User login
Age, C-reactive protein predict COVID-19 death in diabetes
The data, from the retrospective ACCREDIT cohort study, were presented at the virtual annual meeting of the European Association for the Study of Diabetes (EASD 2021) by Daniel Kevin Llanera, MD.
The combination of older age and high levels of the inflammatory marker CRP were linked to a tripled risk for death by day 7 after hospitalization for COVID-19 among people with diabetes. But, in contrast to other studies, recent A1c and body mass index did not predict COVID-19 outcomes.
“Both of these variables are easily available upon admission to hospital,” Dr. Llanera, who now works at Imperial College, London, said in an EASD press release.
“This means we can easily identify patients early on in their hospital stay who will likely require more aggressive interventions to try and improve survival.”
“It makes sense that CRP and age are important,” said Simon Heller, MB BChir, DM, of the University of Sheffield, England. “It may be that diabetes alone overwhelmed the additional effects of obesity and A1c.
“Certainly in other studies, age was the overwhelming bad prognostic sign among people with diabetes, and perhaps long-term diabetes has effects on the immune system which we haven’t yet identified.”
Kidney disease in younger patients also linked to poorer outcomes
The study, conducted when Dr. Llanera worked for the Countess of Chester NHS Foundation Trust, involved 1,004 patients with diabetes admitted with COVID-19 to seven hospitals in northwest England from Jan. 1 through June 30, 2020. The patients were a mean age of 74.1 years, 60.7% were male, and 45% were in the most deprived quintile based on the U.K. government deprivation index. Overall, 56.2% had macrovascular complications and 49.6% had microvascular complications.
They had a median BMI of 27.6 kg/m2, which is lower than that reported in previous studies and might explain the difference, Dr. Llanera noted.
The primary outcome, death within 7 days of admission, occurred in 24%. By day 30, 33% had died. These rates are higher than the rate found in previous studies, possibly because of greater socioeconomic deprivation and older age of the population, Dr. Llanera speculated.
A total of 7.5% of patients received intensive care by day 7 and 9.8% required intravenous insulin infusions.
On univariate analysis, insulin infusion was found to be protective, with those receiving it half as likely to die as those who didn’t need IV insulin (odds ratio [OR], 0.5).
In contrast, chronic kidney disease in people younger than 70 years increased the risk of death more than twofold (OR, 2.74), as did type 2 diabetes compared with other diabetes types (OR, 2.52).
As in previous studies, use of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers were not associated with COVID-19 outcomes, nor was the presence of diabetes-related complications.
In multivariate analysis, CRP and age emerged as the most significant predictors of the primary outcome, with those deemed high risk by a logistic regression model having an OR of 3.44 for death by day 7 compared with those at lower risk based on the two factors.
Data for glycemic control during the time of hospitalization weren’t available for this study, Dr. Llanera said in response to a question.
“We didn’t look into glycemic control during admission, just at entry, so I can’t answer whether strict glucose control is of benefit. I think it’s worth exploring further whether the use of IV insulin may be of benefit.”
Dr. Llanera also pointed out that people with diabetic kidney disease are in a chronic proinflammatory state and have immune dysregulation, thus potentially hindering their ability to “fight off” the virus.
“In addition, ACE2 receptors are upregulated in the kidneys of patients with diabetic kidney disease. These are molecules that facilitate entry of SARS-CoV-2 into the cells. This may lead to direct attack of the kidneys by the virus, possibly leading to worse overall outcomes,” he said.
Dr. Llanera has reported no relevant financial relationships. Dr. Heller has reported serving as consultant or speaker for Novo Nordisk, Eli Lilly, Sanofi Aventis, Mannkind, Zealand, MSD, and Boehringer Ingelheim.
A version of this article first appeared on Medscape.com.
The data, from the retrospective ACCREDIT cohort study, were presented at the virtual annual meeting of the European Association for the Study of Diabetes (EASD 2021) by Daniel Kevin Llanera, MD.
The combination of older age and high levels of the inflammatory marker CRP were linked to a tripled risk for death by day 7 after hospitalization for COVID-19 among people with diabetes. But, in contrast to other studies, recent A1c and body mass index did not predict COVID-19 outcomes.
“Both of these variables are easily available upon admission to hospital,” Dr. Llanera, who now works at Imperial College, London, said in an EASD press release.
“This means we can easily identify patients early on in their hospital stay who will likely require more aggressive interventions to try and improve survival.”
“It makes sense that CRP and age are important,” said Simon Heller, MB BChir, DM, of the University of Sheffield, England. “It may be that diabetes alone overwhelmed the additional effects of obesity and A1c.
“Certainly in other studies, age was the overwhelming bad prognostic sign among people with diabetes, and perhaps long-term diabetes has effects on the immune system which we haven’t yet identified.”
Kidney disease in younger patients also linked to poorer outcomes
The study, conducted when Dr. Llanera worked for the Countess of Chester NHS Foundation Trust, involved 1,004 patients with diabetes admitted with COVID-19 to seven hospitals in northwest England from Jan. 1 through June 30, 2020. The patients were a mean age of 74.1 years, 60.7% were male, and 45% were in the most deprived quintile based on the U.K. government deprivation index. Overall, 56.2% had macrovascular complications and 49.6% had microvascular complications.
They had a median BMI of 27.6 kg/m2, which is lower than that reported in previous studies and might explain the difference, Dr. Llanera noted.
The primary outcome, death within 7 days of admission, occurred in 24%. By day 30, 33% had died. These rates are higher than the rate found in previous studies, possibly because of greater socioeconomic deprivation and older age of the population, Dr. Llanera speculated.
A total of 7.5% of patients received intensive care by day 7 and 9.8% required intravenous insulin infusions.
On univariate analysis, insulin infusion was found to be protective, with those receiving it half as likely to die as those who didn’t need IV insulin (odds ratio [OR], 0.5).
In contrast, chronic kidney disease in people younger than 70 years increased the risk of death more than twofold (OR, 2.74), as did type 2 diabetes compared with other diabetes types (OR, 2.52).
As in previous studies, use of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers were not associated with COVID-19 outcomes, nor was the presence of diabetes-related complications.
In multivariate analysis, CRP and age emerged as the most significant predictors of the primary outcome, with those deemed high risk by a logistic regression model having an OR of 3.44 for death by day 7 compared with those at lower risk based on the two factors.
Data for glycemic control during the time of hospitalization weren’t available for this study, Dr. Llanera said in response to a question.
“We didn’t look into glycemic control during admission, just at entry, so I can’t answer whether strict glucose control is of benefit. I think it’s worth exploring further whether the use of IV insulin may be of benefit.”
Dr. Llanera also pointed out that people with diabetic kidney disease are in a chronic proinflammatory state and have immune dysregulation, thus potentially hindering their ability to “fight off” the virus.
“In addition, ACE2 receptors are upregulated in the kidneys of patients with diabetic kidney disease. These are molecules that facilitate entry of SARS-CoV-2 into the cells. This may lead to direct attack of the kidneys by the virus, possibly leading to worse overall outcomes,” he said.
Dr. Llanera has reported no relevant financial relationships. Dr. Heller has reported serving as consultant or speaker for Novo Nordisk, Eli Lilly, Sanofi Aventis, Mannkind, Zealand, MSD, and Boehringer Ingelheim.
A version of this article first appeared on Medscape.com.
The data, from the retrospective ACCREDIT cohort study, were presented at the virtual annual meeting of the European Association for the Study of Diabetes (EASD 2021) by Daniel Kevin Llanera, MD.
The combination of older age and high levels of the inflammatory marker CRP were linked to a tripled risk for death by day 7 after hospitalization for COVID-19 among people with diabetes. But, in contrast to other studies, recent A1c and body mass index did not predict COVID-19 outcomes.
“Both of these variables are easily available upon admission to hospital,” Dr. Llanera, who now works at Imperial College, London, said in an EASD press release.
“This means we can easily identify patients early on in their hospital stay who will likely require more aggressive interventions to try and improve survival.”
“It makes sense that CRP and age are important,” said Simon Heller, MB BChir, DM, of the University of Sheffield, England. “It may be that diabetes alone overwhelmed the additional effects of obesity and A1c.
“Certainly in other studies, age was the overwhelming bad prognostic sign among people with diabetes, and perhaps long-term diabetes has effects on the immune system which we haven’t yet identified.”
Kidney disease in younger patients also linked to poorer outcomes
The study, conducted when Dr. Llanera worked for the Countess of Chester NHS Foundation Trust, involved 1,004 patients with diabetes admitted with COVID-19 to seven hospitals in northwest England from Jan. 1 through June 30, 2020. The patients were a mean age of 74.1 years, 60.7% were male, and 45% were in the most deprived quintile based on the U.K. government deprivation index. Overall, 56.2% had macrovascular complications and 49.6% had microvascular complications.
They had a median BMI of 27.6 kg/m2, which is lower than that reported in previous studies and might explain the difference, Dr. Llanera noted.
The primary outcome, death within 7 days of admission, occurred in 24%. By day 30, 33% had died. These rates are higher than the rate found in previous studies, possibly because of greater socioeconomic deprivation and older age of the population, Dr. Llanera speculated.
A total of 7.5% of patients received intensive care by day 7 and 9.8% required intravenous insulin infusions.
On univariate analysis, insulin infusion was found to be protective, with those receiving it half as likely to die as those who didn’t need IV insulin (odds ratio [OR], 0.5).
In contrast, chronic kidney disease in people younger than 70 years increased the risk of death more than twofold (OR, 2.74), as did type 2 diabetes compared with other diabetes types (OR, 2.52).
As in previous studies, use of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers were not associated with COVID-19 outcomes, nor was the presence of diabetes-related complications.
In multivariate analysis, CRP and age emerged as the most significant predictors of the primary outcome, with those deemed high risk by a logistic regression model having an OR of 3.44 for death by day 7 compared with those at lower risk based on the two factors.
Data for glycemic control during the time of hospitalization weren’t available for this study, Dr. Llanera said in response to a question.
“We didn’t look into glycemic control during admission, just at entry, so I can’t answer whether strict glucose control is of benefit. I think it’s worth exploring further whether the use of IV insulin may be of benefit.”
Dr. Llanera also pointed out that people with diabetic kidney disease are in a chronic proinflammatory state and have immune dysregulation, thus potentially hindering their ability to “fight off” the virus.
“In addition, ACE2 receptors are upregulated in the kidneys of patients with diabetic kidney disease. These are molecules that facilitate entry of SARS-CoV-2 into the cells. This may lead to direct attack of the kidneys by the virus, possibly leading to worse overall outcomes,” he said.
Dr. Llanera has reported no relevant financial relationships. Dr. Heller has reported serving as consultant or speaker for Novo Nordisk, Eli Lilly, Sanofi Aventis, Mannkind, Zealand, MSD, and Boehringer Ingelheim.
A version of this article first appeared on Medscape.com.
Women with type 2 diabetes get fewer cardioprotective drugs than do men
At study entry, significantly fewer women received a statin, at 73%, or daily aspirin, at 44%, compared with men, who had treatment rates of 81% and 58%, respectively, Giulia Ferrannini, MD, reported at the annual meeting of the European Association for the Study of Diabetes.
