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LAIAs safer, more effective than oral antipsychotics for schizophrenia
– and they carry no increased risk for adverse events, new research shows.
Investigators analyzed data for more than 70,000 patients with schizophrenia and found that, compared with OAs, LAIAs were associated with lower risk for hospitalizations for any cause, hospitalizations for psychiatric disorders, hospitalizations for schizophrenia, and incident suicide attempts.
Among patients treated fully with LAIAs, there were fewer hospitalizations for somatic disorders and cardiovascular diseases and less extrapyramidal symptoms (EPS), compared with those treated fully with OAs. In addition, among those for whom treatment with LAIAs was initiated early, the reduction in these outcome events was greater in comparison with patients for whom treatment was initiated later.
The results “reinforced that LAIAs were associated with a lower risk of hospitalizations, disease relapses, and suicide attempts than OAs, and this association remained during subsequent treatment periods,” wrote the investigators, led by Esther Chan, PhD, Center for Safe Medication Practice and Research, department of pharmacology and pharmacy, University of Hong Kong.
The findings were published online in JAMA Network Open.
Misclassification common
“Current clinical guidelines on the use of LAIAs are derived mainly from randomized clinical trials in which strict inclusion criteria limit generalizability,” the investigators noted. In addition, most of these trials were of “relatively short duration,” so long-term observational studies are “important to establish the safety and effectiveness of LAIAs.”
Moreover, most studies have been based on Western populations, and the findings may not be generalizable to Asian populations, which have been less studied.
Previous studies were also often subject to “misclassification of exposure,” since patients treated with LAIAs alone and those treated concurrently with LAIAs and OAs were categorized together as “LAIA” users and were compared with users of OAs alone, the researchers noted.
To investigate the long-term safety and efficacy of LAIAs, they assessed data from the Clinical Data Analysis and Reporting System, an electronic health records database of the Hong Kong Hospital Authority. They identified 70,396 patients with schizophrenia (52.8% women; mean age, 44.2 years).
The investigators used a self-controlled case series design – “within-individual comparison, based on a case-only approach” – to analyze the data. This model uses incidence rate ratios derived by “comparing the rate of outcomes between exposed and unexposed or reference periods for the same individual.” In this approach, “only people with both the exposure and the outcome are eligible.”
To be included, a patient had to have received at least one OA and LAIA and had to have had at least one outcome event during the observation period of January 2004 or the date of first schizophrenia diagnosis (whichever came later) through December 2019 or death (whichever came first).
The observation period was further subdivided into four periods: a nontreatment period, a period in which OAs were used alone, a period in which LAIAs were used alone, and a period in which a combination of OAs and LAIAs were used together.
Primary outcomes included health care use and disease relapses, such as hospitalizations for psychiatric disorders, hospitalizations for schizophrenia, and incident suicide attempt. Secondary outcomes included hospitalizations for somatic disorders, hospitalizations for cardiovascular diseases, and EPS.
LAIAs superior
Of the total study population, 23,719 patients (33.7%) were prescribed both OAs and LAIAs (mean age, 41.7 years). Of these participants, 15.4% died during the observation period.
The mean duration of follow-up was 12.5 years. The mean duration of exposure to OAs alone was 5 years; for LAIA exposure alone, 1.4 years; and for OA plus LAIA exposure, 4.4 years.
During the observation period, almost all individuals (92.8%) had one or more ED visits, and most (88.4%) had one or more hospitalizations for any psychiatric disorder. Over three-quarters (77.5%) were hospitalized for schizophrenia, and a small percentage (6.1%) had an incident suicide attempt.
Almost all patients experienced EPS (93.5%); over half (64.9%) were hospitalized for somatic disorders; and 15.6% were hospitalized for cardiovascular diseases.
After adjustment, compared with OAs, use of LAIAs was associated with a significantly lower risk for most outcomes.
There were no differences between LAIAs and OAs regarding ED visits.
The reduction in EPS suggests that LAIAs “were not associated with a higher risk of those adverse events than OAs,” the investigators write.
When the patients were stratified by initiation time of LAIAs, early initiators had 76% fewer hospitalizations for schizophrenia during LAIA vs OA treatment (IRR, 0.24; 95% confidence interval, 0.21-0 .27), while late initiators of LAIAs had 55% fewer hospitalizations for schizophrenia (IRR, 0.45; 95% CI, 0.40-0.49), “suggesting that early LAIA initiators could have greater reduction in disease relapse,” the researchers noted.
Participants with comorbid substance use had a significantly lower risk for hospitalizations for any cause, hospitalizations for psychiatric disorders, hospitalizations for schizophrenia, hospitalizations for somatic disorders, incident suicide attempts, and EPS during the time they were treated with LAIAs versus the time they were treated with OAs.
Older adults (> 65 years) treated with LAIAs had a lower risk for ED visits, hospitalizations for any cause, hospitalizations for psychiatric disorders, and hospitalizations for schizophrenia. They were not at increased risk for hospitalizations for somatic disorders or cardiovascular diseases.
There was, however, a higher risk for EPS during initial treatment with LAIAs, so “caution should be exercised when initiating LAIAs” in older individuals, the investigators wrote.
Cited study limitations include the fact that pooled estimates were used for all LAIAs, rather than for individual antipsychotics. Additionally, the dose of these antipsychotics “was not accounted for because the disease information was recorded in a different way for LAIAs and OAs.”
Proactive approach
Commenting on the study, Brittany Gouse, MD, assistant professor at Boston University School of Medicine and a psychiatrist in the wellness and recovery after psychosis program, Boston Medical Center, said the study “adds to the growing body of evidence supporting the longitudinal benefits” of LAIAs for patients with schizophrenia spectrum disorders.
“In particular, there may be a unique benefit to transitioning to long-acting injectable antipsychotics within the first 2 years of illness,” said Dr. Gouse, who coauthored an accompanying editorial and was not involved with the research.
She also called the study “important,” because it suggests that early initiation of LAIAs “may serve as an important tool to reduce morbidity and bridge the premature mortality gap in schizophrenia.”
Dr. Gouse emphasized the importance of prioritizing “tertiary prevention” right from the onset of psychotic illness.
“Clinicians must take a proactive approach and include long-acting antipsychotics in shared decision-making conversations with patients within the first few years of illness,” she said.
The study was funded by the Excellent Young Scientists Fund of the National Natural Science Foundation of China. Dr. Chan received grants from the National Natural Science Foundation of China during the conduct of the study; nonfinancial support from the Wellcome Trust; grants from the Research Grants Council, the Research Fund Secretariat of the Food and Health Bureau, the National Health and Medical Research Council (Australia), the narcotics division of the Security Bureau of Hong Kong SAR, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Janssen, Pfizer, Takeda, and Novartis; and personal fees from Pfizer, Novartis, and the Hong Kong SAR Hospital Authority outside the submitted work. The editorialists reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
– and they carry no increased risk for adverse events, new research shows.
Investigators analyzed data for more than 70,000 patients with schizophrenia and found that, compared with OAs, LAIAs were associated with lower risk for hospitalizations for any cause, hospitalizations for psychiatric disorders, hospitalizations for schizophrenia, and incident suicide attempts.
Among patients treated fully with LAIAs, there were fewer hospitalizations for somatic disorders and cardiovascular diseases and less extrapyramidal symptoms (EPS), compared with those treated fully with OAs. In addition, among those for whom treatment with LAIAs was initiated early, the reduction in these outcome events was greater in comparison with patients for whom treatment was initiated later.
The results “reinforced that LAIAs were associated with a lower risk of hospitalizations, disease relapses, and suicide attempts than OAs, and this association remained during subsequent treatment periods,” wrote the investigators, led by Esther Chan, PhD, Center for Safe Medication Practice and Research, department of pharmacology and pharmacy, University of Hong Kong.
The findings were published online in JAMA Network Open.
Misclassification common
“Current clinical guidelines on the use of LAIAs are derived mainly from randomized clinical trials in which strict inclusion criteria limit generalizability,” the investigators noted. In addition, most of these trials were of “relatively short duration,” so long-term observational studies are “important to establish the safety and effectiveness of LAIAs.”
Moreover, most studies have been based on Western populations, and the findings may not be generalizable to Asian populations, which have been less studied.
Previous studies were also often subject to “misclassification of exposure,” since patients treated with LAIAs alone and those treated concurrently with LAIAs and OAs were categorized together as “LAIA” users and were compared with users of OAs alone, the researchers noted.
To investigate the long-term safety and efficacy of LAIAs, they assessed data from the Clinical Data Analysis and Reporting System, an electronic health records database of the Hong Kong Hospital Authority. They identified 70,396 patients with schizophrenia (52.8% women; mean age, 44.2 years).
The investigators used a self-controlled case series design – “within-individual comparison, based on a case-only approach” – to analyze the data. This model uses incidence rate ratios derived by “comparing the rate of outcomes between exposed and unexposed or reference periods for the same individual.” In this approach, “only people with both the exposure and the outcome are eligible.”
To be included, a patient had to have received at least one OA and LAIA and had to have had at least one outcome event during the observation period of January 2004 or the date of first schizophrenia diagnosis (whichever came later) through December 2019 or death (whichever came first).
The observation period was further subdivided into four periods: a nontreatment period, a period in which OAs were used alone, a period in which LAIAs were used alone, and a period in which a combination of OAs and LAIAs were used together.
Primary outcomes included health care use and disease relapses, such as hospitalizations for psychiatric disorders, hospitalizations for schizophrenia, and incident suicide attempt. Secondary outcomes included hospitalizations for somatic disorders, hospitalizations for cardiovascular diseases, and EPS.
LAIAs superior
Of the total study population, 23,719 patients (33.7%) were prescribed both OAs and LAIAs (mean age, 41.7 years). Of these participants, 15.4% died during the observation period.
The mean duration of follow-up was 12.5 years. The mean duration of exposure to OAs alone was 5 years; for LAIA exposure alone, 1.4 years; and for OA plus LAIA exposure, 4.4 years.
During the observation period, almost all individuals (92.8%) had one or more ED visits, and most (88.4%) had one or more hospitalizations for any psychiatric disorder. Over three-quarters (77.5%) were hospitalized for schizophrenia, and a small percentage (6.1%) had an incident suicide attempt.
Almost all patients experienced EPS (93.5%); over half (64.9%) were hospitalized for somatic disorders; and 15.6% were hospitalized for cardiovascular diseases.
After adjustment, compared with OAs, use of LAIAs was associated with a significantly lower risk for most outcomes.
There were no differences between LAIAs and OAs regarding ED visits.
The reduction in EPS suggests that LAIAs “were not associated with a higher risk of those adverse events than OAs,” the investigators write.
When the patients were stratified by initiation time of LAIAs, early initiators had 76% fewer hospitalizations for schizophrenia during LAIA vs OA treatment (IRR, 0.24; 95% confidence interval, 0.21-0 .27), while late initiators of LAIAs had 55% fewer hospitalizations for schizophrenia (IRR, 0.45; 95% CI, 0.40-0.49), “suggesting that early LAIA initiators could have greater reduction in disease relapse,” the researchers noted.
Participants with comorbid substance use had a significantly lower risk for hospitalizations for any cause, hospitalizations for psychiatric disorders, hospitalizations for schizophrenia, hospitalizations for somatic disorders, incident suicide attempts, and EPS during the time they were treated with LAIAs versus the time they were treated with OAs.
Older adults (> 65 years) treated with LAIAs had a lower risk for ED visits, hospitalizations for any cause, hospitalizations for psychiatric disorders, and hospitalizations for schizophrenia. They were not at increased risk for hospitalizations for somatic disorders or cardiovascular diseases.
There was, however, a higher risk for EPS during initial treatment with LAIAs, so “caution should be exercised when initiating LAIAs” in older individuals, the investigators wrote.
Cited study limitations include the fact that pooled estimates were used for all LAIAs, rather than for individual antipsychotics. Additionally, the dose of these antipsychotics “was not accounted for because the disease information was recorded in a different way for LAIAs and OAs.”
Proactive approach
Commenting on the study, Brittany Gouse, MD, assistant professor at Boston University School of Medicine and a psychiatrist in the wellness and recovery after psychosis program, Boston Medical Center, said the study “adds to the growing body of evidence supporting the longitudinal benefits” of LAIAs for patients with schizophrenia spectrum disorders.
“In particular, there may be a unique benefit to transitioning to long-acting injectable antipsychotics within the first 2 years of illness,” said Dr. Gouse, who coauthored an accompanying editorial and was not involved with the research.
She also called the study “important,” because it suggests that early initiation of LAIAs “may serve as an important tool to reduce morbidity and bridge the premature mortality gap in schizophrenia.”
Dr. Gouse emphasized the importance of prioritizing “tertiary prevention” right from the onset of psychotic illness.
“Clinicians must take a proactive approach and include long-acting antipsychotics in shared decision-making conversations with patients within the first few years of illness,” she said.
The study was funded by the Excellent Young Scientists Fund of the National Natural Science Foundation of China. Dr. Chan received grants from the National Natural Science Foundation of China during the conduct of the study; nonfinancial support from the Wellcome Trust; grants from the Research Grants Council, the Research Fund Secretariat of the Food and Health Bureau, the National Health and Medical Research Council (Australia), the narcotics division of the Security Bureau of Hong Kong SAR, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Janssen, Pfizer, Takeda, and Novartis; and personal fees from Pfizer, Novartis, and the Hong Kong SAR Hospital Authority outside the submitted work. The editorialists reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
– and they carry no increased risk for adverse events, new research shows.
Investigators analyzed data for more than 70,000 patients with schizophrenia and found that, compared with OAs, LAIAs were associated with lower risk for hospitalizations for any cause, hospitalizations for psychiatric disorders, hospitalizations for schizophrenia, and incident suicide attempts.
Among patients treated fully with LAIAs, there were fewer hospitalizations for somatic disorders and cardiovascular diseases and less extrapyramidal symptoms (EPS), compared with those treated fully with OAs. In addition, among those for whom treatment with LAIAs was initiated early, the reduction in these outcome events was greater in comparison with patients for whom treatment was initiated later.
The results “reinforced that LAIAs were associated with a lower risk of hospitalizations, disease relapses, and suicide attempts than OAs, and this association remained during subsequent treatment periods,” wrote the investigators, led by Esther Chan, PhD, Center for Safe Medication Practice and Research, department of pharmacology and pharmacy, University of Hong Kong.
The findings were published online in JAMA Network Open.
Misclassification common
“Current clinical guidelines on the use of LAIAs are derived mainly from randomized clinical trials in which strict inclusion criteria limit generalizability,” the investigators noted. In addition, most of these trials were of “relatively short duration,” so long-term observational studies are “important to establish the safety and effectiveness of LAIAs.”
Moreover, most studies have been based on Western populations, and the findings may not be generalizable to Asian populations, which have been less studied.
Previous studies were also often subject to “misclassification of exposure,” since patients treated with LAIAs alone and those treated concurrently with LAIAs and OAs were categorized together as “LAIA” users and were compared with users of OAs alone, the researchers noted.
To investigate the long-term safety and efficacy of LAIAs, they assessed data from the Clinical Data Analysis and Reporting System, an electronic health records database of the Hong Kong Hospital Authority. They identified 70,396 patients with schizophrenia (52.8% women; mean age, 44.2 years).
The investigators used a self-controlled case series design – “within-individual comparison, based on a case-only approach” – to analyze the data. This model uses incidence rate ratios derived by “comparing the rate of outcomes between exposed and unexposed or reference periods for the same individual.” In this approach, “only people with both the exposure and the outcome are eligible.”
To be included, a patient had to have received at least one OA and LAIA and had to have had at least one outcome event during the observation period of January 2004 or the date of first schizophrenia diagnosis (whichever came later) through December 2019 or death (whichever came first).
The observation period was further subdivided into four periods: a nontreatment period, a period in which OAs were used alone, a period in which LAIAs were used alone, and a period in which a combination of OAs and LAIAs were used together.
Primary outcomes included health care use and disease relapses, such as hospitalizations for psychiatric disorders, hospitalizations for schizophrenia, and incident suicide attempt. Secondary outcomes included hospitalizations for somatic disorders, hospitalizations for cardiovascular diseases, and EPS.
LAIAs superior
Of the total study population, 23,719 patients (33.7%) were prescribed both OAs and LAIAs (mean age, 41.7 years). Of these participants, 15.4% died during the observation period.
The mean duration of follow-up was 12.5 years. The mean duration of exposure to OAs alone was 5 years; for LAIA exposure alone, 1.4 years; and for OA plus LAIA exposure, 4.4 years.
During the observation period, almost all individuals (92.8%) had one or more ED visits, and most (88.4%) had one or more hospitalizations for any psychiatric disorder. Over three-quarters (77.5%) were hospitalized for schizophrenia, and a small percentage (6.1%) had an incident suicide attempt.
Almost all patients experienced EPS (93.5%); over half (64.9%) were hospitalized for somatic disorders; and 15.6% were hospitalized for cardiovascular diseases.
After adjustment, compared with OAs, use of LAIAs was associated with a significantly lower risk for most outcomes.
