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Ruxolitinib for vitiligo: Experts share experiences from first year
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The Food and Drug Administration approved the cream formulation of ruxolitinib (Opzelura), a JAK inhibitor, for repigmentation of nonsegmental vitiligo in July 2022 for people aged 12 years and older.
Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, said that he likes to use ruxolitinib cream in combination with other treatments.
“In the real world with vitiligo patients, we’re oftentimes doing combinatorial therapy anyway. So phototherapy, specifically, narrow-band UVB, is something that we have a lot of clinical evidence for over the years, and it’s a modality that can combine with topical steroids and topical calcineurin inhibitors.”
He said trials to study combinations will yield better guidance on optimal use of ruxolitinib cream. “In general, vitiligo patients can really benefit from phototherapy,” he said in an interview. (Labeling recommends against combination with other JAK inhibitors, biologics, or potent immunosuppressants, such as azathioprine or cyclosporine.)
This first year has shown that ruxolitinib is an effective option, but counseling patients to expect slow improvement is important so that patients stick with it, he noted.
Documenting what treatments patients with vitiligo have used before is important, he said, as is counseling patients that ruxolitinib is approved only for use on up to 10% of a person’s body surface area. (Product labeling recommends that a thin layer be applied twice a day to affected areas up to 10% of body surface area.)
Ruxolitinib has brought a “louder voice” to vitiligo and has opened up options for patients with the disease, Dr. Chovatiya said. “Having the ability to topically treat people who have very extensive disease really gives us a lot more flexibility than we have had before.”
Good experiences with payers at safety-net hospital
Candrice R. Heath, MD, assistant professor of dermatology at Temple University, Philadelphia, said that real-world experience with topical ruxolitinib will be more evident after its been on the market for 18-24 months.
Dr. Heath said she, too, encourages use of narrow-band UVB phototherapy in conjunction with the treatment.
From an insurance reimbursement standpoint, she said that she is glad that there have been fewer hurdles in getting ruxolitinib to patients than she has experienced with other medications.
In her safety-net hospital, she told this news organization, she sees patients with many types of insurance, but most have Medicaid. “So, I’m always expecting the step therapies, denials, pushbacks, etc.,” she said. But the path has been smoother for ruxolitinib coverage, she noted.
Her colleagues are committed to documenting everything the patient has tried, she added, and that helps with prior authorization.
Dr. Heath said that pointing out to insurers that ruxolitinib is the only approved treatment for repigmentation helps facilitate coverage.
“The science is advancing, and I’m happy to be practicing during a time when we actually have something approved for vitiligo,” she said. But she pointed out that phototherapy often is not covered for vitiligo, “which is horrible, when it is readily approved for psoriasis and atopic dermatitis.”
To document progress, Dr. Heath said that she always takes photographs of her patients with vitiligo because “the pictures remind us how far we have come.”
Data spotlight success in adolescents
Data from two trials give a clinical picture of the drug’s safety and efficacy in younger patients.
Adolescents had particularly good results in the first year with ruxolitinib, according to pooled phase 3 data from TRuE-V1 and TRuE-V2, this news organization reported.
The findings, presented at the 25th World Congress of Dermatology in Singapore, indicate that more than half of the participants achieved at least a 50% improvement from baseline in the total Vitiligo Area Scoring Index (T-VASI50) at 52 weeks.
The percentages of young patients aged 12-17 years taking twice-daily ruxolitinib who achieved T-VASI 50 at weeks 12, 24, and 52 were 11.5%, 26.9%, and 57.7%, respectively. The corresponding percentages for all in the study population were 10.7%, 22.7%, and 44.4%, respectively.
At the meeting, the presenter, Julien Seneschal, MD, PhD, professor of dermatology and head of the vitiligo and pigmentary disorders clinic at the University of Bordeaux, France, said, “This suggests that younger patients can respond better to the treatment.” He noted, however, that there were few adolescents in the studies.
New excitement in the field
Daniel Gutierrez, MD, assistant professor of dermatology at New York University, said the treatment has brought new excitement to the field.
“Patients with vitiligo are very motivated to treat their disease,” he said, because it typically is on the face and other highly visual areas, which can affect their overall perception of self.
Previously, he noted in an interview, the only FDA-approved treatment was monobenzone, but that was for depigmentation rather than repigmentation.
Otherwise, treatments were being used off label, and patients were receiving compounded formulations that often weren’t covered by insurance and often had shorter shelf life.
He said that he still occasionally gets denials from payers who consider vitiligo a cosmetic condition.
“I’ve had more luck with insurance, at least in the New York State area.” He added that sometimes payers require use of a topical calcineurin inhibitor for about 12 weeks before they will cover ruxolitinib.
Dr. Gutierrez also recommends using phototherapy with topical ruxolitinib “because they work on slightly different pathways.”
When he starts patients on a new therapy such as ruxolitinib, he asks them to come back in 3 months, and often by then, progress is evident. Facial areas show the most response, he said, while hands and feet are less likely to show significant improvement.
He said that it’s important for physicians and patients to know that improvements can take weeks or months to be noticeable. “I tell patients not to give up,” he added.
Showing the patients pictures from the current appointment and comparing them with pictures from previous appointments can help them better understand their progress, he said.
Lead investigator adds observations
David Rosmarin, MD, chair of the department of dermatology at Indiana University, Indianapolis, was the lead investigator of the pivotal TruE-V1 and TruE-V2 trials for vitiligo. In that role, he has been treating vitiligo patients with topical ruxolitinib since 2015.
In an interview, he said that many patients “don’t hit their optimal results at 3 months, 6 months, even the year mark. With continued use, many can see continued benefit.”
Other patients, he said, don’t respond within the first 6 months but with continued use may eventually respond, he said.
“Unfortunately, we have no way of knowing, based on clinical characteristics or baseline demographics, whether a patient will be a delayed responder or not or an early responder,” Dr. Rosmarin added.
He provided several observations about people who have stopped taking the medication.
“When people stop,” he said, “some maintain their response, but some start to depigment again. Again, we have no way of predicting who will be in which category.”
He said that once patients have hit their desired response, he usually advises them to taper down to maybe twice a week or to stop treatment, but if they see any recurrence, they should start reusing the medicine.
“We have some patients who have gone 6 or 7 years now before they had a recurrence, but others may start to depigment again in 2 to 3 months,” Dr. Rosmarin said.
As for phototherapy, he said, the combination with topical ruxolitinib is being studied.
“We think the combination is synergistic and better than either alone, but we’re still waiting for data to prove that,” he said.
In his practice, he offers patients the option either to use just ruxolitinib cream or the combination early on. Many patients, because of convenience, say they’ll first try the cream to see if that works.
“The challenge with light [therapy] is that it can be very inconvenient,” he said. Patients have to live close to a phototherapy unit to receive therapy 2-3 times a week or have a phototherapy product in their home.
Next in the pipeline
Experts say the progress doesn’t stop with ruxolitinib cream. Current trials of several medications show there’s more to come for patients with vitiligo.
Dr. Chovatiya said that next up may be oral ritlecitinib (Litfulo), a JAK inhibitor that was approved for severe alopecia areata in June for people aged 12 years and older. Phase 2 results have been published for its use with vitiligo.
“This would be an oral medication that may be able to help people with much more extensive disease as far as vitiligo goes,” he said, adding that he expects approval for a vitiligo indication within a few years.
He pointed out that longer-term safety data will be available because it is already on the market for alopecia.
Upadacitinib (Rinvoq), an oral JAK inhibitor, is approved for atopic dermatitis but is being studied for vitiligo as well, he noted. “I’m very excited to see what that holds for patients as well,” Dr. Chovatiya said.
Dr. Gutierrez said that he is excited about oral JAK inhibitors but sees potential in finding new ways to transplant melanocytes into areas where there are none.
The pigmentation field has seen new energy since last year’s approval, he said, particularly among people of color.
“We have new options for vitiligo that were lacking compared with other conditions, such as atopic dermatitis and psoriasis,” he said. “Hopefully, there will be more promising breakthroughs.”
Dr. Rosmarin is the chief investigator for the pivotal trials that led to FDA approval of ruxolitinib. He disclosed ties with AbbVie, Abcuro, AltruBio, Amgen, Arena, Boehringer Ingelheim, Bristol-Meyers Squibb, Celgene, Concert, CSL Behring, Dermavant, Dermira, Galderma, Incyte, Janssen, Kyowa Kirin, Lilly, Merck, Novartis, Pfizer, Regeneron, Revolo Biotherapeutics, Sanofi, Sun Pharmaceuticals, UCB, and Viela Bio. Dr. Chovatiya disclosed ties with AbbVie, Arcutis, Arena, Argenx, Beiersdorf, Bristol-Myers Squibb, Dermavant, Eli Lilly, EPI Health, Incyte, LEO Pharma, L’Oréal, National Eczema Association, Pfizer, Regeneron, Sanofi, and UCB. Dr. Heath and Dr. Gutierrez report no relevant financial relationships.
A version of this article appeared on Medscape.com.
.
The Food and Drug Administration approved the cream formulation of ruxolitinib (Opzelura), a JAK inhibitor, for repigmentation of nonsegmental vitiligo in July 2022 for people aged 12 years and older.
Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, said that he likes to use ruxolitinib cream in combination with other treatments.
“In the real world with vitiligo patients, we’re oftentimes doing combinatorial therapy anyway. So phototherapy, specifically, narrow-band UVB, is something that we have a lot of clinical evidence for over the years, and it’s a modality that can combine with topical steroids and topical calcineurin inhibitors.”
He said trials to study combinations will yield better guidance on optimal use of ruxolitinib cream. “In general, vitiligo patients can really benefit from phototherapy,” he said in an interview. (Labeling recommends against combination with other JAK inhibitors, biologics, or potent immunosuppressants, such as azathioprine or cyclosporine.)
This first year has shown that ruxolitinib is an effective option, but counseling patients to expect slow improvement is important so that patients stick with it, he noted.
Documenting what treatments patients with vitiligo have used before is important, he said, as is counseling patients that ruxolitinib is approved only for use on up to 10% of a person’s body surface area. (Product labeling recommends that a thin layer be applied twice a day to affected areas up to 10% of body surface area.)
Ruxolitinib has brought a “louder voice” to vitiligo and has opened up options for patients with the disease, Dr. Chovatiya said. “Having the ability to topically treat people who have very extensive disease really gives us a lot more flexibility than we have had before.”
Good experiences with payers at safety-net hospital
Candrice R. Heath, MD, assistant professor of dermatology at Temple University, Philadelphia, said that real-world experience with topical ruxolitinib will be more evident after its been on the market for 18-24 months.
Dr. Heath said she, too, encourages use of narrow-band UVB phototherapy in conjunction with the treatment.
From an insurance reimbursement standpoint, she said that she is glad that there have been fewer hurdles in getting ruxolitinib to patients than she has experienced with other medications.
In her safety-net hospital, she told this news organization, she sees patients with many types of insurance, but most have Medicaid. “So, I’m always expecting the step therapies, denials, pushbacks, etc.,” she said. But the path has been smoother for ruxolitinib coverage, she noted.
Her colleagues are committed to documenting everything the patient has tried, she added, and that helps with prior authorization.
Dr. Heath said that pointing out to insurers that ruxolitinib is the only approved treatment for repigmentation helps facilitate coverage.
“The science is advancing, and I’m happy to be practicing during a time when we actually have something approved for vitiligo,” she said. But she pointed out that phototherapy often is not covered for vitiligo, “which is horrible, when it is readily approved for psoriasis and atopic dermatitis.”
To document progress, Dr. Heath said that she always takes photographs of her patients with vitiligo because “the pictures remind us how far we have come.”
Data spotlight success in adolescents
Data from two trials give a clinical picture of the drug’s safety and efficacy in younger patients.
Adolescents had particularly good results in the first year with ruxolitinib, according to pooled phase 3 data from TRuE-V1 and TRuE-V2, this news organization reported.
The findings, presented at the 25th World Congress of Dermatology in Singapore, indicate that more than half of the participants achieved at least a 50% improvement from baseline in the total Vitiligo Area Scoring Index (T-VASI50) at 52 weeks.
The percentages of young patients aged 12-17 years taking twice-daily ruxolitinib who achieved T-VASI 50 at weeks 12, 24, and 52 were 11.5%, 26.9%, and 57.7%, respectively. The corresponding percentages for all in the study population were 10.7%, 22.7%, and 44.4%, respectively.
At the meeting, the presenter, Julien Seneschal, MD, PhD, professor of dermatology and head of the vitiligo and pigmentary disorders clinic at the University of Bordeaux, France, said, “This suggests that younger patients can respond better to the treatment.” He noted, however, that there were few adolescents in the studies.
New excitement in the field
Daniel Gutierrez, MD, assistant professor of dermatology at New York University, said the treatment has brought new excitement to the field.
“Patients with vitiligo are very motivated to treat their disease,” he said, because it typically is on the face and other highly visual areas, which can affect their overall perception of self.
Previously, he noted in an interview, the only FDA-approved treatment was monobenzone, but that was for depigmentation rather than repigmentation.
Otherwise, treatments were being used off label, and patients were receiving compounded formulations that often weren’t covered by insurance and often had shorter shelf life.
He said that he still occasionally gets denials from payers who consider vitiligo a cosmetic condition.
“I’ve had more luck with insurance, at least in the New York State area.” He added that sometimes payers require use of a topical calcineurin inhibitor for about 12 weeks before they will cover ruxolitinib.
Dr. Gutierrez also recommends using phototherapy with topical ruxolitinib “because they work on slightly different pathways.”
When he starts patients on a new therapy such as ruxolitinib, he asks them to come back in 3 months, and often by then, progress is evident. Facial areas show the most response, he said, while hands and feet are less likely to show significant improvement.
He said that it’s important for physicians and patients to know that improvements can take weeks or months to be noticeable. “I tell patients not to give up,” he added.
Showing the patients pictures from the current appointment and comparing them with pictures from previous appointments can help them better understand their progress, he said.
Lead investigator adds observations
David Rosmarin, MD, chair of the department of dermatology at Indiana University, Indianapolis, was the lead investigator of the pivotal TruE-V1 and TruE-V2 trials for vitiligo. In that role, he has been treating vitiligo patients with topical ruxolitinib since 2015.
In an interview, he said that many patients “don’t hit their optimal results at 3 months, 6 months, even the year mark. With continued use, many can see continued benefit.”
Other patients, he said, don’t respond within the first 6 months but with continued use may eventually respond, he said.
“Unfortunately, we have no way of knowing, based on clinical characteristics or baseline demographics, whether a patient will be a delayed responder or not or an early responder,” Dr. Rosmarin added.
He provided several observations about people who have stopped taking the medication.
“When people stop,” he said, “some maintain their response, but some start to depigment again. Again, we have no way of predicting who will be in which category.”
He said that once patients have hit their desired response, he usually advises them to taper down to maybe twice a week or to stop treatment, but if they see any recurrence, they should start reusing the medicine.
“We have some patients who have gone 6 or 7 years now before they had a recurrence, but others may start to depigment again in 2 to 3 months,” Dr. Rosmarin said.
As for phototherapy, he said, the combination with topical ruxolitinib is being studied.
“We think the combination is synergistic and better than either alone, but we’re still waiting for data to prove that,” he said.
In his practice, he offers patients the option either to use just ruxolitinib cream or the combination early on. Many patients, because of convenience, say they’ll first try the cream to see if that works.
“The challenge with light [therapy] is that it can be very inconvenient,” he said. Patients have to live close to a phototherapy unit to receive therapy 2-3 times a week or have a phototherapy product in their home.
Next in the pipeline
Experts say the progress doesn’t stop with ruxolitinib cream. Current trials of several medications show there’s more to come for patients with vitiligo.
Dr. Chovatiya said that next up may be oral ritlecitinib (Litfulo), a JAK inhibitor that was approved for severe alopecia areata in June for people aged 12 years and older. Phase 2 results have been published for its use with vitiligo.
“This would be an oral medication that may be able to help people with much more extensive disease as far as vitiligo goes,” he said, adding that he expects approval for a vitiligo indication within a few years.
He pointed out that longer-term safety data will be available because it is already on the market for alopecia.
Upadacitinib (Rinvoq), an oral JAK inhibitor, is approved for atopic dermatitis but is being studied for vitiligo as well, he noted. “I’m very excited to see what that holds for patients as well,” Dr. Chovatiya said.
Dr. Gutierrez said that he is excited about oral JAK inhibitors but sees potential in finding new ways to transplant melanocytes into areas where there are none.
The pigmentation field has seen new energy since last year’s approval, he said, particularly among people of color.
“We have new options for vitiligo that were lacking compared with other conditions, such as atopic dermatitis and psoriasis,” he said. “Hopefully, there will be more promising breakthroughs.”
Dr. Rosmarin is the chief investigator for the pivotal trials that led to FDA approval of ruxolitinib. He disclosed ties with AbbVie, Abcuro, AltruBio, Amgen, Arena, Boehringer Ingelheim, Bristol-Meyers Squibb, Celgene, Concert, CSL Behring, Dermavant, Dermira, Galderma, Incyte, Janssen, Kyowa Kirin, Lilly, Merck, Novartis, Pfizer, Regeneron, Revolo Biotherapeutics, Sanofi, Sun Pharmaceuticals, UCB, and Viela Bio. Dr. Chovatiya disclosed ties with AbbVie, Arcutis, Arena, Argenx, Beiersdorf, Bristol-Myers Squibb, Dermavant, Eli Lilly, EPI Health, Incyte, LEO Pharma, L’Oréal, National Eczema Association, Pfizer, Regeneron, Sanofi, and UCB. Dr. Heath and Dr. Gutierrez report no relevant financial relationships.
A version of this article appeared on Medscape.com.
.
The Food and Drug Administration approved the cream formulation of ruxolitinib (Opzelura), a JAK inhibitor, for repigmentation of nonsegmental vitiligo in July 2022 for people aged 12 years and older.
Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, said that he likes to use ruxolitinib cream in combination with other treatments.
“In the real world with vitiligo patients, we’re oftentimes doing combinatorial therapy anyway. So phototherapy, specifically, narrow-band UVB, is something that we have a lot of clinical evidence for over the years, and it’s a modality that can combine with topical steroids and topical calcineurin inhibitors.”
He said trials to study combinations will yield better guidance on optimal use of ruxolitinib cream. “In general, vitiligo patients can really benefit from phototherapy,” he said in an interview. (Labeling recommends against combination with other JAK inhibitors, biologics, or potent immunosuppressants, such as azathioprine or cyclosporine.)
This first year has shown that ruxolitinib is an effective option, but counseling patients to expect slow improvement is important so that patients stick with it, he noted.
Documenting what treatments patients with vitiligo have used before is important, he said, as is counseling patients that ruxolitinib is approved only for use on up to 10% of a person’s body surface area. (Product labeling recommends that a thin layer be applied twice a day to affected areas up to 10% of body surface area.)
Ruxolitinib has brought a “louder voice” to vitiligo and has opened up options for patients with the disease, Dr. Chovatiya said. “Having the ability to topically treat people who have very extensive disease really gives us a lot more flexibility than we have had before.”
Good experiences with payers at safety-net hospital
Candrice R. Heath, MD, assistant professor of dermatology at Temple University, Philadelphia, said that real-world experience with topical ruxolitinib will be more evident after its been on the market for 18-24 months.
Dr. Heath said she, too, encourages use of narrow-band UVB phototherapy in conjunction with the treatment.
From an insurance reimbursement standpoint, she said that she is glad that there have been fewer hurdles in getting ruxolitinib to patients than she has experienced with other medications.
In her safety-net hospital, she told this news organization, she sees patients with many types of insurance, but most have Medicaid. “So, I’m always expecting the step therapies, denials, pushbacks, etc.,” she said. But the path has been smoother for ruxolitinib coverage, she noted.
Her colleagues are committed to documenting everything the patient has tried, she added, and that helps with prior authorization.
Dr. Heath said that pointing out to insurers that ruxolitinib is the only approved treatment for repigmentation helps facilitate coverage.
“The science is advancing, and I’m happy to be practicing during a time when we actually have something approved for vitiligo,” she said. But she pointed out that phototherapy often is not covered for vitiligo, “which is horrible, when it is readily approved for psoriasis and atopic dermatitis.”
To document progress, Dr. Heath said that she always takes photographs of her patients with vitiligo because “the pictures remind us how far we have come.”
Data spotlight success in adolescents
Data from two trials give a clinical picture of the drug’s safety and efficacy in younger patients.
Adolescents had particularly good results in the first year with ruxolitinib, according to pooled phase 3 data from TRuE-V1 and TRuE-V2, this news organization reported.
The findings, presented at the 25th World Congress of Dermatology in Singapore, indicate that more than half of the participants achieved at least a 50% improvement from baseline in the total Vitiligo Area Scoring Index (T-VASI50) at 52 weeks.
The percentages of young patients aged 12-17 years taking twice-daily ruxolitinib who achieved T-VASI 50 at weeks 12, 24, and 52 were 11.5%, 26.9%, and 57.7%, respectively. The corresponding percentages for all in the study population were 10.7%, 22.7%, and 44.4%, respectively.
At the meeting, the presenter, Julien Seneschal, MD, PhD, professor of dermatology and head of the vitiligo and pigmentary disorders clinic at the University of Bordeaux, France, said, “This suggests that younger patients can respond better to the treatment.” He noted, however, that there were few adolescents in the studies.
New excitement in the field
Daniel Gutierrez, MD, assistant professor of dermatology at New York University, said the treatment has brought new excitement to the field.
“Patients with vitiligo are very motivated to treat their disease,” he said, because it typically is on the face and other highly visual areas, which can affect their overall perception of self.