The data also show that significantly fewer women received treatment with an ACE inhibitor or angiotensin-receptor blocker (ARB), at 80%, than men, at 83%, although the absolute between-group difference was modest. Rates of a fourth metric of appropriate treatment, receipt of antihypertensive medications if systolic blood pressure was at least 130 mm Hg, were nearly identical among women and men.
Cardiovascular risk in women “less well managed”
“This is confirmation that women are less well managed than men when it comes to cardiovascular risk, especially if they have [type 2] diabetes,” Dr. Ferrannini said in an interview.
Similar observations have been documented before, including in a report in 2019.
The treatment disparity by sex among the 9901 women and men with type 2 diabetes enrolled in REWIND is particularly striking because in clinical trials “patients are generally better managed than in the real world,” Dr. Ferrannini noted. “Despite this, the pattern of disadvantage to women was still evident,” she added.
“In cardiovascular protection the gender issue is preponderant. Women are less well treated,” she said.
REWIND is the cardiovascular outcomes trial for the once-weekly injectable glucagonlike peptide–1 receptor agonist dulaglutide (Trulicity, Lilly) in patients with type 2 diabetes.
The primary results, reported at the 2019 scientific sessions of the American Diabetes Association and simultaneously published in The Lancet, showed dulaglutide significantly reduced major adverse cardiovascular events (MACE) by 12%, compared with placebo. The study ran at about 300 centers worldwide, including many U.S. and Canadian sites, and 46% of enrolled patients were women.
But despite undertreatment, women had significantly better outcomes in terms of MACE, the primary endpoint, during a median 5.4 years of follow-up compared with men. After adjustment for sex, other baseline characteristics, and study-treatment assignment, women had a significant 27% lower composite rate of nonfatal MI, nonfatal stroke, or death from either cardiovascular or unknown causes, compared with men, said Dr. Ferrannini, a researcher at the Karolinska Institute in Stockholm.
The analysis by sex also showed that women had a significant outcome advantage, compared with men, for three of the four components of the combined MACE outcome: nonfatal MI, cardiovascular death, and all-cause death, as well as for the outcome of hospitalization for heart failure, which was not part of the composite MACE outcome. The only MACE outcome component that showed no significant between-group difference was nonfatal stroke, which had roughly equal incidence rates among women and men.
Women had half the prevalence of CVD at baseline
The results also showed that the women with type 2 diabetes enrolled in REWIND had a prevalence of existing cardiovascular disease of 20%, which was half the rate of men at study entry, at 41%. However, the between-sex differences in the primary outcome, as well as each of the individual cardiovascular disease outcomes, didn’t change based on whether or not patients had a history of cardiovascular disease at baseline.
Only one outcome showed a between-sex difference linked to prevalent cardiovascular disease at study entry, the rate of all-cause mortality, which was not significantly different between men and women with a history of cardiovascular disease, but was 39% lower in women compared with men without such a history.
“The good news is that, at baseline and after 2 years, the majority of participants were meeting the relevant treatment targets regardless of sex,” commented Peter Novodvorsky, MUDr, a diabetes researcher at the University of Sheffield (England), who chaired the session during which Dr. Ferrannini presented her findings.
A role for geography, or selection bias?
The new analyses did not examine whether the overall pattern of undertreatment of women differed among each of the 24 participating countries, or by region of the world.
“We have to assume that these results reflect current [routine] practice” in the 24 countries that contributed patients to the trial, noted Dr. Novodvorsky.
There is also “the well-known issue of selection bias” in randomized trials. The current findings raise the question of whether the women willing to take part in the trial somehow differed from the men, he suggested.
Dr. Ferrannini added: “Even if we do observe a gender difference in management, if the majority of women with type 2 diabetes are appropriately treated, this ‘restores’ their cardiovascular risk advantage, compared with men, with the exception of stroke.”
The main hypothesis generated by the post hoc analysis of REWIND is that “women with diabetes have better outcomes than men if they are treated properly,” she stressed, noting that this “would have to be tested in a trial designed to ascertain gender differences.”
REWIND was sponsored by Eli Lilly. Dr. Ferrannini has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
At study entry, significantly fewer women received a statin, at 73%, or daily aspirin, at 44%, compared with men, who had treatment rates of 81% and 58%, respectively, Giulia Ferrannini, MD, reported at the annual meeting of the European Association for the Study of Diabetes.
The data also show that significantly fewer women received treatment with an ACE inhibitor or angiotensin-receptor blocker (ARB), at 80%, than men, at 83%, although the absolute between-group difference was modest. Rates of a fourth metric of appropriate treatment, receipt of antihypertensive medications if systolic blood pressure was at least 130 mm Hg, were nearly identical among women and men.
Cardiovascular risk in women “less well managed”
“This is confirmation that women are less well managed than men when it comes to cardiovascular risk, especially if they have [type 2] diabetes,” Dr. Ferrannini said in an interview.
Similar observations have been documented before, including in a report in 2019.
The treatment disparity by sex among the 9901 women and men with type 2 diabetes enrolled in REWIND is particularly striking because in clinical trials “patients are generally better managed than in the real world,” Dr. Ferrannini noted. “Despite this, the pattern of disadvantage to women was still evident,” she added.
“In cardiovascular protection the gender issue is preponderant. Women are less well treated,” she said.
REWIND is the cardiovascular outcomes trial for the once-weekly injectable glucagonlike peptide–1 receptor agonist dulaglutide (Trulicity, Lilly) in patients with type 2 diabetes.
The primary results, reported at the 2019 scientific sessions of the American Diabetes Association and simultaneously published in The Lancet, showed dulaglutide significantly reduced major adverse cardiovascular events (MACE) by 12%, compared with placebo. The study ran at about 300 centers worldwide, including many U.S. and Canadian sites, and 46% of enrolled patients were women.
But despite undertreatment, women had significantly better outcomes in terms of MACE, the primary endpoint, during a median 5.4 years of follow-up compared with men. After adjustment for sex, other baseline characteristics, and study-treatment assignment, women had a significant 27% lower composite rate of nonfatal MI, nonfatal stroke, or death from either cardiovascular or unknown causes, compared with men, said Dr. Ferrannini, a researcher at the Karolinska Institute in Stockholm.
The analysis by sex also showed that women had a significant outcome advantage, compared with men, for three of the four components of the combined MACE outcome: nonfatal MI, cardiovascular death, and all-cause death, as well as for the outcome of hospitalization for heart failure, which was not part of the composite MACE outcome. The only MACE outcome component that showed no significant between-group difference was nonfatal stroke, which had roughly equal incidence rates among women and men.
Women had half the prevalence of CVD at baseline
The results also showed that the women with type 2 diabetes enrolled in REWIND had a prevalence of existing cardiovascular disease of 20%, which was half the rate of men at study entry, at 41%. However, the between-sex differences in the primary outcome, as well as each of the individual cardiovascular disease outcomes, didn’t change based on whether or not patients had a history of cardiovascular disease at baseline.
Only one outcome showed a between-sex difference linked to prevalent cardiovascular disease at study entry, the rate of all-cause mortality, which was not significantly different between men and women with a history of cardiovascular disease, but was 39% lower in women compared with men without such a history.
“The good news is that, at baseline and after 2 years, the majority of participants were meeting the relevant treatment targets regardless of sex,” commented Peter Novodvorsky, MUDr, a diabetes researcher at the University of Sheffield (England), who chaired the session during which Dr. Ferrannini presented her findings.
A role for geography, or selection bias?
The new analyses did not examine whether the overall pattern of undertreatment of women differed among each of the 24 participating countries, or by region of the world.
“We have to assume that these results reflect current [routine] practice” in the 24 countries that contributed patients to the trial, noted Dr. Novodvorsky.
There is also “the well-known issue of selection bias” in randomized trials. The current findings raise the question of whether the women willing to take part in the trial somehow differed from the men, he suggested.
Dr. Ferrannini added: “Even if we do observe a gender difference in management, if the majority of women with type 2 diabetes are appropriately treated, this ‘restores’ their cardiovascular risk advantage, compared with men, with the exception of stroke.”
The main hypothesis generated by the post hoc analysis of REWIND is that “women with diabetes have better outcomes than men if they are treated properly,” she stressed, noting that this “would have to be tested in a trial designed to ascertain gender differences.”
REWIND was sponsored by Eli Lilly. Dr. Ferrannini has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
At study entry, significantly fewer women received a statin, at 73%, or daily aspirin, at 44%, compared with men, who had treatment rates of 81% and 58%, respectively, Giulia Ferrannini, MD, reported at the annual meeting of the European Association for the Study of Diabetes.
The data also show that significantly fewer women received treatment with an ACE inhibitor or angiotensin-receptor blocker (ARB), at 80%, than men, at 83%, although the absolute between-group difference was modest. Rates of a fourth metric of appropriate treatment, receipt of antihypertensive medications if systolic blood pressure was at least 130 mm Hg, were nearly identical among women and men.
Cardiovascular risk in women “less well managed”
“This is confirmation that women are less well managed than men when it comes to cardiovascular risk, especially if they have [type 2] diabetes,” Dr. Ferrannini said in an interview.
Similar observations have been documented before, including in a report in 2019.
The treatment disparity by sex among the 9901 women and men with type 2 diabetes enrolled in REWIND is particularly striking because in clinical trials “patients are generally better managed than in the real world,” Dr. Ferrannini noted. “Despite this, the pattern of disadvantage to women was still evident,” she added.
“In cardiovascular protection the gender issue is preponderant. Women are less well treated,” she said.
REWIND is the cardiovascular outcomes trial for the once-weekly injectable glucagonlike peptide–1 receptor agonist dulaglutide (Trulicity, Lilly) in patients with type 2 diabetes.
The primary results, reported at the 2019 scientific sessions of the American Diabetes Association and simultaneously published in The Lancet, showed dulaglutide significantly reduced major adverse cardiovascular events (MACE) by 12%, compared with placebo. The study ran at about 300 centers worldwide, including many U.S. and Canadian sites, and 46% of enrolled patients were women.
But despite undertreatment, women had significantly better outcomes in terms of MACE, the primary endpoint, during a median 5.4 years of follow-up compared with men. After adjustment for sex, other baseline characteristics, and study-treatment assignment, women had a significant 27% lower composite rate of nonfatal MI, nonfatal stroke, or death from either cardiovascular or unknown causes, compared with men, said Dr. Ferrannini, a researcher at the Karolinska Institute in Stockholm.
The analysis by sex also showed that women had a significant outcome advantage, compared with men, for three of the four components of the combined MACE outcome: nonfatal MI, cardiovascular death, and all-cause death, as well as for the outcome of hospitalization for heart failure, which was not part of the composite MACE outcome. The only MACE outcome component that showed no significant between-group difference was nonfatal stroke, which had roughly equal incidence rates among women and men.
Women had half the prevalence of CVD at baseline
The results also showed that the women with type 2 diabetes enrolled in REWIND had a prevalence of existing cardiovascular disease of 20%, which was half the rate of men at study entry, at 41%. However, the between-sex differences in the primary outcome, as well as each of the individual cardiovascular disease outcomes, didn’t change based on whether or not patients had a history of cardiovascular disease at baseline.