There were no differences between LAIAs and OAs regarding ED visits.
The reduction in EPS suggests that LAIAs “were not associated with a higher risk of those adverse events than OAs,” the investigators write.
When the patients were stratified by initiation time of LAIAs, early initiators had 76% fewer hospitalizations for schizophrenia during LAIA vs OA treatment (IRR, 0.24; 95% confidence interval, 0.21-0 .27), while late initiators of LAIAs had 55% fewer hospitalizations for schizophrenia (IRR, 0.45; 95% CI, 0.40-0.49), “suggesting that early LAIA initiators could have greater reduction in disease relapse,” the researchers noted.
Participants with comorbid substance use had a significantly lower risk for hospitalizations for any cause, hospitalizations for psychiatric disorders, hospitalizations for schizophrenia, hospitalizations for somatic disorders, incident suicide attempts, and EPS during the time they were treated with LAIAs versus the time they were treated with OAs.
Older adults (> 65 years) treated with LAIAs had a lower risk for ED visits, hospitalizations for any cause, hospitalizations for psychiatric disorders, and hospitalizations for schizophrenia. They were not at increased risk for hospitalizations for somatic disorders or cardiovascular diseases.
There was, however, a higher risk for EPS during initial treatment with LAIAs, so “caution should be exercised when initiating LAIAs” in older individuals, the investigators wrote.
Cited study limitations include the fact that pooled estimates were used for all LAIAs, rather than for individual antipsychotics. Additionally, the dose of these antipsychotics “was not accounted for because the disease information was recorded in a different way for LAIAs and OAs.”
Proactive approach
Commenting on the study, Brittany Gouse, MD, assistant professor at Boston University School of Medicine and a psychiatrist in the wellness and recovery after psychosis program, Boston Medical Center, said the study “adds to the growing body of evidence supporting the longitudinal benefits” of LAIAs for patients with schizophrenia spectrum disorders.
“In particular, there may be a unique benefit to transitioning to long-acting injectable antipsychotics within the first 2 years of illness,” said Dr. Gouse, who coauthored an accompanying editorial and was not involved with the research.
She also called the study “important,” because it suggests that early initiation of LAIAs “may serve as an important tool to reduce morbidity and bridge the premature mortality gap in schizophrenia.”
Dr. Gouse emphasized the importance of prioritizing “tertiary prevention” right from the onset of psychotic illness.
“Clinicians must take a proactive approach and include long-acting antipsychotics in shared decision-making conversations with patients within the first few years of illness,” she said.
The study was funded by the Excellent Young Scientists Fund of the National Natural Science Foundation of China. Dr. Chan received grants from the National Natural Science Foundation of China during the conduct of the study; nonfinancial support from the Wellcome Trust; grants from the Research Grants Council, the Research Fund Secretariat of the Food and Health Bureau, the National Health and Medical Research Council (Australia), the narcotics division of the Security Bureau of Hong Kong SAR, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Janssen, Pfizer, Takeda, and Novartis; and personal fees from Pfizer, Novartis, and the Hong Kong SAR Hospital Authority outside the submitted work. The editorialists reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
NYC switching children’s COVID vaccine sites to monkeypox
The city health department said demand for children’s COVID vaccines had been on the downswing at the clinics, which opened in late June. Meanwhile, monkeypox cases have increased, with the city declaring it a public health emergency July 30.
“We always planned to transition vaccination for very young children to providers,” the city’s health department said in a statement, according to Spectrum News NY1. “Due to the ongoing monkeypox emergency, we transitioned some of these sites to administer monkeypox vaccine.”
All the COVID vaccine sites for children will close by Aug. 14, Spectrum News NY1 said. It’s unclear if the other sites will transition to monkeypox vaccine.
No appointments for children’s COVID vaccinations had to be canceled, the city said. The plan is that children now needing the COVID vaccine can go to doctors, pharmacies, or the health department clinics.
Manhattan City Councilwoman Gale Brewer urged the health department to keep the kids’ COVID vaccine sites open through the fall.
“I strongly urge you to maintain these family-friendly sites, at least until mid-September so that children who are going to day care and school can get vaccinated,” Brewer wrote. City schools open Sept. 8
Ms. Brewer noted that the city-run sites administered the Moderna vaccines, while many doctors and neighborhood health clinics use the Pfizer vaccine. That could be a problem for a child that had not finished the Moderna regimen or for families that prefer Moderna.
According to the city health department, 2,130 people in New York City had tested positive for monkeypox as of Aug. 12.
On Friday, the city announced 9,000 additional monkeypox vaccines would be made available the morning of Aug. 13.
A version of this article first appeared on WebMD.com.
The city health department said demand for children’s COVID vaccines had been on the downswing at the clinics, which opened in late June. Meanwhile, monkeypox cases have increased, with the city declaring it a public health emergency July 30.
“We always planned to transition vaccination for very young children to providers,” the city’s health department said in a statement, according to Spectrum News NY1. “Due to the ongoing monkeypox emergency, we transitioned some of these sites to administer monkeypox vaccine.”
All the COVID vaccine sites for children will close by Aug. 14, Spectrum News NY1 said. It’s unclear if the other sites will transition to monkeypox vaccine.
No appointments for children’s COVID vaccinations had to be canceled, the city said. The plan is that children now needing the COVID vaccine can go to doctors, pharmacies, or the health department clinics.
Manhattan City Councilwoman Gale Brewer urged the health department to keep the kids’ COVID vaccine sites open through the fall.
“I strongly urge you to maintain these family-friendly sites, at least until mid-September so that children who are going to day care and school can get vaccinated,” Brewer wrote. City schools open Sept. 8
Ms. Brewer noted that the city-run sites administered the Moderna vaccines, while many doctors and neighborhood health clinics use the Pfizer vaccine. That could be a problem for a child that had not finished the Moderna regimen or for families that prefer Moderna.
According to the city health department, 2,130 people in New York City had tested positive for monkeypox as of Aug. 12.
On Friday, the city announced 9,000 additional monkeypox vaccines would be made available the morning of Aug. 13.
A version of this article first appeared on WebMD.com.
The city health department said demand for children’s COVID vaccines had been on the downswing at the clinics, which opened in late June. Meanwhile, monkeypox cases have increased, with the city declaring it a public health emergency July 30.
“We always planned to transition vaccination for very young children to providers,” the city’s health department said in a statement, according to Spectrum News NY1. “Due to the ongoing monkeypox emergency, we transitioned some of these sites to administer monkeypox vaccine.”
All the COVID vaccine sites for children will close by Aug. 14, Spectrum News NY1 said. It’s unclear if the other sites will transition to monkeypox vaccine.
No appointments for children’s COVID vaccinations had to be canceled, the city said. The plan is that children now needing the COVID vaccine can go to doctors, pharmacies, or the health department clinics.
Manhattan City Councilwoman Gale Brewer urged the health department to keep the kids’ COVID vaccine sites open through the fall.
“I strongly urge you to maintain these family-friendly sites, at least until mid-September so that children who are going to day care and school can get vaccinated,” Brewer wrote. City schools open Sept. 8
Ms. Brewer noted that the city-run sites administered the Moderna vaccines, while many doctors and neighborhood health clinics use the Pfizer vaccine. That could be a problem for a child that had not finished the Moderna regimen or for families that prefer Moderna.
According to the city health department, 2,130 people in New York City had tested positive for monkeypox as of Aug. 12.
On Friday, the city announced 9,000 additional monkeypox vaccines would be made available the morning of Aug. 13.
A version of this article first appeared on WebMD.com.
Women are underrepresented on rheumatology journal editorial boards
Only 21% of rheumatology journals showed gender-balanced editorial boards, defined as 40%-60% women members, based on data from 34 publications.
Women remain underrepresented on the editorial boards of medical journals in general, and rheumatology journals are no exception, according to Pavel V. Ovseiko, DPhil, of the University of Oxford (England) and colleagues.
“Gender representation on editorial boards matters because editorships-in-chief and editorial board memberships are prestigious roles that increase the visibility of role-holders and provide opportunities to influence research and practice through agenda setting, editorial decision making, and peer review,” the researchers wrote.
In a study published in The Lancet Rheumatology, the researchers examined the websites of 34 rheumatology publications in December 2021. The gender of the board members was estimated using a name-to-gender inference platform and checked against personal pronouns and photos used online.
Overall, six journals (15%) had female editors-in-chief or the equivalent, and 27% of the total editorial board members were women.
Occupation had a significant impact on gender representation. Gender was equally balanced (50%) for the four journals in which a publishing professional served as editor-in-chief, and women comprised 74% of the editorial board memberships held by publishing professionals.
However, women comprised only 11% of editorships and 26% of editorial board memberships held by academics or clinicians.
“Although academic rheumatology is male-dominated, academic publishing is female-dominated,” the researchers wrote.
Gender equity is important for rheumatology in part because most rheumatology patients are women, and the proportion of women in rheumatology is increasing in many countries, the researchers noted.
“Greater diversity on editorial boards is likely to have a positive effect on the quality of science through adequate consideration and reporting of sex-related and gender-related variables,” they said.
The seven journals with gender-balanced editorial boards were Acta Reumatologica Portuguesa, Arthritis & Rheumatology, Arthritis Care & Research, The Lancet Rheumatology, Lupus Science & Medicine, Nature Reviews Rheumatology, and Seminars in Arthritis and Rheumatism.
To achieve gender balance and diversity on editorial boards, the researchers offered strategies including advertising openings through open calls, establishing and monitoring gender diversity targets, and limiting editorial board appointments to fixed terms.
The study received no outside funding. The researchers had no financial conflicts to disclose, but several serve on the editorial boards of various rheumatology journals.
Only 21% of rheumatology journals showed gender-balanced editorial boards, defined as 40%-60% women members, based on data from 34 publications.
Women remain underrepresented on the editorial boards of medical journals in general, and rheumatology journals are no exception, according to Pavel V. Ovseiko, DPhil, of the University of Oxford (England) and colleagues.
“Gender representation on editorial boards matters because editorships-in-chief and editorial board memberships are prestigious roles that increase the visibility of role-holders and provide opportunities to influence research and practice through agenda setting, editorial decision making, and peer review,” the researchers wrote.
In a study published in The Lancet Rheumatology, the researchers examined the websites of 34 rheumatology publications in December 2021. The gender of the board members was estimated using a name-to-gender inference platform and checked against personal pronouns and photos used online.
Overall, six journals (15%) had female editors-in-chief or the equivalent, and 27% of the total editorial board members were women.
Occupation had a significant impact on gender representation. Gender was equally balanced (50%) for the four journals in which a publishing professional served as editor-in-chief, and women comprised 74% of the editorial board memberships held by publishing professionals.
However, women comprised only 11% of editorships and 26% of editorial board memberships held by academics or clinicians.
“Although academic rheumatology is male-dominated, academic publishing is female-dominated,” the researchers wrote.
Gender equity is important for rheumatology in part because most rheumatology patients are women, and the proportion of women in rheumatology is increasing in many countries, the researchers noted.
“Greater diversity on editorial boards is likely to have a positive effect on the quality of science through adequate consideration and reporting of sex-related and gender-related variables,” they said.
The seven journals with gender-balanced editorial boards were Acta Reumatologica Portuguesa, Arthritis & Rheumatology, Arthritis Care & Research, The Lancet Rheumatology, Lupus Science & Medicine, Nature Reviews Rheumatology, and Seminars in Arthritis and Rheumatism.
To achieve gender balance and diversity on editorial boards, the researchers offered strategies including advertising openings through open calls, establishing and monitoring gender diversity targets, and limiting editorial board appointments to fixed terms.
The study received no outside funding. The researchers had no financial conflicts to disclose, but several serve on the editorial boards of various rheumatology journals.
Only 21% of rheumatology journals showed gender-balanced editorial boards, defined as 40%-60% women members, based on data from 34 publications.
Women remain underrepresented on the editorial boards of medical journals in general, and rheumatology journals are no exception, according to Pavel V. Ovseiko, DPhil, of the University of Oxford (England) and colleagues.
“Gender representation on editorial boards matters because editorships-in-chief and editorial board memberships are prestigious roles that increase the visibility of role-holders and provide opportunities to influence research and practice through agenda setting, editorial decision making, and peer review,” the researchers wrote.
In a study published in The Lancet Rheumatology, the researchers examined the websites of 34 rheumatology publications in December 2021. The gender of the board members was estimated using a name-to-gender inference platform and checked against personal pronouns and photos used online.
Overall, six journals (15%) had female editors-in-chief or the equivalent, and 27% of the total editorial board members were women.
Occupation had a significant impact on gender representation. Gender was equally balanced (50%) for the four journals in which a publishing professional served as editor-in-chief, and women comprised 74% of the editorial board memberships held by publishing professionals.
However, women comprised only 11% of editorships and 26% of editorial board memberships held by academics or clinicians.
“Although academic rheumatology is male-dominated, academic publishing is female-dominated,” the researchers wrote.
Gender equity is important for rheumatology in part because most rheumatology patients are women, and the proportion of women in rheumatology is increasing in many countries, the researchers noted.
“Greater diversity on editorial boards is likely to have a positive effect on the quality of science through adequate consideration and reporting of sex-related and gender-related variables,” they said.
The seven journals with gender-balanced editorial boards were Acta Reumatologica Portuguesa, Arthritis & Rheumatology, Arthritis Care & Research, The Lancet Rheumatology, Lupus Science & Medicine, Nature Reviews Rheumatology, and Seminars in Arthritis and Rheumatism.
To achieve gender balance and diversity on editorial boards, the researchers offered strategies including advertising openings through open calls, establishing and monitoring gender diversity targets, and limiting editorial board appointments to fixed terms.
The study received no outside funding. The researchers had no financial conflicts to disclose, but several serve on the editorial boards of various rheumatology journals.
FROM THE LANCET RHEUMATOLOGY
Seniors intend to receive variant-specific COVID booster in coming months
of 2022.
That finding comes from a new poll by researchers at the University of Michigan, Ann Arbor, who also report that when it comes to the shots, people appear to be putting more trust in their health care professionals than in public health authorities.
“When you are a doctor, you are a trusted source of medical information,” said Preeti Malani, MD, MSJ, an infectious disease specialist at the University of Michigan. “Use the ongoing conversation with your patient as an opportunity to answer their questions and counter any confusion.”
The vaccination campaign appears to be having a rub-off effect, too. More people say they’re likely to receive vaccines and boosters for other infections, such as flu, if they have already been vaccinated and boosted against COVID-19.
Inside the poll
Dr. Malani and her colleagues, who published their findings on the National Poll on Healthy Aging’s website, asked 1,024 adults older than 50 about their attitudes on COVID-19 vaccinations and their history of receiving the injections. The questions covered topics including whether the individual had contracted COVID, COVID vaccine doses, and the prevalence of a health care clinician’s opinion on vaccines and boosters. The poll was conducted July 21-26.
The researchers chose the age range of 50-65 years because this group is an important population for new booster shots that target specific variants of the SARS-CoV-2 virus that causes COVID-19.
Only 19% of people aged 50-64 and 44% of those older than 65 said they had received both their first and second COVID-19 booster shots. What’s more, 17% of people said they had not received any doses of a COVID-19 vaccine.
The vast majority (77%) of respondents said their clinician’s recommendations were “very important” or “somewhat important” in their decision to receive the vaccine.
Dr. Malani said that in her practice, patients have expressed hesitation about COVID-19 vaccines because of concerns about the potential side effects of the shots.
Monica Gandhi, MD, MPH, professor of medicine at the University of California, San Francisco, noted that Americans now appear to trust their physicians more than public health authorities such as the U.S. Centers for Disease Control and Prevention when it comes to COVID-19.
“More people are trusting their providers’ opinions [more] than the CDC or other public health agencies. That speaks volumes to me,” Dr. Gandhi said.
Among the more surprising findings of the poll, according to the researchers, was the number of people who said they had yet to contract COVID-19: 50% of those aged 50-64, and 69% of those older than 65. (Another 12% of those aged 50-64 said they were unsure if they’d ever had the infection.)
Dr. Malani said she hoped future studies would explore in depth the people who remain uninfected with COVID-19.
“We focus a lot on the science of COVID,” she said. “But we need to turn our attention to the behavioral aspects and how to address them.”
A version of this article first appeared on Medscape.com.
of 2022.
That finding comes from a new poll by researchers at the University of Michigan, Ann Arbor, who also report that when it comes to the shots, people appear to be putting more trust in their health care professionals than in public health authorities.
“When you are a doctor, you are a trusted source of medical information,” said Preeti Malani, MD, MSJ, an infectious disease specialist at the University of Michigan. “Use the ongoing conversation with your patient as an opportunity to answer their questions and counter any confusion.”
The vaccination campaign appears to be having a rub-off effect, too. More people say they’re likely to receive vaccines and boosters for other infections, such as flu, if they have already been vaccinated and boosted against COVID-19.