Previously, he noted in an interview, the only FDA-approved treatment was monobenzone, but that was for depigmentation rather than repigmentation.
Otherwise, treatments were being used off label, and patients were receiving compounded formulations that often weren’t covered by insurance and often had shorter shelf life.
He said that he still occasionally gets denials from payers who consider vitiligo a cosmetic condition.
“I’ve had more luck with insurance, at least in the New York State area.” He added that sometimes payers require use of a topical calcineurin inhibitor for about 12 weeks before they will cover ruxolitinib.
Dr. Gutierrez also recommends using phototherapy with topical ruxolitinib “because they work on slightly different pathways.”
When he starts patients on a new therapy such as ruxolitinib, he asks them to come back in 3 months, and often by then, progress is evident. Facial areas show the most response, he said, while hands and feet are less likely to show significant improvement.
He said that it’s important for physicians and patients to know that improvements can take weeks or months to be noticeable. “I tell patients not to give up,” he added.
Showing the patients pictures from the current appointment and comparing them with pictures from previous appointments can help them better understand their progress, he said.
Lead investigator adds observations
David Rosmarin, MD, chair of the department of dermatology at Indiana University, Indianapolis, was the lead investigator of the pivotal TruE-V1 and TruE-V2 trials for vitiligo. In that role, he has been treating vitiligo patients with topical ruxolitinib since 2015.
In an interview, he said that many patients “don’t hit their optimal results at 3 months, 6 months, even the year mark. With continued use, many can see continued benefit.”
Other patients, he said, don’t respond within the first 6 months but with continued use may eventually respond, he said.
“Unfortunately, we have no way of knowing, based on clinical characteristics or baseline demographics, whether a patient will be a delayed responder or not or an early responder,” Dr. Rosmarin added.
He provided several observations about people who have stopped taking the medication.
“When people stop,” he said, “some maintain their response, but some start to depigment again. Again, we have no way of predicting who will be in which category.”
He said that once patients have hit their desired response, he usually advises them to taper down to maybe twice a week or to stop treatment, but if they see any recurrence, they should start reusing the medicine.
“We have some patients who have gone 6 or 7 years now before they had a recurrence, but others may start to depigment again in 2 to 3 months,” Dr. Rosmarin said.
As for phototherapy, he said, the combination with topical ruxolitinib is being studied.
“We think the combination is synergistic and better than either alone, but we’re still waiting for data to prove that,” he said.
In his practice, he offers patients the option either to use just ruxolitinib cream or the combination early on. Many patients, because of convenience, say they’ll first try the cream to see if that works.
“The challenge with light [therapy] is that it can be very inconvenient,” he said. Patients have to live close to a phototherapy unit to receive therapy 2-3 times a week or have a phototherapy product in their home.
Next in the pipeline
Experts say the progress doesn’t stop with ruxolitinib cream. Current trials of several medications show there’s more to come for patients with vitiligo.
Dr. Chovatiya said that next up may be oral ritlecitinib (Litfulo), a JAK inhibitor that was approved for severe alopecia areata in June for people aged 12 years and older. Phase 2 results have been published for its use with vitiligo.
“This would be an oral medication that may be able to help people with much more extensive disease as far as vitiligo goes,” he said, adding that he expects approval for a vitiligo indication within a few years.
He pointed out that longer-term safety data will be available because it is already on the market for alopecia.
Upadacitinib (Rinvoq), an oral JAK inhibitor, is approved for atopic dermatitis but is being studied for vitiligo as well, he noted. “I’m very excited to see what that holds for patients as well,” Dr. Chovatiya said.
Dr. Gutierrez said that he is excited about oral JAK inhibitors but sees potential in finding new ways to transplant melanocytes into areas where there are none.
The pigmentation field has seen new energy since last year’s approval, he said, particularly among people of color.
“We have new options for vitiligo that were lacking compared with other conditions, such as atopic dermatitis and psoriasis,” he said. “Hopefully, there will be more promising breakthroughs.”
Dr. Rosmarin is the chief investigator for the pivotal trials that led to FDA approval of ruxolitinib. He disclosed ties with AbbVie, Abcuro, AltruBio, Amgen, Arena, Boehringer Ingelheim, Bristol-Meyers Squibb, Celgene, Concert, CSL Behring, Dermavant, Dermira, Galderma, Incyte, Janssen, Kyowa Kirin, Lilly, Merck, Novartis, Pfizer, Regeneron, Revolo Biotherapeutics, Sanofi, Sun Pharmaceuticals, UCB, and Viela Bio. Dr. Chovatiya disclosed ties with AbbVie, Arcutis, Arena, Argenx, Beiersdorf, Bristol-Myers Squibb, Dermavant, Eli Lilly, EPI Health, Incyte, LEO Pharma, L’Oréal, National Eczema Association, Pfizer, Regeneron, Sanofi, and UCB. Dr. Heath and Dr. Gutierrez report no relevant financial relationships.
A version of this article appeared on Medscape.com.
New trials in prostate cancer: Could your patient benefit?
Prostate cancer at high risk for biochemical recurrence following radical prostatectomy and/or radiation therapy. Adult patients with this diagnosis can join a randomized, double-blind, placebo-controlled, phase 3 study evaluating darolutamide (Nubeqa) plus androgen deprivation therapy against ADT alone. For up to 2 years, one group of participants will take twice-daily tablets of darolutamide, a nonsteroidal antiandrogen approved in 2019, in combination with ADT. A second group will take placebo plus ADT. Sites in California, Colorado, and worldwide started recruiting for 750 participants in April 2023; study centers across 19 other states in the US are gearing up. The primary outcome measure is radiological progression-free survival (PFS). Overall survival and quality of life (QoL) are secondary measures. More details at clinicaltrials.gov.
Commenting on the study, Marc Garnick, MD, professor of medicine, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, said the trial “addresses an important question regarding intensification of androgen deprivation therapy with darolutamide” – specifically, whether this intensified approach is useful for a large proportion of men who experience biochemical recurrence (BCR) – rising PSA levels – after definitive localized therapy.
Dr. Garnick cautioned, however, that “it will be very important for the study investigators to stratify the many characteristics of BCR – and not treat this population as a homogeneous one since initial Gleason Score, time to BCR, and PSA doubling time all may impact the outcomes.”
Metastatic castration-sensitive prostate cancer. Adults with this type of cancer can join a randomized, open-label, phase 3 trial evaluating the nonsteroidal antiandrogen apalutamide (Erleada). Apalutamide, the first treatment approved for nonmetastatic castration-resistant prostate cancer, has also been approved for patients with metastatic castration-sensitive prostate cancer. This new trial will assess an intermittent approach to providing ADT alongside apalutamide in patients with metastatic disease.
All participants will take daily apalutamide tablets plus physician’s choice of ADT for 6 months. Everyone whose PSA falls below 0.2 ng/mL will either receive apalutamide with intermittent ADT per protocol or continue to receive apalutamide plus ADT for a further 18 months or until the patient discontinues the study, whichever happens first. Recruitment of 333 participants is planned for sites in Colorado, New York, Ohio, Utah, and Germany starting in August 2023. Radiographic PFS and hot flash score are the primary endpoints. QoL and overall survival are secondary outcomes. See more details at clinicaltrials.gov.
This study “should add to our knowledge of optimal treatment” for metastatic castrate-sensitive prostate cancer,” Dr. Garnick said. However, “this is a very heterogeneous population of patients and how they get to the [diagnosis] of metastatic castrate-sensitive prostate cancer is important. The sample size and stratifications need to be well studied for this study to provide any meaningful data.”
Localized intermediate- or high-risk prostate cancer. People with one of these clinical scenarios who have not yet had stereotactic body radiation therapy (SBRT) or a prostatectomy are eligible for a randomized, open-label, phase 2 study. This National Cancer Institute (NCI) trial is looking at whether the experimental immunocytokine M9241 can enhance the effectiveness of SBRT. M9241 is designed to assist the immune system to fight cancer by boosting the activity of T cells at necrotic sites in the tumor.
All participants will receive standard of care ADT. One group of people will also receive three subcutaneous injections of M9241 at 4-weekly intervals in deescalating doses, then 10 days of standard SBRT, followed by another three injections of M9241 at the highest tolerable dose. A second group will only undergo SBRT. The National Institutes of Health Clinical Center in Bethesda, Maryland, started recruiting the trial’s 65 participants in June 2023. The primary endpoints are the doses of M9241 in combination with ADT that are safe and tolerable, and T-cell clonality (a measure of immunologic activity). Overall survival and QoL will not be tracked. More details are available at clinicaltrials.gov.
“The M9241 study is very important,” said Dr. Garnick, explaining that he hopes the trial will add to the growing knowledge about the interactions of radiation and its effects on the immune system.
Confirmed prostate cancer. People with prostate cancer eligible for triplet or doublet ADT combination therapy can join a randomized, single-masked, phase 2 NCI investigation of bright white light therapy for ADT-associated fatigue and depression. All participants will receive standard of care ADT combination therapy for up to a year. One group of participants will use AYOpro glasses, a commercial bright white light therapy, daily as ADT starts (“immediate” therapy). A second set of people will start using the glasses after 6 months of ADT therapy (“delayed” therapy). The City of Hope Medical Center, Duarte, Calif., planned to start welcoming the trial’s 210 participants in August 2023. Fatigue is the primary endpoint, QoL is a secondary endpoint, and overall survival will not be recorded. More details are available at clinicaltrials.gov.
“Fatigue is an important feature of cancer therapies in general and any approach to lessen the impact of fatigue should be welcome,” Dr. Garnick said. However, “it would have been helpful” if the official description of the trial had provided more information on the rationale for testing bright white light therapy in prostate cancer.
Metastatic castration-resistant prostate cancer. Adults with this diagnosis who have been treated with one prior androgen receptor axis-targeted therapy (ARAT) can enter a randomized, open-label, phase 2 trial to determine the best dose of the antibody-drug conjugate vobramitamab duocarmazine (MacroGenics). This experimental drug is designed to deliver an alkylating agent that promotes cell death in solid tumors expressing B7-H3. The B7-H3 protein rarely appears in normal tissues but is expressed at high frequency in 60% of cancers.
For approximately 2 years, participants will receive one of two doses of intravenous vobramitamab duocarmazine every 4 weeks. The trial opened in June 2023, looking to recruit 100 participants across nine states in the United States and eight other countries. The primary outcome measure is radiographic PFS. Overall survival and QoL will not be assessed. More details at clinicaltrials.gov.
Localized or biochemically recurrent prostate cancer. Adults in this position who have not received prior GnRH agonist or antagonist therapy are being recruited for a randomized, single-masked, phase 2 study comparing QoL among patients taking ADTs relugolix (Orgovyx, Relumina) and leuprolide acetate for depot suspension (Lupron Depot). For up to 1 year, people in the trial will either take daily tablets of relugolix or receive injections of leuprolide every 3 months. Three study sites in Massachusetts are due to open their doors in August 2023, seeking 110 participants. The study will assess various measures of QoL. Overall survival will not be measured. More details at clinicaltrials.gov.
This study is “sort of plain vanilla,” Dr. Garnick said. Although “the objectives of the study are important, the study number is small and unlikely to show any meaningful differences,” even if differences do exist.
All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov). Dr. Garnick reported no relevant financial relationships. He is editor-in-chief of the Harvard Medical School Annual Report on Prostate Diseases, for which he receives an honorarium.
A version of this article first appeared on Medscape.com.
Prostate cancer at high risk for biochemical recurrence following radical prostatectomy and/or radiation therapy. Adult patients with this diagnosis can join a randomized, double-blind, placebo-controlled, phase 3 study evaluating darolutamide (Nubeqa) plus androgen deprivation therapy against ADT alone. For up to 2 years, one group of participants will take twice-daily tablets of darolutamide, a nonsteroidal antiandrogen approved in 2019, in combination with ADT. A second group will take placebo plus ADT. Sites in California, Colorado, and worldwide started recruiting for 750 participants in April 2023; study centers across 19 other states in the US are gearing up. The primary outcome measure is radiological progression-free survival (PFS). Overall survival and quality of life (QoL) are secondary measures. More details at clinicaltrials.gov.
Commenting on the study, Marc Garnick, MD, professor of medicine, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, said the trial “addresses an important question regarding intensification of androgen deprivation therapy with darolutamide” – specifically, whether this intensified approach is useful for a large proportion of men who experience biochemical recurrence (BCR) – rising PSA levels – after definitive localized therapy.
Dr. Garnick cautioned, however, that “it will be very important for the study investigators to stratify the many characteristics of BCR – and not treat this population as a homogeneous one since initial Gleason Score, time to BCR, and PSA doubling time all may impact the outcomes.”
Metastatic castration-sensitive prostate cancer. Adults with this type of cancer can join a randomized, open-label, phase 3 trial evaluating the nonsteroidal antiandrogen apalutamide (Erleada). Apalutamide, the first treatment approved for nonmetastatic castration-resistant prostate cancer, has also been approved for patients with metastatic castration-sensitive prostate cancer. This new trial will assess an intermittent approach to providing ADT alongside apalutamide in patients with metastatic disease.
All participants will take daily apalutamide tablets plus physician’s choice of ADT for 6 months. Everyone whose PSA falls below 0.2 ng/mL will either receive apalutamide with intermittent ADT per protocol or continue to receive apalutamide plus ADT for a further 18 months or until the patient discontinues the study, whichever happens first. Recruitment of 333 participants is planned for sites in Colorado, New York, Ohio, Utah, and Germany starting in August 2023. Radiographic PFS and hot flash score are the primary endpoints. QoL and overall survival are secondary outcomes. See more details at clinicaltrials.gov.
This study “should add to our knowledge of optimal treatment” for metastatic castrate-sensitive prostate cancer,” Dr. Garnick said. However, “this is a very heterogeneous population of patients and how they get to the [diagnosis] of metastatic castrate-sensitive prostate cancer is important. The sample size and stratifications need to be well studied for this study to provide any meaningful data.”
Localized intermediate- or high-risk prostate cancer. People with one of these clinical scenarios who have not yet had stereotactic body radiation therapy (SBRT) or a prostatectomy are eligible for a randomized, open-label, phase 2 study. This National Cancer Institute (NCI) trial is looking at whether the experimental immunocytokine M9241 can enhance the effectiveness of SBRT. M9241 is designed to assist the immune system to fight cancer by boosting the activity of T cells at necrotic sites in the tumor.
All participants will receive standard of care ADT. One group of people will also receive three subcutaneous injections of M9241 at 4-weekly intervals in deescalating doses, then 10 days of standard SBRT, followed by another three injections of M9241 at the highest tolerable dose. A second group will only undergo SBRT. The National Institutes of Health Clinical Center in Bethesda, Maryland, started recruiting the trial’s 65 participants in June 2023. The primary endpoints are the doses of M9241 in combination with ADT that are safe and tolerable, and T-cell clonality (a measure of immunologic activity). Overall survival and QoL will not be tracked. More details are available at clinicaltrials.gov.
“The M9241 study is very important,” said Dr. Garnick, explaining that he hopes the trial will add to the growing knowledge about the interactions of radiation and its effects on the immune system.
Confirmed prostate cancer. People with prostate cancer eligible for triplet or doublet ADT combination therapy can join a randomized, single-masked, phase 2 NCI investigation of bright white light therapy for ADT-associated fatigue and depression. All participants will receive standard of care ADT combination therapy for up to a year. One group of participants will use AYOpro glasses, a commercial bright white light therapy, daily as ADT starts (“immediate” therapy). A second set of people will start using the glasses after 6 months of ADT therapy (“delayed” therapy). The City of Hope Medical Center, Duarte, Calif., planned to start welcoming the trial’s 210 participants in August 2023. Fatigue is the primary endpoint, QoL is a secondary endpoint, and overall survival will not be recorded. More details are available at clinicaltrials.gov.
“Fatigue is an important feature of cancer therapies in general and any approach to lessen the impact of fatigue should be welcome,” Dr. Garnick said. However, “it would have been helpful” if the official description of the trial had provided more information on the rationale for testing bright white light therapy in prostate cancer.
Metastatic castration-resistant prostate cancer. Adults with this diagnosis who have been treated with one prior androgen receptor axis-targeted therapy (ARAT) can enter a randomized, open-label, phase 2 trial to determine the best dose of the antibody-drug conjugate vobramitamab duocarmazine (MacroGenics). This experimental drug is designed to deliver an alkylating agent that promotes cell death in solid tumors expressing B7-H3. The B7-H3 protein rarely appears in normal tissues but is expressed at high frequency in 60% of cancers.
For approximately 2 years, participants will receive one of two doses of intravenous vobramitamab duocarmazine every 4 weeks. The trial opened in June 2023, looking to recruit 100 participants across nine states in the United States and eight other countries. The primary outcome measure is radiographic PFS. Overall survival and QoL will not be assessed. More details at clinicaltrials.gov.
Localized or biochemically recurrent prostate cancer. Adults in this position who have not received prior GnRH agonist or antagonist therapy are being recruited for a randomized, single-masked, phase 2 study comparing QoL among patients taking ADTs relugolix (Orgovyx, Relumina) and leuprolide acetate for depot suspension (Lupron Depot). For up to 1 year, people in the trial will either take daily tablets of relugolix or receive injections of leuprolide every 3 months. Three study sites in Massachusetts are due to open their doors in August 2023, seeking 110 participants. The study will assess various measures of QoL. Overall survival will not be measured. More details at clinicaltrials.gov.
This study is “sort of plain vanilla,” Dr. Garnick said. Although “the objectives of the study are important, the study number is small and unlikely to show any meaningful differences,” even if differences do exist.
All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov). Dr. Garnick reported no relevant financial relationships. He is editor-in-chief of the Harvard Medical School Annual Report on Prostate Diseases, for which he receives an honorarium.
A version of this article first appeared on Medscape.com.
Prostate cancer at high risk for biochemical recurrence following radical prostatectomy and/or radiation therapy. Adult patients with this diagnosis can join a randomized, double-blind, placebo-controlled, phase 3 study evaluating darolutamide (Nubeqa) plus androgen deprivation therapy against ADT alone. For up to 2 years, one group of participants will take twice-daily tablets of darolutamide, a nonsteroidal antiandrogen approved in 2019, in combination with ADT. A second group will take placebo plus ADT. Sites in California, Colorado, and worldwide started recruiting for 750 participants in April 2023; study centers across 19 other states in the US are gearing up. The primary outcome measure is radiological progression-free survival (PFS). Overall survival and quality of life (QoL) are secondary measures. More details at clinicaltrials.gov.
Commenting on the study, Marc Garnick, MD, professor of medicine, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, said the trial “addresses an important question regarding intensification of androgen deprivation therapy with darolutamide” – specifically, whether this intensified approach is useful for a large proportion of men who experience biochemical recurrence (BCR) – rising PSA levels – after definitive localized therapy.
Dr. Garnick cautioned, however, that “it will be very important for the study investigators to stratify the many characteristics of BCR – and not treat this population as a homogeneous one since initial Gleason Score, time to BCR, and PSA doubling time all may impact the outcomes.”
Metastatic castration-sensitive prostate cancer. Adults with this type of cancer can join a randomized, open-label, phase 3 trial evaluating the nonsteroidal antiandrogen apalutamide (Erleada). Apalutamide, the first treatment approved for nonmetastatic castration-resistant prostate cancer, has also been approved for patients with metastatic castration-sensitive prostate cancer. This new trial will assess an intermittent approach to providing ADT alongside apalutamide in patients with metastatic disease.
All participants will take daily apalutamide tablets plus physician’s choice of ADT for 6 months. Everyone whose PSA falls below 0.2 ng/mL will either receive apalutamide with intermittent ADT per protocol or continue to receive apalutamide plus ADT for a further 18 months or until the patient discontinues the study, whichever happens first. Recruitment of 333 participants is planned for sites in Colorado, New York, Ohio, Utah, and Germany starting in August 2023. Radiographic PFS and hot flash score are the primary endpoints. QoL and overall survival are secondary outcomes. See more details at clinicaltrials.gov.
This study “should add to our knowledge of optimal treatment” for metastatic castrate-sensitive prostate cancer,” Dr. Garnick said. However, “this is a very heterogeneous population of patients and how they get to the [diagnosis] of metastatic castrate-sensitive prostate cancer is important. The sample size and stratifications need to be well studied for this study to provide any meaningful data.”
Localized intermediate- or high-risk prostate cancer. People with one of these clinical scenarios who have not yet had stereotactic body radiation therapy (SBRT) or a prostatectomy are eligible for a randomized, open-label, phase 2 study. This National Cancer Institute (NCI) trial is looking at whether the experimental immunocytokine M9241 can enhance the effectiveness of SBRT. M9241 is designed to assist the immune system to fight cancer by boosting the activity of T cells at necrotic sites in the tumor.
All participants will receive standard of care ADT. One group of people will also receive three subcutaneous injections of M9241 at 4-weekly intervals in deescalating doses, then 10 days of standard SBRT, followed by another three injections of M9241 at the highest tolerable dose. A second group will only undergo SBRT. The National Institutes of Health Clinical Center in Bethesda, Maryland, started recruiting the trial’s 65 participants in June 2023. The primary endpoints are the doses of M9241 in combination with ADT that are safe and tolerable, and T-cell clonality (a measure of immunologic activity). Overall survival and QoL will not be tracked. More details are available at clinicaltrials.gov.
“The M9241 study is very important,” said Dr. Garnick, explaining that he hopes the trial will add to the growing knowledge about the interactions of radiation and its effects on the immune system.