Only one outcome showed a between-sex difference linked to prevalent cardiovascular disease at study entry, the rate of all-cause mortality, which was not significantly different between men and women with a history of cardiovascular disease, but was 39% lower in women compared with men without such a history.
“The good news is that, at baseline and after 2 years, the majority of participants were meeting the relevant treatment targets regardless of sex,” commented Peter Novodvorsky, MUDr, a diabetes researcher at the University of Sheffield (England), who chaired the session during which Dr. Ferrannini presented her findings.
A role for geography, or selection bias?
The new analyses did not examine whether the overall pattern of undertreatment of women differed among each of the 24 participating countries, or by region of the world.
“We have to assume that these results reflect current [routine] practice” in the 24 countries that contributed patients to the trial, noted Dr. Novodvorsky.
There is also “the well-known issue of selection bias” in randomized trials. The current findings raise the question of whether the women willing to take part in the trial somehow differed from the men, he suggested.
Dr. Ferrannini added: “Even if we do observe a gender difference in management, if the majority of women with type 2 diabetes are appropriately treated, this ‘restores’ their cardiovascular risk advantage, compared with men, with the exception of stroke.”
The main hypothesis generated by the post hoc analysis of REWIND is that “women with diabetes have better outcomes than men if they are treated properly,” she stressed, noting that this “would have to be tested in a trial designed to ascertain gender differences.”
REWIND was sponsored by Eli Lilly. Dr. Ferrannini has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Time-restricted eating: An easy way to improve metabolic health?
Time-restricted eating – where caloric intake is restricted within a consistent interval of less than 12 hours without overtly attempting to reduce calories – has “generated impressive [animal] data in preventing or reversing metabolic diseases associated with obesity,” and “more rigorous human studies are needed,” conclude the authors of a new review.
“Time-restricted eating is an easy-to-follow and effective dietary strategy that requires less mental math than counting calories,” said senior author Satchidananda Panda, PhD, of the Panda Lab at the Salk Institute for Biological Studies, La Jolla, Calif.
he noted in a press release from the Endocrine Society.
“People who are trying to lose weight and live a healthier lifestyle should pay more attention to when they eat as well as what they eat,” Dr. Panda advised.
Moreover, “eating at random times breaks the synchrony of our internal program [circadian clock] and make us prone to diseases,” so it is important to eat at consistent times.
Furthermore, time-restricted eating, a type of intermittent fasting, “is a lifestyle that anyone can adopt,” he noted, which “can help eliminate health disparities and lets everyone live a healthy and fulfilling life.”
The article, by Emily N. Manoogian, PhD, a postdoctoral fellow in the same lab, and colleagues was published online Sept. 22 in Endocrine Reviews.
The authors suggest that health care providers should encourage high-risk patients (such as those with obesity) to monitor their eating and sleeping times and make easy-to-implement behavior changes, such as decreasing after-dinner snacking and going to bed at the same time each day.
Animal experiments, early studies in humans
In animal experiments, time-restricted feeding without reducing caloric intake prevented or attenuated the severity of metabolic diseases including obesity, glucose intolerance, hepatic steatosis, dyslipidemia, and age-related decline in cardiac function, Dr. Manoogian and colleagues report.
In pilot human studies, time-restricted eating with or without explicit calorie reduction was associated with reductions in body weight, glucose intolerance, hypertension, and dyslipidemia.
Most studies did not restrict calories or provide dietary recommendations, yet participants commonly reduced their caloric intake by 7%-22%.
39 published clinical trials, many upcoming ones
The authors identified 39 clinical trials of time-restricted eating, which were mostly published in the past 2 years, with the earliest one published in 2013.
Most studies were short and small (4-12 weeks, 10-20 participants) and were of people with obesity, healthy adults, and athletes. Most of the trials had an 8- to 10-hour daily “eating window.”
Body weight decreased in 24 of 39 studies, and “importantly,” time-restricted eating was feasible and safe in all studies, the authors note.
“Larger randomized controlled trials are needed as many of the studies to date are smaller pre-post or crossover trials,” Dr. Manoogian and colleagues summarize. “Yet, the replication of findings, even in diverse patient populations, speaks to the potential impact of [time-restricted eating] as a health intervention.”
The many ongoing international clinical trials of time-restricted eating that are listed on clinicaltrials.gov should improve our understanding of time-restricted eating, they add.
Some of the larger trials are in participants with prediabetes (344 participants, NCT03504683), diabetes (144 participants, NCT04155619), metabolic syndrome (118 participants, NCT04057339), and firefighters on 24-hour shifts (150 participants, NCT03533023). There are also smaller pilot studies in participants with cancer (NCT04243512) and polycystic ovary syndrome (NCT03792282).
Be consistent; do not eat within 3 hours of bedtime
In the meantime, the review authors offer several tips:
- Because high melatonin levels (late at night or early morning) can inhibit proper response to food, choose a time to eat that starts at least an hour after waking and stops at least 3 hours before bedtime. If you sleep 8 hours, that leaves 12 hours for the time-restricted eating window.
- Try to eat within the same time window each day.
- Some research suggests eating earlier in the eating phase is better than eating later.
The study received funding from the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute on Aging, the National Cancer Institute, the Larry l. Hillblom Foundation, the Wu Tsai Human Performance Alliance, the U.S. Department of Defense, and the Federal Emergency Management Agency. Dr. Panda has reported receiving royalties from his book, The Circadian Code. The other authors have reported no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
Time-restricted eating – where caloric intake is restricted within a consistent interval of less than 12 hours without overtly attempting to reduce calories – has “generated impressive [animal] data in preventing or reversing metabolic diseases associated with obesity,” and “more rigorous human studies are needed,” conclude the authors of a new review.
“Time-restricted eating is an easy-to-follow and effective dietary strategy that requires less mental math than counting calories,” said senior author Satchidananda Panda, PhD, of the Panda Lab at the Salk Institute for Biological Studies, La Jolla, Calif.
he noted in a press release from the Endocrine Society.
“People who are trying to lose weight and live a healthier lifestyle should pay more attention to when they eat as well as what they eat,” Dr. Panda advised.
Moreover, “eating at random times breaks the synchrony of our internal program [circadian clock] and make us prone to diseases,” so it is important to eat at consistent times.
Furthermore, time-restricted eating, a type of intermittent fasting, “is a lifestyle that anyone can adopt,” he noted, which “can help eliminate health disparities and lets everyone live a healthy and fulfilling life.”
The article, by Emily N. Manoogian, PhD, a postdoctoral fellow in the same lab, and colleagues was published online Sept. 22 in Endocrine Reviews.
The authors suggest that health care providers should encourage high-risk patients (such as those with obesity) to monitor their eating and sleeping times and make easy-to-implement behavior changes, such as decreasing after-dinner snacking and going to bed at the same time each day.
Animal experiments, early studies in humans
In animal experiments, time-restricted feeding without reducing caloric intake prevented or attenuated the severity of metabolic diseases including obesity, glucose intolerance, hepatic steatosis, dyslipidemia, and age-related decline in cardiac function, Dr. Manoogian and colleagues report.
In pilot human studies, time-restricted eating with or without explicit calorie reduction was associated with reductions in body weight, glucose intolerance, hypertension, and dyslipidemia.
Most studies did not restrict calories or provide dietary recommendations, yet participants commonly reduced their caloric intake by 7%-22%.
39 published clinical trials, many upcoming ones
The authors identified 39 clinical trials of time-restricted eating, which were mostly published in the past 2 years, with the earliest one published in 2013.
Most studies were short and small (4-12 weeks, 10-20 participants) and were of people with obesity, healthy adults, and athletes. Most of the trials had an 8- to 10-hour daily “eating window.”
Body weight decreased in 24 of 39 studies, and “importantly,” time-restricted eating was feasible and safe in all studies, the authors note.
“Larger randomized controlled trials are needed as many of the studies to date are smaller pre-post or crossover trials,” Dr. Manoogian and colleagues summarize. “Yet, the replication of findings, even in diverse patient populations, speaks to the potential impact of [time-restricted eating] as a health intervention.”
The many ongoing international clinical trials of time-restricted eating that are listed on clinicaltrials.gov should improve our understanding of time-restricted eating, they add.
Some of the larger trials are in participants with prediabetes (344 participants, NCT03504683), diabetes (144 participants, NCT04155619), metabolic syndrome (118 participants, NCT04057339), and firefighters on 24-hour shifts (150 participants, NCT03533023). There are also smaller pilot studies in participants with cancer (NCT04243512) and polycystic ovary syndrome (NCT03792282).
Be consistent; do not eat within 3 hours of bedtime
In the meantime, the review authors offer several tips:
- Because high melatonin levels (late at night or early morning) can inhibit proper response to food, choose a time to eat that starts at least an hour after waking and stops at least 3 hours before bedtime. If you sleep 8 hours, that leaves 12 hours for the time-restricted eating window.
- Try to eat within the same time window each day.
- Some research suggests eating earlier in the eating phase is better than eating later.
The study received funding from the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute on Aging, the National Cancer Institute, the Larry l. Hillblom Foundation, the Wu Tsai Human Performance Alliance, the U.S. Department of Defense, and the Federal Emergency Management Agency. Dr. Panda has reported receiving royalties from his book, The Circadian Code. The other authors have reported no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
Time-restricted eating – where caloric intake is restricted within a consistent interval of less than 12 hours without overtly attempting to reduce calories – has “generated impressive [animal] data in preventing or reversing metabolic diseases associated with obesity,” and “more rigorous human studies are needed,” conclude the authors of a new review.
“Time-restricted eating is an easy-to-follow and effective dietary strategy that requires less mental math than counting calories,” said senior author Satchidananda Panda, PhD, of the Panda Lab at the Salk Institute for Biological Studies, La Jolla, Calif.
he noted in a press release from the Endocrine Society.
“People who are trying to lose weight and live a healthier lifestyle should pay more attention to when they eat as well as what they eat,” Dr. Panda advised.
Moreover, “eating at random times breaks the synchrony of our internal program [circadian clock] and make us prone to diseases,” so it is important to eat at consistent times.
Furthermore, time-restricted eating, a type of intermittent fasting, “is a lifestyle that anyone can adopt,” he noted, which “can help eliminate health disparities and lets everyone live a healthy and fulfilling life.”
The article, by Emily N. Manoogian, PhD, a postdoctoral fellow in the same lab, and colleagues was published online Sept. 22 in Endocrine Reviews.
The authors suggest that health care providers should encourage high-risk patients (such as those with obesity) to monitor their eating and sleeping times and make easy-to-implement behavior changes, such as decreasing after-dinner snacking and going to bed at the same time each day.
Animal experiments, early studies in humans
In animal experiments, time-restricted feeding without reducing caloric intake prevented or attenuated the severity of metabolic diseases including obesity, glucose intolerance, hepatic steatosis, dyslipidemia, and age-related decline in cardiac function, Dr. Manoogian and colleagues report.
In pilot human studies, time-restricted eating with or without explicit calorie reduction was associated with reductions in body weight, glucose intolerance, hypertension, and dyslipidemia.
Most studies did not restrict calories or provide dietary recommendations, yet participants commonly reduced their caloric intake by 7%-22%.
