MONTREAL – Pediatric patients with low-risk differentiated thyroid cancer (DTC) who are spared radioactive iodine (RAI) therapy show no increases in the risk of remission, compared with those who do receive it, supporting guidelines that recommend against use of RAI in such patients.

“In 2015, when the American Thyroid Association [ATA] created their pediatric guidelines [on RAI therapy in DTC], they were taking a leap of faith that these [pediatric DTC] patients would be able to achieve remission without RAI,” said first author Mya Bojarsky, Children’s Hospital of Philadelphia (CHOP), when presenting the findings at the American Thyroid Association annual meeting.

“This is the first study to validate those guidelines and support the sentiment that for ATA low-risk pediatric thyroid cancer patients, withholding RAI therapy is clinically beneficial as it reduces exposure to radiation while having no negative impact on remission,” she said.

Prior to 2015, thyroidectomy in combination with RAI was the standard treatment for DTC in pediatric patients. However, data showing that radiation exposure in children increases the risk of secondary hematologic malignancies by 51% and solid malignancies by 23% over a lifetime raised concerns and led to a push to change the treatment approach.

In response, the 2015 ATA pediatric guidelines recommended that patients not receive RAI for the treatment of DTC that was mostly confined to the thyroid (N0 or minimal N1a disease).

Senior author Andrew J. Bauer, MD, noted that, in addition to being the first study to confirm that withholding RAI in low-risk patients is associated with the same rate of achieving remission as patients treated with RAI, the study also endorses that assessments at 1 year can be reliable predictors of remission.

“For these patients, the 1-year mark post-initial treatment (thyroidectomy) is an early and accurate time point for initial assessment of remission, with increasing rates of remission with continued surveillance (at last clinical follow-up) of approximately 90% 2 years post initial treatment,” said Dr. Bauer, medical director, CHOP, and professor of pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.

“This approach has recently been validated through a prospective study in adult patients,” he added. A large recent study of 730 patients, published in the New England Journal of Medicine, supported the omission of RAI in low-risk DTC in adults, showing that, compared with those who received RAI, the no-RAI group was noninferior in the occurrence of functional, structural, and biologic events at 3 years.
 

Safe to eliminate RAI therapy in low-risk DTC in children

With limited data on how or if the change in treatment had an impact on rates of remission in pediatric patients, Ms. Bojarsky and colleagues conducted a retrospective cohort study of patients under the age of 19 years with ATA low-risk DTC who had undergone a total thyroidectomy at CHOP between 2010 and 2020.

Overall, they identified 95 patients, including 50 who had been treated with RAI in addition to thyroidectomy and 45 who did not receive RAI. Among those who did receive RAI, 31 were treated prior to 2015, and 19 were treated after 2019.

For the study, remission was defined as having undetectable thyroglobulin levels as well as no evidence of disease by ultrasound, Ms. Bojarsky said.

“This is important to show, because we want to ensure that as we are reducing our RAI use in the pediatric population, we were not negatively impacting their ability to achieve remission,” she explained.

The percentage of low-risk pediatric patients with DTC treated with RAI had already dropped from 100% in 2010 down to 38% by 2015 when the guidelines were issued, and after a slight rise to 50% by 2018, the practice plummeted to 0% by 2020, the study shows.

In terms of remission, at 1 year post-treatment, 80% of patients who received RAI were in remission, and the rate was even slightly higher, at 84%, among those who did not receive RAI, for a difference that was not significant.

Further looking at disease status as of the last clinical evaluation, 90% in the group treated with RAI had no evidence of disease at a median of 4.9 years of follow-up, and the rate was 87% in the group not receiving RAI, which had a median of 2.7 years of follow-up.

“In ATA low-risk patients, there is no detriment in achieving remission if RAI therapy is withheld,” say investigators.   

The median tumor size in the RAI group was larger (19.5 mm vs. 12.0 mm; P < .001), and the primary tumor was T1 in 44% of the RAI group but 82% in the no-RAI group (P < .001).

The lymph node status was N0 in 72% of those receiving RAI and 76% in the no RAI group, which was not significantly different.

The leading risk factors associated with treatment with RAI included larger primary tumor size (OR, 1.07; P = .003), lymph node metastasis (OR, 3.72; P = .036), and surgery pre-2015 (OR, 9.83; P < .001).

RAI administration, N1a disease, and surgery prior to 2015 were not independent risk factors for evidence of persistent disease or indeterminate status.

Ms. Bojarsky has reported no relevant financial relationships.

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

MONTREAL – Pediatric patients with low-risk differentiated thyroid cancer (DTC) who are spared radioactive iodine (RAI) therapy show no increases in the risk of remission, compared with those who do receive it, supporting guidelines that recommend against use of RAI in such patients.

“In 2015, when the American Thyroid Association [ATA] created their pediatric guidelines [on RAI therapy in DTC], they were taking a leap of faith that these [pediatric DTC] patients would be able to achieve remission without RAI,” said first author Mya Bojarsky, Children’s Hospital of Philadelphia (CHOP), when presenting the findings at the American Thyroid Association annual meeting.