Confirmed prostate cancer. People with prostate cancer eligible for triplet or doublet ADT combination therapy can join a randomized, single-masked, phase 2 NCI investigation of bright white light therapy for ADT-associated fatigue and depression. All participants will receive standard of care ADT combination therapy for up to a year. One group of participants will use AYOpro glasses, a commercial bright white light therapy, daily as ADT starts (“immediate” therapy). A second set of people will start using the glasses after 6 months of ADT therapy (“delayed” therapy). The City of Hope Medical Center, Duarte, Calif., planned to start welcoming the trial’s 210 participants in August 2023. Fatigue is the primary endpoint, QoL is a secondary endpoint, and overall survival will not be recorded. More details are available at clinicaltrials.gov.
“Fatigue is an important feature of cancer therapies in general and any approach to lessen the impact of fatigue should be welcome,” Dr. Garnick said. However, “it would have been helpful” if the official description of the trial had provided more information on the rationale for testing bright white light therapy in prostate cancer.
Metastatic castration-resistant prostate cancer. Adults with this diagnosis who have been treated with one prior androgen receptor axis-targeted therapy (ARAT) can enter a randomized, open-label, phase 2 trial to determine the best dose of the antibody-drug conjugate vobramitamab duocarmazine (MacroGenics). This experimental drug is designed to deliver an alkylating agent that promotes cell death in solid tumors expressing B7-H3. The B7-H3 protein rarely appears in normal tissues but is expressed at high frequency in 60% of cancers.
For approximately 2 years, participants will receive one of two doses of intravenous vobramitamab duocarmazine every 4 weeks. The trial opened in June 2023, looking to recruit 100 participants across nine states in the United States and eight other countries. The primary outcome measure is radiographic PFS. Overall survival and QoL will not be assessed. More details at clinicaltrials.gov.
Localized or biochemically recurrent prostate cancer. Adults in this position who have not received prior GnRH agonist or antagonist therapy are being recruited for a randomized, single-masked, phase 2 study comparing QoL among patients taking ADTs relugolix (Orgovyx, Relumina) and leuprolide acetate for depot suspension (Lupron Depot). For up to 1 year, people in the trial will either take daily tablets of relugolix or receive injections of leuprolide every 3 months. Three study sites in Massachusetts are due to open their doors in August 2023, seeking 110 participants. The study will assess various measures of QoL. Overall survival will not be measured. More details at clinicaltrials.gov.
This study is “sort of plain vanilla,” Dr. Garnick said. Although “the objectives of the study are important, the study number is small and unlikely to show any meaningful differences,” even if differences do exist.
All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov). Dr. Garnick reported no relevant financial relationships. He is editor-in-chief of the Harvard Medical School Annual Report on Prostate Diseases, for which he receives an honorarium.
A version of this article first appeared on Medscape.com.
Poor sleep and chronic pain prove pesky bedfellows
Early in his career as a pain researcher, Daniel Whibley, PhD, was struck by an article that drew parallels between methods of torture and the experiences of patients with insomnia and chronic pain.
The author of that article, Nicole Tang, DPhil, observed that two methods used by torturers – pain infliction and sleep deprivation – harm people in ways that also are experienced by many patients with pain and sleep conditions.
Patients are “essentially living in this perpetually undesirable, at best, situation where both of these features are playing out in their lives,” said Dr. Whibley, a research assistant professor of physical medicine and rehabilitation at the University of Michigan, Ann Arbor.
The problems create a “kind of vicious circle,” he said. Pain disrupts sleep. Insufficient sleep worsens pain.
Studies have established important relationships between the conditions, but investigators are still trying to clarify the mechanisms that connect them and the best ways to intervene to improve patient outcomes.
To that end, Dr. Whibley has developed an intervention known as Move & Snooze to benefit patients with pain associated with osteoarthritis.
The program includes remote exercise coaching and an automated 6-week course of digital cognitive-behavioral therapy for insomnia (CBT-I).
He and his colleagues have tested the intervention in a feasibility study and are in the process of securing grant funding to test it in a large, nationwide trial.
Losing sleep for science
Michael Smith, PhD, is examining the sleep-pain connection from a different angle.
Dr. Smith, the director of the Behavioral Medicine Research Laboratory at Johns Hopkins University, Baltimore, is recruiting healthy adults to endure restless nights and painful stimuli.
His team is conducting a study known as Sleep-MOR that aims to reveal how different types of sleep disturbances influence pain and a person’s response to opioids.
Nearly three dozen participants have completed the study so far, Dr. Smith said, out of what he hopes will be 200 in all.
Participants are randomly assigned to sleep normally or to undergo an experimental condition that is designed to mimic the sleep disturbances of insomnia or obstructive sleep apnea (OSA).
In a “forced awakening” group, participants are awakened for 20-minute intervals every hour and for a full hour-long window during the night. In this condition, they could sleep for about four hours in all. Forced awakening is intended to represent insomnia
A “sleep fragmentation” group is meant to represent patients with OSA. About 30 times per hour, tones and tactile buzzers rouse sleeping participants without fully waking them up. Although the experiment involves brief arousals such as those experienced by patients with OSA, it does not capture another important feature of sleep apnea – the cessation of breathing, Dr. Smith noted.
The next day, researchers perform pain testing and brain imaging and see how opioid receptors respond to pain medication.
“Some of the forms of sleep loss that we are studying may actually alter the efficacy of the binding of those receptors, and that might then require you to have higher doses of an opioid to get the same effect,” Dr. Smith said. “That’s our hypothesis.”
If that bears out, disturbed sleep may play a role in the development of opioid use disorder and have implications for patients who receive opioids after surgery, he said.
In the lab, researchers examine pain thresholds using techniques such as thermal pain testing, in which a thermode attached to a participant’s arm heats up. The temperature “slowly goes up and the patient just says: ‘Ouch,’ when it first hurts. Then we have their pain threshold,” Dr. Smith said.
A bidirectional relationship
Epidemiologic studies have found that, if you follow women who do not have pain, those with complaints about sleep are more than twice as likely to develop fibromyalgia.
Dr. Smith’s group and others have shown that if you deprive a healthy person of sleep, they become more sensitive to pain.
Inflammation could be one possible reason for this effect. In one study, participants who experienced forced awakening experienced less slow-wave sleep, which was tied to more inflammation in the morning. Increased inflammation was linked to greater pain sensitivity.
“We are starting to piece together some of the pathways. That’s just one,” Dr. Smith said.
A recent study by researchers at Harvard University and elsewhere investigated how sleep disturbances affected three pain pathways. In that study, the results varied by sex. The data indicate that optimal treatment approaches might differ for men and women, the researchers said.
Waking up to the problem
Sleep problems can be neglected in medical school and in the clinic. “People just have other things to focus on that they clearly know what they can do about it,” Dr. Smith said.
But clinicians should not hesitate to screen for conditions such as insomnia or OSA and refer patients to a specialist. If a patient has had pain for 6 months and treatments are not working, the chance that they have a treatable sleep disorder “is very high, above 50%,” Dr. Smith said. Many could have more than one sleep disorder, he added.
Continuous positive airway pressure for OSA and CBT for insomnia can improve sleep. Dr. Smith said he expects these measures will improve overall pain management as well.
If treating a sleep disorder fails to help with pain, however, it may still help prevent other sleep-related problems, such as depression, poor glucose control, and heart disease. It also could improve patients’ ability to function day to day, he said.
Evidence on whether treating sleep problems reduces pain has so far been mixed.
“We’ve done some studies showing that if you have CBT-I and you have knee arthritis, improvements in the amount of time you spend awake at night translate into improvements in pain at 6 months. There is a signal there, but it’s not as strong as we would like,” he said. “It may be that it takes longer than anyone would like” to have an effect.
A structured intervention such as CBT-I is likely more beneficial than education about sleep hygiene alone in resolving sleep disturbances, Dr. Whibley said. CBT-I includes active components such as sleep restriction therapy and stimulus control therapy and is recommended by the American Academy of Sleep Medicine as the first-line treatment for chronic insomnia (J Clin Sleep Med. 2008 Oct 15;4[5]:487-504).
Patients should consider the role that sleep may play in their chronic pain condition, he said.
“An increasing number of researchers and clinicians are becoming more interested in this as a foundational pillar of health, alongside activity and diet,” Dr. Whibley said. “Sleep is recognized as just as important but doesn’t seem to get the airtime.”
Clinicians, he added, should regularly assess their patients’ sleep and know where to refer those whom they feel would benefit from more advanced management: “They [should] know that they have at least got it on their radar to check as one of the important pillars of health that you should be able to control.”
Sleep trials seeking pain patients
Researchers around the United States are conducting dozens of studies related to sleep and pain. The following trials are recruiting participants, according to ClinicalTrials.gov.
Sleep and Pain Interventions in Women With Fibromyalgia (SPIN-II). Investigators at the University of Missouri–Columbia are examining two cognitive-behavioral treatments for women with fibromyalgia and insomnia. “This trial will yield important information about the roles of sleep, arousal, and brain structure and function in the development and maintenance of chronic pain in women with fibromyalgia,” the researchers say.
Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids (PRESTO). At the University of California, San Diego, researchers are investigating whether patients with chronic pain who use opioids and have sleep-disordered breathing may benefit from treatment with continuous positive airway pressure. They plan to assess the intervention’s effects on sleep quality, pain, and quality of life. They also will see which patients are least likely to benefit from this treatment approach.
Latent Aging Mechanisms in Pain and Sleep (LAMPS). Researchers at the University of Florida are studying the effects of oral gamma-aminobutyric acid in older adults with chronic pain and sleep difficulties.
Sleep and Pain in Sickle Cell Disease. At Johns Hopkins University, investigators are evaluating how behavioral sleep interventions influence pain and brain function in patients with sickle cell disease.
Pain in Long COVID-19: The Role of Sleep. Researchers at Beth Israel Deaconess Medical Center are conducting an observational study of patients with long COVID who have pain and sleep disturbances. The study aims “to understand the role of sleep in the development and persistence of pain symptoms in long COVID.”
Intervention for Sleep and Pain in Youth: A Randomized Controlled Trial (I-SPY-RCT). Adolescents with migraine are being recruited by a team at Seattle Children’s Hospital for a randomized controlled trial. The study will examine the effects of CBT-I as well as the combined effect of CBT-I and pain interventions on reducing insomnia symptoms and headache-related disability in this population.
A version of this article appeared on Medscape.com.
Early in his career as a pain researcher, Daniel Whibley, PhD, was struck by an article that drew parallels between methods of torture and the experiences of patients with insomnia and chronic pain.
The author of that article, Nicole Tang, DPhil, observed that two methods used by torturers – pain infliction and sleep deprivation – harm people in ways that also are experienced by many patients with pain and sleep conditions.
Patients are “essentially living in this perpetually undesirable, at best, situation where both of these features are playing out in their lives,” said Dr. Whibley, a research assistant professor of physical medicine and rehabilitation at the University of Michigan, Ann Arbor.
The problems create a “kind of vicious circle,” he said. Pain disrupts sleep. Insufficient sleep worsens pain.
Studies have established important relationships between the conditions, but investigators are still trying to clarify the mechanisms that connect them and the best ways to intervene to improve patient outcomes.
To that end, Dr. Whibley has developed an intervention known as Move & Snooze to benefit patients with pain associated with osteoarthritis.
The program includes remote exercise coaching and an automated 6-week course of digital cognitive-behavioral therapy for insomnia (CBT-I).
He and his colleagues have tested the intervention in a feasibility study and are in the process of securing grant funding to test it in a large, nationwide trial.
Losing sleep for science
Michael Smith, PhD, is examining the sleep-pain connection from a different angle.
Dr. Smith, the director of the Behavioral Medicine Research Laboratory at Johns Hopkins University, Baltimore, is recruiting healthy adults to endure restless nights and painful stimuli.
His team is conducting a study known as Sleep-MOR that aims to reveal how different types of sleep disturbances influence pain and a person’s response to opioids.
Nearly three dozen participants have completed the study so far, Dr. Smith said, out of what he hopes will be 200 in all.
Participants are randomly assigned to sleep normally or to undergo an experimental condition that is designed to mimic the sleep disturbances of insomnia or obstructive sleep apnea (OSA).
In a “forced awakening” group, participants are awakened for 20-minute intervals every hour and for a full hour-long window during the night. In this condition, they could sleep for about four hours in all. Forced awakening is intended to represent insomnia
A “sleep fragmentation” group is meant to represent patients with OSA. About 30 times per hour, tones and tactile buzzers rouse sleeping participants without fully waking them up. Although the experiment involves brief arousals such as those experienced by patients with OSA, it does not capture another important feature of sleep apnea – the cessation of breathing, Dr. Smith noted.
The next day, researchers perform pain testing and brain imaging and see how opioid receptors respond to pain medication.
“Some of the forms of sleep loss that we are studying may actually alter the efficacy of the binding of those receptors, and that might then require you to have higher doses of an opioid to get the same effect,” Dr. Smith said. “That’s our hypothesis.”
If that bears out, disturbed sleep may play a role in the development of opioid use disorder and have implications for patients who receive opioids after surgery, he said.
In the lab, researchers examine pain thresholds using techniques such as thermal pain testing, in which a thermode attached to a participant’s arm heats up. The temperature “slowly goes up and the patient just says: ‘Ouch,’ when it first hurts. Then we have their pain threshold,” Dr. Smith said.
A bidirectional relationship
Epidemiologic studies have found that, if you follow women who do not have pain, those with complaints about sleep are more than twice as likely to develop fibromyalgia.
Dr. Smith’s group and others have shown that if you deprive a healthy person of sleep, they become more sensitive to pain.
Inflammation could be one possible reason for this effect. In one study, participants who experienced forced awakening experienced less slow-wave sleep, which was tied to more inflammation in the morning. Increased inflammation was linked to greater pain sensitivity.
“We are starting to piece together some of the pathways. That’s just one,” Dr. Smith said.
A recent study by researchers at Harvard University and elsewhere investigated how sleep disturbances affected three pain pathways. In that study, the results varied by sex. The data indicate that optimal treatment approaches might differ for men and women, the researchers said.
Waking up to the problem
Sleep problems can be neglected in medical school and in the clinic. “People just have other things to focus on that they clearly know what they can do about it,” Dr. Smith said.
But clinicians should not hesitate to screen for conditions such as insomnia or OSA and refer patients to a specialist. If a patient has had pain for 6 months and treatments are not working, the chance that they have a treatable sleep disorder “is very high, above 50%,” Dr. Smith said. Many could have more than one sleep disorder, he added.
Continuous positive airway pressure for OSA and CBT for insomnia can improve sleep. Dr. Smith said he expects these measures will improve overall pain management as well.
If treating a sleep disorder fails to help with pain, however, it may still help prevent other sleep-related problems, such as depression, poor glucose control, and heart disease. It also could improve patients’ ability to function day to day, he said.
Evidence on whether treating sleep problems reduces pain has so far been mixed.
“We’ve done some studies showing that if you have CBT-I and you have knee arthritis, improvements in the amount of time you spend awake at night translate into improvements in pain at 6 months. There is a signal there, but it’s not as strong as we would like,” he said. “It may be that it takes longer than anyone would like” to have an effect.
A structured intervention such as CBT-I is likely more beneficial than education about sleep hygiene alone in resolving sleep disturbances, Dr. Whibley said. CBT-I includes active components such as sleep restriction therapy and stimulus control therapy and is recommended by the American Academy of Sleep Medicine as the first-line treatment for chronic insomnia (J Clin Sleep Med. 2008 Oct 15;4[5]:487-504).
Patients should consider the role that sleep may play in their chronic pain condition, he said.
“An increasing number of researchers and clinicians are becoming more interested in this as a foundational pillar of health, alongside activity and diet,” Dr. Whibley said. “Sleep is recognized as just as important but doesn’t seem to get the airtime.”
Clinicians, he added, should regularly assess their patients’ sleep and know where to refer those whom they feel would benefit from more advanced management: “They [should] know that they have at least got it on their radar to check as one of the important pillars of health that you should be able to control.”
Sleep trials seeking pain patients
Researchers around the United States are conducting dozens of studies related to sleep and pain. The following trials are recruiting participants, according to ClinicalTrials.gov.
Sleep and Pain Interventions in Women With Fibromyalgia (SPIN-II). Investigators at the University of Missouri–Columbia are examining two cognitive-behavioral treatments for women with fibromyalgia and insomnia. “This trial will yield important information about the roles of sleep, arousal, and brain structure and function in the development and maintenance of chronic pain in women with fibromyalgia,” the researchers say.
Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids (PRESTO). At the University of California, San Diego, researchers are investigating whether patients with chronic pain who use opioids and have sleep-disordered breathing may benefit from treatment with continuous positive airway pressure. They plan to assess the intervention’s effects on sleep quality, pain, and quality of life. They also will see which patients are least likely to benefit from this treatment approach.
Latent Aging Mechanisms in Pain and Sleep (LAMPS). Researchers at the University of Florida are studying the effects of oral gamma-aminobutyric acid in older adults with chronic pain and sleep difficulties.
Sleep and Pain in Sickle Cell Disease. At Johns Hopkins University, investigators are evaluating how behavioral sleep interventions influence pain and brain function in patients with sickle cell disease.
Pain in Long COVID-19: The Role of Sleep. Researchers at Beth Israel Deaconess Medical Center are conducting an observational study of patients with long COVID who have pain and sleep disturbances. The study aims “to understand the role of sleep in the development and persistence of pain symptoms in long COVID.”
Intervention for Sleep and Pain in Youth: A Randomized Controlled Trial (I-SPY-RCT). Adolescents with migraine are being recruited by a team at Seattle Children’s Hospital for a randomized controlled trial. The study will examine the effects of CBT-I as well as the combined effect of CBT-I and pain interventions on reducing insomnia symptoms and headache-related disability in this population.
A version of this article appeared on Medscape.com.
Early in his career as a pain researcher, Daniel Whibley, PhD, was struck by an article that drew parallels between methods of torture and the experiences of patients with insomnia and chronic pain.
The author of that article, Nicole Tang, DPhil, observed that two methods used by torturers – pain infliction and sleep deprivation – harm people in ways that also are experienced by many patients with pain and sleep conditions.
Patients are “essentially living in this perpetually undesirable, at best, situation where both of these features are playing out in their lives,” said Dr. Whibley, a research assistant professor of physical medicine and rehabilitation at the University of Michigan, Ann Arbor.
The problems create a “kind of vicious circle,” he said. Pain disrupts sleep. Insufficient sleep worsens pain.
Studies have established important relationships between the conditions, but investigators are still trying to clarify the mechanisms that connect them and the best ways to intervene to improve patient outcomes.
To that end, Dr. Whibley has developed an intervention known as Move & Snooze to benefit patients with pain associated with osteoarthritis.
The program includes remote exercise coaching and an automated 6-week course of digital cognitive-behavioral therapy for insomnia (CBT-I).
He and his colleagues have tested the intervention in a feasibility study and are in the process of securing grant funding to test it in a large, nationwide trial.
Losing sleep for science
Michael Smith, PhD, is examining the sleep-pain connection from a different angle.
Dr. Smith, the director of the Behavioral Medicine Research Laboratory at Johns Hopkins University, Baltimore, is recruiting healthy adults to endure restless nights and painful stimuli.
His team is conducting a study known as Sleep-MOR that aims to reveal how different types of sleep disturbances influence pain and a person’s response to opioids.
Nearly three dozen participants have completed the study so far, Dr. Smith said, out of what he hopes will be 200 in all.
Participants are randomly assigned to sleep normally or to undergo an experimental condition that is designed to mimic the sleep disturbances of insomnia or obstructive sleep apnea (OSA).
In a “forced awakening” group, participants are awakened for 20-minute intervals every hour and for a full hour-long window during the night. In this condition, they could sleep for about four hours in all. Forced awakening is intended to represent insomnia
A “sleep fragmentation” group is meant to represent patients with OSA. About 30 times per hour, tones and tactile buzzers rouse sleeping participants without fully waking them up. Although the experiment involves brief arousals such as those experienced by patients with OSA, it does not capture another important feature of sleep apnea – the cessation of breathing, Dr. Smith noted.
The next day, researchers perform pain testing and brain imaging and see how opioid receptors respond to pain medication.
“Some of the forms of sleep loss that we are studying may actually alter the efficacy of the binding of those receptors, and that might then require you to have higher doses of an opioid to get the same effect,” Dr. Smith said. “That’s our hypothesis.”
If that bears out, disturbed sleep may play a role in the development of opioid use disorder and have implications for patients who receive opioids after surgery, he said.
In the lab, researchers examine pain thresholds using techniques such as thermal pain testing, in which a thermode attached to a participant’s arm heats up. The temperature “slowly goes up and the patient just says: ‘Ouch,’ when it first hurts. Then we have their pain threshold,” Dr. Smith said.
A bidirectional relationship
Epidemiologic studies have found that, if you follow women who do not have pain, those with complaints about sleep are more than twice as likely to develop fibromyalgia.
Dr. Smith’s group and others have shown that if you deprive a healthy person of sleep, they become more sensitive to pain.
Inflammation could be one possible reason for this effect. In one study, participants who experienced forced awakening experienced less slow-wave sleep, which was tied to more inflammation in the morning. Increased inflammation was linked to greater pain sensitivity.
“We are starting to piece together some of the pathways. That’s just one,” Dr. Smith said.
A recent study by researchers at Harvard University and elsewhere investigated how sleep disturbances affected three pain pathways. In that study, the results varied by sex. The data indicate that optimal treatment approaches might differ for men and women, the researchers said.
Waking up to the problem
Sleep problems can be neglected in medical school and in the clinic. “People just have other things to focus on that they clearly know what they can do about it,” Dr. Smith said.
But clinicians should not hesitate to screen for conditions such as insomnia or OSA and refer patients to a specialist. If a patient has had pain for 6 months and treatments are not working, the chance that they have a treatable sleep disorder “is very high, above 50%,” Dr. Smith said. Many could have more than one sleep disorder, he added.
