed specific associations with PD versus NCs, AD, and CVD in the cohort analysis. Their relative risks versus NCs were 2.43, 2.27, 1.17, and 2.38, respectively.

Functional dyspepsia, IBS with diarrhea, diarrhea, and fecal incontinence were not PD specific, but IBS with constipation and intestinal pseudo-obstruction showed PD specificity in both the case-control (OR, 4.11) and cohort analyses (RR, 1.84).

Appendectomy decreased the risk for PD in the cohort analysis (RR, 0.48), but neither inflammatory bowel disease nor vagotomy was associated with PD.

“This study is the first to establish substantial observational evidence that the clinical diagnosis of not only constipation but also dysphagia, gastroparesis, and IBS without diarrhea might specifically predict the development of PD, whereas other exposures were less specific,” the researchers wrote.

However, Dr. Pasricha said, “there is no need for alarm.” Clinicians should reassure patients that “the overall risk for developing PD is low. The overwhelming majority of patients with these GI conditions will never develop PD.”

His team will be doing experimental work on the biological mechanisms that might explain the current study’s findings. “In addition, the U.S. National Institutes of Health has issued a call for proposals to perform research in patients that could help understand these associations better,” he said.
 

Body or brain?

The Parkinson’s Foundation’s National Medical Advisor, Michael S. Okun, MD, called the study “fascinating.”

The findings “confirm many other studies showing that GI symptoms can precede a Parkinson’s disease diagnosis,” he said in an interview.

Although the study was designed to test the Braak hypothesis, “the dataset really cannot confirm or refute Braak pathology, which can only be accomplished with comparison to postmortem samples,” he added.

“The raging debate in the field of body-first versus brain-first Parkinson’s may be somewhat artificial, especially if we consider that Parkinson’s is not one disease,” Dr. Okun noted. “It will take clinical data, pathology, and the collaboration of many researchers to solve the puzzle.”

“The Foundation continues to monitor all the advancements in the ‘gut’ Parkinson field,” he said. “We do not recommend at this time changing the approach to clinical care based on this data.”

No funding or competing interests were declared. Dr. Okun declared no relevant disclosures.

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

Dysphagia, gastroparesis, constipation, and irritable bowel syndrome without diarrhea specifically predicted Parkinson’s disease (PD) in a new study.

Early detection of these conditions might help identify patients at risk for PD, potentially prompting preventive strategies, the researchers suggest.

The results of previous experimental studies by the team supported the Braak hypothesis, which states that idiopathic PD originates in the gut in a subset of patients. However, no previous study had investigated a broad range of gastrointestinal symptoms and syndromes that might occur prior to a PD diagnosis.

Given their preclinical work, the authors were not surprised to find that certain GI syndromes were specifically associated with PD, even when compared with Alzheimer’s disease (AD) and cerebrovascular disease (CVD), principal author Pankaj Jay Pasricha, MBBS, MD, of Mayo Clinic Arizona, Scottsdale, said in an interview. However, they were “impressed by the strength of the associations.”

“Experts have known for a very long time that constipation is a potential risk factor for PD, so this study adds to the list of GI conditions that could potentially be risk factors,” he said.

The study was published online in Gut.
 

Studies converge

To determine the incidence of GI syndromes and interventions preceding PD, the investigators performed a combined case-control and cohort study using a U.S.-based nationwide medical record network.

First, they compared 24,624 individuals with new-onset idiopathic PD with the same number of matched negative controls (NCs), as well as 19,046 people with AD and 23,942 with CVD to investigate the presence of preexisting GI conditions, which the researchers referred to as “exposures.” Overall, the mean age was about 70, and about half of those studied were women.

Eighteen conditions covering the entire GI tract were investigated. These included achalasia, dysphagia, gastroesophageal reflux disease, gastroparesis, functional dyspepsia, paralytic ileus, diarrhea, irritable bowel syndrome (IBS) with and without diarrhea, intestinal pseudo-obstruction, fecal incontinence, Crohn’s disease, ulcerative colitis, and microscopic colitis, as well as appendectomy and vagotomy.