“This is the first study to validate those guidelines and support the sentiment that for ATA low-risk pediatric thyroid cancer patients, withholding RAI therapy is clinically beneficial as it reduces exposure to radiation while having no negative impact on remission,” she said.

Prior to 2015, thyroidectomy in combination with RAI was the standard treatment for DTC in pediatric patients. However, data showing that radiation exposure in children increases the risk of secondary hematologic malignancies by 51% and solid malignancies by 23% over a lifetime raised concerns and led to a push to change the treatment approach.

In response, the 2015 ATA pediatric guidelines recommended that patients not receive RAI for the treatment of DTC that was mostly confined to the thyroid (N0 or minimal N1a disease).

Senior author Andrew J. Bauer, MD, noted that, in addition to being the first study to confirm that withholding RAI in low-risk patients is associated with the same rate of achieving remission as patients treated with RAI, the study also endorses that assessments at 1 year can be reliable predictors of remission.

“For these patients, the 1-year mark post-initial treatment (thyroidectomy) is an early and accurate time point for initial assessment of remission, with increasing rates of remission with continued surveillance (at last clinical follow-up) of approximately 90% 2 years post initial treatment,” said Dr. Bauer, medical director, CHOP, and professor of pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.

“This approach has recently been validated through a prospective study in adult patients,” he added. A large recent study of 730 patients, published in the New England Journal of Medicine, supported the omission of RAI in low-risk DTC in adults, showing that, compared with those who received RAI, the no-RAI group was noninferior in the occurrence of functional, structural, and biologic events at 3 years.
 

Safe to eliminate RAI therapy in low-risk DTC in children

With limited data on how or if the change in treatment had an impact on rates of remission in pediatric patients, Ms. Bojarsky and colleagues conducted a retrospective cohort study of patients under the age of 19 years with ATA low-risk DTC who had undergone a total thyroidectomy at CHOP between 2010 and 2020.

Overall, they identified 95 patients, including 50 who had been treated with RAI in addition to thyroidectomy and 45 who did not receive RAI. Among those who did receive RAI, 31 were treated prior to 2015, and 19 were treated after 2019.

For the study, remission was defined as having undetectable thyroglobulin levels as well as no evidence of disease by ultrasound, Ms. Bojarsky said.

“This is important to show, because we want to ensure that as we are reducing our RAI use in the pediatric population, we were not negatively impacting their ability to achieve remission,” she explained.

The percentage of low-risk pediatric patients with DTC treated with RAI had already dropped from 100% in 2010 down to 38% by 2015 when the guidelines were issued, and after a slight rise to 50% by 2018, the practice plummeted to 0% by 2020, the study shows.

In terms of remission, at 1 year post-treatment, 80% of patients who received RAI were in remission, and the rate was even slightly higher, at 84%, among those who did not receive RAI, for a difference that was not significant.

Further looking at disease status as of the last clinical evaluation, 90% in the group treated with RAI had no evidence of disease at a median of 4.9 years of follow-up, and the rate was 87% in the group not receiving RAI, which had a median of 2.7 years of follow-up.

“In ATA low-risk patients, there is no detriment in achieving remission if RAI therapy is withheld,” say investigators.   

The median tumor size in the RAI group was larger (19.5 mm vs. 12.0 mm; P < .001), and the primary tumor was T1 in 44% of the RAI group but 82% in the no-RAI group (P < .001).

The lymph node status was N0 in 72% of those receiving RAI and 76% in the no RAI group, which was not significantly different.

The leading risk factors associated with treatment with RAI included larger primary tumor size (OR, 1.07; P = .003), lymph node metastasis (OR, 3.72; P = .036), and surgery pre-2015 (OR, 9.83; P < .001).

RAI administration, N1a disease, and surgery prior to 2015 were not independent risk factors for evidence of persistent disease or indeterminate status.

Ms. Bojarsky has reported no relevant financial relationships.

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

MONTREAL – Pediatric patients with low-risk differentiated thyroid cancer (DTC) who are spared radioactive iodine (RAI) therapy show no increases in the risk of remission, compared with those who do receive it, supporting guidelines that recommend against use of RAI in such patients.

“In 2015, when the American Thyroid Association [ATA] created their pediatric guidelines [on RAI therapy in DTC], they were taking a leap of faith that these [pediatric DTC] patients would be able to achieve remission without RAI,” said first author Mya Bojarsky, Children’s Hospital of Philadelphia (CHOP), when presenting the findings at the American Thyroid Association annual meeting.

“This is the first study to validate those guidelines and support the sentiment that for ATA low-risk pediatric thyroid cancer patients, withholding RAI therapy is clinically beneficial as it reduces exposure to radiation while having no negative impact on remission,” she said.

Prior to 2015, thyroidectomy in combination with RAI was the standard treatment for DTC in pediatric patients. However, data showing that radiation exposure in children increases the risk of secondary hematologic malignancies by 51% and solid malignancies by 23% over a lifetime raised concerns and led to a push to change the treatment approach.

In response, the 2015 ATA pediatric guidelines recommended that patients not receive RAI for the treatment of DTC that was mostly confined to the thyroid (N0 or minimal N1a disease).