Continuous positive airway pressure for OSA and CBT for insomnia can improve sleep. Dr. Smith said he expects these measures will improve overall pain management as well.
If treating a sleep disorder fails to help with pain, however, it may still help prevent other sleep-related problems, such as depression, poor glucose control, and heart disease. It also could improve patients’ ability to function day to day, he said.
Evidence on whether treating sleep problems reduces pain has so far been mixed.
“We’ve done some studies showing that if you have CBT-I and you have knee arthritis, improvements in the amount of time you spend awake at night translate into improvements in pain at 6 months. There is a signal there, but it’s not as strong as we would like,” he said. “It may be that it takes longer than anyone would like” to have an effect.
A structured intervention such as CBT-I is likely more beneficial than education about sleep hygiene alone in resolving sleep disturbances, Dr. Whibley said. CBT-I includes active components such as sleep restriction therapy and stimulus control therapy and is recommended by the American Academy of Sleep Medicine as the first-line treatment for chronic insomnia (J Clin Sleep Med. 2008 Oct 15;4[5]:487-504).
Patients should consider the role that sleep may play in their chronic pain condition, he said.
“An increasing number of researchers and clinicians are becoming more interested in this as a foundational pillar of health, alongside activity and diet,” Dr. Whibley said. “Sleep is recognized as just as important but doesn’t seem to get the airtime.”
Clinicians, he added, should regularly assess their patients’ sleep and know where to refer those whom they feel would benefit from more advanced management: “They [should] know that they have at least got it on their radar to check as one of the important pillars of health that you should be able to control.”
Sleep trials seeking pain patients
Researchers around the United States are conducting dozens of studies related to sleep and pain. The following trials are recruiting participants, according to ClinicalTrials.gov.
Sleep and Pain Interventions in Women With Fibromyalgia (SPIN-II). Investigators at the University of Missouri–Columbia are examining two cognitive-behavioral treatments for women with fibromyalgia and insomnia. “This trial will yield important information about the roles of sleep, arousal, and brain structure and function in the development and maintenance of chronic pain in women with fibromyalgia,” the researchers say.
Prospective Randomized Trial of CPAP for SDB in Patients Who Use Opioids (PRESTO). At the University of California, San Diego, researchers are investigating whether patients with chronic pain who use opioids and have sleep-disordered breathing may benefit from treatment with continuous positive airway pressure. They plan to assess the intervention’s effects on sleep quality, pain, and quality of life. They also will see which patients are least likely to benefit from this treatment approach.
Latent Aging Mechanisms in Pain and Sleep (LAMPS). Researchers at the University of Florida are studying the effects of oral gamma-aminobutyric acid in older adults with chronic pain and sleep difficulties.
Sleep and Pain in Sickle Cell Disease. At Johns Hopkins University, investigators are evaluating how behavioral sleep interventions influence pain and brain function in patients with sickle cell disease.
Pain in Long COVID-19: The Role of Sleep. Researchers at Beth Israel Deaconess Medical Center are conducting an observational study of patients with long COVID who have pain and sleep disturbances. The study aims “to understand the role of sleep in the development and persistence of pain symptoms in long COVID.”
Intervention for Sleep and Pain in Youth: A Randomized Controlled Trial (I-SPY-RCT). Adolescents with migraine are being recruited by a team at Seattle Children’s Hospital for a randomized controlled trial. The study will examine the effects of CBT-I as well as the combined effect of CBT-I and pain interventions on reducing insomnia symptoms and headache-related disability in this population.
A version of this article appeared on Medscape.com.
COVID vax: Primary care back at forefront of care delivery
With COVID-19 hospitalizations up by 22% and deaths up by 8% as of Aug. 12, primary care clinicians are readying to distribute the new COVID-19 booster that is expected to arrive in September.
David Cutler, MD, is hoping to vaccinate as many of his patients who want the shots. He and other primary care clinicians are finally back in the business of prevention after being sidelined during the pandemic.
Most primary care clinicians weren’t provided with the vaccine through the height of the pandemic, when federal officials instead focused their efforts on vaccine distribution through hospital systems and retail pharmacies. The consequence, primary care clinicians say, is that they have no records for patients who need the vaccine; they cannot send patients reminders; and they have no idea if an at-risk patient is ready for a booster.
“The role of primary care is educating people about COVID-19, testing for COVID-19 and other infections, providing access to vaccines and treatment, and sustaining our health care system to provide care, fight disease, and save lives,” said Dr. Cutler, a family physician at Providence Saint John’s Health Center in Santa Monica, Calif.
A study published in Health Affairs confirmed that primary care practices were not included in the federal vaccine strategy. The researchers found that by the end of 2021, 43.1% of 2,000 primary care practices had no records of COVID-19 vaccinations for patients. More than 90% had records for historically routine immunizations, such as influenza and shingles.
“I do believe if PCPs had earlier access to the vaccine, we could have done a better job vaccinating more people,” said Ann Greiner, MCP, president and chief executive officer of the Primary Care Collaborative, a nonprofit organization. “We need to make sure they’re back in that seat, providing the lion’s share of those vaccines.”
The roadblocks to vaccines
More than 20,000 primary care clinicians applied to distribute vaccines to patients as of April 2021, according to the Centers for Disease Control and Prevention. A quarter of those received the shots. Fewer than 5% of all vaccine doses were provided to primary care offices during that early stage of rollout.
Natasha Beauvais, MD, MPH, a family physician at Northern Virginia Family Practice in Alexandria, Va., said trying to vaccinate patients back then was a herculean task.
“We were desperate to get the vaccine, like many practices,” Dr. Beauvais said.
It was only by chance – through one of the physician’s work connections – that they got in touch with the city’s health department to request a supply of immunizations.
The requirements for becoming a vaccine provider were stringent: Dr. Beauvais had to show that her practice could appropriately refrigerate or freeze doses at much colder temperatures than most immunizations, monitor the storage unit at all times, and accurately record and schedule every dose. What’s more, most primary care practices lacked the bandwidth to conduct mass vaccinations like larger medical systems.
Robert L. Phillips Jr., MD, MSPH, founding executive director at the American Board of Family Medicine Foundation, said that the decision to sideline primary care practices, along with a poor records system, left clinicians struggling to leverage relationships with patients to boost rates of vaccination.
“Primary care is where most people have trusted health relationships, and it should be more than a footnote in the nation’s epidemic response plans,” said Dr. Phillips, a corresponding author of the Health Affairs study.
The exclusion of primary care has deep roots: These clinicians were mentioned as a footnote in the CDC’s 2017 Pandemic Influenza Plan, according to Dr. Phillips.
“There’s no one in the federal government who wakes up in the morning thinking of primary care,” Dr. Phillips said. “It’s not the only reason the numbers were down, but a big reason.”
Other countries, including Australia, utilized the specialty for vaccine distribution. A 2022 article in Australian Health Review noted that the success of Australia’s COVID-19 vaccine rollout came down to the involvement of primary care.
Dr. Cutler said his clinic also did as much as they could during the early pandemic – from keeping their urgent care clinic open to providing COVID-19 antibody testing and infusions. His practice was able to start vaccinating patients in March 2021, and by that summer, the office had provided the immunization to 4,000 patients. Dr. Cutler was also able to address any health problems these patients reported during their vaccination visit.
“A vaccine is not just a vaccine: It’s an opportunity to have a conversation between a primary care physician and a patient about other health issues, and it encultures people to get important preventive care,” Ms. Greiner said.
The Health Affairs study was supported by the CDC.
A version of this article first appeared on Medscape.com.
With COVID-19 hospitalizations up by 22% and deaths up by 8% as of Aug. 12, primary care clinicians are readying to distribute the new COVID-19 booster that is expected to arrive in September.
David Cutler, MD, is hoping to vaccinate as many of his patients who want the shots. He and other primary care clinicians are finally back in the business of prevention after being sidelined during the pandemic.
Most primary care clinicians weren’t provided with the vaccine through the height of the pandemic, when federal officials instead focused their efforts on vaccine distribution through hospital systems and retail pharmacies. The consequence, primary care clinicians say, is that they have no records for patients who need the vaccine; they cannot send patients reminders; and they have no idea if an at-risk patient is ready for a booster.
“The role of primary care is educating people about COVID-19, testing for COVID-19 and other infections, providing access to vaccines and treatment, and sustaining our health care system to provide care, fight disease, and save lives,” said Dr. Cutler, a family physician at Providence Saint John’s Health Center in Santa Monica, Calif.
A study published in Health Affairs confirmed that primary care practices were not included in the federal vaccine strategy. The researchers found that by the end of 2021, 43.1% of 2,000 primary care practices had no records of COVID-19 vaccinations for patients. More than 90% had records for historically routine immunizations, such as influenza and shingles.
“I do believe if PCPs had earlier access to the vaccine, we could have done a better job vaccinating more people,” said Ann Greiner, MCP, president and chief executive officer of the Primary Care Collaborative, a nonprofit organization. “We need to make sure they’re back in that seat, providing the lion’s share of those vaccines.”
The roadblocks to vaccines
More than 20,000 primary care clinicians applied to distribute vaccines to patients as of April 2021, according to the Centers for Disease Control and Prevention. A quarter of those received the shots. Fewer than 5% of all vaccine doses were provided to primary care offices during that early stage of rollout.
Natasha Beauvais, MD, MPH, a family physician at Northern Virginia Family Practice in Alexandria, Va., said trying to vaccinate patients back then was a herculean task.
“We were desperate to get the vaccine, like many practices,” Dr. Beauvais said.
It was only by chance – through one of the physician’s work connections – that they got in touch with the city’s health department to request a supply of immunizations.
The requirements for becoming a vaccine provider were stringent: Dr. Beauvais had to show that her practice could appropriately refrigerate or freeze doses at much colder temperatures than most immunizations, monitor the storage unit at all times, and accurately record and schedule every dose. What’s more, most primary care practices lacked the bandwidth to conduct mass vaccinations like larger medical systems.
Robert L. Phillips Jr., MD, MSPH, founding executive director at the American Board of Family Medicine Foundation, said that the decision to sideline primary care practices, along with a poor records system, left clinicians struggling to leverage relationships with patients to boost rates of vaccination.
“Primary care is where most people have trusted health relationships, and it should be more than a footnote in the nation’s epidemic response plans,” said Dr. Phillips, a corresponding author of the Health Affairs study.
The exclusion of primary care has deep roots: These clinicians were mentioned as a footnote in the CDC’s 2017 Pandemic Influenza Plan, according to Dr. Phillips.
“There’s no one in the federal government who wakes up in the morning thinking of primary care,” Dr. Phillips said. “It’s not the only reason the numbers were down, but a big reason.”
Other countries, including Australia, utilized the specialty for vaccine distribution. A 2022 article in Australian Health Review noted that the success of Australia’s COVID-19 vaccine rollout came down to the involvement of primary care.
Dr. Cutler said his clinic also did as much as they could during the early pandemic – from keeping their urgent care clinic open to providing COVID-19 antibody testing and infusions. His practice was able to start vaccinating patients in March 2021, and by that summer, the office had provided the immunization to 4,000 patients. Dr. Cutler was also able to address any health problems these patients reported during their vaccination visit.
“A vaccine is not just a vaccine: It’s an opportunity to have a conversation between a primary care physician and a patient about other health issues, and it encultures people to get important preventive care,” Ms. Greiner said.
The Health Affairs study was supported by the CDC.
A version of this article first appeared on Medscape.com.
With COVID-19 hospitalizations up by 22% and deaths up by 8% as of Aug. 12, primary care clinicians are readying to distribute the new COVID-19 booster that is expected to arrive in September.
David Cutler, MD, is hoping to vaccinate as many of his patients who want the shots. He and other primary care clinicians are finally back in the business of prevention after being sidelined during the pandemic.
Most primary care clinicians weren’t provided with the vaccine through the height of the pandemic, when federal officials instead focused their efforts on vaccine distribution through hospital systems and retail pharmacies. The consequence, primary care clinicians say, is that they have no records for patients who need the vaccine; they cannot send patients reminders; and they have no idea if an at-risk patient is ready for a booster.
“The role of primary care is educating people about COVID-19, testing for COVID-19 and other infections, providing access to vaccines and treatment, and sustaining our health care system to provide care, fight disease, and save lives,” said Dr. Cutler, a family physician at Providence Saint John’s Health Center in Santa Monica, Calif.
A study published in Health Affairs confirmed that primary care practices were not included in the federal vaccine strategy. The researchers found that by the end of 2021, 43.1% of 2,000 primary care practices had no records of COVID-19 vaccinations for patients. More than 90% had records for historically routine immunizations, such as influenza and shingles.
“I do believe if PCPs had earlier access to the vaccine, we could have done a better job vaccinating more people,” said Ann Greiner, MCP, president and chief executive officer of the Primary Care Collaborative, a nonprofit organization. “We need to make sure they’re back in that seat, providing the lion’s share of those vaccines.”
The roadblocks to vaccines
More than 20,000 primary care clinicians applied to distribute vaccines to patients as of April 2021, according to the Centers for Disease Control and Prevention. A quarter of those received the shots. Fewer than 5% of all vaccine doses were provided to primary care offices during that early stage of rollout.
Natasha Beauvais, MD, MPH, a family physician at Northern Virginia Family Practice in Alexandria, Va., said trying to vaccinate patients back then was a herculean task.
“We were desperate to get the vaccine, like many practices,” Dr. Beauvais said.
It was only by chance – through one of the physician’s work connections – that they got in touch with the city’s health department to request a supply of immunizations.
The requirements for becoming a vaccine provider were stringent: Dr. Beauvais had to show that her practice could appropriately refrigerate or freeze doses at much colder temperatures than most immunizations, monitor the storage unit at all times, and accurately record and schedule every dose. What’s more, most primary care practices lacked the bandwidth to conduct mass vaccinations like larger medical systems.
Robert L. Phillips Jr., MD, MSPH, founding executive director at the American Board of Family Medicine Foundation, said that the decision to sideline primary care practices, along with a poor records system, left clinicians struggling to leverage relationships with patients to boost rates of vaccination.
“Primary care is where most people have trusted health relationships, and it should be more than a footnote in the nation’s epidemic response plans,” said Dr. Phillips, a corresponding author of the Health Affairs study.
The exclusion of primary care has deep roots: These clinicians were mentioned as a footnote in the CDC’s 2017 Pandemic Influenza Plan, according to Dr. Phillips.
“There’s no one in the federal government who wakes up in the morning thinking of primary care,” Dr. Phillips said. “It’s not the only reason the numbers were down, but a big reason.”
Other countries, including Australia, utilized the specialty for vaccine distribution. A 2022 article in Australian Health Review noted that the success of Australia’s COVID-19 vaccine rollout came down to the involvement of primary care.
Dr. Cutler said his clinic also did as much as they could during the early pandemic – from keeping their urgent care clinic open to providing COVID-19 antibody testing and infusions. His practice was able to start vaccinating patients in March 2021, and by that summer, the office had provided the immunization to 4,000 patients. Dr. Cutler was also able to address any health problems these patients reported during their vaccination visit.
“A vaccine is not just a vaccine: It’s an opportunity to have a conversation between a primary care physician and a patient about other health issues, and it encultures people to get important preventive care,” Ms. Greiner said.
The Health Affairs study was supported by the CDC.
A version of this article first appeared on Medscape.com.
New RSV shot is a monoclonal antibody, not a vaccine
For the first time in the fall of 2023, families will be offered season-long protection for infants and some children against respiratory syncytial virus (RSV).
The Food and Drug Administration in July approved a prevention called nirsevimab (Beyfortus, AstraZeneca/Sanofi) and it is expected to be widely rolled out in the coming weeks as the RSV season begins.
And monoclonal antibodies are often used for treatment rather than prevention.
Adding to potential confusion is the fact the Centers for Disease Control and Prevention has included nirsevimab in the Vaccines for Children program, which covers the costs for uninsured kids and makes it more accessible.
Nirsevimab is approved for infants (up to 8 months old) born during or entering their first RSV season, and in children up to 2 years of age who are still vulnerable to severe RSV through their second season.
It’s recommended that all infants get one injection in their first 8 months for prevention instead of the previous monthly shots used to help prevent kids at high risk from getting severe RSV.
If monoclonal antibodies can be used for preventing disease in infants, could they become a viable vaccine alternative for adults?
Specialists say no.
That’s partly because of the difference in body size. Although an injection is an option for a newborn, pediatricians suggest, it would take far too much of the treatment to work as a shot for adults.
Ruth Karron, MD, an expert in pediatric infectious diseases at Johns Hopkins Medicine, Baltimore, said that, while vaccines come in small amounts and activate immune cells, monoclonal antibodies are more like a drug, with the dose based on weight.
“You’d have to give it intravenously,” for larger doses, she explained, which has never been studied before and would also be very expensive. “It really couldn’t be an option for adults.”
What’s the difference between vaccines and antibodies?
Monoclonal antibodies are proteins made in a lab to mimic the immune system’s ability to fight pathogens such as viruses.
Dr. Karron explained that a wide variety of monoclonal antibodies have long been used to treat diseases such as cancers and autoimmune disease. In recent years, the antibodies have been used to treat COVID.
Monoclonal antibodies have also been used to treat RSV in children, but the effects don’t last long – they confer passive immunity and “when it’s gone, it’s gone,” Dr. Karron said.
That means kids at high risk for severe RSV have had to get monthly injections.
But with nirsevimab, the mutated antibodies stay in circulation longer so they can last 5 or 6 months, enough to cover the RSV season, Dr. Karron explained. “It’s highly, highly effective.”
Vaccines train the body
“The idea with vaccines is that you engage the individual’s immune system. You teach it to make antibodies,” Dr. Karron said. Conversely, “you give an antibody and it’s good for as long as the antibody lasts. It’s not teaching your body anything.”
Frank Esper, MD, a pediatric infectious disease specialist at Cleveland Clinic Children’s Hospital, said monoclonal antibody protection for RSV is particularly welcome. “We’ve been trying to make an RSV vaccine since the 1960s and have done nothing but fail miserably.”
“The best thing is always a vaccine,” Dr. Esper said, explaining that vaccines teach the body to make its own antibodies and confer long-term protection and are “probably more efficacious than anything that’s ever manmade.
“But since we’ve really not done very well for pediatric RSV vaccines, nirsevimab is certainly something I’m looking forward to,” he said.
Fast-acting monoclonal antibodies
An advantage for monoclonal antibodies is that they start working almost immediately.
Children can get sick with RSV in the first few months of life so the speed of the monoclonal antibodies to begin protection is important, Dr. Esper said, adding that RSV “is the worst during the first year of life.”
The peak age for babies getting infected enough to require hospitalization is about 2 months, he said.
By 14 months, he said, kids’ immune systems and airways have matured enough “that it’s not nearly as bad.”
To get protection from a vaccine, he added, “usually takes 2-4 weeks from the time you get your shot to the time you see some benefit. With an antibody, you’re bypassing the processing that the body has to do, and it goes straight to ‘protection’ mode,” Dr. Esper said. “You get protected pretty much as soon as you get the antibody.”
A version of this article first appeared on Medscape.com.
For the first time in the fall of 2023, families will be offered season-long protection for infants and some children against respiratory syncytial virus (RSV).
The Food and Drug Administration in July approved a prevention called nirsevimab (Beyfortus, AstraZeneca/Sanofi) and it is expected to be widely rolled out in the coming weeks as the RSV season begins.
And monoclonal antibodies are often used for treatment rather than prevention.
Adding to potential confusion is the fact the Centers for Disease Control and Prevention has included nirsevimab in the Vaccines for Children program, which covers the costs for uninsured kids and makes it more accessible.
Nirsevimab is approved for infants (up to 8 months old) born during or entering their first RSV season, and in children up to 2 years of age who are still vulnerable to severe RSV through their second season.
It’s recommended that all infants get one injection in their first 8 months for prevention instead of the previous monthly shots used to help prevent kids at high risk from getting severe RSV.
If monoclonal antibodies can be used for preventing disease in infants, could they become a viable vaccine alternative for adults?
Specialists say no.
That’s partly because of the difference in body size. Although an injection is an option for a newborn, pediatricians suggest, it would take far too much of the treatment to work as a shot for adults.
Ruth Karron, MD, an expert in pediatric infectious diseases at Johns Hopkins Medicine, Baltimore, said that, while vaccines come in small amounts and activate immune cells, monoclonal antibodies are more like a drug, with the dose based on weight.
“You’d have to give it intravenously,” for larger doses, she explained, which has never been studied before and would also be very expensive. “It really couldn’t be an option for adults.”
What’s the difference between vaccines and antibodies?
Monoclonal antibodies are proteins made in a lab to mimic the immune system’s ability to fight pathogens such as viruses.
Dr. Karron explained that a wide variety of monoclonal antibodies have long been used to treat diseases such as cancers and autoimmune disease. In recent years, the antibodies have been used to treat COVID.
Monoclonal antibodies have also been used to treat RSV in children, but the effects don’t last long – they confer passive immunity and “when it’s gone, it’s gone,” Dr. Karron said.
That means kids at high risk for severe RSV have had to get monthly injections.
But with nirsevimab, the mutated antibodies stay in circulation longer so they can last 5 or 6 months, enough to cover the RSV season, Dr. Karron explained. “It’s highly, highly effective.”
Vaccines train the body
“The idea with vaccines is that you engage the individual’s immune system. You teach it to make antibodies,” Dr. Karron said. Conversely, “you give an antibody and it’s good for as long as the antibody lasts. It’s not teaching your body anything.”
Frank Esper, MD, a pediatric infectious disease specialist at Cleveland Clinic Children’s Hospital, said monoclonal antibody protection for RSV is particularly welcome. “We’ve been trying to make an RSV vaccine since the 1960s and have done nothing but fail miserably.”