All GI syndromes were significantly increased in the PD group, compared with NCs (odds ratio > 1). However, only preexisting dysphagia (OR, 3.58), gastroparesis (OR, 4.64), functional dyspepsia (OR, 3.39), intestinal pseudo-obstruction (OR, 3.01), diarrhea (OR, 2.85), constipation (OR, 3.32), IBS with constipation (OR, 4.11), IBS with diarrhea (OR, 4.31), IBS without diarrhea (OR, 3.53), and fecal incontinence (OR, 3.76) produced ORs that were numerically greater than the upper limit of the negative exposures.

In addition, only gastroparesis, dysphagia, IBS with constipation, IBS without diarrhea, and constipation were specific for PD, compared with the AD and CVD groups (OR > 1). After correction for false discovery rate, though, gastroparesis and constipation did not remain significantly different, compared with the AD and CVD groups.

Other preexisting GI conditions not only were significantly associated with PD but also showed strong associations with the AD and CVD groups.

To validate the case-control analyses, the team set up a complementary cohort study. Eighteen cohorts – each diagnosed with one of the GI conditions in the case-control analysis – were compared with their respective NC cohorts for the prospective risk of developing PD, AD, or CVD within 5 years.

Gastroparesis, dysphagia, IBS without diarrhea, and constipation showed specific associations with PD versus NCs, AD, and CVD in the cohort analysis. Their relative risks versus NCs were 2.43, 2.27, 1.17, and 2.38, respectively.

Functional dyspepsia, IBS with diarrhea, diarrhea, and fecal incontinence were not PD specific, but IBS with constipation and intestinal pseudo-obstruction showed PD specificity in both the case-control (OR, 4.11) and cohort analyses (RR, 1.84).

Appendectomy decreased the risk for PD in the cohort analysis (RR, 0.48), but neither inflammatory bowel disease nor vagotomy was associated with PD.

“This study is the first to establish substantial observational evidence that the clinical diagnosis of not only constipation but also dysphagia, gastroparesis, and IBS without diarrhea might specifically predict the development of PD, whereas other exposures were less specific,” the researchers wrote.

However, Dr. Pasricha said, “there is no need for alarm.” Clinicians should reassure patients that “the overall risk for developing PD is low. The overwhelming majority of patients with these GI conditions will never develop PD.”

His team will be doing experimental work on the biological mechanisms that might explain the current study’s findings. “In addition, the U.S. National Institutes of Health has issued a call for proposals to perform research in patients that could help understand these associations better,” he said.
 

Body or brain?

The Parkinson’s Foundation’s National Medical Advisor, Michael S. Okun, MD, called the study “fascinating.”

The findings “confirm many other studies showing that GI symptoms can precede a Parkinson’s disease diagnosis,” he said in an interview.

Although the study was designed to test the Braak hypothesis, “the dataset really cannot confirm or refute Braak pathology, which can only be accomplished with comparison to postmortem samples,” he added.

“The raging debate in the field of body-first versus brain-first Parkinson’s may be somewhat artificial, especially if we consider that Parkinson’s is not one disease,” Dr. Okun noted. “It will take clinical data, pathology, and the collaboration of many researchers to solve the puzzle.”

“The Foundation continues to monitor all the advancements in the ‘gut’ Parkinson field,” he said. “We do not recommend at this time changing the approach to clinical care based on this data.”

No funding or competing interests were declared. Dr. Okun declared no relevant disclosures.

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

Dysphagia, gastroparesis, constipation, and irritable bowel syndrome without diarrhea specifically predicted Parkinson’s disease (PD) in a new study.

Early detection of these conditions might help identify patients at risk for PD, potentially prompting preventive strategies, the researchers suggest.

The results of previous experimental studies by the team supported the Braak hypothesis, which states that idiopathic PD originates in the gut in a subset of patients. However, no previous study had investigated a broad range of gastrointestinal symptoms and syndromes that might occur prior to a PD diagnosis.

Given their preclinical work, the authors were not surprised to find that certain GI syndromes were specifically associated with PD, even when compared with Alzheimer’s disease (AD) and cerebrovascular disease (CVD), principal author Pankaj Jay Pasricha, MBBS, MD, of Mayo Clinic Arizona, Scottsdale, said in an interview. However, they were “impressed by the strength of the associations.”

“Experts have known for a very long time that constipation is a potential risk factor for PD, so this study adds to the list of GI conditions that could potentially be risk factors,” he said.

The study was published online in Gut.
 