39 published clinical trials, many upcoming ones
The authors identified 39 clinical trials of time-restricted eating, which were mostly published in the past 2 years, with the earliest one published in 2013.
Most studies were short and small (4-12 weeks, 10-20 participants) and were of people with obesity, healthy adults, and athletes. Most of the trials had an 8- to 10-hour daily “eating window.”
Body weight decreased in 24 of 39 studies, and “importantly,” time-restricted eating was feasible and safe in all studies, the authors note.
“Larger randomized controlled trials are needed as many of the studies to date are smaller pre-post or crossover trials,” Dr. Manoogian and colleagues summarize. “Yet, the replication of findings, even in diverse patient populations, speaks to the potential impact of [time-restricted eating] as a health intervention.”
The many ongoing international clinical trials of time-restricted eating that are listed on clinicaltrials.gov should improve our understanding of time-restricted eating, they add.
Some of the larger trials are in participants with prediabetes (344 participants, NCT03504683), diabetes (144 participants, NCT04155619), metabolic syndrome (118 participants, NCT04057339), and firefighters on 24-hour shifts (150 participants, NCT03533023). There are also smaller pilot studies in participants with cancer (NCT04243512) and polycystic ovary syndrome (NCT03792282).
Be consistent; do not eat within 3 hours of bedtime
In the meantime, the review authors offer several tips:
- Because high melatonin levels (late at night or early morning) can inhibit proper response to food, choose a time to eat that starts at least an hour after waking and stops at least 3 hours before bedtime. If you sleep 8 hours, that leaves 12 hours for the time-restricted eating window.
- Try to eat within the same time window each day.
- Some research suggests eating earlier in the eating phase is better than eating later.
The study received funding from the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute on Aging, the National Cancer Institute, the Larry l. Hillblom Foundation, the Wu Tsai Human Performance Alliance, the U.S. Department of Defense, and the Federal Emergency Management Agency. Dr. Panda has reported receiving royalties from his book, The Circadian Code. The other authors have reported no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
Multiple Sclerosis: The Basics
FDA okays new oral CGRP antagonist for migraine prevention
the manufacturer announced in a release.
The once-daily medication will be available in doses of 10 mg, 30 mg, and 60 mg.
“Qulipta provides a simple oral treatment option specifically developed to prevent migraine attacks and target CGRP, which is believed to be crucially involved in migraine in many patients,” coinvestigator Peter J. Goadsby, MD, PhD, DSc, neurologist and professor at the University of California, Los Angeles, and King’s College London, said in the release.
Approval was based partly on the findings from the phase 3 ADVANCE trial, in which patients with episodic migraine were randomly assigned to receive placebo or a 10-mg, 30-mg, or 60-mg daily dose of atogepant for 12 weeks.
As reported by this news organization, all three doses of atogepant reduced the number of mean monthly migraine days.
With this approval, neurologists will be able to choose from four monoclonal antibodies and two gepants for the preventive treatment of migraine.
“Having another gepant that can also be given preventively is a good idea, because one may be better than the other for a patient,” Alan M. Rapoport, MD, past president of the International Headache Society and founder and director emeritus of the New England Center for Headache, Stamford, Conn., told this news organization.
“Once we have a year or so of experience with atogepant, we’ll have a pretty good idea of which one works better preventively,” said Dr. Rapoport, who was not involved with the research.
Practice changing?
In the ADVANCE trial, there was a reduction of 3.69 migraine days with the 10-mg dose, 3.86 days with the 30-mg dose, and 4.2 days with the 60-mg dose. Placebo was associated with a reduction of 2.48 migraine days.
In addition, more than half of patients in each atogepant arm achieved a reduction in mean monthly migraine days of 50% or greater. This outcome occurred in 55.6% of the 10-mg atogepant group, 58.7% of the 30-mg group, and 60.8% of the 60-mg group. Approximately 29% patients who received placebo achieved this outcome.
The data indicated that atogepant has a favorable safety profile. The most common adverse events associated with treatment were constipation, nausea, and upper respiratory tract infection.
Dr. Rapoport, who is also a clinical professor of neurology at UCLA, noted that he was impressed with the efficacy.
“I’m not as impressed with the adverse events, but they’re not serious, and they don’t necessarily last,” he said.
Although being able to prescribe a single drug for acute and preventive treatment may be an advantage, it remains to be seen whether the tolerability and price of atogepant will be barriers for patients, Dr. Rapoport added.
How the approval will affect clinical practice is also unclear, he noted.
“If you’re going to start someone on a preventive, especially if it’s a woman of childbearing potential, you might just consider one of the two gepants. Doctors will decide once they see how they work,” said Dr. Rapoport.
Not a ‘breakthrough’ treatment
Also commenting ahead of the approval, Elizabeth W. Loder, MD, vice chair for academic affairs in the department of neurology at Brigham and Women’s Hospital, Boston, noted that the “safety of these CGRP medications in pregnancy is uncertain, and there are theoretical reasons to be concerned about it.”
Unlike injectable CGRP medications, atogepant is eliminated from the body relatively quickly after the patient stops taking it, said Dr. Loder, who is also professor of neurology at Harvard Medical School, Boston. However, atogepant may not otherwise differ greatly from other medications of its type.
“I don’t see a reason to think that one of these oral CGRP medicines is much more effective than another one,” said Dr. Loder.
“In my mind, as a clinician who will be prescribing these for patients, it will be cost and the ease of getting it covered that makes the difference,” she added.
These questions may raise concerns. “Those of us who treat patients who do not have private insurance find it very difficult to get these medications for them, even in situations where they have exhausted other alternatives,” said Dr. Loder.
Patients insured by Medicare or Medicaid “usually have no avenue to get some of these new, expensive treatments,” she said.
The approval of atogepant for acute and preventive treatment shows that the distinction between these indications may be artificial, Dr. Loder noted. The approval “will, I hope, help people think more flexibly about the way in which we use medications.”
It is a positive that atogepant has emerged as another option for preventive therapy, but the treatment cannot be considered a breakthrough, Dr. Loder added. The efficacy of atogepant, like that of other preventive treatments for migraine, is modest.
“It would be so nice if we could find things that were more effective than the treatments we currently have,” said Dr. Loder.
A version of this article first appeared on Medscape.com.
the manufacturer announced in a release.
The once-daily medication will be available in doses of 10 mg, 30 mg, and 60 mg.
“Qulipta provides a simple oral treatment option specifically developed to prevent migraine attacks and target CGRP, which is believed to be crucially involved in migraine in many patients,” coinvestigator Peter J. Goadsby, MD, PhD, DSc, neurologist and professor at the University of California, Los Angeles, and King’s College London, said in the release.
Approval was based partly on the findings from the phase 3 ADVANCE trial, in which patients with episodic migraine were randomly assigned to receive placebo or a 10-mg, 30-mg, or 60-mg daily dose of atogepant for 12 weeks.
As reported by this news organization, all three doses of atogepant reduced the number of mean monthly migraine days.
With this approval, neurologists will be able to choose from four monoclonal antibodies and two gepants for the preventive treatment of migraine.
“Having another gepant that can also be given preventively is a good idea, because one may be better than the other for a patient,” Alan M. Rapoport, MD, past president of the International Headache Society and founder and director emeritus of the New England Center for Headache, Stamford, Conn., told this news organization.
“Once we have a year or so of experience with atogepant, we’ll have a pretty good idea of which one works better preventively,” said Dr. Rapoport, who was not involved with the research.
Practice changing?
In the ADVANCE trial, there was a reduction of 3.69 migraine days with the 10-mg dose, 3.86 days with the 30-mg dose, and 4.2 days with the 60-mg dose. Placebo was associated with a reduction of 2.48 migraine days.
In addition, more than half of patients in each atogepant arm achieved a reduction in mean monthly migraine days of 50% or greater. This outcome occurred in 55.6% of the 10-mg atogepant group, 58.7% of the 30-mg group, and 60.8% of the 60-mg group. Approximately 29% patients who received placebo achieved this outcome.
The data indicated that atogepant has a favorable safety profile. The most common adverse events associated with treatment were constipation, nausea, and upper respiratory tract infection.
Dr. Rapoport, who is also a clinical professor of neurology at UCLA, noted that he was impressed with the efficacy.
“I’m not as impressed with the adverse events, but they’re not serious, and they don’t necessarily last,” he said.
Although being able to prescribe a single drug for acute and preventive treatment may be an advantage, it remains to be seen whether the tolerability and price of atogepant will be barriers for patients, Dr. Rapoport added.
How the approval will affect clinical practice is also unclear, he noted.
“If you’re going to start someone on a preventive, especially if it’s a woman of childbearing potential, you might just consider one of the two gepants. Doctors will decide once they see how they work,” said Dr. Rapoport.
Not a ‘breakthrough’ treatment
Also commenting ahead of the approval, Elizabeth W. Loder, MD, vice chair for academic affairs in the department of neurology at Brigham and Women’s Hospital, Boston, noted that the “safety of these CGRP medications in pregnancy is uncertain, and there are theoretical reasons to be concerned about it.”
Unlike injectable CGRP medications, atogepant is eliminated from the body relatively quickly after the patient stops taking it, said Dr. Loder, who is also professor of neurology at Harvard Medical School, Boston. However, atogepant may not otherwise differ greatly from other medications of its type.
“I don’t see a reason to think that one of these oral CGRP medicines is much more effective than another one,” said Dr. Loder.
“In my mind, as a clinician who will be prescribing these for patients, it will be cost and the ease of getting it covered that makes the difference,” she added.
These questions may raise concerns. “Those of us who treat patients who do not have private insurance find it very difficult to get these medications for them, even in situations where they have exhausted other alternatives,” said Dr. Loder.
Patients insured by Medicare or Medicaid “usually have no avenue to get some of these new, expensive treatments,” she said.
The approval of atogepant for acute and preventive treatment shows that the distinction between these indications may be artificial, Dr. Loder noted. The approval “will, I hope, help people think more flexibly about the way in which we use medications.”
It is a positive that atogepant has emerged as another option for preventive therapy, but the treatment cannot be considered a breakthrough, Dr. Loder added. The efficacy of atogepant, like that of other preventive treatments for migraine, is modest.
“It would be so nice if we could find things that were more effective than the treatments we currently have,” said Dr. Loder.
A version of this article first appeared on Medscape.com.
the manufacturer announced in a release.
The once-daily medication will be available in doses of 10 mg, 30 mg, and 60 mg.
“Qulipta provides a simple oral treatment option specifically developed to prevent migraine attacks and target CGRP, which is believed to be crucially involved in migraine in many patients,” coinvestigator Peter J. Goadsby, MD, PhD, DSc, neurologist and professor at the University of California, Los Angeles, and King’s College London, said in the release.
Approval was based partly on the findings from the phase 3 ADVANCE trial, in which patients with episodic migraine were randomly assigned to receive placebo or a 10-mg, 30-mg, or 60-mg daily dose of atogepant for 12 weeks.
As reported by this news organization, all three doses of atogepant reduced the number of mean monthly migraine days.
With this approval, neurologists will be able to choose from four monoclonal antibodies and two gepants for the preventive treatment of migraine.