“The best thing is always a vaccine,” Dr. Esper said, explaining that vaccines teach the body to make its own antibodies and confer long-term protection and are “probably more efficacious than anything that’s ever manmade.
“But since we’ve really not done very well for pediatric RSV vaccines, nirsevimab is certainly something I’m looking forward to,” he said.
Fast-acting monoclonal antibodies
An advantage for monoclonal antibodies is that they start working almost immediately.
Children can get sick with RSV in the first few months of life so the speed of the monoclonal antibodies to begin protection is important, Dr. Esper said, adding that RSV “is the worst during the first year of life.”
The peak age for babies getting infected enough to require hospitalization is about 2 months, he said.
By 14 months, he said, kids’ immune systems and airways have matured enough “that it’s not nearly as bad.”
To get protection from a vaccine, he added, “usually takes 2-4 weeks from the time you get your shot to the time you see some benefit. With an antibody, you’re bypassing the processing that the body has to do, and it goes straight to ‘protection’ mode,” Dr. Esper said. “You get protected pretty much as soon as you get the antibody.”
A version of this article first appeared on Medscape.com.
For the first time in the fall of 2023, families will be offered season-long protection for infants and some children against respiratory syncytial virus (RSV).
The Food and Drug Administration in July approved a prevention called nirsevimab (Beyfortus, AstraZeneca/Sanofi) and it is expected to be widely rolled out in the coming weeks as the RSV season begins.
And monoclonal antibodies are often used for treatment rather than prevention.
Adding to potential confusion is the fact the Centers for Disease Control and Prevention has included nirsevimab in the Vaccines for Children program, which covers the costs for uninsured kids and makes it more accessible.
Nirsevimab is approved for infants (up to 8 months old) born during or entering their first RSV season, and in children up to 2 years of age who are still vulnerable to severe RSV through their second season.
It’s recommended that all infants get one injection in their first 8 months for prevention instead of the previous monthly shots used to help prevent kids at high risk from getting severe RSV.
If monoclonal antibodies can be used for preventing disease in infants, could they become a viable vaccine alternative for adults?
Specialists say no.
That’s partly because of the difference in body size. Although an injection is an option for a newborn, pediatricians suggest, it would take far too much of the treatment to work as a shot for adults.
Ruth Karron, MD, an expert in pediatric infectious diseases at Johns Hopkins Medicine, Baltimore, said that, while vaccines come in small amounts and activate immune cells, monoclonal antibodies are more like a drug, with the dose based on weight.
“You’d have to give it intravenously,” for larger doses, she explained, which has never been studied before and would also be very expensive. “It really couldn’t be an option for adults.”
What’s the difference between vaccines and antibodies?
Monoclonal antibodies are proteins made in a lab to mimic the immune system’s ability to fight pathogens such as viruses.
Dr. Karron explained that a wide variety of monoclonal antibodies have long been used to treat diseases such as cancers and autoimmune disease. In recent years, the antibodies have been used to treat COVID.
Monoclonal antibodies have also been used to treat RSV in children, but the effects don’t last long – they confer passive immunity and “when it’s gone, it’s gone,” Dr. Karron said.
That means kids at high risk for severe RSV have had to get monthly injections.
But with nirsevimab, the mutated antibodies stay in circulation longer so they can last 5 or 6 months, enough to cover the RSV season, Dr. Karron explained. “It’s highly, highly effective.”
Vaccines train the body
“The idea with vaccines is that you engage the individual’s immune system. You teach it to make antibodies,” Dr. Karron said. Conversely, “you give an antibody and it’s good for as long as the antibody lasts. It’s not teaching your body anything.”
Frank Esper, MD, a pediatric infectious disease specialist at Cleveland Clinic Children’s Hospital, said monoclonal antibody protection for RSV is particularly welcome. “We’ve been trying to make an RSV vaccine since the 1960s and have done nothing but fail miserably.”
“The best thing is always a vaccine,” Dr. Esper said, explaining that vaccines teach the body to make its own antibodies and confer long-term protection and are “probably more efficacious than anything that’s ever manmade.
“But since we’ve really not done very well for pediatric RSV vaccines, nirsevimab is certainly something I’m looking forward to,” he said.
Fast-acting monoclonal antibodies
An advantage for monoclonal antibodies is that they start working almost immediately.
Children can get sick with RSV in the first few months of life so the speed of the monoclonal antibodies to begin protection is important, Dr. Esper said, adding that RSV “is the worst during the first year of life.”
The peak age for babies getting infected enough to require hospitalization is about 2 months, he said.
By 14 months, he said, kids’ immune systems and airways have matured enough “that it’s not nearly as bad.”
To get protection from a vaccine, he added, “usually takes 2-4 weeks from the time you get your shot to the time you see some benefit. With an antibody, you’re bypassing the processing that the body has to do, and it goes straight to ‘protection’ mode,” Dr. Esper said. “You get protected pretty much as soon as you get the antibody.”
A version of this article first appeared on Medscape.com.
Dupilumab gains off-label uses as clinicians turn to drug for more indications
.
The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.
As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.
The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
A well-tolerated – if expensive – drug
Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.
Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.
“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”
Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.
“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.
Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.
“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”
Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.
“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.
Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.
As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.
Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.
“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”
“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”
Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.
“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”
Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.
“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”
Making injections less bothersome
Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.
“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”
Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.
For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”
Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
Off-label dupixent can be expensive, difficult to obtain
The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”
Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.
“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”
The experts who commented have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
.
The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.
As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.
The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
A well-tolerated – if expensive – drug
Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.
Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.
“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”
Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.
“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.
Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.
“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”
Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.
“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.
Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.
As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.
Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.
“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”
“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”
Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.
“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”
Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.
“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”
Making injections less bothersome
Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.
“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”
Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.
For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”
Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
Off-label dupixent can be expensive, difficult to obtain
The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”
Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.
“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”
The experts who commented have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
.
The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.
As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.
The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
A well-tolerated – if expensive – drug
Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.
Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.
“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”
Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.
“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.
Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.
“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”
Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.
“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.
Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.
As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.
Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.
“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”
“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”
Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.
“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”
Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.
“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”
Making injections less bothersome
Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.
“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”
Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.
For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”
Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
Off-label dupixent can be expensive, difficult to obtain
The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”
Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.
“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”
The experts who commented have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
Lymphoma specialist to lead MD Anderson’s cancer medicine division
“My research uncovered a series of physicians who served as ‘clinical champions’ and dramatically sped the process of drug development,” Dr. Flowers recalled in an interview. “This early career research inspired me to become the type of clinical champion that I uncovered.”
Over his career, hematologist-oncologist Dr. Flowers has developed lifesaving therapies for lymphoma, which has transformed into a highly treatable and even curable disease. He’s listed as a coauthor of hundreds of peer-reviewed cancer studies, reports, and medical society guidelines. And he’s revealed stark disparities in blood cancer care: His research shows that non-White patients suffer from worse outcomes, regardless of factors like income and insurance coverage.
The University of Texas MD Anderson Cancer Center, Houston, recently named physician-scientist Dr. Flowers as division head of cancer medicine, a position he’s held on an interim basis. As of Sept. 1, he will permanently oversee 300 faculty and more than 2,000 staff members.
A running start in Seattle
For Dr. Flowers, track and field is a sport that runs in the family. His grandfather was a top runner in both high school and college, and both Dr. Flowers and his brother ran competitively in Seattle, where they grew up. But Dr. Flowers chose a career in oncology, earning a medical degree at Stanford and master’s degrees at both Stanford and the University of Washington, Seattle.
The late Kenneth Melmon, MD, a groundbreaking pharmacologist, was a major influence. “He was one of the first people that I met when I began as an undergraduate at Stanford. We grew to be long-standing friends, and he demonstrated what outstanding mentorship looks like. In our research collaboration, we investigated the work of Dr. Gertrude Elion and Dr. George Hitchings involving the translation of pharmacological data from cellular and animal models to clinically useful drugs including 6-mercaptopurine, allopurinol, azathioprine, acyclovir, and zidovudine.”
The late Oliver Press, MD, a blood cancer specialist, inspired Dr. Flower’s interest in lymphoma. “I began work with him during an internship at the University of Washington. Ollie was a great inspiration and a key leader in the development of innovative therapies for lymphoma. He embodied the role of a clinical champion translating work in radioimmunotherapy to new therapeutics for patients with lymphomas. Working with him ultimately led me to pursue a career in hematology and oncology with a focus on the care for patients with lymphomas.”
Career blooms as lymphoma care advances
Dr. Flowers went on to Emory University, Atlanta, where he served as scientific director of the Research Informatics Shared Resource and a faculty member in the department of biomedical informatics. “I applied my training in informatics and my clinical expertise to support active grants from the Burroughs Wellcome Fund for Innovation in Regulatory Science and from the National Cancer Institute to develop informatics tools for pathology image analysis and prognostic modeling.”
For 13 years, he also served the Winship Cancer Institute as director of the Emory Healthcare lymphoma program (where his patients included Kansas City Chiefs football star Eric Berry), and for 4 years as scientific director of research informatics. Meanwhile, Dr. Flowers helped develop national practice guidelines for the American Society of Clinical Oncology, the American Cancer Society, and the American College of Radiology. He also chaired the ASCO guideline on management of febrile neutropenia.
In 2019, MD Anderson hired Dr. Flowers as chair of the department of lymphoma/myeloma. A year later, he was appointed division head ad interim for cancer medicine.
“Chris is a unique leader who expertly combines mentorship, sponsorship, and bidirectional open, honest communication,” said Sairah Ahmed, MD, associate professor of lymphoma at MD Anderson. “He doesn’t just empower his team to reach their goals. He also inspires those around him to turn vision into reality.”
As Dr. Flowers noted, many patients with lymphoma are now able to recover and live normal lives. He himself played a direct role himself in boosting lifespans.
“I have been fortunate to play a role in the development of several treatments that have led to advances in first-line therapy for patients with aggressive lymphomas. I partnered with others at MD Anderson, including Dr. Sattva Neelapu and Dr. Jason Westin, who have developed novel therapies like chimeric antigen receptor T-cell therapy for patients with relapse lymphomas,” he said. “Leaders in the field at MD Anderson like Dr. Michael Wang have developed new oral treatments for patients with rare lymphoma subtypes like mantle cell lymphoma. Other colleagues such as Dr. Nathan Fowler and Dr. Loretta Nastoupil have focused on the care for patients with indolent lymphomas and developed less-toxic therapies that are now in common use.”
Exposing the disparities in blood cancer care
Dr. Flowers, who’s African American, has also been a leader in health disparity research. In 2016, for example, he was coauthor of a study into non-Hodgkin’s lymphoma that revealed that Blacks in the United States have dramatically lower survival rates than Whites. The 10-year survival rate for Black women with chronic lymphocytic leukemia was just 47%, for example, compared with 66% for White females. “Although incidence rates of lymphoid neoplasms are generally higher among Whites, Black men tend to have poorer survival,” Dr. Flowers and colleagues wrote.
In a 2021 report for the ASCO Educational Book, Dr. Flowers and hematologist-oncologist Demetria Smith-Graziani, MD, now with Emory University, explored disparities across blood cancers and barriers to minority enrollment in clinical trials. “Some approaches that clinicians can apply to address these disparities include increasing systems-level awareness, improving access to care, and reducing biases in clinical setting,” the authors wrote.
Luis Malpica Castillo, MD, assistant professor of lymphoma at MD Anderson Cancer Center, lauded the work of Dr. Flowers in expanding opportunities for minority patients with the disease.
“During the past years, Dr. Flowers’ work has not only had a positive impact on the Texan community, but minority populations living with cancer in the United States and abroad,” he said. “Currently, we are implementing cancer care networks aimed to increase diversity in clinical trials by enrolling a larger number of Hispanic and African American patients, who otherwise may not have benefited from novel therapies. The ultimate goal is to provide high-quality care to all patients living with cancer.”
In addition to his research work, Dr. Flowers is an advocate for diversity within the hematology community. He’s a founding member and former chair of the American Society of Hematology’s Committee on Diversity, Equity and Inclusion (formerly the Committee on Promoting Diversity), and he helped develop the society’s Minority Recruitment Initiative.
What’s next for Dr. Flowers? For one, he plans to continue working as a mentor; he received the ASH Mentor Award in honor of his service in 2022. “I am strongly committed to increasing the number of tenure-track investigators trained in clinical and translational cancer research and to promote their career development.”
And he looks forward to helping develop MD Anderson’s recently announced $2.5 billion hospital in Austin. “This will extend the exceptional care that we provide as the No. 1 cancer center in the United States,” he said. “It will also create new opportunities for research and collaboration with experts at UT Austin.”
When he’s not in clinic, Dr. Flowers embraces his lifelong love of speeding through life on his own two feet. He’s even inspired his children to share his passion. “I run most days of the week,” he said. “Running provides a great opportunity to think and process new research ideas, work through leadership challenges, and sometimes just to relax and let go of the day.”
“My research uncovered a series of physicians who served as ‘clinical champions’ and dramatically sped the process of drug development,” Dr. Flowers recalled in an interview. “This early career research inspired me to become the type of clinical champion that I uncovered.”
Over his career, hematologist-oncologist Dr. Flowers has developed lifesaving therapies for lymphoma, which has transformed into a highly treatable and even curable disease. He’s listed as a coauthor of hundreds of peer-reviewed cancer studies, reports, and medical society guidelines. And he’s revealed stark disparities in blood cancer care: His research shows that non-White patients suffer from worse outcomes, regardless of factors like income and insurance coverage.
The University of Texas MD Anderson Cancer Center, Houston, recently named physician-scientist Dr. Flowers as division head of cancer medicine, a position he’s held on an interim basis. As of Sept. 1, he will permanently oversee 300 faculty and more than 2,000 staff members.
A running start in Seattle
For Dr. Flowers, track and field is a sport that runs in the family. His grandfather was a top runner in both high school and college, and both Dr. Flowers and his brother ran competitively in Seattle, where they grew up. But Dr. Flowers chose a career in oncology, earning a medical degree at Stanford and master’s degrees at both Stanford and the University of Washington, Seattle.
The late Kenneth Melmon, MD, a groundbreaking pharmacologist, was a major influence. “He was one of the first people that I met when I began as an undergraduate at Stanford. We grew to be long-standing friends, and he demonstrated what outstanding mentorship looks like. In our research collaboration, we investigated the work of Dr. Gertrude Elion and Dr. George Hitchings involving the translation of pharmacological data from cellular and animal models to clinically useful drugs including 6-mercaptopurine, allopurinol, azathioprine, acyclovir, and zidovudine.”
The late Oliver Press, MD, a blood cancer specialist, inspired Dr. Flower’s interest in lymphoma. “I began work with him during an internship at the University of Washington. Ollie was a great inspiration and a key leader in the development of innovative therapies for lymphoma. He embodied the role of a clinical champion translating work in radioimmunotherapy to new therapeutics for patients with lymphomas. Working with him ultimately led me to pursue a career in hematology and oncology with a focus on the care for patients with lymphomas.”
Career blooms as lymphoma care advances
Dr. Flowers went on to Emory University, Atlanta, where he served as scientific director of the Research Informatics Shared Resource and a faculty member in the department of biomedical informatics. “I applied my training in informatics and my clinical expertise to support active grants from the Burroughs Wellcome Fund for Innovation in Regulatory Science and from the National Cancer Institute to develop informatics tools for pathology image analysis and prognostic modeling.”
For 13 years, he also served the Winship Cancer Institute as director of the Emory Healthcare lymphoma program (where his patients included Kansas City Chiefs football star Eric Berry), and for 4 years as scientific director of research informatics. Meanwhile, Dr. Flowers helped develop national practice guidelines for the American Society of Clinical Oncology, the American Cancer Society, and the American College of Radiology. He also chaired the ASCO guideline on management of febrile neutropenia.
In 2019, MD Anderson hired Dr. Flowers as chair of the department of lymphoma/myeloma. A year later, he was appointed division head ad interim for cancer medicine.
“Chris is a unique leader who expertly combines mentorship, sponsorship, and bidirectional open, honest communication,” said Sairah Ahmed, MD, associate professor of lymphoma at MD Anderson. “He doesn’t just empower his team to reach their goals. He also inspires those around him to turn vision into reality.”
As Dr. Flowers noted, many patients with lymphoma are now able to recover and live normal lives. He himself played a direct role himself in boosting lifespans.
“I have been fortunate to play a role in the development of several treatments that have led to advances in first-line therapy for patients with aggressive lymphomas. I partnered with others at MD Anderson, including Dr. Sattva Neelapu and Dr. Jason Westin, who have developed novel therapies like chimeric antigen receptor T-cell therapy for patients with relapse lymphomas,” he said. “Leaders in the field at MD Anderson like Dr. Michael Wang have developed new oral treatments for patients with rare lymphoma subtypes like mantle cell lymphoma. Other colleagues such as Dr. Nathan Fowler and Dr. Loretta Nastoupil have focused on the care for patients with indolent lymphomas and developed less-toxic therapies that are now in common use.”
Exposing the disparities in blood cancer care
Dr. Flowers, who’s African American, has also been a leader in health disparity research. In 2016, for example, he was coauthor of a study into non-Hodgkin’s lymphoma that revealed that Blacks in the United States have dramatically lower survival rates than Whites. The 10-year survival rate for Black women with chronic lymphocytic leukemia was just 47%, for example, compared with 66% for White females. “Although incidence rates of lymphoid neoplasms are generally higher among Whites, Black men tend to have poorer survival,” Dr. Flowers and colleagues wrote.
In a 2021 report for the ASCO Educational Book, Dr. Flowers and hematologist-oncologist Demetria Smith-Graziani, MD, now with Emory University, explored disparities across blood cancers and barriers to minority enrollment in clinical trials. “Some approaches that clinicians can apply to address these disparities include increasing systems-level awareness, improving access to care, and reducing biases in clinical setting,” the authors wrote.
Luis Malpica Castillo, MD, assistant professor of lymphoma at MD Anderson Cancer Center, lauded the work of Dr. Flowers in expanding opportunities for minority patients with the disease.
“During the past years, Dr. Flowers’ work has not only had a positive impact on the Texan community, but minority populations living with cancer in the United States and abroad,” he said. “Currently, we are implementing cancer care networks aimed to increase diversity in clinical trials by enrolling a larger number of Hispanic and African American patients, who otherwise may not have benefited from novel therapies. The ultimate goal is to provide high-quality care to all patients living with cancer.”
In addition to his research work, Dr. Flowers is an advocate for diversity within the hematology community. He’s a founding member and former chair of the American Society of Hematology’s Committee on Diversity, Equity and Inclusion (formerly the Committee on Promoting Diversity), and he helped develop the society’s Minority Recruitment Initiative.
What’s next for Dr. Flowers? For one, he plans to continue working as a mentor; he received the ASH Mentor Award in honor of his service in 2022. “I am strongly committed to increasing the number of tenure-track investigators trained in clinical and translational cancer research and to promote their career development.”
And he looks forward to helping develop MD Anderson’s recently announced $2.5 billion hospital in Austin. “This will extend the exceptional care that we provide as the No. 1 cancer center in the United States,” he said. “It will also create new opportunities for research and collaboration with experts at UT Austin.”
When he’s not in clinic, Dr. Flowers embraces his lifelong love of speeding through life on his own two feet. He’s even inspired his children to share his passion. “I run most days of the week,” he said. “Running provides a great opportunity to think and process new research ideas, work through leadership challenges, and sometimes just to relax and let go of the day.”
“My research uncovered a series of physicians who served as ‘clinical champions’ and dramatically sped the process of drug development,” Dr. Flowers recalled in an interview. “This early career research inspired me to become the type of clinical champion that I uncovered.”
Over his career, hematologist-oncologist Dr. Flowers has developed lifesaving therapies for lymphoma, which has transformed into a highly treatable and even curable disease. He’s listed as a coauthor of hundreds of peer-reviewed cancer studies, reports, and medical society guidelines. And he’s revealed stark disparities in blood cancer care: His research shows that non-White patients suffer from worse outcomes, regardless of factors like income and insurance coverage.
The University of Texas MD Anderson Cancer Center, Houston, recently named physician-scientist Dr. Flowers as division head of cancer medicine, a position he’s held on an interim basis. As of Sept. 1, he will permanently oversee 300 faculty and more than 2,000 staff members.
A running start in Seattle
For Dr. Flowers, track and field is a sport that runs in the family. His grandfather was a top runner in both high school and college, and both Dr. Flowers and his brother ran competitively in Seattle, where they grew up. But Dr. Flowers chose a career in oncology, earning a medical degree at Stanford and master’s degrees at both Stanford and the University of Washington, Seattle.
The late Kenneth Melmon, MD, a groundbreaking pharmacologist, was a major influence. “He was one of the first people that I met when I began as an undergraduate at Stanford. We grew to be long-standing friends, and he demonstrated what outstanding mentorship looks like. In our research collaboration, we investigated the work of Dr. Gertrude Elion and Dr. George Hitchings involving the translation of pharmacological data from cellular and animal models to clinically useful drugs including 6-mercaptopurine, allopurinol, azathioprine, acyclovir, and zidovudine.”
The late Oliver Press, MD, a blood cancer specialist, inspired Dr. Flower’s interest in lymphoma. “I began work with him during an internship at the University of Washington. Ollie was a great inspiration and a key leader in the development of innovative therapies for lymphoma. He embodied the role of a clinical champion translating work in radioimmunotherapy to new therapeutics for patients with lymphomas. Working with him ultimately led me to pursue a career in hematology and oncology with a focus on the care for patients with lymphomas.”