Studies converge

To determine the incidence of GI syndromes and interventions preceding PD, the investigators performed a combined case-control and cohort study using a U.S.-based nationwide medical record network.

First, they compared 24,624 individuals with new-onset idiopathic PD with the same number of matched negative controls (NCs), as well as 19,046 people with AD and 23,942 with CVD to investigate the presence of preexisting GI conditions, which the researchers referred to as “exposures.” Overall, the mean age was about 70, and about half of those studied were women.

Eighteen conditions covering the entire GI tract were investigated. These included achalasia, dysphagia, gastroesophageal reflux disease, gastroparesis, functional dyspepsia, paralytic ileus, diarrhea, irritable bowel syndrome (IBS) with and without diarrhea, intestinal pseudo-obstruction, fecal incontinence, Crohn’s disease, ulcerative colitis, and microscopic colitis, as well as appendectomy and vagotomy.

All GI syndromes were significantly increased in the PD group, compared with NCs (odds ratio > 1). However, only preexisting dysphagia (OR, 3.58), gastroparesis (OR, 4.64), functional dyspepsia (OR, 3.39), intestinal pseudo-obstruction (OR, 3.01), diarrhea (OR, 2.85), constipation (OR, 3.32), IBS with constipation (OR, 4.11), IBS with diarrhea (OR, 4.31), IBS without diarrhea (OR, 3.53), and fecal incontinence (OR, 3.76) produced ORs that were numerically greater than the upper limit of the negative exposures.

In addition, only gastroparesis, dysphagia, IBS with constipation, IBS without diarrhea, and constipation were specific for PD, compared with the AD and CVD groups (OR > 1). After correction for false discovery rate, though, gastroparesis and constipation did not remain significantly different, compared with the AD and CVD groups.

Other preexisting GI conditions not only were significantly associated with PD but also showed strong associations with the AD and CVD groups.

To validate the case-control analyses, the team set up a complementary cohort study. Eighteen cohorts – each diagnosed with one of the GI conditions in the case-control analysis – were compared with their respective NC cohorts for the prospective risk of developing PD, AD, or CVD within 5 years.

Gastroparesis, dysphagia, IBS without diarrhea, and constipation showed specific associations with PD versus NCs, AD, and CVD in the cohort analysis. Their relative risks versus NCs were 2.43, 2.27, 1.17, and 2.38, respectively.

Functional dyspepsia, IBS with diarrhea, diarrhea, and fecal incontinence were not PD specific, but IBS with constipation and intestinal pseudo-obstruction showed PD specificity in both the case-control (OR, 4.11) and cohort analyses (RR, 1.84).

Appendectomy decreased the risk for PD in the cohort analysis (RR, 0.48), but neither inflammatory bowel disease nor vagotomy was associated with PD.

“This study is the first to establish substantial observational evidence that the clinical diagnosis of not only constipation but also dysphagia, gastroparesis, and IBS without diarrhea might specifically predict the development of PD, whereas other exposures were less specific,” the researchers wrote.

However, Dr. Pasricha said, “there is no need for alarm.” Clinicians should reassure patients that “the overall risk for developing PD is low. The overwhelming majority of patients with these GI conditions will never develop PD.”

His team will be doing experimental work on the biological mechanisms that might explain the current study’s findings. “In addition, the U.S. National Institutes of Health has issued a call for proposals to perform research in patients that could help understand these associations better,” he said.
 

Body or brain?

The Parkinson’s Foundation’s National Medical Advisor, Michael S. Okun, MD, called the study “fascinating.”

The findings “confirm many other studies showing that GI symptoms can precede a Parkinson’s disease diagnosis,” he said in an interview.

Although the study was designed to test the Braak hypothesis, “the dataset really cannot confirm or refute Braak pathology, which can only be accomplished with comparison to postmortem samples,” he added.

“The raging debate in the field of body-first versus brain-first Parkinson’s may be somewhat artificial, especially if we consider that Parkinson’s is not one disease,” Dr. Okun noted. “It will take clinical data, pathology, and the collaboration of many researchers to solve the puzzle.”

“The Foundation continues to monitor all the advancements in the ‘gut’ Parkinson field,” he said. “We do not recommend at this time changing the approach to clinical care based on this data.”

No funding or competing interests were declared. Dr. Okun declared no relevant disclosures.