“Having another gepant that can also be given preventively is a good idea, because one may be better than the other for a patient,” Alan M. Rapoport, MD, past president of the International Headache Society and founder and director emeritus of the New England Center for Headache, Stamford, Conn., told this news organization.
“Once we have a year or so of experience with atogepant, we’ll have a pretty good idea of which one works better preventively,” said Dr. Rapoport, who was not involved with the research.
Practice changing?
In the ADVANCE trial, there was a reduction of 3.69 migraine days with the 10-mg dose, 3.86 days with the 30-mg dose, and 4.2 days with the 60-mg dose. Placebo was associated with a reduction of 2.48 migraine days.
In addition, more than half of patients in each atogepant arm achieved a reduction in mean monthly migraine days of 50% or greater. This outcome occurred in 55.6% of the 10-mg atogepant group, 58.7% of the 30-mg group, and 60.8% of the 60-mg group. Approximately 29% patients who received placebo achieved this outcome.
The data indicated that atogepant has a favorable safety profile. The most common adverse events associated with treatment were constipation, nausea, and upper respiratory tract infection.
Dr. Rapoport, who is also a clinical professor of neurology at UCLA, noted that he was impressed with the efficacy.
“I’m not as impressed with the adverse events, but they’re not serious, and they don’t necessarily last,” he said.
Although being able to prescribe a single drug for acute and preventive treatment may be an advantage, it remains to be seen whether the tolerability and price of atogepant will be barriers for patients, Dr. Rapoport added.
How the approval will affect clinical practice is also unclear, he noted.
“If you’re going to start someone on a preventive, especially if it’s a woman of childbearing potential, you might just consider one of the two gepants. Doctors will decide once they see how they work,” said Dr. Rapoport.
Not a ‘breakthrough’ treatment
Also commenting ahead of the approval, Elizabeth W. Loder, MD, vice chair for academic affairs in the department of neurology at Brigham and Women’s Hospital, Boston, noted that the “safety of these CGRP medications in pregnancy is uncertain, and there are theoretical reasons to be concerned about it.”
Unlike injectable CGRP medications, atogepant is eliminated from the body relatively quickly after the patient stops taking it, said Dr. Loder, who is also professor of neurology at Harvard Medical School, Boston. However, atogepant may not otherwise differ greatly from other medications of its type.
“I don’t see a reason to think that one of these oral CGRP medicines is much more effective than another one,” said Dr. Loder.
“In my mind, as a clinician who will be prescribing these for patients, it will be cost and the ease of getting it covered that makes the difference,” she added.
These questions may raise concerns. “Those of us who treat patients who do not have private insurance find it very difficult to get these medications for them, even in situations where they have exhausted other alternatives,” said Dr. Loder.
Patients insured by Medicare or Medicaid “usually have no avenue to get some of these new, expensive treatments,” she said.
The approval of atogepant for acute and preventive treatment shows that the distinction between these indications may be artificial, Dr. Loder noted. The approval “will, I hope, help people think more flexibly about the way in which we use medications.”
It is a positive that atogepant has emerged as another option for preventive therapy, but the treatment cannot be considered a breakthrough, Dr. Loder added. The efficacy of atogepant, like that of other preventive treatments for migraine, is modest.
“It would be so nice if we could find things that were more effective than the treatments we currently have,” said Dr. Loder.
A version of this article first appeared on Medscape.com.
COVID-19 hospitalization 80% more likely for smokers
Observational data was analyzed alongside hospital coronavirus test data and UK Biobank genetic information for the first time, and the findings are published in Thorax.
The data cover 421,469 people overall. Of these, 3.2% took a polymerase chain reaction swab test, 0.4% of these tested positive, 0.2% of them required hospitalization for COVID-19, and 0.1% of them died because of COVID-19.
When it came to smoking status, 59% had never smoked, 37% were ex-smokers, and 3% were current smokers.
Current smokers were 80% more likely to be admitted to hospital, and significantly more likely to die from COVID-19, than nonsmokers.
Time to quit
Heavy smokers who smoked more than 20 cigarettes a day were 6.11 times more likely to die from COVID-19 than people who had never smoked.
Analysis also showed those with a genetic predisposition to being smokers had a 45% higher infection risk, and 60% higher hospitalization risk.
The authors wrote: “Overall, the congruence of observational analyses indicating associations with recent smoking behaviors and [Mendelian randomization] analyses indicating associations with lifelong predisposition to smoking and smoking heaviness support a causal effect of smoking on COVID-19 severity.”
In a linked podcast, lead researcher Dr. Ashley Clift, said: “Our results strongly suggest that smoking is related to your risk of getting severe COVID, and just as smoking affects your risk of heart disease, different cancers, and all those other conditions we know smoking is linked to, it appears that it’s the same for COVID. So now might be as good a time as any to quit cigarettes and quit smoking.”
These results contrast with previous studies that have suggested a protective effect of smoking against COVID-19. In a linked editorial, Anthony Laverty, PhD, and Christopher Millet, PhD, Imperial College London, wrote: “The idea that tobacco smoking may protect against COVID-19 was always an improbable one.”
A version of this article first appeared on Medscape.com.
Observational data was analyzed alongside hospital coronavirus test data and UK Biobank genetic information for the first time, and the findings are published in Thorax.
The data cover 421,469 people overall. Of these, 3.2% took a polymerase chain reaction swab test, 0.4% of these tested positive, 0.2% of them required hospitalization for COVID-19, and 0.1% of them died because of COVID-19.
When it came to smoking status, 59% had never smoked, 37% were ex-smokers, and 3% were current smokers.
Current smokers were 80% more likely to be admitted to hospital, and significantly more likely to die from COVID-19, than nonsmokers.
Time to quit
Heavy smokers who smoked more than 20 cigarettes a day were 6.11 times more likely to die from COVID-19 than people who had never smoked.
Analysis also showed those with a genetic predisposition to being smokers had a 45% higher infection risk, and 60% higher hospitalization risk.
The authors wrote: “Overall, the congruence of observational analyses indicating associations with recent smoking behaviors and [Mendelian randomization] analyses indicating associations with lifelong predisposition to smoking and smoking heaviness support a causal effect of smoking on COVID-19 severity.”
In a linked podcast, lead researcher Dr. Ashley Clift, said: “Our results strongly suggest that smoking is related to your risk of getting severe COVID, and just as smoking affects your risk of heart disease, different cancers, and all those other conditions we know smoking is linked to, it appears that it’s the same for COVID. So now might be as good a time as any to quit cigarettes and quit smoking.”
These results contrast with previous studies that have suggested a protective effect of smoking against COVID-19. In a linked editorial, Anthony Laverty, PhD, and Christopher Millet, PhD, Imperial College London, wrote: “The idea that tobacco smoking may protect against COVID-19 was always an improbable one.”
A version of this article first appeared on Medscape.com.
Observational data was analyzed alongside hospital coronavirus test data and UK Biobank genetic information for the first time, and the findings are published in Thorax.
The data cover 421,469 people overall. Of these, 3.2% took a polymerase chain reaction swab test, 0.4% of these tested positive, 0.2% of them required hospitalization for COVID-19, and 0.1% of them died because of COVID-19.
When it came to smoking status, 59% had never smoked, 37% were ex-smokers, and 3% were current smokers.
Current smokers were 80% more likely to be admitted to hospital, and significantly more likely to die from COVID-19, than nonsmokers.
Time to quit
Heavy smokers who smoked more than 20 cigarettes a day were 6.11 times more likely to die from COVID-19 than people who had never smoked.
Analysis also showed those with a genetic predisposition to being smokers had a 45% higher infection risk, and 60% higher hospitalization risk.
The authors wrote: “Overall, the congruence of observational analyses indicating associations with recent smoking behaviors and [Mendelian randomization] analyses indicating associations with lifelong predisposition to smoking and smoking heaviness support a causal effect of smoking on COVID-19 severity.”
In a linked podcast, lead researcher Dr. Ashley Clift, said: “Our results strongly suggest that smoking is related to your risk of getting severe COVID, and just as smoking affects your risk of heart disease, different cancers, and all those other conditions we know smoking is linked to, it appears that it’s the same for COVID. So now might be as good a time as any to quit cigarettes and quit smoking.”
These results contrast with previous studies that have suggested a protective effect of smoking against COVID-19. In a linked editorial, Anthony Laverty, PhD, and Christopher Millet, PhD, Imperial College London, wrote: “The idea that tobacco smoking may protect against COVID-19 was always an improbable one.”
A version of this article first appeared on Medscape.com.
Optimizing thyroid management in reproduction
The attraction of reproductive endocrinology and infertility (REI), personally, is the hormonal interplay of the hypothalamus and pituitary with the end organs that are intimately involved in female reproduction. While the sex hormone–producing organs, such as the ovaries and adrenal glands, are directly related to reproductive function, the thyroid gland is typically overlooked until dysfunction occurs, resulting in ovulation dysfunction and pregnancy complications, namely miscarriage and preterm labor. This month we address thyroid function, given its vital role for fertility and pregnancy health and the fetus’ reliance on maternal thyroid hormone during the first trimester to ensure normal neurologic development.
Thyroid disease is the second most common endocrine disorder affecting women of reproductive age; the first being polycystic ovary syndrome (PCOS). Thyroid dysfunction can impair ovulation and, consequently, fertility. Hyperthyroidism is found in approximately 2.3% of women presenting with fertility problems, compared with 1.5% of women in the general population. Hypothyroidism affects 0.5% of women of reproductive age and has been shown to result in impaired reproductive outcomes, including miscarriage, along with adverse obstetric and fetal outcomes. Subclinical hypothyroidism (SCH), defined as an elevated thyroid-stimulating hormone (TSH) level with a normal free T4, has an incidence of 4%-8% in the reproductive-age population. While there is fair evidence SCH increases miscarriage, treatment may result in improved outcomes.
The prevalence of thyroid autoimmunity (TAI) among women of reproductive age is 8%-14% worldwide and it is increased in the infertility population. TAI, defined as the presence of thyroid peroxidase and thyroglobulin antibodies, has been shown to be associated with a reduced live birth rate, increase in preterm birth, and a two- to threefold increase in miscarriage.
The endocrinologic “pendulum” of guidance regarding the effect on and management of thyroid function regarding fertility, pregnancy, and baby has conflicting results. Controlled ovarian hyperstimulation for in vitro fertilization appears to alter TSH levels and levothyroxine requirements increase in the first trimester by approximately 50%. The controversy lies in which population of women should be tested for TAI, which TSH level is acceptable, and how to manage, if at all, euthyroid women with TAI or women with SCH who are trying to conceive. Ultimately, which women would benefit from levothyroxine while trying to conceive and during pregnancy?
Summary of salient studies
- In a meta-analysis, untreated women with SCH had a higher prevalence of miscarriage, compared with euthyroid women (RR, 1.90). Miscarriage rates were even higher in SCH with TIA, compared with women with SCH. The authors recommend “early treatments to avoid adverse pregnancy outcomes and complications.”