Career blooms as lymphoma care advances
Dr. Flowers went on to Emory University, Atlanta, where he served as scientific director of the Research Informatics Shared Resource and a faculty member in the department of biomedical informatics. “I applied my training in informatics and my clinical expertise to support active grants from the Burroughs Wellcome Fund for Innovation in Regulatory Science and from the National Cancer Institute to develop informatics tools for pathology image analysis and prognostic modeling.”
For 13 years, he also served the Winship Cancer Institute as director of the Emory Healthcare lymphoma program (where his patients included Kansas City Chiefs football star Eric Berry), and for 4 years as scientific director of research informatics. Meanwhile, Dr. Flowers helped develop national practice guidelines for the American Society of Clinical Oncology, the American Cancer Society, and the American College of Radiology. He also chaired the ASCO guideline on management of febrile neutropenia.
In 2019, MD Anderson hired Dr. Flowers as chair of the department of lymphoma/myeloma. A year later, he was appointed division head ad interim for cancer medicine.
“Chris is a unique leader who expertly combines mentorship, sponsorship, and bidirectional open, honest communication,” said Sairah Ahmed, MD, associate professor of lymphoma at MD Anderson. “He doesn’t just empower his team to reach their goals. He also inspires those around him to turn vision into reality.”
As Dr. Flowers noted, many patients with lymphoma are now able to recover and live normal lives. He himself played a direct role himself in boosting lifespans.
“I have been fortunate to play a role in the development of several treatments that have led to advances in first-line therapy for patients with aggressive lymphomas. I partnered with others at MD Anderson, including Dr. Sattva Neelapu and Dr. Jason Westin, who have developed novel therapies like chimeric antigen receptor T-cell therapy for patients with relapse lymphomas,” he said. “Leaders in the field at MD Anderson like Dr. Michael Wang have developed new oral treatments for patients with rare lymphoma subtypes like mantle cell lymphoma. Other colleagues such as Dr. Nathan Fowler and Dr. Loretta Nastoupil have focused on the care for patients with indolent lymphomas and developed less-toxic therapies that are now in common use.”
Exposing the disparities in blood cancer care
Dr. Flowers, who’s African American, has also been a leader in health disparity research. In 2016, for example, he was coauthor of a study into non-Hodgkin’s lymphoma that revealed that Blacks in the United States have dramatically lower survival rates than Whites. The 10-year survival rate for Black women with chronic lymphocytic leukemia was just 47%, for example, compared with 66% for White females. “Although incidence rates of lymphoid neoplasms are generally higher among Whites, Black men tend to have poorer survival,” Dr. Flowers and colleagues wrote.
In a 2021 report for the ASCO Educational Book, Dr. Flowers and hematologist-oncologist Demetria Smith-Graziani, MD, now with Emory University, explored disparities across blood cancers and barriers to minority enrollment in clinical trials. “Some approaches that clinicians can apply to address these disparities include increasing systems-level awareness, improving access to care, and reducing biases in clinical setting,” the authors wrote.
Luis Malpica Castillo, MD, assistant professor of lymphoma at MD Anderson Cancer Center, lauded the work of Dr. Flowers in expanding opportunities for minority patients with the disease.
“During the past years, Dr. Flowers’ work has not only had a positive impact on the Texan community, but minority populations living with cancer in the United States and abroad,” he said. “Currently, we are implementing cancer care networks aimed to increase diversity in clinical trials by enrolling a larger number of Hispanic and African American patients, who otherwise may not have benefited from novel therapies. The ultimate goal is to provide high-quality care to all patients living with cancer.”
In addition to his research work, Dr. Flowers is an advocate for diversity within the hematology community. He’s a founding member and former chair of the American Society of Hematology’s Committee on Diversity, Equity and Inclusion (formerly the Committee on Promoting Diversity), and he helped develop the society’s Minority Recruitment Initiative.
What’s next for Dr. Flowers? For one, he plans to continue working as a mentor; he received the ASH Mentor Award in honor of his service in 2022. “I am strongly committed to increasing the number of tenure-track investigators trained in clinical and translational cancer research and to promote their career development.”
And he looks forward to helping develop MD Anderson’s recently announced $2.5 billion hospital in Austin. “This will extend the exceptional care that we provide as the No. 1 cancer center in the United States,” he said. “It will also create new opportunities for research and collaboration with experts at UT Austin.”
When he’s not in clinic, Dr. Flowers embraces his lifelong love of speeding through life on his own two feet. He’s even inspired his children to share his passion. “I run most days of the week,” he said. “Running provides a great opportunity to think and process new research ideas, work through leadership challenges, and sometimes just to relax and let go of the day.”
Long COVID lawsuits coming, but not likely to succeed, experts predict
By now, concerns about COVID-related lawsuits have faded into the rear view mirror for most physicians.
While some say it’s doubtful the claims will succeed, the lawsuits could still create legal headaches for doctors in the form of time and money.
Long COVID claims are defined as complaints that allege that a diagnosis of long COVID was missed or delayed and that caused harm or injury. Lawsuits may also include claims in which patients allege that they were misdiagnosed as having long COVID when they were really suffering from another condition.
So far, a handful of long COVID claims have come down the pipeline, said Peter A. Kolbert, JD, senior vice president of claims and litigation services for Healthcare Risk Advisors, part of TDC Group.
“This is an area that is emerging as we speak,” Mr. Kolbert said. “We are starting to see these claims trickle in.”
In a recent case, for example, a patient sued her primary care physician for negligence, alleging her original SARS-CoV-2 infection was mismanaged and that this led to permanent neuropathy from long COVID. Had the patient been treated appropriately, the patient contends, she would not have developed long COVID or the resulting neuropathy, said Mr. Kolbert. An outcome in the case has not yet been reached, added Mr. Kolbert, who heard about the claim from a colleague.
The increase in the number of lawsuits raises concerns about how courts and juries might decide long COVID claims when so much about the condition is still unknown and best treatment practices are still developing. Research shows that long COVID occurs in at least 10% of cases of SARS-CoV-2 infection, and more than 200 symptoms have been identified. A Kaiser Family Foundation study found that 15% of the U.S. population believe they have experienced the symptoms of long COVID at some point, and 6% of people believe they currently have long COVID.
The risk of long COVID lawsuits underscores the importance of physicians taking proactive steps to protect themselves from liability when treating patients who might have the condition, say legal experts.
“There are legal standards that say new, unestablished scientific principles shouldn’t be first tested by a jury, they should be recognized and established within their [professional] area,” Mr. Kolbert said. “While we are seeing lawsuits related to long COVID, I think it is truly putting the cart before the horse, because there needs to be societal recognition that we’re still learning how to define and treat long COVID.”
What are patients alleging?
In the few long COVID claims that have arisen, some complaints have alleged delay in the recognition and treatment of long COVID, according to Mr. Kolbert. There have also been claims that physicians failed to refer a patient with long COVID to a specialist in a timely way and that this results in the patient’s experiencing chronic fatigue or a neuropathy.
Fatigue is one of the most common symptoms associated with long COVID, according to recent studies. Other symptoms include postexertional malaise, brain fog, and gastrointestinal problems.
Another rising legal theme is failure to adequately communicate with patients about what long COVID is and what it entails.
Whether plaintiffs who bring long COVID claims will be successful in court remains a question.
Andrew D. DeSimone, JD, a Lexington, Ky.–based medical malpractice defense attorney, said he has not seen any claims involving long COVID. He added that a long COVID claim would be challenging to prove, considering the standard of care for treating the condition is still evolving. Plaintiffs in a medical malpractice action must prove that physicians owed a duty of care to the patient, that the doctor breached that duty by failing to conform to the standard of care, and that the breach caused an injury that harmed the patient.
Mr. DeSimone also doubts whether juries would be very sympathetic to such plaintiffs.
“There’s a lot of fatigue around COVID still,” he said. “I don’t know if a jury would buy into someone claiming long COVID. I think the claim would have a hard time gaining traction. Not that it’s impossible.”
Another unanswered question is whether legal protections enacted by states during the pandemic might apply to long COVID claims.
Shortly after the pandemic started, most states enacted laws or executive orders that shielded physicians from liability claims relating to the prevention and treatment of COVID-19, unless gross negligence or willful misconduct is proved. The U.S. Department of Health and Human Services published a declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) that provided liability immunity to health care professionals for any activity related to medical countermeasures against COVID-19.
Some of these state immunities have since expired. Other states have extended their legal protections for short periods. In Indiana, for example, physicians and businesses are protected until Dec. 31, 2024, from civil tort actions that allege damages arising from COVID-19.
It’s possible that in long COVID lawsuits, physicians would be protected by the immunities unless the cases come after the protections expire, said J. Richard Moore, a medical liability defense attorney based in Indianapolis.
“I could foresee long COVID claims that don’t accrue until after December 2024, meaning it only becomes clear that a patient is struggling with long COVID–related symptoms after that date,” he said. “That could result in COVID claims that do not fall under the immunities.”
Mr. Moore said that if long COVID claims become truly problematic, the legislature could extend the immunities.
Other states, such as Washington, have statutes in place that increase the burden of proof for plaintiffs in cases in which care is affected by COVID and/or the treating of COVID. Elizabeth A. Leedom, a Seattle-based medical liability defense attorney, said the law would likely encompass long COVID claims if the care and treatment at issue occurred during the COVID state of emergency.
Compliance with current treatment guidelines is likely to be a good defense against any claim of delay/failure to diagnose COVID, including long COVID, she said.
Mr. Kolbert, however, doubts that the state immunities would protect against the claims.
“Courts are enforcing qualified immunities as to [traditional] COVID claims. However, I suspect that long COVID claims will fall into a category of traditional medical malpractice claim, such as delay in or failure to diagnose,” he said. In such cases, physicians “may not be able to take advantage of state-qualified immunities. Of course, this will depend upon the language of each state’s qualified immunity provisions.”
As for the statute of limitations, the clock generally starts running either when the alleged negligent conduct occurred or when the patient knew or, in the exercise of ordinary diligence, should have known, that they had been harmed by the alleged negligence, Mr. Moore said. Statutes of limitations are state specific, but the majority of states mandate a 2- to 3-year limit between the injury and the filing of a claim.
So, while the statute of limitations may be soon expiring for alleged harm that occurred during the pandemic, for patients newly diagnosed with long COVID or who have just discovered associated injuries, the clock may have just started ticking.
How to protect yourself against suits
Avoiding liability associated with long COVID involves the traditional legal guidance physicians are used to hearing, but with an added factor, Mr. Kolbert said.
There always needs to be communication with patients regarding the disease process, but in this area, there needs to be strong communication as to whether patients have had COVID in the past and what symptoms they are experiencing, he said. Physicians should ensure that patients know that long COVID may present in a variety of ways and that there is no definitive test for long COVID.
Physicians should document when the patient has been instructed to follow up and should take necessary steps to ensure the patient returns for follow-up care, he added.
On the opposite side of the spectrum is making sure not to assume a condition or symptom is the result of long COVID, he said. Care should be taken not to diagnose long COVID without excluding traditional causes.
“Ensure that patients know that COVID is not over, per se, and that science supports vaccination,” Mr. Kolbert said. “The best defense here is a strong communicative offense, engaging with the patient and thoughtfully charting about this.”
A version of this article first appeared on Medscape.com.
By now, concerns about COVID-related lawsuits have faded into the rear view mirror for most physicians.
While some say it’s doubtful the claims will succeed, the lawsuits could still create legal headaches for doctors in the form of time and money.
Long COVID claims are defined as complaints that allege that a diagnosis of long COVID was missed or delayed and that caused harm or injury. Lawsuits may also include claims in which patients allege that they were misdiagnosed as having long COVID when they were really suffering from another condition.
So far, a handful of long COVID claims have come down the pipeline, said Peter A. Kolbert, JD, senior vice president of claims and litigation services for Healthcare Risk Advisors, part of TDC Group.
“This is an area that is emerging as we speak,” Mr. Kolbert said. “We are starting to see these claims trickle in.”
In a recent case, for example, a patient sued her primary care physician for negligence, alleging her original SARS-CoV-2 infection was mismanaged and that this led to permanent neuropathy from long COVID. Had the patient been treated appropriately, the patient contends, she would not have developed long COVID or the resulting neuropathy, said Mr. Kolbert. An outcome in the case has not yet been reached, added Mr. Kolbert, who heard about the claim from a colleague.
The increase in the number of lawsuits raises concerns about how courts and juries might decide long COVID claims when so much about the condition is still unknown and best treatment practices are still developing. Research shows that long COVID occurs in at least 10% of cases of SARS-CoV-2 infection, and more than 200 symptoms have been identified. A Kaiser Family Foundation study found that 15% of the U.S. population believe they have experienced the symptoms of long COVID at some point, and 6% of people believe they currently have long COVID.
The risk of long COVID lawsuits underscores the importance of physicians taking proactive steps to protect themselves from liability when treating patients who might have the condition, say legal experts.
“There are legal standards that say new, unestablished scientific principles shouldn’t be first tested by a jury, they should be recognized and established within their [professional] area,” Mr. Kolbert said. “While we are seeing lawsuits related to long COVID, I think it is truly putting the cart before the horse, because there needs to be societal recognition that we’re still learning how to define and treat long COVID.”
What are patients alleging?
In the few long COVID claims that have arisen, some complaints have alleged delay in the recognition and treatment of long COVID, according to Mr. Kolbert. There have also been claims that physicians failed to refer a patient with long COVID to a specialist in a timely way and that this results in the patient’s experiencing chronic fatigue or a neuropathy.
Fatigue is one of the most common symptoms associated with long COVID, according to recent studies. Other symptoms include postexertional malaise, brain fog, and gastrointestinal problems.
Another rising legal theme is failure to adequately communicate with patients about what long COVID is and what it entails.
Whether plaintiffs who bring long COVID claims will be successful in court remains a question.
Andrew D. DeSimone, JD, a Lexington, Ky.–based medical malpractice defense attorney, said he has not seen any claims involving long COVID. He added that a long COVID claim would be challenging to prove, considering the standard of care for treating the condition is still evolving. Plaintiffs in a medical malpractice action must prove that physicians owed a duty of care to the patient, that the doctor breached that duty by failing to conform to the standard of care, and that the breach caused an injury that harmed the patient.
Mr. DeSimone also doubts whether juries would be very sympathetic to such plaintiffs.
“There’s a lot of fatigue around COVID still,” he said. “I don’t know if a jury would buy into someone claiming long COVID. I think the claim would have a hard time gaining traction. Not that it’s impossible.”
Another unanswered question is whether legal protections enacted by states during the pandemic might apply to long COVID claims.
Shortly after the pandemic started, most states enacted laws or executive orders that shielded physicians from liability claims relating to the prevention and treatment of COVID-19, unless gross negligence or willful misconduct is proved. The U.S. Department of Health and Human Services published a declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) that provided liability immunity to health care professionals for any activity related to medical countermeasures against COVID-19.
Some of these state immunities have since expired. Other states have extended their legal protections for short periods. In Indiana, for example, physicians and businesses are protected until Dec. 31, 2024, from civil tort actions that allege damages arising from COVID-19.
It’s possible that in long COVID lawsuits, physicians would be protected by the immunities unless the cases come after the protections expire, said J. Richard Moore, a medical liability defense attorney based in Indianapolis.
“I could foresee long COVID claims that don’t accrue until after December 2024, meaning it only becomes clear that a patient is struggling with long COVID–related symptoms after that date,” he said. “That could result in COVID claims that do not fall under the immunities.”
Mr. Moore said that if long COVID claims become truly problematic, the legislature could extend the immunities.
Other states, such as Washington, have statutes in place that increase the burden of proof for plaintiffs in cases in which care is affected by COVID and/or the treating of COVID. Elizabeth A. Leedom, a Seattle-based medical liability defense attorney, said the law would likely encompass long COVID claims if the care and treatment at issue occurred during the COVID state of emergency.
Compliance with current treatment guidelines is likely to be a good defense against any claim of delay/failure to diagnose COVID, including long COVID, she said.
Mr. Kolbert, however, doubts that the state immunities would protect against the claims.
“Courts are enforcing qualified immunities as to [traditional] COVID claims. However, I suspect that long COVID claims will fall into a category of traditional medical malpractice claim, such as delay in or failure to diagnose,” he said. In such cases, physicians “may not be able to take advantage of state-qualified immunities. Of course, this will depend upon the language of each state’s qualified immunity provisions.”
As for the statute of limitations, the clock generally starts running either when the alleged negligent conduct occurred or when the patient knew or, in the exercise of ordinary diligence, should have known, that they had been harmed by the alleged negligence, Mr. Moore said. Statutes of limitations are state specific, but the majority of states mandate a 2- to 3-year limit between the injury and the filing of a claim.
So, while the statute of limitations may be soon expiring for alleged harm that occurred during the pandemic, for patients newly diagnosed with long COVID or who have just discovered associated injuries, the clock may have just started ticking.
How to protect yourself against suits
Avoiding liability associated with long COVID involves the traditional legal guidance physicians are used to hearing, but with an added factor, Mr. Kolbert said.
There always needs to be communication with patients regarding the disease process, but in this area, there needs to be strong communication as to whether patients have had COVID in the past and what symptoms they are experiencing, he said. Physicians should ensure that patients know that long COVID may present in a variety of ways and that there is no definitive test for long COVID.
Physicians should document when the patient has been instructed to follow up and should take necessary steps to ensure the patient returns for follow-up care, he added.
On the opposite side of the spectrum is making sure not to assume a condition or symptom is the result of long COVID, he said. Care should be taken not to diagnose long COVID without excluding traditional causes.
“Ensure that patients know that COVID is not over, per se, and that science supports vaccination,” Mr. Kolbert said. “The best defense here is a strong communicative offense, engaging with the patient and thoughtfully charting about this.”
A version of this article first appeared on Medscape.com.
By now, concerns about COVID-related lawsuits have faded into the rear view mirror for most physicians.
While some say it’s doubtful the claims will succeed, the lawsuits could still create legal headaches for doctors in the form of time and money.
Long COVID claims are defined as complaints that allege that a diagnosis of long COVID was missed or delayed and that caused harm or injury. Lawsuits may also include claims in which patients allege that they were misdiagnosed as having long COVID when they were really suffering from another condition.
So far, a handful of long COVID claims have come down the pipeline, said Peter A. Kolbert, JD, senior vice president of claims and litigation services for Healthcare Risk Advisors, part of TDC Group.
“This is an area that is emerging as we speak,” Mr. Kolbert said. “We are starting to see these claims trickle in.”
In a recent case, for example, a patient sued her primary care physician for negligence, alleging her original SARS-CoV-2 infection was mismanaged and that this led to permanent neuropathy from long COVID. Had the patient been treated appropriately, the patient contends, she would not have developed long COVID or the resulting neuropathy, said Mr. Kolbert. An outcome in the case has not yet been reached, added Mr. Kolbert, who heard about the claim from a colleague.
The increase in the number of lawsuits raises concerns about how courts and juries might decide long COVID claims when so much about the condition is still unknown and best treatment practices are still developing. Research shows that long COVID occurs in at least 10% of cases of SARS-CoV-2 infection, and more than 200 symptoms have been identified. A Kaiser Family Foundation study found that 15% of the U.S. population believe they have experienced the symptoms of long COVID at some point, and 6% of people believe they currently have long COVID.
The risk of long COVID lawsuits underscores the importance of physicians taking proactive steps to protect themselves from liability when treating patients who might have the condition, say legal experts.
“There are legal standards that say new, unestablished scientific principles shouldn’t be first tested by a jury, they should be recognized and established within their [professional] area,” Mr. Kolbert said. “While we are seeing lawsuits related to long COVID, I think it is truly putting the cart before the horse, because there needs to be societal recognition that we’re still learning how to define and treat long COVID.”
What are patients alleging?
In the few long COVID claims that have arisen, some complaints have alleged delay in the recognition and treatment of long COVID, according to Mr. Kolbert. There have also been claims that physicians failed to refer a patient with long COVID to a specialist in a timely way and that this results in the patient’s experiencing chronic fatigue or a neuropathy.
Fatigue is one of the most common symptoms associated with long COVID, according to recent studies. Other symptoms include postexertional malaise, brain fog, and gastrointestinal problems.
Another rising legal theme is failure to adequately communicate with patients about what long COVID is and what it entails.
Whether plaintiffs who bring long COVID claims will be successful in court remains a question.
Andrew D. DeSimone, JD, a Lexington, Ky.–based medical malpractice defense attorney, said he has not seen any claims involving long COVID. He added that a long COVID claim would be challenging to prove, considering the standard of care for treating the condition is still evolving. Plaintiffs in a medical malpractice action must prove that physicians owed a duty of care to the patient, that the doctor breached that duty by failing to conform to the standard of care, and that the breach caused an injury that harmed the patient.
Mr. DeSimone also doubts whether juries would be very sympathetic to such plaintiffs.
“There’s a lot of fatigue around COVID still,” he said. “I don’t know if a jury would buy into someone claiming long COVID. I think the claim would have a hard time gaining traction. Not that it’s impossible.”
Another unanswered question is whether legal protections enacted by states during the pandemic might apply to long COVID claims.
Shortly after the pandemic started, most states enacted laws or executive orders that shielded physicians from liability claims relating to the prevention and treatment of COVID-19, unless gross negligence or willful misconduct is proved. The U.S. Department of Health and Human Services published a declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) that provided liability immunity to health care professionals for any activity related to medical countermeasures against COVID-19.
Some of these state immunities have since expired. Other states have extended their legal protections for short periods. In Indiana, for example, physicians and businesses are protected until Dec. 31, 2024, from civil tort actions that allege damages arising from COVID-19.
It’s possible that in long COVID lawsuits, physicians would be protected by the immunities unless the cases come after the protections expire, said J. Richard Moore, a medical liability defense attorney based in Indianapolis.