Inside the poll
Dr. Malani and her colleagues, who published their findings on the National Poll on Healthy Aging’s website, asked 1,024 adults older than 50 about their attitudes on COVID-19 vaccinations and their history of receiving the injections. The questions covered topics including whether the individual had contracted COVID, COVID vaccine doses, and the prevalence of a health care clinician’s opinion on vaccines and boosters. The poll was conducted July 21-26.
The researchers chose the age range of 50-65 years because this group is an important population for new booster shots that target specific variants of the SARS-CoV-2 virus that causes COVID-19.
Only 19% of people aged 50-64 and 44% of those older than 65 said they had received both their first and second COVID-19 booster shots. What’s more, 17% of people said they had not received any doses of a COVID-19 vaccine.
The vast majority (77%) of respondents said their clinician’s recommendations were “very important” or “somewhat important” in their decision to receive the vaccine.
Dr. Malani said that in her practice, patients have expressed hesitation about COVID-19 vaccines because of concerns about the potential side effects of the shots.
Monica Gandhi, MD, MPH, professor of medicine at the University of California, San Francisco, noted that Americans now appear to trust their physicians more than public health authorities such as the U.S. Centers for Disease Control and Prevention when it comes to COVID-19.
“More people are trusting their providers’ opinions [more] than the CDC or other public health agencies. That speaks volumes to me,” Dr. Gandhi said.
Among the more surprising findings of the poll, according to the researchers, was the number of people who said they had yet to contract COVID-19: 50% of those aged 50-64, and 69% of those older than 65. (Another 12% of those aged 50-64 said they were unsure if they’d ever had the infection.)
Dr. Malani said she hoped future studies would explore in depth the people who remain uninfected with COVID-19.
“We focus a lot on the science of COVID,” she said. “But we need to turn our attention to the behavioral aspects and how to address them.”
A version of this article first appeared on Medscape.com.
of 2022.
That finding comes from a new poll by researchers at the University of Michigan, Ann Arbor, who also report that when it comes to the shots, people appear to be putting more trust in their health care professionals than in public health authorities.
“When you are a doctor, you are a trusted source of medical information,” said Preeti Malani, MD, MSJ, an infectious disease specialist at the University of Michigan. “Use the ongoing conversation with your patient as an opportunity to answer their questions and counter any confusion.”
The vaccination campaign appears to be having a rub-off effect, too. More people say they’re likely to receive vaccines and boosters for other infections, such as flu, if they have already been vaccinated and boosted against COVID-19.
Inside the poll
Dr. Malani and her colleagues, who published their findings on the National Poll on Healthy Aging’s website, asked 1,024 adults older than 50 about their attitudes on COVID-19 vaccinations and their history of receiving the injections. The questions covered topics including whether the individual had contracted COVID, COVID vaccine doses, and the prevalence of a health care clinician’s opinion on vaccines and boosters. The poll was conducted July 21-26.
The researchers chose the age range of 50-65 years because this group is an important population for new booster shots that target specific variants of the SARS-CoV-2 virus that causes COVID-19.
Only 19% of people aged 50-64 and 44% of those older than 65 said they had received both their first and second COVID-19 booster shots. What’s more, 17% of people said they had not received any doses of a COVID-19 vaccine.
The vast majority (77%) of respondents said their clinician’s recommendations were “very important” or “somewhat important” in their decision to receive the vaccine.
Dr. Malani said that in her practice, patients have expressed hesitation about COVID-19 vaccines because of concerns about the potential side effects of the shots.
Monica Gandhi, MD, MPH, professor of medicine at the University of California, San Francisco, noted that Americans now appear to trust their physicians more than public health authorities such as the U.S. Centers for Disease Control and Prevention when it comes to COVID-19.
“More people are trusting their providers’ opinions [more] than the CDC or other public health agencies. That speaks volumes to me,” Dr. Gandhi said.
Among the more surprising findings of the poll, according to the researchers, was the number of people who said they had yet to contract COVID-19: 50% of those aged 50-64, and 69% of those older than 65. (Another 12% of those aged 50-64 said they were unsure if they’d ever had the infection.)
Dr. Malani said she hoped future studies would explore in depth the people who remain uninfected with COVID-19.
“We focus a lot on the science of COVID,” she said. “But we need to turn our attention to the behavioral aspects and how to address them.”
A version of this article first appeared on Medscape.com.
Sexual dysfunction, hair loss linked with long COVID
according to findings of a large study.
Anuradhaa Subramanian, PhD, with the Institute of Applied Health Research at the University of Birmingham (England), led the research published online in Nature Medicine.
The team analyzed 486,149 electronic health records from adult patients with confirmed COVID in the United Kingdom, compared with 1.9 million people with no history of COVID, from January 2020 to April 2021. Researchers matched both groups closely in terms of demographic, social, and clinical traits.
New symptoms
The team identified 62 symptoms, including the well-known indicators of long COVID, such as fatigue, loss of sense of smell, shortness of breath, and brain fog, but also hair loss, sexual dysfunction, chest pain, fever, loss of control of bowel movements, and limb swelling.
“These differences in symptoms reported between the infected and uninfected groups remained even after we accounted for age, sex, ethnic group, socioeconomic status, body mass index, smoking status, the presence of more than 80 health conditions, and past reporting of the same symptom,” Dr. Subramanian and coresearcher Shamil Haroon, PhD, wrote in a summary of their research in The Conversation.
They pointed out that only 20 of the symptoms they found are included in the World Health Organization’s clinical case definition for long COVID.
They also found that people more likely to have persistent symptoms 3 months after COVID infection were also more likely to be young, female, smokers, to belong to certain minority ethnic groups, and to have lower socioeconomic status. They were also more likely to be obese and have a wide range of health conditions.
Dr. Haroon, an associate clinical professor at the University of Birmingham, said that one reason it appeared that younger people were more likely to get symptoms of long COVID may be that older adults with COVID were more likely to be hospitalized and weren’t included in this study.
“Since we only considered nonhospitalized adults, the older adults we included in our study may have been relatively healthier and thus had a lower symptom burden,” he said.
Dr. Subramania noted that older patients were more likely to report lasting COVID-related symptoms in the study, but when researchers accounted for a wide range of other conditions that patients had before infection (which generally more commonly happen in older adults), they found younger age as a risk factor for long-term COVID-related symptoms.
In the study period, most patients were unvaccinated, and results came before the widespread Delta and Omicron variants.
More than half (56.6%) of the patients infected with the virus that causes COVID had been diagnosed in 2020, and 43.4% in 2021. Less than 5% (4.5%) of the patients infected with the virus and 4.7% of the patients with no recorded evidence of a COVID infection had received at least a single dose of a COVID vaccine before the study started.
Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, said more studies need to be done to see whether results would be different with vaccination status and evolving variants.
But he noted that this study has several strengths: “The hair loss, libido loss, and ejaculation difficulty are all new symptoms,” and the study – large and carefully controlled – shows these issues were among those more likely to occur.
A loss of sense of smell – which is not a new observation – was still the most likely risk shown in the study, followed by hair loss, sneezing, ejaculation difficulty, and reduced sex drive; followed by shortness of breath, fatigue, chest pain associated with breathing difficulties, hoarseness, and fever.
Three main clusters of symptoms
Given the wide range of symptoms, long COVID likely represents a group of conditions, the authors wrote.
They found three main clusters. The largest, with roughly 80% of people with long COVID in the study, faced a broad spectrum of symptoms, ranging from fatigue to headache and pain. The second-largest group, (15%) mostly had symptoms having to do with mental health and thinking skills, including depression, anxiety, brain fog, and insomnia. The smallest group (5%) had mainly respiratory symptoms such as shortness of breath, coughing, and wheezing.
Putting symptoms in clusters will be important to start understanding what leads to long COVID, said Farha Ikramuddin, MD, a rehabilitation specialist at the University of Minnesota, Minneapolis.
She added that, while the symptoms listed in this paper are new in published research, she has certainly been seeing them over time in her long COVID clinic. (The researchers also used only coded health care data, so they were limited in what symptoms they could discover, she notes.)
Dr. Ikramuddin said a strength of the paper is its large size, but she also cautioned that it’s difficult to determine whether members of the comparison group truly had no COVID infection when the information is taken from their medical records. Often, people test at home or assume they have COVID and don’t test; therefore the information wouldn’t be recorded.
Evaluating nonhospitalized patients is also important, she said, as much of the research on long COVID has come from hospitalized patients, so little has been known about the symptoms of those with milder infections.
“Patients who have been hospitalized and have long COVID look very different from the patients who were not hospitalized,” Dr. Ikramuddin said.
One clear message from the paper, she said, is that listening and asking extensive questions about symptoms are important with patients who have had COVID.
“Counseling has also become very important for our patients in the pandemic,” she said.
It will also be important to do studies on returning to work for patients with long COVID to see how many are able to return and at what capacity, Dr. Ikramuddin said.
A version of this article first appeared on WebMD.com.
according to findings of a large study.
Anuradhaa Subramanian, PhD, with the Institute of Applied Health Research at the University of Birmingham (England), led the research published online in Nature Medicine.
The team analyzed 486,149 electronic health records from adult patients with confirmed COVID in the United Kingdom, compared with 1.9 million people with no history of COVID, from January 2020 to April 2021. Researchers matched both groups closely in terms of demographic, social, and clinical traits.
New symptoms
The team identified 62 symptoms, including the well-known indicators of long COVID, such as fatigue, loss of sense of smell, shortness of breath, and brain fog, but also hair loss, sexual dysfunction, chest pain, fever, loss of control of bowel movements, and limb swelling.
“These differences in symptoms reported between the infected and uninfected groups remained even after we accounted for age, sex, ethnic group, socioeconomic status, body mass index, smoking status, the presence of more than 80 health conditions, and past reporting of the same symptom,” Dr. Subramanian and coresearcher Shamil Haroon, PhD, wrote in a summary of their research in The Conversation.
They pointed out that only 20 of the symptoms they found are included in the World Health Organization’s clinical case definition for long COVID.
They also found that people more likely to have persistent symptoms 3 months after COVID infection were also more likely to be young, female, smokers, to belong to certain minority ethnic groups, and to have lower socioeconomic status. They were also more likely to be obese and have a wide range of health conditions.
Dr. Haroon, an associate clinical professor at the University of Birmingham, said that one reason it appeared that younger people were more likely to get symptoms of long COVID may be that older adults with COVID were more likely to be hospitalized and weren’t included in this study.
“Since we only considered nonhospitalized adults, the older adults we included in our study may have been relatively healthier and thus had a lower symptom burden,” he said.
Dr. Subramania noted that older patients were more likely to report lasting COVID-related symptoms in the study, but when researchers accounted for a wide range of other conditions that patients had before infection (which generally more commonly happen in older adults), they found younger age as a risk factor for long-term COVID-related symptoms.
In the study period, most patients were unvaccinated, and results came before the widespread Delta and Omicron variants.
More than half (56.6%) of the patients infected with the virus that causes COVID had been diagnosed in 2020, and 43.4% in 2021. Less than 5% (4.5%) of the patients infected with the virus and 4.7% of the patients with no recorded evidence of a COVID infection had received at least a single dose of a COVID vaccine before the study started.
Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, said more studies need to be done to see whether results would be different with vaccination status and evolving variants.
But he noted that this study has several strengths: “The hair loss, libido loss, and ejaculation difficulty are all new symptoms,” and the study – large and carefully controlled – shows these issues were among those more likely to occur.
A loss of sense of smell – which is not a new observation – was still the most likely risk shown in the study, followed by hair loss, sneezing, ejaculation difficulty, and reduced sex drive; followed by shortness of breath, fatigue, chest pain associated with breathing difficulties, hoarseness, and fever.
Three main clusters of symptoms
Given the wide range of symptoms, long COVID likely represents a group of conditions, the authors wrote.
They found three main clusters. The largest, with roughly 80% of people with long COVID in the study, faced a broad spectrum of symptoms, ranging from fatigue to headache and pain. The second-largest group, (15%) mostly had symptoms having to do with mental health and thinking skills, including depression, anxiety, brain fog, and insomnia. The smallest group (5%) had mainly respiratory symptoms such as shortness of breath, coughing, and wheezing.
Putting symptoms in clusters will be important to start understanding what leads to long COVID, said Farha Ikramuddin, MD, a rehabilitation specialist at the University of Minnesota, Minneapolis.
She added that, while the symptoms listed in this paper are new in published research, she has certainly been seeing them over time in her long COVID clinic. (The researchers also used only coded health care data, so they were limited in what symptoms they could discover, she notes.)
Dr. Ikramuddin said a strength of the paper is its large size, but she also cautioned that it’s difficult to determine whether members of the comparison group truly had no COVID infection when the information is taken from their medical records. Often, people test at home or assume they have COVID and don’t test; therefore the information wouldn’t be recorded.
Evaluating nonhospitalized patients is also important, she said, as much of the research on long COVID has come from hospitalized patients, so little has been known about the symptoms of those with milder infections.
“Patients who have been hospitalized and have long COVID look very different from the patients who were not hospitalized,” Dr. Ikramuddin said.
One clear message from the paper, she said, is that listening and asking extensive questions about symptoms are important with patients who have had COVID.
“Counseling has also become very important for our patients in the pandemic,” she said.
It will also be important to do studies on returning to work for patients with long COVID to see how many are able to return and at what capacity, Dr. Ikramuddin said.
A version of this article first appeared on WebMD.com.
according to findings of a large study.
Anuradhaa Subramanian, PhD, with the Institute of Applied Health Research at the University of Birmingham (England), led the research published online in Nature Medicine.
The team analyzed 486,149 electronic health records from adult patients with confirmed COVID in the United Kingdom, compared with 1.9 million people with no history of COVID, from January 2020 to April 2021. Researchers matched both groups closely in terms of demographic, social, and clinical traits.
New symptoms
The team identified 62 symptoms, including the well-known indicators of long COVID, such as fatigue, loss of sense of smell, shortness of breath, and brain fog, but also hair loss, sexual dysfunction, chest pain, fever, loss of control of bowel movements, and limb swelling.
“These differences in symptoms reported between the infected and uninfected groups remained even after we accounted for age, sex, ethnic group, socioeconomic status, body mass index, smoking status, the presence of more than 80 health conditions, and past reporting of the same symptom,” Dr. Subramanian and coresearcher Shamil Haroon, PhD, wrote in a summary of their research in The Conversation.
They pointed out that only 20 of the symptoms they found are included in the World Health Organization’s clinical case definition for long COVID.
They also found that people more likely to have persistent symptoms 3 months after COVID infection were also more likely to be young, female, smokers, to belong to certain minority ethnic groups, and to have lower socioeconomic status. They were also more likely to be obese and have a wide range of health conditions.
Dr. Haroon, an associate clinical professor at the University of Birmingham, said that one reason it appeared that younger people were more likely to get symptoms of long COVID may be that older adults with COVID were more likely to be hospitalized and weren’t included in this study.
“Since we only considered nonhospitalized adults, the older adults we included in our study may have been relatively healthier and thus had a lower symptom burden,” he said.
Dr. Subramania noted that older patients were more likely to report lasting COVID-related symptoms in the study, but when researchers accounted for a wide range of other conditions that patients had before infection (which generally more commonly happen in older adults), they found younger age as a risk factor for long-term COVID-related symptoms.
In the study period, most patients were unvaccinated, and results came before the widespread Delta and Omicron variants.
More than half (56.6%) of the patients infected with the virus that causes COVID had been diagnosed in 2020, and 43.4% in 2021. Less than 5% (4.5%) of the patients infected with the virus and 4.7% of the patients with no recorded evidence of a COVID infection had received at least a single dose of a COVID vaccine before the study started.
Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, said more studies need to be done to see whether results would be different with vaccination status and evolving variants.
But he noted that this study has several strengths: “The hair loss, libido loss, and ejaculation difficulty are all new symptoms,” and the study – large and carefully controlled – shows these issues were among those more likely to occur.
A loss of sense of smell – which is not a new observation – was still the most likely risk shown in the study, followed by hair loss, sneezing, ejaculation difficulty, and reduced sex drive; followed by shortness of breath, fatigue, chest pain associated with breathing difficulties, hoarseness, and fever.
Three main clusters of symptoms
Given the wide range of symptoms, long COVID likely represents a group of conditions, the authors wrote.
They found three main clusters. The largest, with roughly 80% of people with long COVID in the study, faced a broad spectrum of symptoms, ranging from fatigue to headache and pain. The second-largest group, (15%) mostly had symptoms having to do with mental health and thinking skills, including depression, anxiety, brain fog, and insomnia. The smallest group (5%) had mainly respiratory symptoms such as shortness of breath, coughing, and wheezing.
Putting symptoms in clusters will be important to start understanding what leads to long COVID, said Farha Ikramuddin, MD, a rehabilitation specialist at the University of Minnesota, Minneapolis.
She added that, while the symptoms listed in this paper are new in published research, she has certainly been seeing them over time in her long COVID clinic. (The researchers also used only coded health care data, so they were limited in what symptoms they could discover, she notes.)
Dr. Ikramuddin said a strength of the paper is its large size, but she also cautioned that it’s difficult to determine whether members of the comparison group truly had no COVID infection when the information is taken from their medical records. Often, people test at home or assume they have COVID and don’t test; therefore the information wouldn’t be recorded.