- A randomized controlled trial from China studied women who were euthyroid with TAI undergoing IVF. The authors demonstrated levothyroxine did not reduce miscarriage rates or increase live birth rates. To dive further into their cohort, the authors addressed whether TSH above 2.5 mIU/L or above 4 mIU/L (per the American Society for Reproductive Medicine cutoff values) impaired reproductive outcome and found no benefit of levothyroxine in any subgroup. This is consistent with other studies that showed no detrimental effect on pregnancy outcome with TSH levels above 2.5 mIU/L in the normal range and no reduction in miscarriage with the addition of levothyroxine.
- An observational cohort study of IVF patients that underwent preimplantation genetic testing for aneuploidy did not demonstrate an association between chromosomally normal embryos that miscarried and maternal antithyroid antibodies in recurrent miscarriage patients.
- A double-blind, placebo-controlled trial on the use of levothyroxine in euthyroid women with TAI did not result in a higher rate of live births, lower rate of pregnancy loss, or preterm birth, compared with placebo.
Consensus statements
- The American Society for Reproductive Medicine considers it reasonable to test infertile women trying to conceive and to treat SCH with levothyroxine to maintain a TSH less than 2.5 mIU/L and within the normal range. Women who have TAI and TSH greater than 2.5 mIU/L can be considered for treatment with levothyroxine.
- The Endocrine Society recommends levothyroxine in women with SCH who have TAI.
- The American Thyroid Association guideline recommends women with SCH who are undergoing IVF be treated with levothyroxine to achieve a TSH concentration less than 2.5mIU/L.
- The 2011 guidelines of the American Thyroid Association and the 2012 guidelines of the Endocrine Society recommended the specific reference ranges for TSH in the early, middle, and late stages of pregnancy as 0.1-2.5 mIU/L, 0.2-3.0 mIU/L, and 0.3-3.0 mIU/L, respectively.
- The American College of Obstetricians & Gynecologists recommend avoiding universal thyroid screening in pregnancy since “identification and treatment of maternal subclinical hypothyroidism has not been shown to result in improved pregnancy outcomes and neurocognitive function in offspring.”
Conclusion
The 2019 Cochrane Database states there are no clear conclusions regarding treatment with levothyroxine in euthyroid TAI or SCH because of the low quality of evidence reported. While TAI and SCH have been associated with pregnancy complications, there is no apparent benefit of levothyroxine in women with TAI or TSH levels between 2.5 and 4 mIU/L.
So, the conundrum is which preconception women to test and how to manage nonovert thyroid disease. For now, it is reasonable to obtain a serum TSH on all women desiring fertility, to treat SCH with levothyroxine to maintain TSH less than 2.5 mIU/L in the normal range, and to adjust levothyroxine accordingly throughout pregnancy.
Dr. Trolice is director of fertility at CARE – The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando. He has no disclosures. Email him at [email protected].
The attraction of reproductive endocrinology and infertility (REI), personally, is the hormonal interplay of the hypothalamus and pituitary with the end organs that are intimately involved in female reproduction. While the sex hormone–producing organs, such as the ovaries and adrenal glands, are directly related to reproductive function, the thyroid gland is typically overlooked until dysfunction occurs, resulting in ovulation dysfunction and pregnancy complications, namely miscarriage and preterm labor. This month we address thyroid function, given its vital role for fertility and pregnancy health and the fetus’ reliance on maternal thyroid hormone during the first trimester to ensure normal neurologic development.
Thyroid disease is the second most common endocrine disorder affecting women of reproductive age; the first being polycystic ovary syndrome (PCOS). Thyroid dysfunction can impair ovulation and, consequently, fertility. Hyperthyroidism is found in approximately 2.3% of women presenting with fertility problems, compared with 1.5% of women in the general population. Hypothyroidism affects 0.5% of women of reproductive age and has been shown to result in impaired reproductive outcomes, including miscarriage, along with adverse obstetric and fetal outcomes. Subclinical hypothyroidism (SCH), defined as an elevated thyroid-stimulating hormone (TSH) level with a normal free T4, has an incidence of 4%-8% in the reproductive-age population. While there is fair evidence SCH increases miscarriage, treatment may result in improved outcomes.
The prevalence of thyroid autoimmunity (TAI) among women of reproductive age is 8%-14% worldwide and it is increased in the infertility population. TAI, defined as the presence of thyroid peroxidase and thyroglobulin antibodies, has been shown to be associated with a reduced live birth rate, increase in preterm birth, and a two- to threefold increase in miscarriage.
The endocrinologic “pendulum” of guidance regarding the effect on and management of thyroid function regarding fertility, pregnancy, and baby has conflicting results. Controlled ovarian hyperstimulation for in vitro fertilization appears to alter TSH levels and levothyroxine requirements increase in the first trimester by approximately 50%. The controversy lies in which population of women should be tested for TAI, which TSH level is acceptable, and how to manage, if at all, euthyroid women with TAI or women with SCH who are trying to conceive. Ultimately, which women would benefit from levothyroxine while trying to conceive and during pregnancy?
Summary of salient studies
- In a meta-analysis, untreated women with SCH had a higher prevalence of miscarriage, compared with euthyroid women (RR, 1.90). Miscarriage rates were even higher in SCH with TIA, compared with women with SCH. The authors recommend “early treatments to avoid adverse pregnancy outcomes and complications.”
- A randomized controlled trial from China studied women who were euthyroid with TAI undergoing IVF. The authors demonstrated levothyroxine did not reduce miscarriage rates or increase live birth rates. To dive further into their cohort, the authors addressed whether TSH above 2.5 mIU/L or above 4 mIU/L (per the American Society for Reproductive Medicine cutoff values) impaired reproductive outcome and found no benefit of levothyroxine in any subgroup. This is consistent with other studies that showed no detrimental effect on pregnancy outcome with TSH levels above 2.5 mIU/L in the normal range and no reduction in miscarriage with the addition of levothyroxine.
- An observational cohort study of IVF patients that underwent preimplantation genetic testing for aneuploidy did not demonstrate an association between chromosomally normal embryos that miscarried and maternal antithyroid antibodies in recurrent miscarriage patients.
- A double-blind, placebo-controlled trial on the use of levothyroxine in euthyroid women with TAI did not result in a higher rate of live births, lower rate of pregnancy loss, or preterm birth, compared with placebo.
Consensus statements
- The American Society for Reproductive Medicine considers it reasonable to test infertile women trying to conceive and to treat SCH with levothyroxine to maintain a TSH less than 2.5 mIU/L and within the normal range. Women who have TAI and TSH greater than 2.5 mIU/L can be considered for treatment with levothyroxine.
- The Endocrine Society recommends levothyroxine in women with SCH who have TAI.
- The American Thyroid Association guideline recommends women with SCH who are undergoing IVF be treated with levothyroxine to achieve a TSH concentration less than 2.5mIU/L.
- The 2011 guidelines of the American Thyroid Association and the 2012 guidelines of the Endocrine Society recommended the specific reference ranges for TSH in the early, middle, and late stages of pregnancy as 0.1-2.5 mIU/L, 0.2-3.0 mIU/L, and 0.3-3.0 mIU/L, respectively.
- The American College of Obstetricians & Gynecologists recommend avoiding universal thyroid screening in pregnancy since “identification and treatment of maternal subclinical hypothyroidism has not been shown to result in improved pregnancy outcomes and neurocognitive function in offspring.”
Conclusion
The 2019 Cochrane Database states there are no clear conclusions regarding treatment with levothyroxine in euthyroid TAI or SCH because of the low quality of evidence reported. While TAI and SCH have been associated with pregnancy complications, there is no apparent benefit of levothyroxine in women with TAI or TSH levels between 2.5 and 4 mIU/L.
So, the conundrum is which preconception women to test and how to manage nonovert thyroid disease. For now, it is reasonable to obtain a serum TSH on all women desiring fertility, to treat SCH with levothyroxine to maintain TSH less than 2.5 mIU/L in the normal range, and to adjust levothyroxine accordingly throughout pregnancy.
Dr. Trolice is director of fertility at CARE – The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando. He has no disclosures. Email him at [email protected].
The attraction of reproductive endocrinology and infertility (REI), personally, is the hormonal interplay of the hypothalamus and pituitary with the end organs that are intimately involved in female reproduction. While the sex hormone–producing organs, such as the ovaries and adrenal glands, are directly related to reproductive function, the thyroid gland is typically overlooked until dysfunction occurs, resulting in ovulation dysfunction and pregnancy complications, namely miscarriage and preterm labor. This month we address thyroid function, given its vital role for fertility and pregnancy health and the fetus’ reliance on maternal thyroid hormone during the first trimester to ensure normal neurologic development.
Thyroid disease is the second most common endocrine disorder affecting women of reproductive age; the first being polycystic ovary syndrome (PCOS). Thyroid dysfunction can impair ovulation and, consequently, fertility. Hyperthyroidism is found in approximately 2.3% of women presenting with fertility problems, compared with 1.5% of women in the general population. Hypothyroidism affects 0.5% of women of reproductive age and has been shown to result in impaired reproductive outcomes, including miscarriage, along with adverse obstetric and fetal outcomes. Subclinical hypothyroidism (SCH), defined as an elevated thyroid-stimulating hormone (TSH) level with a normal free T4, has an incidence of 4%-8% in the reproductive-age population. While there is fair evidence SCH increases miscarriage, treatment may result in improved outcomes.
The prevalence of thyroid autoimmunity (TAI) among women of reproductive age is 8%-14% worldwide and it is increased in the infertility population. TAI, defined as the presence of thyroid peroxidase and thyroglobulin antibodies, has been shown to be associated with a reduced live birth rate, increase in preterm birth, and a two- to threefold increase in miscarriage.
The endocrinologic “pendulum” of guidance regarding the effect on and management of thyroid function regarding fertility, pregnancy, and baby has conflicting results. Controlled ovarian hyperstimulation for in vitro fertilization appears to alter TSH levels and levothyroxine requirements increase in the first trimester by approximately 50%. The controversy lies in which population of women should be tested for TAI, which TSH level is acceptable, and how to manage, if at all, euthyroid women with TAI or women with SCH who are trying to conceive. Ultimately, which women would benefit from levothyroxine while trying to conceive and during pregnancy?
Summary of salient studies
- In a meta-analysis, untreated women with SCH had a higher prevalence of miscarriage, compared with euthyroid women (RR, 1.90). Miscarriage rates were even higher in SCH with TIA, compared with women with SCH. The authors recommend “early treatments to avoid adverse pregnancy outcomes and complications.”
- A randomized controlled trial from China studied women who were euthyroid with TAI undergoing IVF. The authors demonstrated levothyroxine did not reduce miscarriage rates or increase live birth rates. To dive further into their cohort, the authors addressed whether TSH above 2.5 mIU/L or above 4 mIU/L (per the American Society for Reproductive Medicine cutoff values) impaired reproductive outcome and found no benefit of levothyroxine in any subgroup. This is consistent with other studies that showed no detrimental effect on pregnancy outcome with TSH levels above 2.5 mIU/L in the normal range and no reduction in miscarriage with the addition of levothyroxine.
- An observational cohort study of IVF patients that underwent preimplantation genetic testing for aneuploidy did not demonstrate an association between chromosomally normal embryos that miscarried and maternal antithyroid antibodies in recurrent miscarriage patients.