“I could foresee long COVID claims that don’t accrue until after December 2024, meaning it only becomes clear that a patient is struggling with long COVID–related symptoms after that date,” he said. “That could result in COVID claims that do not fall under the immunities.”
Mr. Moore said that if long COVID claims become truly problematic, the legislature could extend the immunities.
Other states, such as Washington, have statutes in place that increase the burden of proof for plaintiffs in cases in which care is affected by COVID and/or the treating of COVID. Elizabeth A. Leedom, a Seattle-based medical liability defense attorney, said the law would likely encompass long COVID claims if the care and treatment at issue occurred during the COVID state of emergency.
Compliance with current treatment guidelines is likely to be a good defense against any claim of delay/failure to diagnose COVID, including long COVID, she said.
Mr. Kolbert, however, doubts that the state immunities would protect against the claims.
“Courts are enforcing qualified immunities as to [traditional] COVID claims. However, I suspect that long COVID claims will fall into a category of traditional medical malpractice claim, such as delay in or failure to diagnose,” he said. In such cases, physicians “may not be able to take advantage of state-qualified immunities. Of course, this will depend upon the language of each state’s qualified immunity provisions.”
As for the statute of limitations, the clock generally starts running either when the alleged negligent conduct occurred or when the patient knew or, in the exercise of ordinary diligence, should have known, that they had been harmed by the alleged negligence, Mr. Moore said. Statutes of limitations are state specific, but the majority of states mandate a 2- to 3-year limit between the injury and the filing of a claim.
So, while the statute of limitations may be soon expiring for alleged harm that occurred during the pandemic, for patients newly diagnosed with long COVID or who have just discovered associated injuries, the clock may have just started ticking.
How to protect yourself against suits
Avoiding liability associated with long COVID involves the traditional legal guidance physicians are used to hearing, but with an added factor, Mr. Kolbert said.
There always needs to be communication with patients regarding the disease process, but in this area, there needs to be strong communication as to whether patients have had COVID in the past and what symptoms they are experiencing, he said. Physicians should ensure that patients know that long COVID may present in a variety of ways and that there is no definitive test for long COVID.
Physicians should document when the patient has been instructed to follow up and should take necessary steps to ensure the patient returns for follow-up care, he added.
On the opposite side of the spectrum is making sure not to assume a condition or symptom is the result of long COVID, he said. Care should be taken not to diagnose long COVID without excluding traditional causes.
“Ensure that patients know that COVID is not over, per se, and that science supports vaccination,” Mr. Kolbert said. “The best defense here is a strong communicative offense, engaging with the patient and thoughtfully charting about this.”
A version of this article first appeared on Medscape.com.
Could a malpractice insurer drop you when you need it most?
You’ve practiced medicine for years without issues, but now you are facing a medical malpractice case. No worries – you’ve had professional liability insurance all this time, so surely there’s nothing to be concerned about. Undoubtedly, your medical malpractice insurer will cover the costs of defending you. Or will they? One case casts questions on just this issue.
Professional liability insurance
According to the American Medical Association, almost one in three physicians (31%) have had a medical malpractice lawsuit filed against them at some point in their careers. These numbers only increase the longer a physician practices; almost half of doctors 55 and over have been sued, compared with less than 10% of physicians under 40.
And while the majority of cases are dropped or dismissed, and the small minority of cases that do go to trial are mostly won by the defense, the cost of defending these cases can be extremely high. Physicians have medical malpractice insurance to defray these costs.
Malpractice insurance generally covers the costs of attorney fees, court costs, arbitration, compensatory damages, and settlements related to patient injury or death. Insurance sometimes, but not always, pays for the costs of malpractice lawsuits arising out of Health Insurance Portability and Accountability Act (HIPAA) violations.
But it is what the policies don’t pay for that should be of most interest to practitioners.
Exclusions to medical malpractice insurance
All professional liability insurance policies contain exclusions, and it is essential that you know what they are. While the exclusions may vary by policy, most malpractice insurance policies exclude claims stemming from:
- Reckless or intentional acts.
- Illegal/criminal activities, including theft.
- Misrepresentation, including dishonesty, fraudulent activity, falsification, and misrepresentation on forms.
- Practicing under the influence of alcohol or drugs.
- Altering patient or hospital records.
- Sexual misconduct.
- Cyber security issues, which typically require a separate cyber liability policy to protect against cyber attacks and data breaches affecting patient medical records.
It’s essential to know what your specific policy’s exclusions are, or you may be surprised to find that your malpractice liability insurance doesn’t cover you when you expected that it would. Such was the situation in a recently decided case.
Also essential is knowing what type of coverage your policy provides – claims-made or occurrence-based. Occurrence policies offer lifetime coverage for incidents that occurred during the policy period, no matter when the claim is made. Claims-made policies cover only incidents that occur and are reported within the policy’s time period (unless a “tail” policy is purchased to extend the reporting period).
The case
Dr. P was a neurologist specializing in pain management. He had a professional liability insurance policy with an insurance company. In 2012, Dr. P’s insurance agent saw a television news story about the physician being accused by the state medical board for overprescribing opioids, resulting in the deaths of 17 patients. The next day, the agent obtained copies of documents from the state medical board, including a summary suspension order and a notice of contemplated action.
The notice of contemplated action specified that Dr. P had deviated from the standard of care through injudicious prescribing, leading to approximately 17 patient deaths due to drug toxicity. Because the agent realized that lawsuits could be filed against Dr. P for the deaths, she sent the insurance company the paperwork from the medical board so the insurer would be aware of the potential claims.
However, when the insurer received the information, it did not investigate or seek more information as it was required to do. The insurer failed to get medical records, or specific patient names, and none of the 17 deaths were recorded in the insurance company’s claims system (a failure to follow company procedure). Instead, the insurance company decided to cancel Dr. P’s policy effective the following month.
The company sent Dr. P a cancellation letter advising him that his policy was being terminated due to “license suspension, nature of allegations, and practice profile,” and offered him a tail policy to purchase.
The insurance company did not advise Dr. P that he should ensure all potential claims were reported, including the 17 deaths, before his policy expired. The company also did not advise him that he had a claims-made policy and what that meant regarding future lawsuits that might be filed after his policy period expired.
A year later, Dr. P was sued in two wrongful death lawsuits by the families of two of the 17 opioid-related deaths. When he was served with the papers, he promptly notified the insurance company. The insurance company issued a denial letter, incorrectly asserting that the 17 drug-toxicity deaths that they were aware of did not qualify as claims under Dr. P’s policy.
After his insurance company failed to represent him, Dr. P divorced his wife of 35 years and filed for bankruptcy. The only creditors with claims were the two families who had sued him. The bankruptcy trustee filed a lawsuit against the insurance company on behalf of Dr. P for the insurer’s failure to defend and indemnify Dr. P against the wrongful death lawsuits. In 2017, the bankruptcy trustee settled the two wrongful death cases by paying the families a certain amount of cash and assigning the insurance bad faith lawsuit to them.
Court and jury decide
In 2020, the case against the insurance company ended up in court. By 2022, the court had decided some of the issues and left some for the jury to determine.
The court found that the insurance company had breached its obligation to defend and indemnify Dr. P, committed unfair insurance claims practices, and committed bad faith in failing to defend the physician. The court limited the compensation to the amount of cash that had been paid to settle the two cases, and any fees and costs that Dr. P had incurred defending himself.
However, this still left the jury to decide whether the insurance company had committed bad faith in failing to indemnify (secure a person against legal liability for his/her actions) Dr. P, whether it had violated the state’s Unfair Insurance Practices Act, and whether punitive damages should be levied against the insurer.
The jury trial ended in a stunning $52 million verdict against the insurance company after less than 2 hours of deliberation. The jury found that the insurance company had acted in bad faith and willfully violated the Unfair Insurances Practices Act.
While the jury ultimately decided against the insurance company and sent it a strong message with a large verdict, Dr. P’s career was still over. He had stopped practicing medicine, was bankrupt, and his personal life was in shambles. The litigation had taken about a decade. Sometimes a win isn’t a victory.
Protecting yourself
The best way to protect yourself from a situation in which your insurer will not defend you is to really know and understand your insurance policy. Is it occurrence-based or claims-made insurance? What exactly does it cover? How are claims supposed to be made? Your professional liability insurance can be extremely important if you get sued, so it is equally important to choose it carefully and to really understand what is being covered.
Other ways to protect yourself:
- Know your agent. Your agent is key to explaining your policy as well as helping in the event that you need to make a claim. Dr. P’s agent saw a news story about him on television, which is why she submitted the information to the insurance company. Dr. P would have been far better off calling the agent directly when he was being investigated by the state medical board to explain the situation and seek advice.
- Be aware of exclusions to your policy. Many – such as criminal acts, reckless or intentional acts, or practicing under the influence – were mentioned earlier in this article. Some may be unexpected, so it is extremely important that you understand the specific exclusions to your particular policy.
- Be aware of your state law, and how changes might affect you. For example, in states that have outlawed or criminalized abortion, an insurance company would probably not have to represent a policy holder who was sued for malpractice involving an abortion. On the other hand, be aware that not treating a patient who needs life-saving care because you are afraid of running afoul of the law can also get you in trouble if the patient is harmed by not being treated. (For example, the Centers for Medicare & Medicaid Services is currently investigating two hospitals that failed to provide necessary stabilizing abortion care to a patient with an emergency medication condition resulting from a miscarriage.)
- Know how your policy defines ‘intentional’ acts (which are typically excluded from coverage). This is important. In some jurisdictions, the insured clinician has to merely intend to commit the acts in order for the claim to be excluded. In other jurisdictions, the insured doctor has to intend to cause the resulting damage. This can result in a very different outcome.
- The best thing doctors can do is to really understand what the policy covers and be prepared to make some noise if the company is not covering something that it should. Don’t be afraid to ask questions if you think your insurer is doing something wrong, and if the answers don’t satisfy you, consult an attorney.
The future
In the fall of 2022, at least partially in response to the Dobbs v. Jackson Women’s Health Organization decision regarding abortion, one professional liability company (Physician’s Insurance) launched criminal defense reimbursement coverage for physicians and hospitals to pay for defense costs incurred in responding to criminal allegations arising directly from patient care.
The add-on Criminal Defense Reimbursement Endorsement was made available in Washington State in January 2023, and will be offered in other states pending regulatory approval. It reimburses defense costs up to $250,000 when criminal actions have arisen from direct patient care.
In a press release announcing the new coverage, Physician’s Insurance CEO Bill Cotter explained the company’s reasoning in providing it: “The already challenging environment for physicians and hospitals has been made even more difficult as they now navigate the legal ramifications of increased criminal medical negligence claims as seen in the case of the Nashville nurse at the Vanderbilt University Medical Center, the potential for criminal state claims arising out of the U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, and the subsequent state criminalization of healthcare practices that have long been the professionally accepted standard of care.”
Expect to see more insurance companies offering new coverage options for physicians in the future as they recognize that physicians may be facing more than just medical malpractice lawsuits arising out of patient care.
A version of this article first appeared on Medscape.com.
You’ve practiced medicine for years without issues, but now you are facing a medical malpractice case. No worries – you’ve had professional liability insurance all this time, so surely there’s nothing to be concerned about. Undoubtedly, your medical malpractice insurer will cover the costs of defending you. Or will they? One case casts questions on just this issue.
Professional liability insurance
According to the American Medical Association, almost one in three physicians (31%) have had a medical malpractice lawsuit filed against them at some point in their careers. These numbers only increase the longer a physician practices; almost half of doctors 55 and over have been sued, compared with less than 10% of physicians under 40.
And while the majority of cases are dropped or dismissed, and the small minority of cases that do go to trial are mostly won by the defense, the cost of defending these cases can be extremely high. Physicians have medical malpractice insurance to defray these costs.
Malpractice insurance generally covers the costs of attorney fees, court costs, arbitration, compensatory damages, and settlements related to patient injury or death. Insurance sometimes, but not always, pays for the costs of malpractice lawsuits arising out of Health Insurance Portability and Accountability Act (HIPAA) violations.
But it is what the policies don’t pay for that should be of most interest to practitioners.
Exclusions to medical malpractice insurance
All professional liability insurance policies contain exclusions, and it is essential that you know what they are. While the exclusions may vary by policy, most malpractice insurance policies exclude claims stemming from:
- Reckless or intentional acts.
- Illegal/criminal activities, including theft.
- Misrepresentation, including dishonesty, fraudulent activity, falsification, and misrepresentation on forms.
- Practicing under the influence of alcohol or drugs.
- Altering patient or hospital records.
- Sexual misconduct.
- Cyber security issues, which typically require a separate cyber liability policy to protect against cyber attacks and data breaches affecting patient medical records.
It’s essential to know what your specific policy’s exclusions are, or you may be surprised to find that your malpractice liability insurance doesn’t cover you when you expected that it would. Such was the situation in a recently decided case.
Also essential is knowing what type of coverage your policy provides – claims-made or occurrence-based. Occurrence policies offer lifetime coverage for incidents that occurred during the policy period, no matter when the claim is made. Claims-made policies cover only incidents that occur and are reported within the policy’s time period (unless a “tail” policy is purchased to extend the reporting period).
The case
Dr. P was a neurologist specializing in pain management. He had a professional liability insurance policy with an insurance company. In 2012, Dr. P’s insurance agent saw a television news story about the physician being accused by the state medical board for overprescribing opioids, resulting in the deaths of 17 patients. The next day, the agent obtained copies of documents from the state medical board, including a summary suspension order and a notice of contemplated action.
The notice of contemplated action specified that Dr. P had deviated from the standard of care through injudicious prescribing, leading to approximately 17 patient deaths due to drug toxicity. Because the agent realized that lawsuits could be filed against Dr. P for the deaths, she sent the insurance company the paperwork from the medical board so the insurer would be aware of the potential claims.
However, when the insurer received the information, it did not investigate or seek more information as it was required to do. The insurer failed to get medical records, or specific patient names, and none of the 17 deaths were recorded in the insurance company’s claims system (a failure to follow company procedure). Instead, the insurance company decided to cancel Dr. P’s policy effective the following month.
The company sent Dr. P a cancellation letter advising him that his policy was being terminated due to “license suspension, nature of allegations, and practice profile,” and offered him a tail policy to purchase.
The insurance company did not advise Dr. P that he should ensure all potential claims were reported, including the 17 deaths, before his policy expired. The company also did not advise him that he had a claims-made policy and what that meant regarding future lawsuits that might be filed after his policy period expired.
A year later, Dr. P was sued in two wrongful death lawsuits by the families of two of the 17 opioid-related deaths. When he was served with the papers, he promptly notified the insurance company. The insurance company issued a denial letter, incorrectly asserting that the 17 drug-toxicity deaths that they were aware of did not qualify as claims under Dr. P’s policy.
After his insurance company failed to represent him, Dr. P divorced his wife of 35 years and filed for bankruptcy. The only creditors with claims were the two families who had sued him. The bankruptcy trustee filed a lawsuit against the insurance company on behalf of Dr. P for the insurer’s failure to defend and indemnify Dr. P against the wrongful death lawsuits. In 2017, the bankruptcy trustee settled the two wrongful death cases by paying the families a certain amount of cash and assigning the insurance bad faith lawsuit to them.
Court and jury decide
In 2020, the case against the insurance company ended up in court. By 2022, the court had decided some of the issues and left some for the jury to determine.
The court found that the insurance company had breached its obligation to defend and indemnify Dr. P, committed unfair insurance claims practices, and committed bad faith in failing to defend the physician. The court limited the compensation to the amount of cash that had been paid to settle the two cases, and any fees and costs that Dr. P had incurred defending himself.
However, this still left the jury to decide whether the insurance company had committed bad faith in failing to indemnify (secure a person against legal liability for his/her actions) Dr. P, whether it had violated the state’s Unfair Insurance Practices Act, and whether punitive damages should be levied against the insurer.
The jury trial ended in a stunning $52 million verdict against the insurance company after less than 2 hours of deliberation. The jury found that the insurance company had acted in bad faith and willfully violated the Unfair Insurances Practices Act.
While the jury ultimately decided against the insurance company and sent it a strong message with a large verdict, Dr. P’s career was still over. He had stopped practicing medicine, was bankrupt, and his personal life was in shambles. The litigation had taken about a decade. Sometimes a win isn’t a victory.
Protecting yourself
The best way to protect yourself from a situation in which your insurer will not defend you is to really know and understand your insurance policy. Is it occurrence-based or claims-made insurance? What exactly does it cover? How are claims supposed to be made? Your professional liability insurance can be extremely important if you get sued, so it is equally important to choose it carefully and to really understand what is being covered.
Other ways to protect yourself:
- Know your agent. Your agent is key to explaining your policy as well as helping in the event that you need to make a claim. Dr. P’s agent saw a news story about him on television, which is why she submitted the information to the insurance company. Dr. P would have been far better off calling the agent directly when he was being investigated by the state medical board to explain the situation and seek advice.
- Be aware of exclusions to your policy. Many – such as criminal acts, reckless or intentional acts, or practicing under the influence – were mentioned earlier in this article. Some may be unexpected, so it is extremely important that you understand the specific exclusions to your particular policy.
- Be aware of your state law, and how changes might affect you. For example, in states that have outlawed or criminalized abortion, an insurance company would probably not have to represent a policy holder who was sued for malpractice involving an abortion. On the other hand, be aware that not treating a patient who needs life-saving care because you are afraid of running afoul of the law can also get you in trouble if the patient is harmed by not being treated. (For example, the Centers for Medicare & Medicaid Services is currently investigating two hospitals that failed to provide necessary stabilizing abortion care to a patient with an emergency medication condition resulting from a miscarriage.)
- Know how your policy defines ‘intentional’ acts (which are typically excluded from coverage). This is important. In some jurisdictions, the insured clinician has to merely intend to commit the acts in order for the claim to be excluded. In other jurisdictions, the insured doctor has to intend to cause the resulting damage. This can result in a very different outcome.
- The best thing doctors can do is to really understand what the policy covers and be prepared to make some noise if the company is not covering something that it should. Don’t be afraid to ask questions if you think your insurer is doing something wrong, and if the answers don’t satisfy you, consult an attorney.
The future
In the fall of 2022, at least partially in response to the Dobbs v. Jackson Women’s Health Organization decision regarding abortion, one professional liability company (Physician’s Insurance) launched criminal defense reimbursement coverage for physicians and hospitals to pay for defense costs incurred in responding to criminal allegations arising directly from patient care.
The add-on Criminal Defense Reimbursement Endorsement was made available in Washington State in January 2023, and will be offered in other states pending regulatory approval. It reimburses defense costs up to $250,000 when criminal actions have arisen from direct patient care.
In a press release announcing the new coverage, Physician’s Insurance CEO Bill Cotter explained the company’s reasoning in providing it: “The already challenging environment for physicians and hospitals has been made even more difficult as they now navigate the legal ramifications of increased criminal medical negligence claims as seen in the case of the Nashville nurse at the Vanderbilt University Medical Center, the potential for criminal state claims arising out of the U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, and the subsequent state criminalization of healthcare practices that have long been the professionally accepted standard of care.”
Expect to see more insurance companies offering new coverage options for physicians in the future as they recognize that physicians may be facing more than just medical malpractice lawsuits arising out of patient care.
A version of this article first appeared on Medscape.com.
You’ve practiced medicine for years without issues, but now you are facing a medical malpractice case. No worries – you’ve had professional liability insurance all this time, so surely there’s nothing to be concerned about. Undoubtedly, your medical malpractice insurer will cover the costs of defending you. Or will they? One case casts questions on just this issue.
Professional liability insurance
According to the American Medical Association, almost one in three physicians (31%) have had a medical malpractice lawsuit filed against them at some point in their careers. These numbers only increase the longer a physician practices; almost half of doctors 55 and over have been sued, compared with less than 10% of physicians under 40.
And while the majority of cases are dropped or dismissed, and the small minority of cases that do go to trial are mostly won by the defense, the cost of defending these cases can be extremely high. Physicians have medical malpractice insurance to defray these costs.
Malpractice insurance generally covers the costs of attorney fees, court costs, arbitration, compensatory damages, and settlements related to patient injury or death. Insurance sometimes, but not always, pays for the costs of malpractice lawsuits arising out of Health Insurance Portability and Accountability Act (HIPAA) violations.
But it is what the policies don’t pay for that should be of most interest to practitioners.
Exclusions to medical malpractice insurance
All professional liability insurance policies contain exclusions, and it is essential that you know what they are. While the exclusions may vary by policy, most malpractice insurance policies exclude claims stemming from:
- Reckless or intentional acts.
- Illegal/criminal activities, including theft.
- Misrepresentation, including dishonesty, fraudulent activity, falsification, and misrepresentation on forms.
- Practicing under the influence of alcohol or drugs.
- Altering patient or hospital records.
- Sexual misconduct.
- Cyber security issues, which typically require a separate cyber liability policy to protect against cyber attacks and data breaches affecting patient medical records.
It’s essential to know what your specific policy’s exclusions are, or you may be surprised to find that your malpractice liability insurance doesn’t cover you when you expected that it would. Such was the situation in a recently decided case.
Also essential is knowing what type of coverage your policy provides – claims-made or occurrence-based. Occurrence policies offer lifetime coverage for incidents that occurred during the policy period, no matter when the claim is made. Claims-made policies cover only incidents that occur and are reported within the policy’s time period (unless a “tail” policy is purchased to extend the reporting period).
The case
Dr. P was a neurologist specializing in pain management. He had a professional liability insurance policy with an insurance company. In 2012, Dr. P’s insurance agent saw a television news story about the physician being accused by the state medical board for overprescribing opioids, resulting in the deaths of 17 patients. The next day, the agent obtained copies of documents from the state medical board, including a summary suspension order and a notice of contemplated action.