Evaluating nonhospitalized patients is also important, she said, as much of the research on long COVID has come from hospitalized patients, so little has been known about the symptoms of those with milder infections.
“Patients who have been hospitalized and have long COVID look very different from the patients who were not hospitalized,” Dr. Ikramuddin said.
One clear message from the paper, she said, is that listening and asking extensive questions about symptoms are important with patients who have had COVID.
“Counseling has also become very important for our patients in the pandemic,” she said.
It will also be important to do studies on returning to work for patients with long COVID to see how many are able to return and at what capacity, Dr. Ikramuddin said.
A version of this article first appeared on WebMD.com.
FROM NATURE MEDICINE
#ShowMeYourBuns: Social media outrage over nurses’ messy hair policy
Social media comic Blake Lynch, BSN, RN, known to his millions of followers as “Nurse Blake,” took to his online platforms recently to voice outrage over a Nebraska health care system’s personal appearance policy.
His posts included a screenshot explanation that was presented at a Bryan Health clinical manager meeting featuring an image of women’s hair in buns and the statement: “There is emphasis on hair being clean, neatly managed, therefore ‘no messy buns.’ “
“If you really want to make a difference, don’t worry about hair,” Mr. Lynch said in his social media posts. “Let’s talk safe staffing. Let’s talk mandatory breaks, uninterrupted breaks. Since when is hair an indication if a nurse is a good nurse or a bad nurse? ... Nurses are running around over 12 hours, sweating in patient rooms, putting on PPE, taking off PPE, saving lives, doing CPR. They don’t even have time for beaks, so what nurse is going to be worrying about what their hair looks like?”
Mr. Lynch’s video response to the statement and image attracted more than 560,000 views on Facebook. He subsequently encouraged followers to post photos of their messy buns under the hashtags #showmeyourbuns and #messybunhairday.
Mr. Lynch, who tours the country as a comedian and leads continuing nurse education programs, told this news organization he was not surprised by the reaction to his “messy buns” video. “I think this particular post got so much attention because it resonated with so many nurses,” he said.
He reiterated that
Bryan Health, based in Lincoln, Neb., responded on Twitter and in a more extensive statement to this news organization that in his “messy bun” post, Mr. Lynch misrepresented a long-standing health system policy on personal appearance and cleanliness.
The health system’s dress code policy does not mention “messy buns,” the health system stated. The policy mirrors those of other health systems and industries that try to maintain safety and sanitation, the statement continued.
The portion of the policy that sparked interest was not about securing hair but eliminating previous language pertaining to unnatural hair colors, Bryan Health stated.
The relaxed language reads: “Haircuts and colors will not be restricted, but all hair is to be clean, neatly managed, and appropriately secured out of the face. Headbands worn should be simple and professional in color or pattern.”
The health system’s statement continued: “The policy does and will continue to reference clean, neatly managed hair, appropriately secured out of the face. Appropriately secured hair is important for a number of safety reasons.”
A pediatric nurse who goes by “CB” on Twitter responded to Mr. Lynch’s post by indicating that she worked at the Nebraska hospital. “What a joke!!!” Earlier in her response, she said, “You realize most hospitals are dealing with severely understaffed units and nurse burnout. How about you worry about your staff ratios, not your nurses’ hair.”
Mr. Lynch said a nurse sent him a screenshot of “messy buns,” like other followers who send him items for discussion on his social media page. Since the post went viral, Mr. Lynch said he’s had followers inform him of how hair policies such as Bryan Health’s have targeted people of color for more than a decade. And a Nebraska health system told him they’d welcome any nurses with messy hair to offset their nursing shortage.
A version of this article first appeared on Medscape.com.
Social media comic Blake Lynch, BSN, RN, known to his millions of followers as “Nurse Blake,” took to his online platforms recently to voice outrage over a Nebraska health care system’s personal appearance policy.
His posts included a screenshot explanation that was presented at a Bryan Health clinical manager meeting featuring an image of women’s hair in buns and the statement: “There is emphasis on hair being clean, neatly managed, therefore ‘no messy buns.’ “
“If you really want to make a difference, don’t worry about hair,” Mr. Lynch said in his social media posts. “Let’s talk safe staffing. Let’s talk mandatory breaks, uninterrupted breaks. Since when is hair an indication if a nurse is a good nurse or a bad nurse? ... Nurses are running around over 12 hours, sweating in patient rooms, putting on PPE, taking off PPE, saving lives, doing CPR. They don’t even have time for beaks, so what nurse is going to be worrying about what their hair looks like?”
Mr. Lynch’s video response to the statement and image attracted more than 560,000 views on Facebook. He subsequently encouraged followers to post photos of their messy buns under the hashtags #showmeyourbuns and #messybunhairday.
Mr. Lynch, who tours the country as a comedian and leads continuing nurse education programs, told this news organization he was not surprised by the reaction to his “messy buns” video. “I think this particular post got so much attention because it resonated with so many nurses,” he said.
He reiterated that
Bryan Health, based in Lincoln, Neb., responded on Twitter and in a more extensive statement to this news organization that in his “messy bun” post, Mr. Lynch misrepresented a long-standing health system policy on personal appearance and cleanliness.
The health system’s dress code policy does not mention “messy buns,” the health system stated. The policy mirrors those of other health systems and industries that try to maintain safety and sanitation, the statement continued.
The portion of the policy that sparked interest was not about securing hair but eliminating previous language pertaining to unnatural hair colors, Bryan Health stated.
The relaxed language reads: “Haircuts and colors will not be restricted, but all hair is to be clean, neatly managed, and appropriately secured out of the face. Headbands worn should be simple and professional in color or pattern.”
The health system’s statement continued: “The policy does and will continue to reference clean, neatly managed hair, appropriately secured out of the face. Appropriately secured hair is important for a number of safety reasons.”
A pediatric nurse who goes by “CB” on Twitter responded to Mr. Lynch’s post by indicating that she worked at the Nebraska hospital. “What a joke!!!” Earlier in her response, she said, “You realize most hospitals are dealing with severely understaffed units and nurse burnout. How about you worry about your staff ratios, not your nurses’ hair.”
Mr. Lynch said a nurse sent him a screenshot of “messy buns,” like other followers who send him items for discussion on his social media page. Since the post went viral, Mr. Lynch said he’s had followers inform him of how hair policies such as Bryan Health’s have targeted people of color for more than a decade. And a Nebraska health system told him they’d welcome any nurses with messy hair to offset their nursing shortage.
A version of this article first appeared on Medscape.com.
Social media comic Blake Lynch, BSN, RN, known to his millions of followers as “Nurse Blake,” took to his online platforms recently to voice outrage over a Nebraska health care system’s personal appearance policy.
His posts included a screenshot explanation that was presented at a Bryan Health clinical manager meeting featuring an image of women’s hair in buns and the statement: “There is emphasis on hair being clean, neatly managed, therefore ‘no messy buns.’ “
“If you really want to make a difference, don’t worry about hair,” Mr. Lynch said in his social media posts. “Let’s talk safe staffing. Let’s talk mandatory breaks, uninterrupted breaks. Since when is hair an indication if a nurse is a good nurse or a bad nurse? ... Nurses are running around over 12 hours, sweating in patient rooms, putting on PPE, taking off PPE, saving lives, doing CPR. They don’t even have time for beaks, so what nurse is going to be worrying about what their hair looks like?”
Mr. Lynch’s video response to the statement and image attracted more than 560,000 views on Facebook. He subsequently encouraged followers to post photos of their messy buns under the hashtags #showmeyourbuns and #messybunhairday.
Mr. Lynch, who tours the country as a comedian and leads continuing nurse education programs, told this news organization he was not surprised by the reaction to his “messy buns” video. “I think this particular post got so much attention because it resonated with so many nurses,” he said.
He reiterated that
Bryan Health, based in Lincoln, Neb., responded on Twitter and in a more extensive statement to this news organization that in his “messy bun” post, Mr. Lynch misrepresented a long-standing health system policy on personal appearance and cleanliness.
The health system’s dress code policy does not mention “messy buns,” the health system stated. The policy mirrors those of other health systems and industries that try to maintain safety and sanitation, the statement continued.
The portion of the policy that sparked interest was not about securing hair but eliminating previous language pertaining to unnatural hair colors, Bryan Health stated.
The relaxed language reads: “Haircuts and colors will not be restricted, but all hair is to be clean, neatly managed, and appropriately secured out of the face. Headbands worn should be simple and professional in color or pattern.”
The health system’s statement continued: “The policy does and will continue to reference clean, neatly managed hair, appropriately secured out of the face. Appropriately secured hair is important for a number of safety reasons.”
A pediatric nurse who goes by “CB” on Twitter responded to Mr. Lynch’s post by indicating that she worked at the Nebraska hospital. “What a joke!!!” Earlier in her response, she said, “You realize most hospitals are dealing with severely understaffed units and nurse burnout. How about you worry about your staff ratios, not your nurses’ hair.”
Mr. Lynch said a nurse sent him a screenshot of “messy buns,” like other followers who send him items for discussion on his social media page. Since the post went viral, Mr. Lynch said he’s had followers inform him of how hair policies such as Bryan Health’s have targeted people of color for more than a decade. And a Nebraska health system told him they’d welcome any nurses with messy hair to offset their nursing shortage.
A version of this article first appeared on Medscape.com.
Should you sell your practice to a private equity firm?
More and more physicians are being wooed by private equity firms that want to buy their practices. The total value of private equity deals in health care in 2019 is estimated at about $120 billion, and it’s expected to grow over the coming years.
While the potential profit may seem alluring, physicians have mixed feelings as to whether this will be a boon or a disappointment.
Angelo Falcone, MD, a former emergency physician in Rockville, Md., found that a private equity investment transformed his career path.
For 19 years, Dr. Falcone was CEO of an emergency medicine group with 35 partners that staffed 10 emergency departments, mostly in Maryland. “We were a pretty small operation looking to get bigger, but to do that would require a substantial investment,” he said.
In 2015, after checking out all their options, the partners decided to sell to US Acute Care Solutions (USACS), a new private equity company founded by Welsh, Carson, Anderson & Stowe, an investment firm in New York. Private equity can be used to expand practices and pay for new equipment. Dr. Falcone, serving as a USACS board member and its operational president, helped spur the company’s astounding growth. Today, USACS has about 5,000 physicians and other clinicians operating in 30 states.
In 2019, Dr. Falcone stepped down from his management post at USACS, took training in integrative medicine, and 2 years later opened a solo integrative medicine practice in Rockville. The new practice, which operates on a concierge model, is not connected with USACS, but Dr, Falcone still sits on the USACS board.
“I had a great experience at USACS. I believe in the power of private equity to support our patients and physicians,” Dr. Falcone said. “Now, at age 58, I have a second career in integrative medicine.”
Private equity is still controversial
David Fleeger, MD, has a different opinion of private equity. “I get offers from private equity firms fairly often, but I’m not seriously interested,” said Dr. Fleeger, a surgeon with Central Texas Colon and Rectal Surgeons in Austin.
“We don’t want to sell to anybody; we want to control our destiny,” he said. “We don’t have to borrow money or repay loans, and we don’t expect to get a windfall for the practice. The profits in medicine are too narrow for that to be realistic. There is no free lunch.”
Some of the doctors who sign up for private equity deals become dissatisfied and want to end the arrangement, according to John Pinto, an ophthalmic practice management consultant in San Diego.
“I get calls about once a month from doctors who want to get out of a private equity deal or revise the terms,” he said. “Some complaints are that the PE firm was too tight with the budget, wouldn’t hire needed staff, mismanaged operations, or otherwise mishandled their investment in the practice.”
It’s difficult for disgruntled physicians to exit a private equity deal, Mr. Pinto said. They commonly have to give up part of the payment they had received for their practice if they leave prematurely, and depending on the jurisdiction, stiff noncompete clauses in their contract won’t allow them to practice nearby.
Disillusioned physicians – and even many physicians who had good experiences with private equity – usually don’t want to air their complaints in public. One reason most of these doctors keep silent is that they have signed nondisclosure and nondisparagement agreements that are part of most private equity deals.
The private equity proposition
Private equity firms typically pay a great deal more for practices than hospitals or even many large private practices, according to James D. Wall, an attorney in Winston-Salem, N.C., who has handled many private equity deals. Mr. Wall said private equity often organizes physicians around one specialty. One advantage these physicians have over hospital-employed physicians is that they aren’t under pressure to refer within a network.
Private equity companies set values for practices on the basis of their earnings before interest, taxes, depreciation, and amortization (EBITDA), said Howard Bogard, an attorney with Burr & Forman in Raleigh, N.C., who has handled many deals. Mr. Bogard said the amount physicians are paid is usually between 4 and 12 times’ EBITDA, so if your practice is earning $1 million a year in EBITDA, you would get $4 million to $12 million for it.
Of the total price tag, “Doctors get a hefty immediate payment when they sell,” Mr. Bogard said. “It might be 70% of the purchase price up front, and the 30% left over is equity in the buyer. The private equity firm then sells the practice 5-7 years later, and at that time, the physician’s equity is converted to cash and equity in the new buyer, often at the same 70/30 ratio. The idea is to keep the doctor interested in staying.”
Private equity firms expand practices to receive more favorable reimbursements and achieve economies of scale, according to Jane Zhu, MD, an assistant professor of medicine at Oregon Health & Science University, Portland, who has studied the phenomenon. Dr. Zhu said these firms may enhance profits by contracting with Medicare Advantage plans, joining accountable care organizations (ACOs), having their physicians work longer hours, and using advanced-practice clinicians instead of physicians.
“They want to make a large return in the order of 20% per year over several years, but they don’t want to strip the practice of value, because they’ll need to sell it to a new investor,” Dr. Zhu said.
When doctors sell to a private equity firm, they become employees and often have to take a pay cut, but their pay may rise again as new efficiencies are instituted. This occurred for partners in Minnesota Eye Consultants (MEC), an 11-member ophthalmology practice in Bloomington, Minn., that helped found Unifeye Vision Partners (UVP), a private equity company financed by Chicago-based Waud Capital Partners.
“When we sold the practice in 2017, we expected to see a 30% cut in the partners’ personal income,” said Richard L. Lindstrom, MD, who headed MEC until he retired last year. “Now, coming into the 6th year, all of the former partners who are still working are earning 10% above presale levels, except for one doctor who wanted to work fewer hours.” These doctors aren’t working longer hours but rather are benefiting from efficiencies, such as adding scribes and improving scheduling, he said.
Private equity brought discipline to the practice, said Dr. Lindstrom, who still sits on the Unifeye board. “In an independent practice, the partners may decide on a new piece of equipment because it would be fun to have, not because they’ve done a financial analysis,” he said. “We don’t wing it anymore.”
On the other hand, according to Dr. Zhu, some private equity firms may use draconian methods to improve efficiency. “Doctors may be expected to order or perform more services or work faster or longer to reach a certain threshold,” she said.
Can private equity uphold your interests?
To win over doctors, a private equity firm may agree to finance projects that the doctors want. For example, Dr. Lindstrom said after his group joined Unifeye, Waud Capital agreed to finance the doctors’ plan to open a new $6 million office. Before the deal, the partners would have had to take out a $6 million loan and personally guarantee it, he said.
A private equity firm may even agree to support the selling doctors’ practice philosophy, such as serving low-income patients – as long as it has a revenue stream. Luis Benavides, MD, is part of a seven-physician family medicine practice that treats many low-income patients in Laredo, Tex. “There is a lot of poverty here,” he said. This March, the group sold to a large private equity company, whose name Dr. Benavides preferred not to reveal.
One reason they made the new arrangement, Dr. Benavides said, was to qualify for ACO REACH, a new Medicare payment program that is mostly used in underserved areas and that allows more distribution of shared savings payments. “Our goal has always been better care,” he said. “We want to know how we can best serve our community.”
Dr. Benavides acknowledges that he has less independence in the new arrangement, but “I already lost my independence when I went from solo practice to a group,” he said. “The upside of a larger organization is that other people may have better ideas than you have.”
Private equity firms often set up governance structures to give physicians some measure of control. Dr. Lindstrom said the governing board of his former practice is solely made up of physicians and deals with local issues such as what office doctors will work in and how many patients they will see. Waud Capital has control of the Unifeye board of directors, but it mainly deals with larger issues, such as acquisition of more practices, he said.
In rare instances, private equity gives doctors control. Dr. Falcone said that from the start of USACS, doctors owned 65% of the company, and in 2020, the physician partners bought out Welsh Carson. “Then we engaged the private equity firm Apollo Global Management, which lent us money for the buyout and became our capital partner, with the doctors now owning 98% of the company,” he said.
On the other hand, some private equity arrangements reportedly have little regard for doctors’ well-being, especially if they are new doctors who didn’t participate in the deal and don’t have equity in it. Dr. Zhu recalled that a new physician was recruited by a practice and was promised a partnership track, but she wasn’t told that the partners were negotiating a private equity deal. “She didn’t find out until the practice was sold months later,” Dr. Zhu said. “The chances of her getting any equity now are unclear.”