- A double-blind, placebo-controlled trial on the use of levothyroxine in euthyroid women with TAI did not result in a higher rate of live births, lower rate of pregnancy loss, or preterm birth, compared with placebo.
Consensus statements
- The American Society for Reproductive Medicine considers it reasonable to test infertile women trying to conceive and to treat SCH with levothyroxine to maintain a TSH less than 2.5 mIU/L and within the normal range. Women who have TAI and TSH greater than 2.5 mIU/L can be considered for treatment with levothyroxine.
- The Endocrine Society recommends levothyroxine in women with SCH who have TAI.
- The American Thyroid Association guideline recommends women with SCH who are undergoing IVF be treated with levothyroxine to achieve a TSH concentration less than 2.5mIU/L.
- The 2011 guidelines of the American Thyroid Association and the 2012 guidelines of the Endocrine Society recommended the specific reference ranges for TSH in the early, middle, and late stages of pregnancy as 0.1-2.5 mIU/L, 0.2-3.0 mIU/L, and 0.3-3.0 mIU/L, respectively.
- The American College of Obstetricians & Gynecologists recommend avoiding universal thyroid screening in pregnancy since “identification and treatment of maternal subclinical hypothyroidism has not been shown to result in improved pregnancy outcomes and neurocognitive function in offspring.”
Conclusion
The 2019 Cochrane Database states there are no clear conclusions regarding treatment with levothyroxine in euthyroid TAI or SCH because of the low quality of evidence reported. While TAI and SCH have been associated with pregnancy complications, there is no apparent benefit of levothyroxine in women with TAI or TSH levels between 2.5 and 4 mIU/L.
So, the conundrum is which preconception women to test and how to manage nonovert thyroid disease. For now, it is reasonable to obtain a serum TSH on all women desiring fertility, to treat SCH with levothyroxine to maintain TSH less than 2.5 mIU/L in the normal range, and to adjust levothyroxine accordingly throughout pregnancy.
Dr. Trolice is director of fertility at CARE – The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando. He has no disclosures. Email him at [email protected].
‘Beloved’ fired oncologist inspires patient-funded billboards
Driving along busy Custer Avenue in Helena, Mont., residents and visitors may notice a large billboard that simply reads: “We Support Dr. Tom Weiner.”
They got together to raise $5,000 through a huge yard sale this summer. Some of the volunteers were cancer patients with active disease, challenged by a record-breaking heatwave, but determined to show up for the man they call “our doc.”
Dr. Weiner was their medical oncologist, and they want him back.
After working for 24 years at the only medical center in Helena, including the last five as its sole medical oncologist, Dr. Weiner was suddenly fired in November 2020.
He was removed for allegedly causing harm to patients, despite having a flawless record with the state’s Board of Medical Examiners, as previously reported by this news organization.
Since then, Dr. Weiner launched a lawsuit against the medical center, St. Peter’s Health, and seeks damages in a jury trial, now scheduled for the fall of 2022.
Patients and families quickly rallied to support him. Within days, they formed the Facebook group We stand with Dr. Tom Weiner (4,000+ members) and, later, the more activist-oriented Patients and Friends of Dr. Tom Weiner (600+ members). Unlike some cause-oriented social media sites, the groups are busy, with fresh posts nearly every day.
In the past year, these supporters, who sometimes call themselves “Team Weiner,” have become a presence in Helena (population 32,000), undertaking a steady stream of activism, including performing weekly “stand-in” protests outside St. Peter’s.
In addition to funding billboards, the collection of patients, family members, and friends have installed lawn signs and worn face masks and T-shirts with pro-Weiner messages. All promotions are paid for by supporters.
Dr. Weiner does not participate in these activities, nor does he receive any of the money raised, his supporters emphasize.
A number of patients have also filed their own lawsuit against St. Peter’s for allegedly removing its only oncologist “without adequate notice or planning,” which “caused the hundreds of cancer patients to be left in a lurch without adequate care,” according to Keif Storrar, a lawyer involved in the suit.
Nearly a year after firing Dr. Weiner, St. Peter’s still does not have a replacement.
“We currently have three locum tenens medical oncologists and hematologists,” said Kathryn Gallagher, a spokesperson for St. Peter’s.
The medical center is “working closely with Huntsman Cancer Institute [in Utah] to operationalize our affiliation and recruit permanent medical oncologists to St. Peter’s,” she added.
Doc not working for nearly a year
Dr. Weiner, who is married with two adult children, has not worked over the past 11 months.
During that time, many of his former patients and their loved ones have been unwavering in their support for him. Some lit up their homes at Christmas with unifying purple lights to keep their tie with the oncologist symbolically alive.
“This is something of a phenomenon — this doctor is so beloved in this community. We will not give up,” commented Laura Fix, a local wine and spirits store owner who is married to one of Dr. Weiner’s former patients.
“Funny story,” said Ms. Fix, “when all this happened and we got the Facebook page going, and everyone was telling their personal story [about Dr. Weiner], I said to my husband, ‘God, I thought he just liked us.’ I realized he was wonderful with everybody and then I liked him even more.”
Dr. Weiner’s case has created a movement among otherwise strangers.
“None of us knew each other before,” said Dayna Hartley, a former patient treated for ovarian cancer and under Dr. Weiner’s care at the time of his firing.
“We all came together in our love for Dr. Weiner. Now we’re tight. Super tight,” she commented.
A former patient of Dr. Weiner’s at a weekly “stand-in” protest near St. Peter’s Health in Helena.
A silent prayer vigil for Dr. Weiner is planned for October 15, the 1-year anniversary of his being suspended by St Peter’s (which was followed by his firing in November). The candlelight event will take place on sidewalks outside of the medical center’s campus.
Ms. Gallagher said the medical center has not attempted to stop the near-yearlong protests: “We respect peaceful protest on public property,” she noted.
Vigil participants can sign a card for Dr. Weiner or deposit one with the organizers, which will be sent to the oncologist. He does not work with the activists and will not attend the vigil.
His lawyer, J. Devlan Geddes, said that Dr. Weiner “is very humbled and appreciative of the support he has received from the community” and hopes to return to work in Helena.
Another $6,000 raised this month
The pro-Weiner billboard scheme is the brainchild of Ms. Hartley, a resident of nearby Montana City, which is part of the larger Helena “micropolitan” area (population 81,000).
Ms. Hartley says that she first tried to place the ad with local billboard companies. “No one would touch them,” she said.
She speculates that this is because Dr. Weiner was fired by St Peter’s Health, the largest employer in town after the state government (Helena is the state capital). “They [St Peter’s] spend a lot of money and a lot of local businesses don’t want to upset them,” she said.
The activists eventually turned to Lamar Advertising, one of the largest billboard companies in the world. But the cost of billboards tested the supporters’ resources. So Ms. Hartley hatched a second idea — a big yard sale, which needed a big space.
That’s when Ms. Fix and her husband Bud Clinch stepped up. Mr. Clinch was diagnosed with chronic myeloid leukemia (CML) by Dr. Weiner 14 years ago (after a set of misdiagnoses from other physicians) and was under his care until the firing.
The couple have a 48-acre ranch about a mile outside of town and offered to host the event. A team of organizers set a date for the yard sale — July 23 and 24 — and moved toward it.
The sale was advertised in the town’s newspaper and online in social media groups, and generated buzz.
First, donations poured in.
“I was in tears,” said Ms. Fix. “People arrived with pickup trucks and U-Hauls full of goods to drop off — and not just a bunch of junk. The generosity of people was unbelievable.”
There was a core group of about 20 volunteers, she said. “I can’t tell you how much those people worked in the hot sun.”
A fundraising yard sale was held in July to help pay for the billboard supporting Dr. Tom Weiner.
Folks in Helena are known for “pitch-in” events to help out neighbors, Ms. Fix said. But this was unlike anything the native Montanan had ever seen. “Hundreds” of bargain hunters attended the sale, she says, which included some high-end items such as designer purses donated by a woman in California who is a Dr. Weiner supporter.
The ranch’s guesthouse, a former creamery on the onetime farm, was stocked with water, vitamin water, sandwiches, trail mix and home-baked goods for volunteers to get out of the sun and the near-100°F temperatures.
The couple’s twin grandchildren ran a lemonade stand. Both of their grandfathers were treated by Dr. Weiner — Poppa Bud for CML and Poppa Tom for colon cancer, said Ms. Fix.
A second yard sale, also at the Clinch and Fix ranch, was held just 2 weeks ago and raised another $6,000.
Billboards in different locations in Helena are now planned until the year’s end, said Ms. Hartley. Receipts from the yard sales cover the costs. Ms. Hartley’s not worried about raising more money after that nor about the length of time needed to keep their fight going.
Dr. Weiner’s supporters, she said, “will plan to do more [billboards] in the future, for as long as it takes to vindicate our Doc.”
A version of this article first appeared on Medscape.com.
Driving along busy Custer Avenue in Helena, Mont., residents and visitors may notice a large billboard that simply reads: “We Support Dr. Tom Weiner.”
They got together to raise $5,000 through a huge yard sale this summer. Some of the volunteers were cancer patients with active disease, challenged by a record-breaking heatwave, but determined to show up for the man they call “our doc.”
Dr. Weiner was their medical oncologist, and they want him back.
After working for 24 years at the only medical center in Helena, including the last five as its sole medical oncologist, Dr. Weiner was suddenly fired in November 2020.
He was removed for allegedly causing harm to patients, despite having a flawless record with the state’s Board of Medical Examiners, as previously reported by this news organization.
Since then, Dr. Weiner launched a lawsuit against the medical center, St. Peter’s Health, and seeks damages in a jury trial, now scheduled for the fall of 2022.
Patients and families quickly rallied to support him. Within days, they formed the Facebook group We stand with Dr. Tom Weiner (4,000+ members) and, later, the more activist-oriented Patients and Friends of Dr. Tom Weiner (600+ members). Unlike some cause-oriented social media sites, the groups are busy, with fresh posts nearly every day.
In the past year, these supporters, who sometimes call themselves “Team Weiner,” have become a presence in Helena (population 32,000), undertaking a steady stream of activism, including performing weekly “stand-in” protests outside St. Peter’s.
In addition to funding billboards, the collection of patients, family members, and friends have installed lawn signs and worn face masks and T-shirts with pro-Weiner messages. All promotions are paid for by supporters.
Dr. Weiner does not participate in these activities, nor does he receive any of the money raised, his supporters emphasize.
A number of patients have also filed their own lawsuit against St. Peter’s for allegedly removing its only oncologist “without adequate notice or planning,” which “caused the hundreds of cancer patients to be left in a lurch without adequate care,” according to Keif Storrar, a lawyer involved in the suit.
Nearly a year after firing Dr. Weiner, St. Peter’s still does not have a replacement.
“We currently have three locum tenens medical oncologists and hematologists,” said Kathryn Gallagher, a spokesperson for St. Peter’s.
The medical center is “working closely with Huntsman Cancer Institute [in Utah] to operationalize our affiliation and recruit permanent medical oncologists to St. Peter’s,” she added.
Doc not working for nearly a year
Dr. Weiner, who is married with two adult children, has not worked over the past 11 months.