The notice of contemplated action specified that Dr. P had deviated from the standard of care through injudicious prescribing, leading to approximately 17 patient deaths due to drug toxicity. Because the agent realized that lawsuits could be filed against Dr. P for the deaths, she sent the insurance company the paperwork from the medical board so the insurer would be aware of the potential claims.
However, when the insurer received the information, it did not investigate or seek more information as it was required to do. The insurer failed to get medical records, or specific patient names, and none of the 17 deaths were recorded in the insurance company’s claims system (a failure to follow company procedure). Instead, the insurance company decided to cancel Dr. P’s policy effective the following month.
The company sent Dr. P a cancellation letter advising him that his policy was being terminated due to “license suspension, nature of allegations, and practice profile,” and offered him a tail policy to purchase.
The insurance company did not advise Dr. P that he should ensure all potential claims were reported, including the 17 deaths, before his policy expired. The company also did not advise him that he had a claims-made policy and what that meant regarding future lawsuits that might be filed after his policy period expired.
A year later, Dr. P was sued in two wrongful death lawsuits by the families of two of the 17 opioid-related deaths. When he was served with the papers, he promptly notified the insurance company. The insurance company issued a denial letter, incorrectly asserting that the 17 drug-toxicity deaths that they were aware of did not qualify as claims under Dr. P’s policy.
After his insurance company failed to represent him, Dr. P divorced his wife of 35 years and filed for bankruptcy. The only creditors with claims were the two families who had sued him. The bankruptcy trustee filed a lawsuit against the insurance company on behalf of Dr. P for the insurer’s failure to defend and indemnify Dr. P against the wrongful death lawsuits. In 2017, the bankruptcy trustee settled the two wrongful death cases by paying the families a certain amount of cash and assigning the insurance bad faith lawsuit to them.
Court and jury decide
In 2020, the case against the insurance company ended up in court. By 2022, the court had decided some of the issues and left some for the jury to determine.
The court found that the insurance company had breached its obligation to defend and indemnify Dr. P, committed unfair insurance claims practices, and committed bad faith in failing to defend the physician. The court limited the compensation to the amount of cash that had been paid to settle the two cases, and any fees and costs that Dr. P had incurred defending himself.
However, this still left the jury to decide whether the insurance company had committed bad faith in failing to indemnify (secure a person against legal liability for his/her actions) Dr. P, whether it had violated the state’s Unfair Insurance Practices Act, and whether punitive damages should be levied against the insurer.
The jury trial ended in a stunning $52 million verdict against the insurance company after less than 2 hours of deliberation. The jury found that the insurance company had acted in bad faith and willfully violated the Unfair Insurances Practices Act.
While the jury ultimately decided against the insurance company and sent it a strong message with a large verdict, Dr. P’s career was still over. He had stopped practicing medicine, was bankrupt, and his personal life was in shambles. The litigation had taken about a decade. Sometimes a win isn’t a victory.
Protecting yourself
The best way to protect yourself from a situation in which your insurer will not defend you is to really know and understand your insurance policy. Is it occurrence-based or claims-made insurance? What exactly does it cover? How are claims supposed to be made? Your professional liability insurance can be extremely important if you get sued, so it is equally important to choose it carefully and to really understand what is being covered.
Other ways to protect yourself:
- Know your agent. Your agent is key to explaining your policy as well as helping in the event that you need to make a claim. Dr. P’s agent saw a news story about him on television, which is why she submitted the information to the insurance company. Dr. P would have been far better off calling the agent directly when he was being investigated by the state medical board to explain the situation and seek advice.
- Be aware of exclusions to your policy. Many – such as criminal acts, reckless or intentional acts, or practicing under the influence – were mentioned earlier in this article. Some may be unexpected, so it is extremely important that you understand the specific exclusions to your particular policy.
- Be aware of your state law, and how changes might affect you. For example, in states that have outlawed or criminalized abortion, an insurance company would probably not have to represent a policy holder who was sued for malpractice involving an abortion. On the other hand, be aware that not treating a patient who needs life-saving care because you are afraid of running afoul of the law can also get you in trouble if the patient is harmed by not being treated. (For example, the Centers for Medicare & Medicaid Services is currently investigating two hospitals that failed to provide necessary stabilizing abortion care to a patient with an emergency medication condition resulting from a miscarriage.)
- Know how your policy defines ‘intentional’ acts (which are typically excluded from coverage). This is important. In some jurisdictions, the insured clinician has to merely intend to commit the acts in order for the claim to be excluded. In other jurisdictions, the insured doctor has to intend to cause the resulting damage. This can result in a very different outcome.
- The best thing doctors can do is to really understand what the policy covers and be prepared to make some noise if the company is not covering something that it should. Don’t be afraid to ask questions if you think your insurer is doing something wrong, and if the answers don’t satisfy you, consult an attorney.
The future
In the fall of 2022, at least partially in response to the Dobbs v. Jackson Women’s Health Organization decision regarding abortion, one professional liability company (Physician’s Insurance) launched criminal defense reimbursement coverage for physicians and hospitals to pay for defense costs incurred in responding to criminal allegations arising directly from patient care.
The add-on Criminal Defense Reimbursement Endorsement was made available in Washington State in January 2023, and will be offered in other states pending regulatory approval. It reimburses defense costs up to $250,000 when criminal actions have arisen from direct patient care.
In a press release announcing the new coverage, Physician’s Insurance CEO Bill Cotter explained the company’s reasoning in providing it: “The already challenging environment for physicians and hospitals has been made even more difficult as they now navigate the legal ramifications of increased criminal medical negligence claims as seen in the case of the Nashville nurse at the Vanderbilt University Medical Center, the potential for criminal state claims arising out of the U.S. Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, and the subsequent state criminalization of healthcare practices that have long been the professionally accepted standard of care.”
Expect to see more insurance companies offering new coverage options for physicians in the future as they recognize that physicians may be facing more than just medical malpractice lawsuits arising out of patient care.
A version of this article first appeared on Medscape.com.
Docs using AI? Some love it, most remain wary
When OpenAI released ChatGPT-3 publicly last November, some doctors decided to try out the free AI tool that learns language and writes human-like text. Some physicians found the chatbot made mistakes and stopped using it, while others were happy with the results and plan to use it more often.
“We’ve played around with it. It was very early on in AI and we noticed it gave us incorrect information with regards to clinical guidance,” said Monalisa Tailor, MD, an internal medicine physician at Norton Health Care in Louisville, Ky. “We decided not to pursue it further,” she said.
Orthopedic spine surgeon Daniel Choi, MD, who owns a small medical/surgical practice in Long Island, New York, tested the chatbot’s performance with a few administrative tasks, including writing a job listing for an administrator and prior authorization letters.
He was enthusiastic. “A well-polished job posting that would usually take me 2-3 hours to write was done in 5 minutes,” Dr. Choi said. “I was blown away by the writing – it was much better than anything I could write.”
The chatbot can also automate administrative tasks in doctors’ practices from appointment scheduling and billing to clinical documentation, saving doctors time and money, experts say.
Most physicians are proceeding cautiously. About 10% of more than 500 medical group leaders, responding to a March poll by the Medical Group Management Association, said their practices regularly use AI tools.
More than half of the respondents not using AI said they first want more evidence that the technology works as intended.
“None of them work as advertised,” said one respondent.
MGMA practice management consultant Dawn Plested acknowledges that many of the physician practices she’s worked with are still wary. “I have yet to encounter a practice that is using any AI tool, even something as low-risk as appointment scheduling,” she said.
Physician groups may be concerned about the costs and logistics of integrating ChatGPT with their electronic health record systems (EHRs) and how that would work, said Ms. Plested.
Doctors may also be skeptical of AI based on their experience with EHRs, she said.
“They were promoted as a panacea to many problems; they were supposed to automate business practice, reduce staff and clinician’s work, and improve billing/coding/documentation. Unfortunately, they have become a major source of frustration for doctors,” said Ms. Plested.
Drawing the line at patient care
Patients are worried about their doctors relying on AI for their care, according to a Pew Research Center poll released in February. About 60% of U.S. adults say they would feel uncomfortable if their own health care professional relied on artificial intelligence to do things like diagnose disease and recommend treatments; about 40% say they would feel comfortable with this.
“We have not yet gone into using ChatGPT for clinical purposes and will be very cautious with these types of applications due to concerns about inaccuracies,” Dr. Choi said.
Practice leaders reported in the MGMA poll that the most common uses of AI were nonclinical, such as:
- Patient communications, including call center answering service to help triage calls, to sort/distribute incoming fax messages, and outreach such as appointment reminders and marketing materials.
- Capturing clinical documentation, often with natural language processing or speech recognition platforms to help virtually scribe.
- Improving billing operations and predictive analytics.
Some doctors told The New York Times that ChatGPT helped them communicate with patients in a more compassionate way.
They used chatbots “to find words to break bad news and express concerns about a patient’s suffering, or to just more clearly explain medical recommendations,” the story noted.
Is regulation needed?
Some legal scholars and medical groups say that AI should be regulated to protect patients and doctors from risks, including medical errors, that could harm patients.
“It’s very important to evaluate the accuracy, safety, and privacy of language learning models (LLMs) before integrating them into the medical system. The same should be true of any new medical tool,” said Mason Marks, MD, JD, a health law professor at the Florida State University College of Law in Tallahassee.
In mid-June, the American Medical Association approved two resolutions calling for greater government oversight of AI. The AMA will develop proposed state and federal regulations and work with the federal government and other organizations to protect patients from false or misleading AI-generated medical advice.
Dr. Marks pointed to existing federal rules that apply to AI. “The Federal Trade Commission already has regulation that can potentially be used to combat unfair or deceptive trade practices associated with chatbots,” he said.
In addition, “the U.S. Food and Drug Administration can also regulate these tools, but it needs to update how it approaches risk when it comes to AI. The FDA has an outdated view of risk as physical harm, for instance, from traditional medical devices. That view of risk needs to be updated and expanded to encompass the unique harms of AI,” Dr. Marks said.
There should also be more transparency about how LLM software is used in medicine, he said. “That could be a norm implemented by the LLM developers and it could also be enforced by federal agencies. For instance, the FDA could require developers to be more transparent regarding training data and methods, and the FTC could require greater transparency regarding how consumer data might be used and opportunities to opt out of certain uses,” said Dr. Marks.
What should doctors do?
Dr. Marks advised doctors to be cautious when using ChatGPT and other LLMs, especially for medical advice. “The same would apply to any new medical tool, but we know that the current generation of LLMs [is] particularly prone to making things up, which could lead to medical errors if relied on in clinical settings,” he said.
There is also potential for breaches of patient confidentiality if doctors input clinical information. ChatGPT and OpenAI-enabled tools may not be compliant with the Health Insurance Portability and Accountability Act, which set national standards to protect individuals’ medical records and individually identifiable health information.
“The best approach is to use chatbots cautiously and with skepticism. Don’t input patient information, confirm the accuracy of information produced, and don’t use them as replacements for professional judgment,” Dr. Marks recommended.
Ms. Plested suggested that doctors who want to experiment with AI start with a low-risk tool such as appointment reminders that could save staff time and money. “I never recommend they start with something as high-stakes as coding/billing,” she said.
A version of this article appeared on Medscape.com.
When OpenAI released ChatGPT-3 publicly last November, some doctors decided to try out the free AI tool that learns language and writes human-like text. Some physicians found the chatbot made mistakes and stopped using it, while others were happy with the results and plan to use it more often.
“We’ve played around with it. It was very early on in AI and we noticed it gave us incorrect information with regards to clinical guidance,” said Monalisa Tailor, MD, an internal medicine physician at Norton Health Care in Louisville, Ky. “We decided not to pursue it further,” she said.
Orthopedic spine surgeon Daniel Choi, MD, who owns a small medical/surgical practice in Long Island, New York, tested the chatbot’s performance with a few administrative tasks, including writing a job listing for an administrator and prior authorization letters.
He was enthusiastic. “A well-polished job posting that would usually take me 2-3 hours to write was done in 5 minutes,” Dr. Choi said. “I was blown away by the writing – it was much better than anything I could write.”
The chatbot can also automate administrative tasks in doctors’ practices from appointment scheduling and billing to clinical documentation, saving doctors time and money, experts say.
Most physicians are proceeding cautiously. About 10% of more than 500 medical group leaders, responding to a March poll by the Medical Group Management Association, said their practices regularly use AI tools.
More than half of the respondents not using AI said they first want more evidence that the technology works as intended.
“None of them work as advertised,” said one respondent.
MGMA practice management consultant Dawn Plested acknowledges that many of the physician practices she’s worked with are still wary. “I have yet to encounter a practice that is using any AI tool, even something as low-risk as appointment scheduling,” she said.
Physician groups may be concerned about the costs and logistics of integrating ChatGPT with their electronic health record systems (EHRs) and how that would work, said Ms. Plested.
Doctors may also be skeptical of AI based on their experience with EHRs, she said.
“They were promoted as a panacea to many problems; they were supposed to automate business practice, reduce staff and clinician’s work, and improve billing/coding/documentation. Unfortunately, they have become a major source of frustration for doctors,” said Ms. Plested.
Drawing the line at patient care
Patients are worried about their doctors relying on AI for their care, according to a Pew Research Center poll released in February. About 60% of U.S. adults say they would feel uncomfortable if their own health care professional relied on artificial intelligence to do things like diagnose disease and recommend treatments; about 40% say they would feel comfortable with this.
“We have not yet gone into using ChatGPT for clinical purposes and will be very cautious with these types of applications due to concerns about inaccuracies,” Dr. Choi said.
Practice leaders reported in the MGMA poll that the most common uses of AI were nonclinical, such as:
- Patient communications, including call center answering service to help triage calls, to sort/distribute incoming fax messages, and outreach such as appointment reminders and marketing materials.
- Capturing clinical documentation, often with natural language processing or speech recognition platforms to help virtually scribe.
- Improving billing operations and predictive analytics.
Some doctors told The New York Times that ChatGPT helped them communicate with patients in a more compassionate way.
They used chatbots “to find words to break bad news and express concerns about a patient’s suffering, or to just more clearly explain medical recommendations,” the story noted.
Is regulation needed?
Some legal scholars and medical groups say that AI should be regulated to protect patients and doctors from risks, including medical errors, that could harm patients.
“It’s very important to evaluate the accuracy, safety, and privacy of language learning models (LLMs) before integrating them into the medical system. The same should be true of any new medical tool,” said Mason Marks, MD, JD, a health law professor at the Florida State University College of Law in Tallahassee.
In mid-June, the American Medical Association approved two resolutions calling for greater government oversight of AI. The AMA will develop proposed state and federal regulations and work with the federal government and other organizations to protect patients from false or misleading AI-generated medical advice.
Dr. Marks pointed to existing federal rules that apply to AI. “The Federal Trade Commission already has regulation that can potentially be used to combat unfair or deceptive trade practices associated with chatbots,” he said.
In addition, “the U.S. Food and Drug Administration can also regulate these tools, but it needs to update how it approaches risk when it comes to AI. The FDA has an outdated view of risk as physical harm, for instance, from traditional medical devices. That view of risk needs to be updated and expanded to encompass the unique harms of AI,” Dr. Marks said.
There should also be more transparency about how LLM software is used in medicine, he said. “That could be a norm implemented by the LLM developers and it could also be enforced by federal agencies. For instance, the FDA could require developers to be more transparent regarding training data and methods, and the FTC could require greater transparency regarding how consumer data might be used and opportunities to opt out of certain uses,” said Dr. Marks.
What should doctors do?
Dr. Marks advised doctors to be cautious when using ChatGPT and other LLMs, especially for medical advice. “The same would apply to any new medical tool, but we know that the current generation of LLMs [is] particularly prone to making things up, which could lead to medical errors if relied on in clinical settings,” he said.
There is also potential for breaches of patient confidentiality if doctors input clinical information. ChatGPT and OpenAI-enabled tools may not be compliant with the Health Insurance Portability and Accountability Act, which set national standards to protect individuals’ medical records and individually identifiable health information.
“The best approach is to use chatbots cautiously and with skepticism. Don’t input patient information, confirm the accuracy of information produced, and don’t use them as replacements for professional judgment,” Dr. Marks recommended.
Ms. Plested suggested that doctors who want to experiment with AI start with a low-risk tool such as appointment reminders that could save staff time and money. “I never recommend they start with something as high-stakes as coding/billing,” she said.
A version of this article appeared on Medscape.com.
When OpenAI released ChatGPT-3 publicly last November, some doctors decided to try out the free AI tool that learns language and writes human-like text. Some physicians found the chatbot made mistakes and stopped using it, while others were happy with the results and plan to use it more often.
“We’ve played around with it. It was very early on in AI and we noticed it gave us incorrect information with regards to clinical guidance,” said Monalisa Tailor, MD, an internal medicine physician at Norton Health Care in Louisville, Ky. “We decided not to pursue it further,” she said.
Orthopedic spine surgeon Daniel Choi, MD, who owns a small medical/surgical practice in Long Island, New York, tested the chatbot’s performance with a few administrative tasks, including writing a job listing for an administrator and prior authorization letters.
He was enthusiastic. “A well-polished job posting that would usually take me 2-3 hours to write was done in 5 minutes,” Dr. Choi said. “I was blown away by the writing – it was much better than anything I could write.”
The chatbot can also automate administrative tasks in doctors’ practices from appointment scheduling and billing to clinical documentation, saving doctors time and money, experts say.
Most physicians are proceeding cautiously. About 10% of more than 500 medical group leaders, responding to a March poll by the Medical Group Management Association, said their practices regularly use AI tools.
More than half of the respondents not using AI said they first want more evidence that the technology works as intended.
“None of them work as advertised,” said one respondent.
MGMA practice management consultant Dawn Plested acknowledges that many of the physician practices she’s worked with are still wary. “I have yet to encounter a practice that is using any AI tool, even something as low-risk as appointment scheduling,” she said.
Physician groups may be concerned about the costs and logistics of integrating ChatGPT with their electronic health record systems (EHRs) and how that would work, said Ms. Plested.
Doctors may also be skeptical of AI based on their experience with EHRs, she said.
“They were promoted as a panacea to many problems; they were supposed to automate business practice, reduce staff and clinician’s work, and improve billing/coding/documentation. Unfortunately, they have become a major source of frustration for doctors,” said Ms. Plested.
Drawing the line at patient care
Patients are worried about their doctors relying on AI for their care, according to a Pew Research Center poll released in February. About 60% of U.S. adults say they would feel uncomfortable if their own health care professional relied on artificial intelligence to do things like diagnose disease and recommend treatments; about 40% say they would feel comfortable with this.
“We have not yet gone into using ChatGPT for clinical purposes and will be very cautious with these types of applications due to concerns about inaccuracies,” Dr. Choi said.
Practice leaders reported in the MGMA poll that the most common uses of AI were nonclinical, such as:
- Patient communications, including call center answering service to help triage calls, to sort/distribute incoming fax messages, and outreach such as appointment reminders and marketing materials.
- Capturing clinical documentation, often with natural language processing or speech recognition platforms to help virtually scribe.
- Improving billing operations and predictive analytics.
Some doctors told The New York Times that ChatGPT helped them communicate with patients in a more compassionate way.
They used chatbots “to find words to break bad news and express concerns about a patient’s suffering, or to just more clearly explain medical recommendations,” the story noted.
Is regulation needed?
Some legal scholars and medical groups say that AI should be regulated to protect patients and doctors from risks, including medical errors, that could harm patients.
“It’s very important to evaluate the accuracy, safety, and privacy of language learning models (LLMs) before integrating them into the medical system. The same should be true of any new medical tool,” said Mason Marks, MD, JD, a health law professor at the Florida State University College of Law in Tallahassee.
In mid-June, the American Medical Association approved two resolutions calling for greater government oversight of AI. The AMA will develop proposed state and federal regulations and work with the federal government and other organizations to protect patients from false or misleading AI-generated medical advice.
Dr. Marks pointed to existing federal rules that apply to AI. “The Federal Trade Commission already has regulation that can potentially be used to combat unfair or deceptive trade practices associated with chatbots,” he said.
In addition, “the U.S. Food and Drug Administration can also regulate these tools, but it needs to update how it approaches risk when it comes to AI. The FDA has an outdated view of risk as physical harm, for instance, from traditional medical devices. That view of risk needs to be updated and expanded to encompass the unique harms of AI,” Dr. Marks said.
There should also be more transparency about how LLM software is used in medicine, he said. “That could be a norm implemented by the LLM developers and it could also be enforced by federal agencies. For instance, the FDA could require developers to be more transparent regarding training data and methods, and the FTC could require greater transparency regarding how consumer data might be used and opportunities to opt out of certain uses,” said Dr. Marks.
What should doctors do?
Dr. Marks advised doctors to be cautious when using ChatGPT and other LLMs, especially for medical advice. “The same would apply to any new medical tool, but we know that the current generation of LLMs [is] particularly prone to making things up, which could lead to medical errors if relied on in clinical settings,” he said.
There is also potential for breaches of patient confidentiality if doctors input clinical information. ChatGPT and OpenAI-enabled tools may not be compliant with the Health Insurance Portability and Accountability Act, which set national standards to protect individuals’ medical records and individually identifiable health information.
“The best approach is to use chatbots cautiously and with skepticism. Don’t input patient information, confirm the accuracy of information produced, and don’t use them as replacements for professional judgment,” Dr. Marks recommended.
Ms. Plested suggested that doctors who want to experiment with AI start with a low-risk tool such as appointment reminders that could save staff time and money. “I never recommend they start with something as high-stakes as coding/billing,” she said.
A version of this article appeared on Medscape.com.