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

U.S. regulators this year will begin to demand reports from cosmetics manufacturers about the ingredients used in their products. They are also preparing to assess potential risks of so-called forever chemicals in these products.

The Food and Drug Administration last year gained new authority over cosmetics when Congress passed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by adding this bill to a December budget package.

Yulia Lisitsa/iStock/Getty Images Plus

“On average, consumers in the U.S. use six to 12 cosmetics products daily. But, until recently the FDA didn’t have the authority to require manufacturers to submit cosmetic product listings, including a list of ingredients used in these products, or register the facilities where they were produced,” Namandjé Bumpus, PhD, FDA’s chief scientist, said in a press release.

In the statement, the FDA announced the release of a draft guidance document that is intended to help companies comply with the transparency requirements slated to kick in this December. The agency is accepting comments on this draft guidance through Sept. 7.

“Later this year, registration and listing of cosmetic product facilities and products will become a requirement, making information about cosmetic products, including the ingredients used in products and the facilities where they are produced, readily available to the agency,” Dr. Bumpus said.

The products, according to the FDA statement, include makeup, nail polishes, shaving creams, other grooming products, perfumes, face and body cleansers, hair products, moisturizers, and other skin care items.

MoCRA “represents a sea change in how FDA regulates the cosmetics industry,” attorneys Frederick R. Ball, Alyson Walker Lotman, and Kelly A. Bonner, wrote in an article for the Food and Drug Law Institute published in spring 2023.

The FDA has called the MoCRA law “the most significant expansion” of its authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938.

The agency is in the process of expanding its staff to carry out newly authorized duties, including the tracking of adverse events. The FDA budget request for fiscal 2024, which begins Oct. 1, seeks $5 million for work needed to implement MoCRA.

PFAS, or ‘forever chemicals’

Some of the requested FDA funding is intended to prepare the agency to assess the use of per-and polyfluoroalkyl substances (PFAS) in cosmetics.

MoCRA sets a 3-year deadline for the FDA to issue an assessment of the use and potential risks of PFAS in cosmetics products. PFAS are sometimes added as ingredients in some cosmetic products, including lotions, cleansers, nail polish, shaving cream, foundation, lipstick, eyeliner, eyeshadow, and mascara, according to the FDA. Sometimes the presence of PFAS in cosmetics is unintentional and is the result of impurities in raw materials or is due to the breakdown of ingredients, the FDA said.

The FDA’s website says that so far, the available research doesn’t allow for “definitive conclusions about the potential health risks of PFAS in cosmetics.”

The Centers for Disease Control and Prevention has stated that research has suggested potential links between high levels of certain PFAS, in general, with increased cholesterol levels, changes in liver enzyme levels, increased risk of hypertension or preeclampsia in pregnant women, and increased risk of kidney or testicular cancer.

PFAS compounds often are used to resist grease, oil, water, and heat in industrial settings. They are used in thousands of products, from nonstick cookware to firefighting foams and protective gear, because they can reduce friction, according to a National Academies of Sciences, Engineering, and Medicine report on PFAS that was issued last year.

PFAS are known as “forever chemicals” because they contain a carbon-fluorine bond, which does not break naturally. Even when PFAS are transformed in the body, they can assume other forms of PFAS that preserve the troublesome carbon-fluorine bond. With PFAS, the human body is confronted with a substance it doesn’t have the tools to process.

This is in contrast to proteins and carbohydrates, which are in a sense prepackaged for relatively easy disassembly in the human body. Many of these compounds have weak links that enzymes and stomach acid can take apart, such as sulfur-to-sulfur (disulfide) bonds. That’s why protein-based biotech drugs are injected instead of administered as pills. The ultimate goal of this digestion is for the body to gain energy from these compounds.

But with PFAS, the body faces the challenge of carbon-fluorine bonds that are very hard to break down, and there is no payoff for these efforts, Graham F. Peaslee, PhD, professor of physics at the University of Notre Dame (Indiana), told this news organization.

“Nothing will naturally eat it because when you break the bond, it’s like eating celery,” he said. “You use more calories to eat the celery than you gain back from it.”
 

Interest from a U.S. senator

Dr. Peaslee was one of the authors of a 2021 article about PFAS in cosmetics that appeared in the journal Environmental Science and Technology Letters.