Making sure that you pick a company that has your interests at heart requires a lot of digging. Dr. Lindstrom said he and his partners took 3 years to make a decision. They hired a broker to pick the 10 best private equity firms. Then they met with those companies and hired a law firm and an accounting firm to assess them. As the partners inched toward a deal, they voted on each of five critical steps in the decision-making process, he said. He noted that each vote was unanimous.
Impact of private equity
“Private equity deals are changing the health care landscape,” Mr. Wall said. “They are creating large, independent practices that help physicians remain independent from hospital systems and potentially have the clout to get more favorable reimbursements.”
“There is a lot of misunderstanding and mistrust among physicians about private equity,” Dr. Benavides said. “I imagine it will take a while for it to be accepted.”
Until the COVID pandemic, the annual number of private equity deals for doctors had been rising. Will it recover that pace? Mr. Pinto said rising interest rates may dampen activity in the near future.
“The private equity firm often performs a leveraged buyout using borrowed money,” he explained. “This works better when interest rates are low, but interest rates are trending higher. Private equity firms aren’t going away, but they may have to be less generous as the cost of money rises.”
A version of this article first appeared on Medscape.com.
More and more physicians are being wooed by private equity firms that want to buy their practices. The total value of private equity deals in health care in 2019 is estimated at about $120 billion, and it’s expected to grow over the coming years.
While the potential profit may seem alluring, physicians have mixed feelings as to whether this will be a boon or a disappointment.
Angelo Falcone, MD, a former emergency physician in Rockville, Md., found that a private equity investment transformed his career path.
For 19 years, Dr. Falcone was CEO of an emergency medicine group with 35 partners that staffed 10 emergency departments, mostly in Maryland. “We were a pretty small operation looking to get bigger, but to do that would require a substantial investment,” he said.
In 2015, after checking out all their options, the partners decided to sell to US Acute Care Solutions (USACS), a new private equity company founded by Welsh, Carson, Anderson & Stowe, an investment firm in New York. Private equity can be used to expand practices and pay for new equipment. Dr. Falcone, serving as a USACS board member and its operational president, helped spur the company’s astounding growth. Today, USACS has about 5,000 physicians and other clinicians operating in 30 states.
In 2019, Dr. Falcone stepped down from his management post at USACS, took training in integrative medicine, and 2 years later opened a solo integrative medicine practice in Rockville. The new practice, which operates on a concierge model, is not connected with USACS, but Dr, Falcone still sits on the USACS board.
“I had a great experience at USACS. I believe in the power of private equity to support our patients and physicians,” Dr. Falcone said. “Now, at age 58, I have a second career in integrative medicine.”
Private equity is still controversial
David Fleeger, MD, has a different opinion of private equity. “I get offers from private equity firms fairly often, but I’m not seriously interested,” said Dr. Fleeger, a surgeon with Central Texas Colon and Rectal Surgeons in Austin.
“We don’t want to sell to anybody; we want to control our destiny,” he said. “We don’t have to borrow money or repay loans, and we don’t expect to get a windfall for the practice. The profits in medicine are too narrow for that to be realistic. There is no free lunch.”
Some of the doctors who sign up for private equity deals become dissatisfied and want to end the arrangement, according to John Pinto, an ophthalmic practice management consultant in San Diego.
“I get calls about once a month from doctors who want to get out of a private equity deal or revise the terms,” he said. “Some complaints are that the PE firm was too tight with the budget, wouldn’t hire needed staff, mismanaged operations, or otherwise mishandled their investment in the practice.”
It’s difficult for disgruntled physicians to exit a private equity deal, Mr. Pinto said. They commonly have to give up part of the payment they had received for their practice if they leave prematurely, and depending on the jurisdiction, stiff noncompete clauses in their contract won’t allow them to practice nearby.
Disillusioned physicians – and even many physicians who had good experiences with private equity – usually don’t want to air their complaints in public. One reason most of these doctors keep silent is that they have signed nondisclosure and nondisparagement agreements that are part of most private equity deals.
The private equity proposition
Private equity firms typically pay a great deal more for practices than hospitals or even many large private practices, according to James D. Wall, an attorney in Winston-Salem, N.C., who has handled many private equity deals. Mr. Wall said private equity often organizes physicians around one specialty. One advantage these physicians have over hospital-employed physicians is that they aren’t under pressure to refer within a network.
Private equity companies set values for practices on the basis of their earnings before interest, taxes, depreciation, and amortization (EBITDA), said Howard Bogard, an attorney with Burr & Forman in Raleigh, N.C., who has handled many deals. Mr. Bogard said the amount physicians are paid is usually between 4 and 12 times’ EBITDA, so if your practice is earning $1 million a year in EBITDA, you would get $4 million to $12 million for it.
Of the total price tag, “Doctors get a hefty immediate payment when they sell,” Mr. Bogard said. “It might be 70% of the purchase price up front, and the 30% left over is equity in the buyer. The private equity firm then sells the practice 5-7 years later, and at that time, the physician’s equity is converted to cash and equity in the new buyer, often at the same 70/30 ratio. The idea is to keep the doctor interested in staying.”
Private equity firms expand practices to receive more favorable reimbursements and achieve economies of scale, according to Jane Zhu, MD, an assistant professor of medicine at Oregon Health & Science University, Portland, who has studied the phenomenon. Dr. Zhu said these firms may enhance profits by contracting with Medicare Advantage plans, joining accountable care organizations (ACOs), having their physicians work longer hours, and using advanced-practice clinicians instead of physicians.
“They want to make a large return in the order of 20% per year over several years, but they don’t want to strip the practice of value, because they’ll need to sell it to a new investor,” Dr. Zhu said.
When doctors sell to a private equity firm, they become employees and often have to take a pay cut, but their pay may rise again as new efficiencies are instituted. This occurred for partners in Minnesota Eye Consultants (MEC), an 11-member ophthalmology practice in Bloomington, Minn., that helped found Unifeye Vision Partners (UVP), a private equity company financed by Chicago-based Waud Capital Partners.
“When we sold the practice in 2017, we expected to see a 30% cut in the partners’ personal income,” said Richard L. Lindstrom, MD, who headed MEC until he retired last year. “Now, coming into the 6th year, all of the former partners who are still working are earning 10% above presale levels, except for one doctor who wanted to work fewer hours.” These doctors aren’t working longer hours but rather are benefiting from efficiencies, such as adding scribes and improving scheduling, he said.
Private equity brought discipline to the practice, said Dr. Lindstrom, who still sits on the Unifeye board. “In an independent practice, the partners may decide on a new piece of equipment because it would be fun to have, not because they’ve done a financial analysis,” he said. “We don’t wing it anymore.”
On the other hand, according to Dr. Zhu, some private equity firms may use draconian methods to improve efficiency. “Doctors may be expected to order or perform more services or work faster or longer to reach a certain threshold,” she said.
Can private equity uphold your interests?
To win over doctors, a private equity firm may agree to finance projects that the doctors want. For example, Dr. Lindstrom said after his group joined Unifeye, Waud Capital agreed to finance the doctors’ plan to open a new $6 million office. Before the deal, the partners would have had to take out a $6 million loan and personally guarantee it, he said.
A private equity firm may even agree to support the selling doctors’ practice philosophy, such as serving low-income patients – as long as it has a revenue stream. Luis Benavides, MD, is part of a seven-physician family medicine practice that treats many low-income patients in Laredo, Tex. “There is a lot of poverty here,” he said. This March, the group sold to a large private equity company, whose name Dr. Benavides preferred not to reveal.
One reason they made the new arrangement, Dr. Benavides said, was to qualify for ACO REACH, a new Medicare payment program that is mostly used in underserved areas and that allows more distribution of shared savings payments. “Our goal has always been better care,” he said. “We want to know how we can best serve our community.”
Dr. Benavides acknowledges that he has less independence in the new arrangement, but “I already lost my independence when I went from solo practice to a group,” he said. “The upside of a larger organization is that other people may have better ideas than you have.”
Private equity firms often set up governance structures to give physicians some measure of control. Dr. Lindstrom said the governing board of his former practice is solely made up of physicians and deals with local issues such as what office doctors will work in and how many patients they will see. Waud Capital has control of the Unifeye board of directors, but it mainly deals with larger issues, such as acquisition of more practices, he said.
In rare instances, private equity gives doctors control. Dr. Falcone said that from the start of USACS, doctors owned 65% of the company, and in 2020, the physician partners bought out Welsh Carson. “Then we engaged the private equity firm Apollo Global Management, which lent us money for the buyout and became our capital partner, with the doctors now owning 98% of the company,” he said.
On the other hand, some private equity arrangements reportedly have little regard for doctors’ well-being, especially if they are new doctors who didn’t participate in the deal and don’t have equity in it. Dr. Zhu recalled that a new physician was recruited by a practice and was promised a partnership track, but she wasn’t told that the partners were negotiating a private equity deal. “She didn’t find out until the practice was sold months later,” Dr. Zhu said. “The chances of her getting any equity now are unclear.”
Making sure that you pick a company that has your interests at heart requires a lot of digging. Dr. Lindstrom said he and his partners took 3 years to make a decision. They hired a broker to pick the 10 best private equity firms. Then they met with those companies and hired a law firm and an accounting firm to assess them. As the partners inched toward a deal, they voted on each of five critical steps in the decision-making process, he said. He noted that each vote was unanimous.
Impact of private equity
“Private equity deals are changing the health care landscape,” Mr. Wall said. “They are creating large, independent practices that help physicians remain independent from hospital systems and potentially have the clout to get more favorable reimbursements.”
“There is a lot of misunderstanding and mistrust among physicians about private equity,” Dr. Benavides said. “I imagine it will take a while for it to be accepted.”
Until the COVID pandemic, the annual number of private equity deals for doctors had been rising. Will it recover that pace? Mr. Pinto said rising interest rates may dampen activity in the near future.
“The private equity firm often performs a leveraged buyout using borrowed money,” he explained. “This works better when interest rates are low, but interest rates are trending higher. Private equity firms aren’t going away, but they may have to be less generous as the cost of money rises.”
A version of this article first appeared on Medscape.com.
More and more physicians are being wooed by private equity firms that want to buy their practices. The total value of private equity deals in health care in 2019 is estimated at about $120 billion, and it’s expected to grow over the coming years.
While the potential profit may seem alluring, physicians have mixed feelings as to whether this will be a boon or a disappointment.
Angelo Falcone, MD, a former emergency physician in Rockville, Md., found that a private equity investment transformed his career path.
For 19 years, Dr. Falcone was CEO of an emergency medicine group with 35 partners that staffed 10 emergency departments, mostly in Maryland. “We were a pretty small operation looking to get bigger, but to do that would require a substantial investment,” he said.
In 2015, after checking out all their options, the partners decided to sell to US Acute Care Solutions (USACS), a new private equity company founded by Welsh, Carson, Anderson & Stowe, an investment firm in New York. Private equity can be used to expand practices and pay for new equipment. Dr. Falcone, serving as a USACS board member and its operational president, helped spur the company’s astounding growth. Today, USACS has about 5,000 physicians and other clinicians operating in 30 states.
In 2019, Dr. Falcone stepped down from his management post at USACS, took training in integrative medicine, and 2 years later opened a solo integrative medicine practice in Rockville. The new practice, which operates on a concierge model, is not connected with USACS, but Dr, Falcone still sits on the USACS board.
“I had a great experience at USACS. I believe in the power of private equity to support our patients and physicians,” Dr. Falcone said. “Now, at age 58, I have a second career in integrative medicine.”
Private equity is still controversial
David Fleeger, MD, has a different opinion of private equity. “I get offers from private equity firms fairly often, but I’m not seriously interested,” said Dr. Fleeger, a surgeon with Central Texas Colon and Rectal Surgeons in Austin.
“We don’t want to sell to anybody; we want to control our destiny,” he said. “We don’t have to borrow money or repay loans, and we don’t expect to get a windfall for the practice. The profits in medicine are too narrow for that to be realistic. There is no free lunch.”
Some of the doctors who sign up for private equity deals become dissatisfied and want to end the arrangement, according to John Pinto, an ophthalmic practice management consultant in San Diego.
“I get calls about once a month from doctors who want to get out of a private equity deal or revise the terms,” he said. “Some complaints are that the PE firm was too tight with the budget, wouldn’t hire needed staff, mismanaged operations, or otherwise mishandled their investment in the practice.”
It’s difficult for disgruntled physicians to exit a private equity deal, Mr. Pinto said. They commonly have to give up part of the payment they had received for their practice if they leave prematurely, and depending on the jurisdiction, stiff noncompete clauses in their contract won’t allow them to practice nearby.
Disillusioned physicians – and even many physicians who had good experiences with private equity – usually don’t want to air their complaints in public. One reason most of these doctors keep silent is that they have signed nondisclosure and nondisparagement agreements that are part of most private equity deals.
The private equity proposition
Private equity firms typically pay a great deal more for practices than hospitals or even many large private practices, according to James D. Wall, an attorney in Winston-Salem, N.C., who has handled many private equity deals. Mr. Wall said private equity often organizes physicians around one specialty. One advantage these physicians have over hospital-employed physicians is that they aren’t under pressure to refer within a network.
Private equity companies set values for practices on the basis of their earnings before interest, taxes, depreciation, and amortization (EBITDA), said Howard Bogard, an attorney with Burr & Forman in Raleigh, N.C., who has handled many deals. Mr. Bogard said the amount physicians are paid is usually between 4 and 12 times’ EBITDA, so if your practice is earning $1 million a year in EBITDA, you would get $4 million to $12 million for it.
Of the total price tag, “Doctors get a hefty immediate payment when they sell,” Mr. Bogard said. “It might be 70% of the purchase price up front, and the 30% left over is equity in the buyer. The private equity firm then sells the practice 5-7 years later, and at that time, the physician’s equity is converted to cash and equity in the new buyer, often at the same 70/30 ratio. The idea is to keep the doctor interested in staying.”
Private equity firms expand practices to receive more favorable reimbursements and achieve economies of scale, according to Jane Zhu, MD, an assistant professor of medicine at Oregon Health & Science University, Portland, who has studied the phenomenon. Dr. Zhu said these firms may enhance profits by contracting with Medicare Advantage plans, joining accountable care organizations (ACOs), having their physicians work longer hours, and using advanced-practice clinicians instead of physicians.
“They want to make a large return in the order of 20% per year over several years, but they don’t want to strip the practice of value, because they’ll need to sell it to a new investor,” Dr. Zhu said.
When doctors sell to a private equity firm, they become employees and often have to take a pay cut, but their pay may rise again as new efficiencies are instituted. This occurred for partners in Minnesota Eye Consultants (MEC), an 11-member ophthalmology practice in Bloomington, Minn., that helped found Unifeye Vision Partners (UVP), a private equity company financed by Chicago-based Waud Capital Partners.
“When we sold the practice in 2017, we expected to see a 30% cut in the partners’ personal income,” said Richard L. Lindstrom, MD, who headed MEC until he retired last year. “Now, coming into the 6th year, all of the former partners who are still working are earning 10% above presale levels, except for one doctor who wanted to work fewer hours.” These doctors aren’t working longer hours but rather are benefiting from efficiencies, such as adding scribes and improving scheduling, he said.
Private equity brought discipline to the practice, said Dr. Lindstrom, who still sits on the Unifeye board. “In an independent practice, the partners may decide on a new piece of equipment because it would be fun to have, not because they’ve done a financial analysis,” he said. “We don’t wing it anymore.”
On the other hand, according to Dr. Zhu, some private equity firms may use draconian methods to improve efficiency. “Doctors may be expected to order or perform more services or work faster or longer to reach a certain threshold,” she said.
Can private equity uphold your interests?
To win over doctors, a private equity firm may agree to finance projects that the doctors want. For example, Dr. Lindstrom said after his group joined Unifeye, Waud Capital agreed to finance the doctors’ plan to open a new $6 million office. Before the deal, the partners would have had to take out a $6 million loan and personally guarantee it, he said.
A private equity firm may even agree to support the selling doctors’ practice philosophy, such as serving low-income patients – as long as it has a revenue stream. Luis Benavides, MD, is part of a seven-physician family medicine practice that treats many low-income patients in Laredo, Tex. “There is a lot of poverty here,” he said. This March, the group sold to a large private equity company, whose name Dr. Benavides preferred not to reveal.
One reason they made the new arrangement, Dr. Benavides said, was to qualify for ACO REACH, a new Medicare payment program that is mostly used in underserved areas and that allows more distribution of shared savings payments. “Our goal has always been better care,” he said. “We want to know how we can best serve our community.”
Dr. Benavides acknowledges that he has less independence in the new arrangement, but “I already lost my independence when I went from solo practice to a group,” he said. “The upside of a larger organization is that other people may have better ideas than you have.”
Private equity firms often set up governance structures to give physicians some measure of control. Dr. Lindstrom said the governing board of his former practice is solely made up of physicians and deals with local issues such as what office doctors will work in and how many patients they will see. Waud Capital has control of the Unifeye board of directors, but it mainly deals with larger issues, such as acquisition of more practices, he said.