During that time, many of his former patients and their loved ones have been unwavering in their support for him. Some lit up their homes at Christmas with unifying purple lights to keep their tie with the oncologist symbolically alive.
“This is something of a phenomenon — this doctor is so beloved in this community. We will not give up,” commented Laura Fix, a local wine and spirits store owner who is married to one of Dr. Weiner’s former patients.
“Funny story,” said Ms. Fix, “when all this happened and we got the Facebook page going, and everyone was telling their personal story [about Dr. Weiner], I said to my husband, ‘God, I thought he just liked us.’ I realized he was wonderful with everybody and then I liked him even more.”
Dr. Weiner’s case has created a movement among otherwise strangers.
“None of us knew each other before,” said Dayna Hartley, a former patient treated for ovarian cancer and under Dr. Weiner’s care at the time of his firing.
“We all came together in our love for Dr. Weiner. Now we’re tight. Super tight,” she commented.
A former patient of Dr. Weiner’s at a weekly “stand-in” protest near St. Peter’s Health in Helena.
A silent prayer vigil for Dr. Weiner is planned for October 15, the 1-year anniversary of his being suspended by St Peter’s (which was followed by his firing in November). The candlelight event will take place on sidewalks outside of the medical center’s campus.
Ms. Gallagher said the medical center has not attempted to stop the near-yearlong protests: “We respect peaceful protest on public property,” she noted.
Vigil participants can sign a card for Dr. Weiner or deposit one with the organizers, which will be sent to the oncologist. He does not work with the activists and will not attend the vigil.
His lawyer, J. Devlan Geddes, said that Dr. Weiner “is very humbled and appreciative of the support he has received from the community” and hopes to return to work in Helena.
Another $6,000 raised this month
The pro-Weiner billboard scheme is the brainchild of Ms. Hartley, a resident of nearby Montana City, which is part of the larger Helena “micropolitan” area (population 81,000).
Ms. Hartley says that she first tried to place the ad with local billboard companies. “No one would touch them,” she said.
She speculates that this is because Dr. Weiner was fired by St Peter’s Health, the largest employer in town after the state government (Helena is the state capital). “They [St Peter’s] spend a lot of money and a lot of local businesses don’t want to upset them,” she said.
The activists eventually turned to Lamar Advertising, one of the largest billboard companies in the world. But the cost of billboards tested the supporters’ resources. So Ms. Hartley hatched a second idea — a big yard sale, which needed a big space.
That’s when Ms. Fix and her husband Bud Clinch stepped up. Mr. Clinch was diagnosed with chronic myeloid leukemia (CML) by Dr. Weiner 14 years ago (after a set of misdiagnoses from other physicians) and was under his care until the firing.
The couple have a 48-acre ranch about a mile outside of town and offered to host the event. A team of organizers set a date for the yard sale — July 23 and 24 — and moved toward it.
The sale was advertised in the town’s newspaper and online in social media groups, and generated buzz.
First, donations poured in.
“I was in tears,” said Ms. Fix. “People arrived with pickup trucks and U-Hauls full of goods to drop off — and not just a bunch of junk. The generosity of people was unbelievable.”
There was a core group of about 20 volunteers, she said. “I can’t tell you how much those people worked in the hot sun.”
A fundraising yard sale was held in July to help pay for the billboard supporting Dr. Tom Weiner.
Folks in Helena are known for “pitch-in” events to help out neighbors, Ms. Fix said. But this was unlike anything the native Montanan had ever seen. “Hundreds” of bargain hunters attended the sale, she says, which included some high-end items such as designer purses donated by a woman in California who is a Dr. Weiner supporter.
The ranch’s guesthouse, a former creamery on the onetime farm, was stocked with water, vitamin water, sandwiches, trail mix and home-baked goods for volunteers to get out of the sun and the near-100°F temperatures.
The couple’s twin grandchildren ran a lemonade stand. Both of their grandfathers were treated by Dr. Weiner — Poppa Bud for CML and Poppa Tom for colon cancer, said Ms. Fix.
A second yard sale, also at the Clinch and Fix ranch, was held just 2 weeks ago and raised another $6,000.
Billboards in different locations in Helena are now planned until the year’s end, said Ms. Hartley. Receipts from the yard sales cover the costs. Ms. Hartley’s not worried about raising more money after that nor about the length of time needed to keep their fight going.
Dr. Weiner’s supporters, she said, “will plan to do more [billboards] in the future, for as long as it takes to vindicate our Doc.”
A version of this article first appeared on Medscape.com.
Driving along busy Custer Avenue in Helena, Mont., residents and visitors may notice a large billboard that simply reads: “We Support Dr. Tom Weiner.”
They got together to raise $5,000 through a huge yard sale this summer. Some of the volunteers were cancer patients with active disease, challenged by a record-breaking heatwave, but determined to show up for the man they call “our doc.”
Dr. Weiner was their medical oncologist, and they want him back.
After working for 24 years at the only medical center in Helena, including the last five as its sole medical oncologist, Dr. Weiner was suddenly fired in November 2020.
He was removed for allegedly causing harm to patients, despite having a flawless record with the state’s Board of Medical Examiners, as previously reported by this news organization.
Since then, Dr. Weiner launched a lawsuit against the medical center, St. Peter’s Health, and seeks damages in a jury trial, now scheduled for the fall of 2022.
Patients and families quickly rallied to support him. Within days, they formed the Facebook group We stand with Dr. Tom Weiner (4,000+ members) and, later, the more activist-oriented Patients and Friends of Dr. Tom Weiner (600+ members). Unlike some cause-oriented social media sites, the groups are busy, with fresh posts nearly every day.
In the past year, these supporters, who sometimes call themselves “Team Weiner,” have become a presence in Helena (population 32,000), undertaking a steady stream of activism, including performing weekly “stand-in” protests outside St. Peter’s.
In addition to funding billboards, the collection of patients, family members, and friends have installed lawn signs and worn face masks and T-shirts with pro-Weiner messages. All promotions are paid for by supporters.
Dr. Weiner does not participate in these activities, nor does he receive any of the money raised, his supporters emphasize.
A number of patients have also filed their own lawsuit against St. Peter’s for allegedly removing its only oncologist “without adequate notice or planning,” which “caused the hundreds of cancer patients to be left in a lurch without adequate care,” according to Keif Storrar, a lawyer involved in the suit.
Nearly a year after firing Dr. Weiner, St. Peter’s still does not have a replacement.
“We currently have three locum tenens medical oncologists and hematologists,” said Kathryn Gallagher, a spokesperson for St. Peter’s.
The medical center is “working closely with Huntsman Cancer Institute [in Utah] to operationalize our affiliation and recruit permanent medical oncologists to St. Peter’s,” she added.
Doc not working for nearly a year
Dr. Weiner, who is married with two adult children, has not worked over the past 11 months.
During that time, many of his former patients and their loved ones have been unwavering in their support for him. Some lit up their homes at Christmas with unifying purple lights to keep their tie with the oncologist symbolically alive.
“This is something of a phenomenon — this doctor is so beloved in this community. We will not give up,” commented Laura Fix, a local wine and spirits store owner who is married to one of Dr. Weiner’s former patients.
“Funny story,” said Ms. Fix, “when all this happened and we got the Facebook page going, and everyone was telling their personal story [about Dr. Weiner], I said to my husband, ‘God, I thought he just liked us.’ I realized he was wonderful with everybody and then I liked him even more.”
Dr. Weiner’s case has created a movement among otherwise strangers.
“None of us knew each other before,” said Dayna Hartley, a former patient treated for ovarian cancer and under Dr. Weiner’s care at the time of his firing.
“We all came together in our love for Dr. Weiner. Now we’re tight. Super tight,” she commented.
A former patient of Dr. Weiner’s at a weekly “stand-in” protest near St. Peter’s Health in Helena.
A silent prayer vigil for Dr. Weiner is planned for October 15, the 1-year anniversary of his being suspended by St Peter’s (which was followed by his firing in November). The candlelight event will take place on sidewalks outside of the medical center’s campus.
Ms. Gallagher said the medical center has not attempted to stop the near-yearlong protests: “We respect peaceful protest on public property,” she noted.
Vigil participants can sign a card for Dr. Weiner or deposit one with the organizers, which will be sent to the oncologist. He does not work with the activists and will not attend the vigil.
His lawyer, J. Devlan Geddes, said that Dr. Weiner “is very humbled and appreciative of the support he has received from the community” and hopes to return to work in Helena.
Another $6,000 raised this month
The pro-Weiner billboard scheme is the brainchild of Ms. Hartley, a resident of nearby Montana City, which is part of the larger Helena “micropolitan” area (population 81,000).
Ms. Hartley says that she first tried to place the ad with local billboard companies. “No one would touch them,” she said.
She speculates that this is because Dr. Weiner was fired by St Peter’s Health, the largest employer in town after the state government (Helena is the state capital). “They [St Peter’s] spend a lot of money and a lot of local businesses don’t want to upset them,” she said.
The activists eventually turned to Lamar Advertising, one of the largest billboard companies in the world. But the cost of billboards tested the supporters’ resources. So Ms. Hartley hatched a second idea — a big yard sale, which needed a big space.
That’s when Ms. Fix and her husband Bud Clinch stepped up. Mr. Clinch was diagnosed with chronic myeloid leukemia (CML) by Dr. Weiner 14 years ago (after a set of misdiagnoses from other physicians) and was under his care until the firing.
The couple have a 48-acre ranch about a mile outside of town and offered to host the event. A team of organizers set a date for the yard sale — July 23 and 24 — and moved toward it.
The sale was advertised in the town’s newspaper and online in social media groups, and generated buzz.
First, donations poured in.
“I was in tears,” said Ms. Fix. “People arrived with pickup trucks and U-Hauls full of goods to drop off — and not just a bunch of junk. The generosity of people was unbelievable.”
There was a core group of about 20 volunteers, she said. “I can’t tell you how much those people worked in the hot sun.”
A fundraising yard sale was held in July to help pay for the billboard supporting Dr. Tom Weiner.
Folks in Helena are known for “pitch-in” events to help out neighbors, Ms. Fix said. But this was unlike anything the native Montanan had ever seen. “Hundreds” of bargain hunters attended the sale, she says, which included some high-end items such as designer purses donated by a woman in California who is a Dr. Weiner supporter.
The ranch’s guesthouse, a former creamery on the onetime farm, was stocked with water, vitamin water, sandwiches, trail mix and home-baked goods for volunteers to get out of the sun and the near-100°F temperatures.
The couple’s twin grandchildren ran a lemonade stand. Both of their grandfathers were treated by Dr. Weiner — Poppa Bud for CML and Poppa Tom for colon cancer, said Ms. Fix.
A second yard sale, also at the Clinch and Fix ranch, was held just 2 weeks ago and raised another $6,000.
Billboards in different locations in Helena are now planned until the year’s end, said Ms. Hartley. Receipts from the yard sales cover the costs. Ms. Hartley’s not worried about raising more money after that nor about the length of time needed to keep their fight going.
Dr. Weiner’s supporters, she said, “will plan to do more [billboards] in the future, for as long as it takes to vindicate our Doc.”
A version of this article first appeared on Medscape.com.