In the article, Dr. Peaslee and colleagues reported on their screening of 231 cosmetic products purchased in the United States and Canada using particle-induced gamma-ray emission spectroscopy. They found cases of undisclosed PFAS in cosmetic products. Foundations, mascaras, and lip products were noted as being especially problematic.

Sen. Susan Collins (R-ME) cited Dr. Peaslee’s article in a 2021 floor speech as she argued for having the FDA ban the intentional addition of PFAS to cosmetics.

“The findings of this study are particularly alarming, as many of these products are subject to direct human exposure,” Sen. Collins said. “For example, lipstick is often inadvertently ingested, and mascara is sometimes absorbed through tear ducts.”

In addition, workers at cosmetics plants may be exposed to PFAS and discarded cosmetics that have these compounds, which could potentially contaminate drinking water, Sen. Collins said. In 2021, she introduced legislation seeking a ban on PFAS that are intentionally added to cosmetics. That legislation did not advance through the Senate.

But the Senate Appropriations Committee, on which Sen. Collins is the ranking Republican, wants the FDA to keep a ban on PFAS in mind.

The Senate Agriculture Appropriations subcommittee, which oversees the FDA’s budget, raised the issue of PFAS and cosmetics in a June report. The FDA should develop a plan outlining research needed to inform “regulatory decision making, including potential development of a proposed rule to ban intentionally added PFAS substances in cosmetics,” the subcommittee said.
 

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

U.S. regulators this year will begin to demand reports from cosmetics manufacturers about the ingredients used in their products. They are also preparing to assess potential risks of so-called forever chemicals in these products.

The Food and Drug Administration last year gained new authority over cosmetics when Congress passed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by adding this bill to a December budget package.

Yulia Lisitsa/iStock/Getty Images Plus

“On average, consumers in the U.S. use six to 12 cosmetics products daily. But, until recently the FDA didn’t have the authority to require manufacturers to submit cosmetic product listings, including a list of ingredients used in these products, or register the facilities where they were produced,” Namandjé Bumpus, PhD, FDA’s chief scientist, said in a press release.

In the statement, the FDA announced the release of a draft guidance document that is intended to help companies comply with the transparency requirements slated to kick in this December. The agency is accepting comments on this draft guidance through Sept. 7.

“Later this year, registration and listing of cosmetic product facilities and products will become a requirement, making information about cosmetic products, including the ingredients used in products and the facilities where they are produced, readily available to the agency,” Dr. Bumpus said.

The products, according to the FDA statement, include makeup, nail polishes, shaving creams, other grooming products, perfumes, face and body cleansers, hair products, moisturizers, and other skin care items.

MoCRA “represents a sea change in how FDA regulates the cosmetics industry,” attorneys Frederick R. Ball, Alyson Walker Lotman, and Kelly A. Bonner, wrote in an article for the Food and Drug Law Institute published in spring 2023.

The FDA has called the MoCRA law “the most significant expansion” of its authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938.

The agency is in the process of expanding its staff to carry out newly authorized duties, including the tracking of adverse events. The FDA budget request for fiscal 2024, which begins Oct. 1, seeks $5 million for work needed to implement MoCRA.

PFAS, or ‘forever chemicals’

Some of the requested FDA funding is intended to prepare the agency to assess the use of per-and polyfluoroalkyl substances (PFAS) in cosmetics.

MoCRA sets a 3-year deadline for the FDA to issue an assessment of the use and potential risks of PFAS in cosmetics products. PFAS are sometimes added as ingredients in some cosmetic products, including lotions, cleansers, nail polish, shaving cream, foundation, lipstick, eyeliner, eyeshadow, and mascara, according to the FDA. Sometimes the presence of PFAS in cosmetics is unintentional and is the result of impurities in raw materials or is due to the breakdown of ingredients, the FDA said.

The FDA’s website says that so far, the available research doesn’t allow for “definitive conclusions about the potential health risks of PFAS in cosmetics.”

The Centers for Disease Control and Prevention has stated that research has suggested potential links between high levels of certain PFAS, in general, with increased cholesterol levels, changes in liver enzyme levels, increased risk of hypertension or preeclampsia in pregnant women, and increased risk of kidney or testicular cancer.