In rare instances, private equity gives doctors control. Dr. Falcone said that from the start of USACS, doctors owned 65% of the company, and in 2020, the physician partners bought out Welsh Carson. “Then we engaged the private equity firm Apollo Global Management, which lent us money for the buyout and became our capital partner, with the doctors now owning 98% of the company,” he said.
On the other hand, some private equity arrangements reportedly have little regard for doctors’ well-being, especially if they are new doctors who didn’t participate in the deal and don’t have equity in it. Dr. Zhu recalled that a new physician was recruited by a practice and was promised a partnership track, but she wasn’t told that the partners were negotiating a private equity deal. “She didn’t find out until the practice was sold months later,” Dr. Zhu said. “The chances of her getting any equity now are unclear.”
Making sure that you pick a company that has your interests at heart requires a lot of digging. Dr. Lindstrom said he and his partners took 3 years to make a decision. They hired a broker to pick the 10 best private equity firms. Then they met with those companies and hired a law firm and an accounting firm to assess them. As the partners inched toward a deal, they voted on each of five critical steps in the decision-making process, he said. He noted that each vote was unanimous.
Impact of private equity
“Private equity deals are changing the health care landscape,” Mr. Wall said. “They are creating large, independent practices that help physicians remain independent from hospital systems and potentially have the clout to get more favorable reimbursements.”
“There is a lot of misunderstanding and mistrust among physicians about private equity,” Dr. Benavides said. “I imagine it will take a while for it to be accepted.”
Until the COVID pandemic, the annual number of private equity deals for doctors had been rising. Will it recover that pace? Mr. Pinto said rising interest rates may dampen activity in the near future.
“The private equity firm often performs a leveraged buyout using borrowed money,” he explained. “This works better when interest rates are low, but interest rates are trending higher. Private equity firms aren’t going away, but they may have to be less generous as the cost of money rises.”
A version of this article first appeared on Medscape.com.
A look at lung cancer screening in resource-limited countries
Lung cancer screening has been a success story in high-income countries, leading to a shift in diagnoses to earlier stages and a reduction in mortality among eligible groups.
A new report shows that middle- and low-income countries are being left out. “We do have good screening programs and some national ones, even in smaller European countries and in Canada, but either at all or not implemented nationwide. This is a huge problem in the world,” said Milena Cavic, PhD, who presented the interim results on behalf of the diagnostics working group of the International Association for the Study of Lung Cancer early detection and screening committee at a press conference on Aug. 7 at the World Conference on Lung Cancer. Dr. Cavic is a senior research associate at the Institute for Oncology and Radiology of Serbia in Belgrade.
“It’s definitely a work in progress, and it’s also about raising awareness of the problem. In several parts of Asia, in Taiwan, in Korea, smoking is not the major, or at least, not the only reason for getting lung cancer. The other reasons are family history and also environmental factors like cooking fires, etc. So, the criteria we have for screening in Western countries are not one to one implementable in these countries,” said Rudolf Huber, MD, PhD, a respiratory physician at Ludwig Maximilian University of Munich and a coauthor of the report.
The report also pointed out the lack of recommendations for lung cancer screening in middle- and low-income countries. One approach would be to produce recommendations for countries with similar infrastructures and health resources, as well as primary risk factors such as smoking or cooking fires. “We have to adapt it to the various situations,” said Dr. Huber.
Another possibility is to rework existing recommendations for high income countries to adapt them to low- and middle-income countries. In the coming year, the working group will conduct a modeling study of Serbia, China, South Africa, and Columbia. It will look at population-specific and geographic factors from each country to produce country-specific models. “It will be interesting to see if these models will give us new recommendations for countries like this. So we can derive something from the high-income countries, but it will need to be adapted very, very much,” said Dr. Cavic.
The report highlighted some of the disparities between countries. CT scanners are far more common in high-income countries. Japan leads the way at 111.5 per million residents, followed by Australia at 70.2, Iceland at 47.6, and the United States at 44.9. At the other end is Columbia with 1.3, which trails Mexico at 5.9, Hungary at 9.4, and the United Kingdom at 9.5. However, the authors point out that there is no consensus on the optimum number of CT scanners per capita, since too few can lead to lack of access and too many can result in overuse. In fact, the greatest number of CT scans performed per capita was in the United States (278.5 per million), followed by Iceland (234.4), Japan (230.8), and Korea (228.1).
Lung cancer screening can be at odds with other health priorities, especially in low-income countries. These can include HIV, tuberculosis, and granulomatous diseases. But that could also provide an opportunity, according to Dr. Huber. “For example, in South Africa, tuberculosis programs are done by chest x-ray. We now have data that [allows us to] detect nodules by artificial intelligence, so one of the things we are thinking about is whether we could even use chest x-ray to get an earlier detection. At the end, it may be that in some countries it’s possible to do the classical CT screening, while in other countries we have to adapt to other options – probably chest x-ray using artificial intelligence or computer-aided diagnosis. And, then a consequent program for following up and managing the incidentally diagnosed nodules.”
The group is hoping to explore the environmental factors that could affect lung cancer risk in middle- and low-income countries. That is difficult to do, however, because smoking data can be hard to come by in many countries, and there is general uncertainty about what other risk factors may exist, though air pollution is a clear suspect. “It is something we are hoping to focus on in the future because there is a subgroup of individuals without a smoking history who are at high risk. It would be really good to find this high-risk population that should actually be screened in the future,” Dr. Cavic said.
Some countries have no data on lung cancer screening. For example, only South Africa is represented from Africa, and data is missing from many countries in Asia. The diagnostics working group of the IASLC early detection and screening committee has created a survey to gather information on the availability of lung cancer screening and its effect on diagnosis and treatment in countries throughout the world.
Dr. Cavic and Dr. Huber reported no relevant financial disclosures. The meeting was sponsored by the IASLC.
Lung cancer screening has been a success story in high-income countries, leading to a shift in diagnoses to earlier stages and a reduction in mortality among eligible groups.
A new report shows that middle- and low-income countries are being left out. “We do have good screening programs and some national ones, even in smaller European countries and in Canada, but either at all or not implemented nationwide. This is a huge problem in the world,” said Milena Cavic, PhD, who presented the interim results on behalf of the diagnostics working group of the International Association for the Study of Lung Cancer early detection and screening committee at a press conference on Aug. 7 at the World Conference on Lung Cancer. Dr. Cavic is a senior research associate at the Institute for Oncology and Radiology of Serbia in Belgrade.
“It’s definitely a work in progress, and it’s also about raising awareness of the problem. In several parts of Asia, in Taiwan, in Korea, smoking is not the major, or at least, not the only reason for getting lung cancer. The other reasons are family history and also environmental factors like cooking fires, etc. So, the criteria we have for screening in Western countries are not one to one implementable in these countries,” said Rudolf Huber, MD, PhD, a respiratory physician at Ludwig Maximilian University of Munich and a coauthor of the report.
The report also pointed out the lack of recommendations for lung cancer screening in middle- and low-income countries. One approach would be to produce recommendations for countries with similar infrastructures and health resources, as well as primary risk factors such as smoking or cooking fires. “We have to adapt it to the various situations,” said Dr. Huber.
Another possibility is to rework existing recommendations for high income countries to adapt them to low- and middle-income countries. In the coming year, the working group will conduct a modeling study of Serbia, China, South Africa, and Columbia. It will look at population-specific and geographic factors from each country to produce country-specific models. “It will be interesting to see if these models will give us new recommendations for countries like this. So we can derive something from the high-income countries, but it will need to be adapted very, very much,” said Dr. Cavic.
The report highlighted some of the disparities between countries. CT scanners are far more common in high-income countries. Japan leads the way at 111.5 per million residents, followed by Australia at 70.2, Iceland at 47.6, and the United States at 44.9. At the other end is Columbia with 1.3, which trails Mexico at 5.9, Hungary at 9.4, and the United Kingdom at 9.5. However, the authors point out that there is no consensus on the optimum number of CT scanners per capita, since too few can lead to lack of access and too many can result in overuse. In fact, the greatest number of CT scans performed per capita was in the United States (278.5 per million), followed by Iceland (234.4), Japan (230.8), and Korea (228.1).
Lung cancer screening can be at odds with other health priorities, especially in low-income countries. These can include HIV, tuberculosis, and granulomatous diseases. But that could also provide an opportunity, according to Dr. Huber. “For example, in South Africa, tuberculosis programs are done by chest x-ray. We now have data that [allows us to] detect nodules by artificial intelligence, so one of the things we are thinking about is whether we could even use chest x-ray to get an earlier detection. At the end, it may be that in some countries it’s possible to do the classical CT screening, while in other countries we have to adapt to other options – probably chest x-ray using artificial intelligence or computer-aided diagnosis. And, then a consequent program for following up and managing the incidentally diagnosed nodules.”
The group is hoping to explore the environmental factors that could affect lung cancer risk in middle- and low-income countries. That is difficult to do, however, because smoking data can be hard to come by in many countries, and there is general uncertainty about what other risk factors may exist, though air pollution is a clear suspect. “It is something we are hoping to focus on in the future because there is a subgroup of individuals without a smoking history who are at high risk. It would be really good to find this high-risk population that should actually be screened in the future,” Dr. Cavic said.
Some countries have no data on lung cancer screening. For example, only South Africa is represented from Africa, and data is missing from many countries in Asia. The diagnostics working group of the IASLC early detection and screening committee has created a survey to gather information on the availability of lung cancer screening and its effect on diagnosis and treatment in countries throughout the world.
Dr. Cavic and Dr. Huber reported no relevant financial disclosures. The meeting was sponsored by the IASLC.
Lung cancer screening has been a success story in high-income countries, leading to a shift in diagnoses to earlier stages and a reduction in mortality among eligible groups.
A new report shows that middle- and low-income countries are being left out. “We do have good screening programs and some national ones, even in smaller European countries and in Canada, but either at all or not implemented nationwide. This is a huge problem in the world,” said Milena Cavic, PhD, who presented the interim results on behalf of the diagnostics working group of the International Association for the Study of Lung Cancer early detection and screening committee at a press conference on Aug. 7 at the World Conference on Lung Cancer. Dr. Cavic is a senior research associate at the Institute for Oncology and Radiology of Serbia in Belgrade.
“It’s definitely a work in progress, and it’s also about raising awareness of the problem. In several parts of Asia, in Taiwan, in Korea, smoking is not the major, or at least, not the only reason for getting lung cancer. The other reasons are family history and also environmental factors like cooking fires, etc. So, the criteria we have for screening in Western countries are not one to one implementable in these countries,” said Rudolf Huber, MD, PhD, a respiratory physician at Ludwig Maximilian University of Munich and a coauthor of the report.
The report also pointed out the lack of recommendations for lung cancer screening in middle- and low-income countries. One approach would be to produce recommendations for countries with similar infrastructures and health resources, as well as primary risk factors such as smoking or cooking fires. “We have to adapt it to the various situations,” said Dr. Huber.
Another possibility is to rework existing recommendations for high income countries to adapt them to low- and middle-income countries. In the coming year, the working group will conduct a modeling study of Serbia, China, South Africa, and Columbia. It will look at population-specific and geographic factors from each country to produce country-specific models. “It will be interesting to see if these models will give us new recommendations for countries like this. So we can derive something from the high-income countries, but it will need to be adapted very, very much,” said Dr. Cavic.
The report highlighted some of the disparities between countries. CT scanners are far more common in high-income countries. Japan leads the way at 111.5 per million residents, followed by Australia at 70.2, Iceland at 47.6, and the United States at 44.9. At the other end is Columbia with 1.3, which trails Mexico at 5.9, Hungary at 9.4, and the United Kingdom at 9.5. However, the authors point out that there is no consensus on the optimum number of CT scanners per capita, since too few can lead to lack of access and too many can result in overuse. In fact, the greatest number of CT scans performed per capita was in the United States (278.5 per million), followed by Iceland (234.4), Japan (230.8), and Korea (228.1).
Lung cancer screening can be at odds with other health priorities, especially in low-income countries. These can include HIV, tuberculosis, and granulomatous diseases. But that could also provide an opportunity, according to Dr. Huber. “For example, in South Africa, tuberculosis programs are done by chest x-ray. We now have data that [allows us to] detect nodules by artificial intelligence, so one of the things we are thinking about is whether we could even use chest x-ray to get an earlier detection. At the end, it may be that in some countries it’s possible to do the classical CT screening, while in other countries we have to adapt to other options – probably chest x-ray using artificial intelligence or computer-aided diagnosis. And, then a consequent program for following up and managing the incidentally diagnosed nodules.”
The group is hoping to explore the environmental factors that could affect lung cancer risk in middle- and low-income countries. That is difficult to do, however, because smoking data can be hard to come by in many countries, and there is general uncertainty about what other risk factors may exist, though air pollution is a clear suspect. “It is something we are hoping to focus on in the future because there is a subgroup of individuals without a smoking history who are at high risk. It would be really good to find this high-risk population that should actually be screened in the future,” Dr. Cavic said.
Some countries have no data on lung cancer screening. For example, only South Africa is represented from Africa, and data is missing from many countries in Asia. The diagnostics working group of the IASLC early detection and screening committee has created a survey to gather information on the availability of lung cancer screening and its effect on diagnosis and treatment in countries throughout the world.
Dr. Cavic and Dr. Huber reported no relevant financial disclosures. The meeting was sponsored by the IASLC.
FROM WCLC 2022
Genomic Assays in HR-Positive/HER2-Negative Breast Cancer
As both a clinician and investigator in the breast cancer space, how would you describe our current understanding of genomic assays in hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative disease?
Dr. Kalinsky: There are a number of commercially-available assays for patients with early-stage HR-positive/HER2-negative breast cancer. We have seen the results of 3 large randomized phase 3 trials that have demonstrated and helped establish the clinical utility of assays, including the oncotype DX 21-gene recurrence score. This was evaluated in patients with node-negative breast cancer in the TAILORx trial and in patients with 1 to 3 nodes involved in the RxPONDER trial.
We also have data with the 70-gene MammaPrint assay from the MINDACT study, looking for patients who had a discordance between clinical and genomic risk. MINDACT has been published and was updated recently with data for 8-year distant metastasis-free survival. It is these studies that have helped establish what we do in the clinic and when we consider offering genomic assays in patients with this subtype of breast cancer.
How are you working to bring these genomic assays into practice?
Dr. Kalinsky: In 2020, we reported the initial results from the RxPonder study demonstrating that for patients with HR-positive HER2-negative breast cancer with 1 to 3 nodes involved, two-thirds of the patients were postmenopausal. For patients who had a recurrence score of 25 or less, we did not identify a subgroup of patients who benefited from chemotherapy.
For the premenopausal women, which was one-third of the patients, we saw that all those patients benefited from the addition of chemotherapy if the recurrence score was 25 or less. We did a number of subgroup analyses, which we reported on at the San Antonio Breast Cancer Symposium in 2021.
Several analyses are ongoing. These include some subgroup analyses looking at quality of life as well as a collection of circulating markers. In addition, there is ongoing biomarker work looking at tumor tissue to see if there are differences between the biology of premenopausal versus postmenopausal women.
What value does genomic testing bring to the treatment of HR-positive/HER2-negative breast cancer?
Dr. Kalinsky: These assays have achieved clinical utility, and this has been reflected in the recent update to the ASCO Guidelines for genomic assays. We have also learned that it is not just the assay by itself, but also the clinical features of a patient that help determine risk. In other words, it’s not just dependent on the score, but also involves the context of other important clinical features, including patient and tumor characteristics such as tumor size, patient age, and tumor grade. All of these add value and help us assess a patient’s individualized risk.
Is there a specific profile or qualifications candidates must meet for genomic testing to be done?
Dr. Kalinsky: We offer genomic tests for patients with HR-positive/HER2-negative breast cancer who are node-negative or have 1 to 3 nodes involved. There are other commercially-available tests such as the Breast Cancer Index, which assesses risk of recurrence in years 5 to 10 and looks at whether there is potential utility for continuing anti-estrogen therapy. That assay provides both prognostic and predictive information.
Is there any additional insight on genomic assays in HR-positive/HER2-negative breast cancer you would like to share?
Dr. Kalinsky: We’ve been talking about tumor-based assays. However, the question is, what’s going to be the role for circulating markers, such as circulating tumor DNA (ctDNA) or circulating tumor cells? There is a lot of information that we’re hoping to understand, not just regarding the prognostic significance but also the predictive utility. If you have a patient with a subtype of breast cancer and we know this subgroup can be at risk for late recurrence, if you identify said marker and you switch the therapy, do you see clearance of ctDNA? Does that lead to an improvement in outcome? That is an important question that is going to be answered in current and future trials.
As both a clinician and investigator in the breast cancer space, how would you describe our current understanding of genomic assays in hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative disease?