PFAS compounds often are used to resist grease, oil, water, and heat in industrial settings. They are used in thousands of products, from nonstick cookware to firefighting foams and protective gear, because they can reduce friction, according to a National Academies of Sciences, Engineering, and Medicine report on PFAS that was issued last year.

PFAS are known as “forever chemicals” because they contain a carbon-fluorine bond, which does not break naturally. Even when PFAS are transformed in the body, they can assume other forms of PFAS that preserve the troublesome carbon-fluorine bond. With PFAS, the human body is confronted with a substance it doesn’t have the tools to process.

This is in contrast to proteins and carbohydrates, which are in a sense prepackaged for relatively easy disassembly in the human body. Many of these compounds have weak links that enzymes and stomach acid can take apart, such as sulfur-to-sulfur (disulfide) bonds. That’s why protein-based biotech drugs are injected instead of administered as pills. The ultimate goal of this digestion is for the body to gain energy from these compounds.

But with PFAS, the body faces the challenge of carbon-fluorine bonds that are very hard to break down, and there is no payoff for these efforts, Graham F. Peaslee, PhD, professor of physics at the University of Notre Dame (Indiana), told this news organization.

“Nothing will naturally eat it because when you break the bond, it’s like eating celery,” he said. “You use more calories to eat the celery than you gain back from it.”
 

Interest from a U.S. senator

Dr. Peaslee was one of the authors of a 2021 article about PFAS in cosmetics that appeared in the journal Environmental Science and Technology Letters.

In the article, Dr. Peaslee and colleagues reported on their screening of 231 cosmetic products purchased in the United States and Canada using particle-induced gamma-ray emission spectroscopy. They found cases of undisclosed PFAS in cosmetic products. Foundations, mascaras, and lip products were noted as being especially problematic.

Sen. Susan Collins (R-ME) cited Dr. Peaslee’s article in a 2021 floor speech as she argued for having the FDA ban the intentional addition of PFAS to cosmetics.

“The findings of this study are particularly alarming, as many of these products are subject to direct human exposure,” Sen. Collins said. “For example, lipstick is often inadvertently ingested, and mascara is sometimes absorbed through tear ducts.”

In addition, workers at cosmetics plants may be exposed to PFAS and discarded cosmetics that have these compounds, which could potentially contaminate drinking water, Sen. Collins said. In 2021, she introduced legislation seeking a ban on PFAS that are intentionally added to cosmetics. That legislation did not advance through the Senate.

But the Senate Appropriations Committee, on which Sen. Collins is the ranking Republican, wants the FDA to keep a ban on PFAS in mind.

The Senate Agriculture Appropriations subcommittee, which oversees the FDA’s budget, raised the issue of PFAS and cosmetics in a June report. The FDA should develop a plan outlining research needed to inform “regulatory decision making, including potential development of a proposed rule to ban intentionally added PFAS substances in cosmetics,” the subcommittee said.
 

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

U.S. regulators this year will begin to demand reports from cosmetics manufacturers about the ingredients used in their products. They are also preparing to assess potential risks of so-called forever chemicals in these products.

The Food and Drug Administration last year gained new authority over cosmetics when Congress passed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by adding this bill to a December budget package.

Yulia Lisitsa/iStock/Getty Images Plus

“On average, consumers in the U.S. use six to 12 cosmetics products daily. But, until recently the FDA didn’t have the authority to require manufacturers to submit cosmetic product listings, including a list of ingredients used in these products, or register the facilities where they were produced,” Namandjé Bumpus, PhD, FDA’s chief scientist, said in a press release.

In the statement, the FDA announced the release of a draft guidance document that is intended to help companies comply with the transparency requirements slated to kick in this December. The agency is accepting comments on this draft guidance through Sept. 7.

“Later this year, registration and listing of cosmetic product facilities and products will become a requirement, making information about cosmetic products, including the ingredients used in products and the facilities where they are produced, readily available to the agency,” Dr. Bumpus said.

The products, according to the FDA statement, include makeup, nail polishes, shaving creams, other grooming products, perfumes, face and body cleansers, hair products, moisturizers, and other skin care items.

MoCRA “represents a sea change in how FDA regulates the cosmetics industry,” attorneys Frederick R. Ball, Alyson Walker Lotman, and Kelly A. Bonner, wrote in an article for the Food and Drug Law Institute published in spring 2023.

The FDA has called the MoCRA law “the most significant expansion” of its authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938.

The agency is in the process of expanding its staff to carry out newly authorized duties, including the tracking of adverse events. The FDA budget request for fiscal 2024, which begins Oct. 1, seeks $5 million for work needed to implement MoCRA.

PFAS, or ‘forever chemicals’

Some of the requested FDA funding is intended to prepare the agency to assess the use of per-and polyfluoroalkyl substances (PFAS) in cosmetics.

MoCRA sets a 3-year deadline for the FDA to issue an assessment of the use and potential risks of PFAS in cosmetics products. PFAS are sometimes added as ingredients in some cosmetic products, including lotions, cleansers, nail polish, shaving cream, foundation, lipstick, eyeliner, eyeshadow, and mascara, according to the FDA. Sometimes the presence of PFAS in cosmetics is unintentional and is the result of impurities in raw materials or is due to the breakdown of ingredients, the FDA said.

The FDA’s website says that so far, the available research doesn’t allow for “definitive conclusions about the potential health risks of PFAS in cosmetics.”

The Centers for Disease Control and Prevention has stated that research has suggested potential links between high levels of certain PFAS, in general, with increased cholesterol levels, changes in liver enzyme levels, increased risk of hypertension or preeclampsia in pregnant women, and increased risk of kidney or testicular cancer.

PFAS compounds often are used to resist grease, oil, water, and heat in industrial settings. They are used in thousands of products, from nonstick cookware to firefighting foams and protective gear, because they can reduce friction, according to a National Academies of Sciences, Engineering, and Medicine report on PFAS that was issued last year.

PFAS are known as “forever chemicals” because they contain a carbon-fluorine bond, which does not break naturally. Even when PFAS are transformed in the body, they can assume other forms of PFAS that preserve the troublesome carbon-fluorine bond. With PFAS, the human body is confronted with a substance it doesn’t have the tools to process.

This is in contrast to proteins and carbohydrates, which are in a sense prepackaged for relatively easy disassembly in the human body. Many of these compounds have weak links that enzymes and stomach acid can take apart, such as sulfur-to-sulfur (disulfide) bonds. That’s why protein-based biotech drugs are injected instead of administered as pills. The ultimate goal of this digestion is for the body to gain energy from these compounds.

But with PFAS, the body faces the challenge of carbon-fluorine bonds that are very hard to break down, and there is no payoff for these efforts, Graham F. Peaslee, PhD, professor of physics at the University of Notre Dame (Indiana), told this news organization.

“Nothing will naturally eat it because when you break the bond, it’s like eating celery,” he said. “You use more calories to eat the celery than you gain back from it.”
 

Interest from a U.S. senator

Dr. Peaslee was one of the authors of a 2021 article about PFAS in cosmetics that appeared in the journal Environmental Science and Technology Letters.

In the article, Dr. Peaslee and colleagues reported on their screening of 231 cosmetic products purchased in the United States and Canada using particle-induced gamma-ray emission spectroscopy. They found cases of undisclosed PFAS in cosmetic products. Foundations, mascaras, and lip products were noted as being especially problematic.

Sen. Susan Collins (R-ME) cited Dr. Peaslee’s article in a 2021 floor speech as she argued for having the FDA ban the intentional addition of PFAS to cosmetics.

“The findings of this study are particularly alarming, as many of these products are subject to direct human exposure,” Sen. Collins said. “For example, lipstick is often inadvertently ingested, and mascara is sometimes absorbed through tear ducts.”

In addition, workers at cosmetics plants may be exposed to PFAS and discarded cosmetics that have these compounds, which could potentially contaminate drinking water, Sen. Collins said. In 2021, she introduced legislation seeking a ban on PFAS that are intentionally added to cosmetics. That legislation did not advance through the Senate.

But the Senate Appropriations Committee, on which Sen. Collins is the ranking Republican, wants the FDA to keep a ban on PFAS in mind.

The Senate Agriculture Appropriations subcommittee, which oversees the FDA’s budget, raised the issue of PFAS and cosmetics in a June report. The FDA should develop a plan outlining research needed to inform “regulatory decision making, including potential development of a proposed rule to ban intentionally added PFAS substances in cosmetics,” the subcommittee said.
 

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