Dr. Kalinsky: There are a number of commercially-available assays for patients with early-stage HR-positive/HER2-negative breast cancer. We have seen the results of 3 large randomized phase 3 trials that have demonstrated and helped establish the clinical utility of assays, including the oncotype DX 21-gene recurrence score. This was evaluated in patients with node-negative breast cancer in the TAILORx trial and in patients with 1 to 3 nodes involved in the RxPONDER trial.
We also have data with the 70-gene MammaPrint assay from the MINDACT study, looking for patients who had a discordance between clinical and genomic risk. MINDACT has been published and was updated recently with data for 8-year distant metastasis-free survival. It is these studies that have helped establish what we do in the clinic and when we consider offering genomic assays in patients with this subtype of breast cancer.
How are you working to bring these genomic assays into practice?
Dr. Kalinsky: In 2020, we reported the initial results from the RxPonder study demonstrating that for patients with HR-positive HER2-negative breast cancer with 1 to 3 nodes involved, two-thirds of the patients were postmenopausal. For patients who had a recurrence score of 25 or less, we did not identify a subgroup of patients who benefited from chemotherapy.
For the premenopausal women, which was one-third of the patients, we saw that all those patients benefited from the addition of chemotherapy if the recurrence score was 25 or less. We did a number of subgroup analyses, which we reported on at the San Antonio Breast Cancer Symposium in 2021.
Several analyses are ongoing. These include some subgroup analyses looking at quality of life as well as a collection of circulating markers. In addition, there is ongoing biomarker work looking at tumor tissue to see if there are differences between the biology of premenopausal versus postmenopausal women.
What value does genomic testing bring to the treatment of HR-positive/HER2-negative breast cancer?
Dr. Kalinsky: These assays have achieved clinical utility, and this has been reflected in the recent update to the ASCO Guidelines for genomic assays. We have also learned that it is not just the assay by itself, but also the clinical features of a patient that help determine risk. In other words, it’s not just dependent on the score, but also involves the context of other important clinical features, including patient and tumor characteristics such as tumor size, patient age, and tumor grade. All of these add value and help us assess a patient’s individualized risk.
Is there a specific profile or qualifications candidates must meet for genomic testing to be done?
Dr. Kalinsky: We offer genomic tests for patients with HR-positive/HER2-negative breast cancer who are node-negative or have 1 to 3 nodes involved. There are other commercially-available tests such as the Breast Cancer Index, which assesses risk of recurrence in years 5 to 10 and looks at whether there is potential utility for continuing anti-estrogen therapy. That assay provides both prognostic and predictive information.
Is there any additional insight on genomic assays in HR-positive/HER2-negative breast cancer you would like to share?
Dr. Kalinsky: We’ve been talking about tumor-based assays. However, the question is, what’s going to be the role for circulating markers, such as circulating tumor DNA (ctDNA) or circulating tumor cells? There is a lot of information that we’re hoping to understand, not just regarding the prognostic significance but also the predictive utility. If you have a patient with a subtype of breast cancer and we know this subgroup can be at risk for late recurrence, if you identify said marker and you switch the therapy, do you see clearance of ctDNA? Does that lead to an improvement in outcome? That is an important question that is going to be answered in current and future trials.
As both a clinician and investigator in the breast cancer space, how would you describe our current understanding of genomic assays in hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative disease?
Dr. Kalinsky: There are a number of commercially-available assays for patients with early-stage HR-positive/HER2-negative breast cancer. We have seen the results of 3 large randomized phase 3 trials that have demonstrated and helped establish the clinical utility of assays, including the oncotype DX 21-gene recurrence score. This was evaluated in patients with node-negative breast cancer in the TAILORx trial and in patients with 1 to 3 nodes involved in the RxPONDER trial.
We also have data with the 70-gene MammaPrint assay from the MINDACT study, looking for patients who had a discordance between clinical and genomic risk. MINDACT has been published and was updated recently with data for 8-year distant metastasis-free survival. It is these studies that have helped establish what we do in the clinic and when we consider offering genomic assays in patients with this subtype of breast cancer.
How are you working to bring these genomic assays into practice?
Dr. Kalinsky: In 2020, we reported the initial results from the RxPonder study demonstrating that for patients with HR-positive HER2-negative breast cancer with 1 to 3 nodes involved, two-thirds of the patients were postmenopausal. For patients who had a recurrence score of 25 or less, we did not identify a subgroup of patients who benefited from chemotherapy.
For the premenopausal women, which was one-third of the patients, we saw that all those patients benefited from the addition of chemotherapy if the recurrence score was 25 or less. We did a number of subgroup analyses, which we reported on at the San Antonio Breast Cancer Symposium in 2021.
Several analyses are ongoing. These include some subgroup analyses looking at quality of life as well as a collection of circulating markers. In addition, there is ongoing biomarker work looking at tumor tissue to see if there are differences between the biology of premenopausal versus postmenopausal women.
What value does genomic testing bring to the treatment of HR-positive/HER2-negative breast cancer?
Dr. Kalinsky: These assays have achieved clinical utility, and this has been reflected in the recent update to the ASCO Guidelines for genomic assays. We have also learned that it is not just the assay by itself, but also the clinical features of a patient that help determine risk. In other words, it’s not just dependent on the score, but also involves the context of other important clinical features, including patient and tumor characteristics such as tumor size, patient age, and tumor grade. All of these add value and help us assess a patient’s individualized risk.
Is there a specific profile or qualifications candidates must meet for genomic testing to be done?
Dr. Kalinsky: We offer genomic tests for patients with HR-positive/HER2-negative breast cancer who are node-negative or have 1 to 3 nodes involved. There are other commercially-available tests such as the Breast Cancer Index, which assesses risk of recurrence in years 5 to 10 and looks at whether there is potential utility for continuing anti-estrogen therapy. That assay provides both prognostic and predictive information.
Is there any additional insight on genomic assays in HR-positive/HER2-negative breast cancer you would like to share?
Dr. Kalinsky: We’ve been talking about tumor-based assays. However, the question is, what’s going to be the role for circulating markers, such as circulating tumor DNA (ctDNA) or circulating tumor cells? There is a lot of information that we’re hoping to understand, not just regarding the prognostic significance but also the predictive utility. If you have a patient with a subtype of breast cancer and we know this subgroup can be at risk for late recurrence, if you identify said marker and you switch the therapy, do you see clearance of ctDNA? Does that lead to an improvement in outcome? That is an important question that is going to be answered in current and future trials.
Obesity drug shortage triggers frustrations, workarounds
The glucagon-like peptide-1 (GLP-1) agonist semaglutide formulated for treating obesity (Wegovy) had a roaring takeoff a little more than a year ago, with surging patient demand after the U.S. Food and Drug Administration approved it in June 2021. But starting doses of the Wegovy form of semaglutide went missing in action starting late 2021 and continue to date, frustrating patients and their health care providers.
The arrival of Wegovy last year was hailed by obesity medicine specialists and others as a “game changer” for treating people with obesity because of semaglutide’s proven safety and efficacy at the subcutaneous dose of 2.4 mg delivered once a week to produce at least 15% weight loss in half the people who received it, as documented last year in results from one of the drug’s pivotal clinical trials.
But during the months following semaglutide’s approval for treating obesity (it also received an FDA marketing nod in late 2017 as Ozempic for treating type 2 diabetes), a worldwide shortage of Wegovy, including in the United States, emerged.
A manufacturing glitch shut down the primary location for production of U.S.-bound Wegovy injector pens for several months starting in late 2021, according to a December report from Novo Nordisk, the company that makes and markets the agent. (The Wegovy production issue appears to have had a very modest impact, especially in U.S. pharmacies, on the supply of semaglutide formulated as Ozempic, also marketed by Novo Nordisk, although Wegovy supply and demand have dramatically limited Ozempic availability in Australia.)
‘Unprecedented demand’ for Wegovy derailed when plant went offline
The supply side for Wegovy became so hopelessly broken that just months after U.S. sales began and immediately skyrocketed, Novo Nordisk made the remarkable decision to pull starting doses of Wegovy from the market to make it much harder to initiate patients (semaglutide and other GLP-1 agonists require gradual dose ramp-up to avoid gastrointestinal side effects), and the company publicly implored clinicians to not start new patients on the agent, which is where the status remains as of early August 2022.
Novo Nordisk’s financial report for the second quarter of 2022, released on Aug. 3, said the company “expects to make all Wegovy dose strengths available in the United States towards the end of 2022.”
A Dear Health Care Provider letter that Novo Nordisk posted on its U.S. Wegovy website last spring cited “unprecedented demand” that exceeded every prior product launch in the company’s history. It forced Novo Nordisk to pull the plug on all U.S. promotion of Wegovy and compelled the company to ask U.S. clinicians to halt new patient starts.
“I stopped offering Wegovy to new patients” since about the beginning of 2022, says Lauren D. Oshman, MD, a family and obesity medicine specialist at the University of Michigan, Ann Arbor. “It’s very frustrating to not have patients [with obesity] receive the optimal treatment available.” Although she adds that she tries to match obesity treatments to each patient’s clinical needs, and a GLP-1 agonist is not the first choice for every person with obesity.
“It was a disastrous rollout,” says Catherine W. Varney, DO, a family and obesity medicine specialist at the University of Virginia, Charlottesville. “It’s frustrating to know that the treatment is there but not being able to use it,” she said in an interview.
“I had about 800 patients on Wegovy” when the supply dropped earlier this year, and “I couldn’t handle the volume of messages that I got from patients,” recalls Angela Fitch, MD, associate director of the Massachusetts General Hospital Weight Center, Boston. “It was painful,” she said in an interview.
“Frustrating and chaotic,” is the description from Ivania M. Rizo, MD, director of obesity medicine at Boston Medical Center.
The liraglutide/Saxenda workaround
The upshot is that people with obesity and their health care providers have been busy devising workarounds to try to meet the intense demand for this drug-assisted approach to appetite control and weight loss. Their tactics run a wide gamut based on the crazy-quilt diversity of health insurance coverage across America.
Because the bottleneck for starting Wegovy resulted from unavailable starting doses (dosing starts at 0.25 mg delivered subcutaneously once a week, eventually ramping up to a maximum of 2.4 mg weekly), one option was to start patients on a different GLP-1 agonist, such as liraglutide (Saxenda, approved for obesity).
Starting a patient on liraglutide involves the same sort of up-titration and acclimation to a GLP-1 agonist that semaglutide requires, and transition between these agents seems feasible for at least some. It also means daily injections of liraglutide rather than the weekly schedule for semaglutide, although some patients prefer maintaining a daily dosing schedule. Another limitation of liraglutide is that evidence shows it is not nearly as effective for weight loss as semaglutide.
Results from the head-to-head STEP 8 trial, published in JAMA, showed an average weight loss from baseline of about 16% with semaglutide and about 6% with liraglutide (and about 2% with placebo).
A ‘reasonable’ evidence base, but more work
Changing from Saxenda to Wegovy, or from Wegovy to Saxenda, “would be reasonably evidence-based medicine,” said Dr. Oshman in an interview. She has managed a Wegovy-to-Saxenda switch for a “handful” of patients to deal with Wegovy shortages, but she has not yet moved anyone to Wegovy after a Saxenda initiation.
“No prospective study has looked at this transition,” but dose equivalence tables exist based on expert opinion, noted Dr. Oshman, as in this 2020 report.
Dr. Varney has several patients on the Saxenda-to-Wegovy track. She up-titrates patients on Saxenda to the maximum daily dose of 3.0 mg and then switches them to the 1.7 mg weekly dose of Wegovy, one of the “destination” Wegovy doses that has remained generally available during the shortage. But Dr. Varney’s experience is that only half of her patients made the changeover smoothly, with the others having “severe gastrointestinal distress,” including vomiting, she notes.
Dr. Fitch has also successfully used this Saxenda-to-Wegovy approach for some of her patients, but it hasn’t been easy.
“It’s more work and more prior authorizations. It’s harder and adds a layer of stress,” but, Dr. Fitch adds, “people are willing to work on it because the weight loss is worth it.”
The liraglutide to semaglutide shuffle is “doable,” says Dr. Rizo, “but I’m looking forward to not having to do it and being able to just start Wegovy.”
The tirzepatide coupon program works ‘off label’ for obesity
Another workaround depends on the FDA approval in May for tirzepatide (Mounjaro) for type 2 diabetes. Tirzepatide is a related GLP-1 agonist that also adds a second incretin-like agonist activity that mimics the glucose-dependent insulinotropic polypeptide.
Soon after approval, Lilly, the company that markets tirzepatide, started a U.S. coupon program geared exclusively to people with commercial insurance. Within certain refill and dollar limits, the program lets patients buy tirzepatide at pharmacies at an out-of-pocket cost of $25 for a 4-week supply (tirzepatide is also dosed by weekly subcutaneous injections). The program will extend into 2023.
Novo Nordisk offered U.S. patients with commercial insurance a similar discount when Wegovy first hit the U.S. market in 2021, but the program closed down once the supply shortage began.
Despite tirzepatide’s current approval only for type 2 diabetes, Dr. Varney has been successfully prescribing it to patients without diabetes off-label for weight loss.
“The coupons still work even when tirzepatide is used off-label,” she notes. And while the drug’s rollout is still only a couple of months old, so far, it’s gone “beautifully” with no hints of supply issues, she says.
But a major drawback to relying on an introductory coupon program that makes these agents affordable to patients is their ability to maintain treatment once the discounts inevitably end.
“We try to only prescribe agents that patients can continue to access,” says Dr. Fitch, who has had some patients with commercial insurance start on Wegovy with coupon discounts only to later lose access.
Many commercial U.S. insurers do not cover obesity treatments, a decision often driven by the employers who sponsor the coverage, she notes.
Study results have documented that when people with obesity stop taking a GLP-1 agonist their lost weight rebounds, as in a study that tracked people who stopped taking semaglutide.
Dr. Fitch has had success prescribing tirzepatide to patients with obesity but without diabetes who have certain types of Medicare drug coverage policies, which often do not deny off-label drug coverage. That approach works until patients reach the “donut hole” in their drug coverage and are faced with a certain level of out-of-pocket costs that can balloon to several thousand dollars.
Even more workarounds
Other approaches patients have used to acquire Wegovy include purchasing it in other countries, such as Canada or Brazil, says Dr. Fitch. But prices outside the United States, while substantially lower, can still be a barrier for many patients, notes Dr. Oshman.
Semaglutide in Canada goes for about $300 for a 4-week supply, roughly a quarter the U.S. price, she says, but is “still too high for many of my patients.”
Intense patient demand sometimes bordering on desperation has prompted some to seek semaglutide from private compounding pharmacies, a step clinicians regard as downright dangerous.
“Semaglutide from compounding pharmacies is not known to be safe. We feel strongly that it’s not something that people should do,” says Dr. Fitch.
“Compounding pharmacies have no FDA regulation. People don’t know what they’re getting. It’s dangerous,” agrees Dr. Varney. Physicians who refer people for privately compounded semaglutide “are taking advantage of desperate people,” she adds.
Although it seems likely that Novo Nordisk will soon sort out the supply problems and Wegovy will once again become more widely available, some of the issues patients have had with access to the weight loss medication stem from more systemic issues in the United States health insurance landscape: an unwillingness by payers to cover the costs of weight loss medications, a shortcoming that also exists for Medicare and Medicaid.
“We need to make obesity treatment a standard benefit, and not something that can be carved out,” says Dr. Fitch. People with obesity “deserve access to effective treatments for their disease,” she declares.
Dr. Oshman, Dr. Varney, and Dr. Rizo have reported no relevant financial relationships. Dr. Fitch has reported being an advisor to Jenny Craig.
A version of this article first appeared on Medscape.com.
The glucagon-like peptide-1 (GLP-1) agonist semaglutide formulated for treating obesity (Wegovy) had a roaring takeoff a little more than a year ago, with surging patient demand after the U.S. Food and Drug Administration approved it in June 2021. But starting doses of the Wegovy form of semaglutide went missing in action starting late 2021 and continue to date, frustrating patients and their health care providers.
The arrival of Wegovy last year was hailed by obesity medicine specialists and others as a “game changer” for treating people with obesity because of semaglutide’s proven safety and efficacy at the subcutaneous dose of 2.4 mg delivered once a week to produce at least 15% weight loss in half the people who received it, as documented last year in results from one of the drug’s pivotal clinical trials.
But during the months following semaglutide’s approval for treating obesity (it also received an FDA marketing nod in late 2017 as Ozempic for treating type 2 diabetes), a worldwide shortage of Wegovy, including in the United States, emerged.
A manufacturing glitch shut down the primary location for production of U.S.-bound Wegovy injector pens for several months starting in late 2021, according to a December report from Novo Nordisk, the company that makes and markets the agent. (The Wegovy production issue appears to have had a very modest impact, especially in U.S. pharmacies, on the supply of semaglutide formulated as Ozempic, also marketed by Novo Nordisk, although Wegovy supply and demand have dramatically limited Ozempic availability in Australia.)
‘Unprecedented demand’ for Wegovy derailed when plant went offline
The supply side for Wegovy became so hopelessly broken that just months after U.S. sales began and immediately skyrocketed, Novo Nordisk made the remarkable decision to pull starting doses of Wegovy from the market to make it much harder to initiate patients (semaglutide and other GLP-1 agonists require gradual dose ramp-up to avoid gastrointestinal side effects), and the company publicly implored clinicians to not start new patients on the agent, which is where the status remains as of early August 2022.
Novo Nordisk’s financial report for the second quarter of 2022, released on Aug. 3, said the company “expects to make all Wegovy dose strengths available in the United States towards the end of 2022.”
A Dear Health Care Provider letter that Novo Nordisk posted on its U.S. Wegovy website last spring cited “unprecedented demand” that exceeded every prior product launch in the company’s history. It forced Novo Nordisk to pull the plug on all U.S. promotion of Wegovy and compelled the company to ask U.S. clinicians to halt new patient starts.
“I stopped offering Wegovy to new patients” since about the beginning of 2022, says Lauren D. Oshman, MD, a family and obesity medicine specialist at the University of Michigan, Ann Arbor. “It’s very frustrating to not have patients [with obesity] receive the optimal treatment available.” Although she adds that she tries to match obesity treatments to each patient’s clinical needs, and a GLP-1 agonist is not the first choice for every person with obesity.
“It was a disastrous rollout,” says Catherine W. Varney, DO, a family and obesity medicine specialist at the University of Virginia, Charlottesville. “It’s frustrating to know that the treatment is there but not being able to use it,” she said in an interview.
“I had about 800 patients on Wegovy” when the supply dropped earlier this year, and “I couldn’t handle the volume of messages that I got from patients,” recalls Angela Fitch, MD, associate director of the Massachusetts General Hospital Weight Center, Boston. “It was painful,” she said in an interview.
“Frustrating and chaotic,” is the description from Ivania M. Rizo, MD, director of obesity medicine at Boston Medical Center.
The liraglutide/Saxenda workaround
The upshot is that people with obesity and their health care providers have been busy devising workarounds to try to meet the intense demand for this drug-assisted approach to appetite control and weight loss. Their tactics run a wide gamut based on the crazy-quilt diversity of health insurance coverage across America.
Because the bottleneck for starting Wegovy resulted from unavailable starting doses (dosing starts at 0.25 mg delivered subcutaneously once a week, eventually ramping up to a maximum of 2.4 mg weekly), one option was to start patients on a different GLP-1 agonist, such as liraglutide (Saxenda, approved for obesity).
Starting a patient on liraglutide involves the same sort of up-titration and acclimation to a GLP-1 agonist that semaglutide requires, and transition between these agents seems feasible for at least some. It also means daily injections of liraglutide rather than the weekly schedule for semaglutide, although some patients prefer maintaining a daily dosing schedule. Another limitation of liraglutide is that evidence shows it is not nearly as effective for weight loss as semaglutide.
Results from the head-to-head STEP 8 trial, published in JAMA, showed an average weight loss from baseline of about 16% with semaglutide and about 6% with liraglutide (and about 2% with placebo).
A ‘reasonable’ evidence base, but more work
Changing from Saxenda to Wegovy, or from Wegovy to Saxenda, “would be reasonably evidence-based medicine,” said Dr. Oshman in an interview. She has managed a Wegovy-to-Saxenda switch for a “handful” of patients to deal with Wegovy shortages, but she has not yet moved anyone to Wegovy after a Saxenda initiation.
“No prospective study has looked at this transition,” but dose equivalence tables exist based on expert opinion, noted Dr. Oshman, as in this 2020 report.
Dr. Varney has several patients on the Saxenda-to-Wegovy track. She up-titrates patients on Saxenda to the maximum daily dose of 3.0 mg and then switches them to the 1.7 mg weekly dose of Wegovy, one of the “destination” Wegovy doses that has remained generally available during the shortage. But Dr. Varney’s experience is that only half of her patients made the changeover smoothly, with the others having “severe gastrointestinal distress,” including vomiting, she notes.
Dr. Fitch has also successfully used this Saxenda-to-Wegovy approach for some of her patients, but it hasn’t been easy.
“It’s more work and more prior authorizations. It’s harder and adds a layer of stress,” but, Dr. Fitch adds, “people are willing to work on it because the weight loss is worth it.”
The liraglutide to semaglutide shuffle is “doable,” says Dr. Rizo, “but I’m looking forward to not having to do it and being able to just start Wegovy.”
The tirzepatide coupon program works ‘off label’ for obesity
Another workaround depends on the FDA approval in May for tirzepatide (Mounjaro) for type 2 diabetes. Tirzepatide is a related GLP-1 agonist that also adds a second incretin-like agonist activity that mimics the glucose-dependent insulinotropic polypeptide.
Soon after approval, Lilly, the company that markets tirzepatide, started a U.S. coupon program geared exclusively to people with commercial insurance. Within certain refill and dollar limits, the program lets patients buy tirzepatide at pharmacies at an out-of-pocket cost of $25 for a 4-week supply (tirzepatide is also dosed by weekly subcutaneous injections). The program will extend into 2023.
Novo Nordisk offered U.S. patients with commercial insurance a similar discount when Wegovy first hit the U.S. market in 2021, but the program closed down once the supply shortage began.
Despite tirzepatide’s current approval only for type 2 diabetes, Dr. Varney has been successfully prescribing it to patients without diabetes off-label for weight loss.
“The coupons still work even when tirzepatide is used off-label,” she notes. And while the drug’s rollout is still only a couple of months old, so far, it’s gone “beautifully” with no hints of supply issues, she says.
But a major drawback to relying on an introductory coupon program that makes these agents affordable to patients is their ability to maintain treatment once the discounts inevitably end.
“We try to only prescribe agents that patients can continue to access,” says Dr. Fitch, who has had some patients with commercial insurance start on Wegovy with coupon discounts only to later lose access.
Many commercial U.S. insurers do not cover obesity treatments, a decision often driven by the employers who sponsor the coverage, she notes.
Study results have documented that when people with obesity stop taking a GLP-1 agonist their lost weight rebounds, as in a study that tracked people who stopped taking semaglutide.
Dr. Fitch has had success prescribing tirzepatide to patients with obesity but without diabetes who have certain types of Medicare drug coverage policies, which often do not deny off-label drug coverage. That approach works until patients reach the “donut hole” in their drug coverage and are faced with a certain level of out-of-pocket costs that can balloon to several thousand dollars.
Even more workarounds
Other approaches patients have used to acquire Wegovy include purchasing it in other countries, such as Canada or Brazil, says Dr. Fitch. But prices outside the United States, while substantially lower, can still be a barrier for many patients, notes Dr. Oshman.
Semaglutide in Canada goes for about $300 for a 4-week supply, roughly a quarter the U.S. price, she says, but is “still too high for many of my patients.”
Intense patient demand sometimes bordering on desperation has prompted some to seek semaglutide from private compounding pharmacies, a step clinicians regard as downright dangerous.
“Semaglutide from compounding pharmacies is not known to be safe. We feel strongly that it’s not something that people should do,” says Dr. Fitch.
“Compounding pharmacies have no FDA regulation. People don’t know what they’re getting. It’s dangerous,” agrees Dr. Varney. Physicians who refer people for privately compounded semaglutide “are taking advantage of desperate people,” she adds.
Although it seems likely that Novo Nordisk will soon sort out the supply problems and Wegovy will once again become more widely available, some of the issues patients have had with access to the weight loss medication stem from more systemic issues in the United States health insurance landscape: an unwillingness by payers to cover the costs of weight loss medications, a shortcoming that also exists for Medicare and Medicaid.
“We need to make obesity treatment a standard benefit, and not something that can be carved out,” says Dr. Fitch. People with obesity “deserve access to effective treatments for their disease,” she declares.
Dr. Oshman, Dr. Varney, and Dr. Rizo have reported no relevant financial relationships. Dr. Fitch has reported being an advisor to Jenny Craig.
A version of this article first appeared on Medscape.com.
The glucagon-like peptide-1 (GLP-1) agonist semaglutide formulated for treating obesity (Wegovy) had a roaring takeoff a little more than a year ago, with surging patient demand after the U.S. Food and Drug Administration approved it in June 2021. But starting doses of the Wegovy form of semaglutide went missing in action starting late 2021 and continue to date, frustrating patients and their health care providers.
The arrival of Wegovy last year was hailed by obesity medicine specialists and others as a “game changer” for treating people with obesity because of semaglutide’s proven safety and efficacy at the subcutaneous dose of 2.4 mg delivered once a week to produce at least 15% weight loss in half the people who received it, as documented last year in results from one of the drug’s pivotal clinical trials.
But during the months following semaglutide’s approval for treating obesity (it also received an FDA marketing nod in late 2017 as Ozempic for treating type 2 diabetes), a worldwide shortage of Wegovy, including in the United States, emerged.
A manufacturing glitch shut down the primary location for production of U.S.-bound Wegovy injector pens for several months starting in late 2021, according to a December report from Novo Nordisk, the company that makes and markets the agent. (The Wegovy production issue appears to have had a very modest impact, especially in U.S. pharmacies, on the supply of semaglutide formulated as Ozempic, also marketed by Novo Nordisk, although Wegovy supply and demand have dramatically limited Ozempic availability in Australia.)
‘Unprecedented demand’ for Wegovy derailed when plant went offline
The supply side for Wegovy became so hopelessly broken that just months after U.S. sales began and immediately skyrocketed, Novo Nordisk made the remarkable decision to pull starting doses of Wegovy from the market to make it much harder to initiate patients (semaglutide and other GLP-1 agonists require gradual dose ramp-up to avoid gastrointestinal side effects), and the company publicly implored clinicians to not start new patients on the agent, which is where the status remains as of early August 2022.
Novo Nordisk’s financial report for the second quarter of 2022, released on Aug. 3, said the company “expects to make all Wegovy dose strengths available in the United States towards the end of 2022.”
A Dear Health Care Provider letter that Novo Nordisk posted on its U.S. Wegovy website last spring cited “unprecedented demand” that exceeded every prior product launch in the company’s history. It forced Novo Nordisk to pull the plug on all U.S. promotion of Wegovy and compelled the company to ask U.S. clinicians to halt new patient starts.
“I stopped offering Wegovy to new patients” since about the beginning of 2022, says Lauren D. Oshman, MD, a family and obesity medicine specialist at the University of Michigan, Ann Arbor. “It’s very frustrating to not have patients [with obesity] receive the optimal treatment available.” Although she adds that she tries to match obesity treatments to each patient’s clinical needs, and a GLP-1 agonist is not the first choice for every person with obesity.
“It was a disastrous rollout,” says Catherine W. Varney, DO, a family and obesity medicine specialist at the University of Virginia, Charlottesville. “It’s frustrating to know that the treatment is there but not being able to use it,” she said in an interview.
“I had about 800 patients on Wegovy” when the supply dropped earlier this year, and “I couldn’t handle the volume of messages that I got from patients,” recalls Angela Fitch, MD, associate director of the Massachusetts General Hospital Weight Center, Boston. “It was painful,” she said in an interview.
“Frustrating and chaotic,” is the description from Ivania M. Rizo, MD, director of obesity medicine at Boston Medical Center.
The liraglutide/Saxenda workaround
The upshot is that people with obesity and their health care providers have been busy devising workarounds to try to meet the intense demand for this drug-assisted approach to appetite control and weight loss. Their tactics run a wide gamut based on the crazy-quilt diversity of health insurance coverage across America.
Because the bottleneck for starting Wegovy resulted from unavailable starting doses (dosing starts at 0.25 mg delivered subcutaneously once a week, eventually ramping up to a maximum of 2.4 mg weekly), one option was to start patients on a different GLP-1 agonist, such as liraglutide (Saxenda, approved for obesity).
Starting a patient on liraglutide involves the same sort of up-titration and acclimation to a GLP-1 agonist that semaglutide requires, and transition between these agents seems feasible for at least some. It also means daily injections of liraglutide rather than the weekly schedule for semaglutide, although some patients prefer maintaining a daily dosing schedule. Another limitation of liraglutide is that evidence shows it is not nearly as effective for weight loss as semaglutide.
Results from the head-to-head STEP 8 trial, published in JAMA, showed an average weight loss from baseline of about 16% with semaglutide and about 6% with liraglutide (and about 2% with placebo).
A ‘reasonable’ evidence base, but more work
Changing from Saxenda to Wegovy, or from Wegovy to Saxenda, “would be reasonably evidence-based medicine,” said Dr. Oshman in an interview. She has managed a Wegovy-to-Saxenda switch for a “handful” of patients to deal with Wegovy shortages, but she has not yet moved anyone to Wegovy after a Saxenda initiation.
“No prospective study has looked at this transition,” but dose equivalence tables exist based on expert opinion, noted Dr. Oshman, as in this 2020 report.
Dr. Varney has several patients on the Saxenda-to-Wegovy track. She up-titrates patients on Saxenda to the maximum daily dose of 3.0 mg and then switches them to the 1.7 mg weekly dose of Wegovy, one of the “destination” Wegovy doses that has remained generally available during the shortage. But Dr. Varney’s experience is that only half of her patients made the changeover smoothly, with the others having “severe gastrointestinal distress,” including vomiting, she notes.
Dr. Fitch has also successfully used this Saxenda-to-Wegovy approach for some of her patients, but it hasn’t been easy.
“It’s more work and more prior authorizations. It’s harder and adds a layer of stress,” but, Dr. Fitch adds, “people are willing to work on it because the weight loss is worth it.”
The liraglutide to semaglutide shuffle is “doable,” says Dr. Rizo, “but I’m looking forward to not having to do it and being able to just start Wegovy.”
The tirzepatide coupon program works ‘off label’ for obesity
Another workaround depends on the FDA approval in May for tirzepatide (Mounjaro) for type 2 diabetes. Tirzepatide is a related GLP-1 agonist that also adds a second incretin-like agonist activity that mimics the glucose-dependent insulinotropic polypeptide.
Soon after approval, Lilly, the company that markets tirzepatide, started a U.S. coupon program geared exclusively to people with commercial insurance. Within certain refill and dollar limits, the program lets patients buy tirzepatide at pharmacies at an out-of-pocket cost of $25 for a 4-week supply (tirzepatide is also dosed by weekly subcutaneous injections). The program will extend into 2023.
Novo Nordisk offered U.S. patients with commercial insurance a similar discount when Wegovy first hit the U.S. market in 2021, but the program closed down once the supply shortage began.
Despite tirzepatide’s current approval only for type 2 diabetes, Dr. Varney has been successfully prescribing it to patients without diabetes off-label for weight loss.
“The coupons still work even when tirzepatide is used off-label,” she notes. And while the drug’s rollout is still only a couple of months old, so far, it’s gone “beautifully” with no hints of supply issues, she says.
But a major drawback to relying on an introductory coupon program that makes these agents affordable to patients is their ability to maintain treatment once the discounts inevitably end.
“We try to only prescribe agents that patients can continue to access,” says Dr. Fitch, who has had some patients with commercial insurance start on Wegovy with coupon discounts only to later lose access.
Many commercial U.S. insurers do not cover obesity treatments, a decision often driven by the employers who sponsor the coverage, she notes.
Study results have documented that when people with obesity stop taking a GLP-1 agonist their lost weight rebounds, as in a study that tracked people who stopped taking semaglutide.
Dr. Fitch has had success prescribing tirzepatide to patients with obesity but without diabetes who have certain types of Medicare drug coverage policies, which often do not deny off-label drug coverage. That approach works until patients reach the “donut hole” in their drug coverage and are faced with a certain level of out-of-pocket costs that can balloon to several thousand dollars.
Even more workarounds
Other approaches patients have used to acquire Wegovy include purchasing it in other countries, such as Canada or Brazil, says Dr. Fitch. But prices outside the United States, while substantially lower, can still be a barrier for many patients, notes Dr. Oshman.
Semaglutide in Canada goes for about $300 for a 4-week supply, roughly a quarter the U.S. price, she says, but is “still too high for many of my patients.”
Intense patient demand sometimes bordering on desperation has prompted some to seek semaglutide from private compounding pharmacies, a step clinicians regard as downright dangerous.
“Semaglutide from compounding pharmacies is not known to be safe. We feel strongly that it’s not something that people should do,” says Dr. Fitch.
“Compounding pharmacies have no FDA regulation. People don’t know what they’re getting. It’s dangerous,” agrees Dr. Varney. Physicians who refer people for privately compounded semaglutide “are taking advantage of desperate people,” she adds.
Although it seems likely that Novo Nordisk will soon sort out the supply problems and Wegovy will once again become more widely available, some of the issues patients have had with access to the weight loss medication stem from more systemic issues in the United States health insurance landscape: an unwillingness by payers to cover the costs of weight loss medications, a shortcoming that also exists for Medicare and Medicaid.
“We need to make obesity treatment a standard benefit, and not something that can be carved out,” says Dr. Fitch. People with obesity “deserve access to effective treatments for their disease,” she declares.
Dr. Oshman, Dr. Varney, and Dr. Rizo have reported no relevant financial relationships. Dr. Fitch has reported being an advisor to Jenny Craig.
A version of this article first appeared on Medscape.com.