Senior author Andrew J. Bauer, MD, noted that, in addition to being the first study to confirm that withholding RAI in low-risk patients is associated with the same rate of achieving remission as patients treated with RAI, the study also endorses that assessments at 1 year can be reliable predictors of remission.

“For these patients, the 1-year mark post-initial treatment (thyroidectomy) is an early and accurate time point for initial assessment of remission, with increasing rates of remission with continued surveillance (at last clinical follow-up) of approximately 90% 2 years post initial treatment,” said Dr. Bauer, medical director, CHOP, and professor of pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.

“This approach has recently been validated through a prospective study in adult patients,” he added. A large recent study of 730 patients, published in the New England Journal of Medicine, supported the omission of RAI in low-risk DTC in adults, showing that, compared with those who received RAI, the no-RAI group was noninferior in the occurrence of functional, structural, and biologic events at 3 years.
 

Safe to eliminate RAI therapy in low-risk DTC in children

With limited data on how or if the change in treatment had an impact on rates of remission in pediatric patients, Ms. Bojarsky and colleagues conducted a retrospective cohort study of patients under the age of 19 years with ATA low-risk DTC who had undergone a total thyroidectomy at CHOP between 2010 and 2020.

Overall, they identified 95 patients, including 50 who had been treated with RAI in addition to thyroidectomy and 45 who did not receive RAI. Among those who did receive RAI, 31 were treated prior to 2015, and 19 were treated after 2019.

For the study, remission was defined as having undetectable thyroglobulin levels as well as no evidence of disease by ultrasound, Ms. Bojarsky said.

“This is important to show, because we want to ensure that as we are reducing our RAI use in the pediatric population, we were not negatively impacting their ability to achieve remission,” she explained.

The percentage of low-risk pediatric patients with DTC treated with RAI had already dropped from 100% in 2010 down to 38% by 2015 when the guidelines were issued, and after a slight rise to 50% by 2018, the practice plummeted to 0% by 2020, the study shows.

In terms of remission, at 1 year post-treatment, 80% of patients who received RAI were in remission, and the rate was even slightly higher, at 84%, among those who did not receive RAI, for a difference that was not significant.

Further looking at disease status as of the last clinical evaluation, 90% in the group treated with RAI had no evidence of disease at a median of 4.9 years of follow-up, and the rate was 87% in the group not receiving RAI, which had a median of 2.7 years of follow-up.

“In ATA low-risk patients, there is no detriment in achieving remission if RAI therapy is withheld,” say investigators.   

The median tumor size in the RAI group was larger (19.5 mm vs. 12.0 mm; P < .001), and the primary tumor was T1 in 44% of the RAI group but 82% in the no-RAI group (P < .001).

The lymph node status was N0 in 72% of those receiving RAI and 76% in the no RAI group, which was not significantly different.

The leading risk factors associated with treatment with RAI included larger primary tumor size (OR, 1.07; P = .003), lymph node metastasis (OR, 3.72; P = .036), and surgery pre-2015 (OR, 9.83; P < .001).

RAI administration, N1a disease, and surgery prior to 2015 were not independent risk factors for evidence of persistent disease or indeterminate status.

Ms. Bojarsky has reported no relevant financial relationships.

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

Women eating a reduced-fat vegan diet combined with a daily serving of soybeans experienced a 78% reduction in frequency of menopausal hot flashes over 12 weeks, in a small, nonblinded, randomized-controlled trial.

“We do not fully understand yet why this combination works, but it seems that these three elements are key: avoiding animal products, reducing fat, and adding a serving of soybeans,” lead researcher Neal Barnard, MD, explained in a press release. “These new results suggest that a diet change should be considered as a first-line treatment for troublesome vasomotor symptoms, including night sweats and hot flashes,” added Dr. Barnard, who is president of the Physicians Committee for Responsible Medicine, and adjunct professor at George Washington University, Washington. 

Elliott O’Donovan Photography

But, while “the findings from this very small study complement everything we know about the benefits of an excellent diet and the health benefits of soy,” they should be interpreted with some caution, commented Susan Reed, MD, president of the North American Menopause Society, and associate program director of the women’s reproductive research program at the University of Washington, Seattle.

For the trial, called WAVS (Women’s Study for the Alleviation of Vasomotor Symptoms), the researchers randomized 84 postmenopausal women with at least two moderate to severe hot flashes daily to either the intervention or usual diet, with a total of 71 subjects completing the 12-week study, published in Menopause. Criteria for exclusion included any cause of vasomotor symptoms other than natural menopause, current use of a low-fat, vegan diet that includes daily soy products, soy allergy, and body mass index < 18.5 kg/m².

Participants in the intervention group were asked to avoid animal-derived foods, minimize their use of oils and fatty foods such as nuts and avocados, and include half a cup (86 g) of cooked soybeans daily in their diets. They were also offered 1-hour virtual group meetings each week, in which a registered dietitian or research staff provided information on food preparation and managing common dietary challenges.

Control group participants were asked to continue their usual diets and attend four 1-hour group sessions.

At baseline and then after the 12-week study period, dietary intake was self-recorded for 2 weekdays and 1 weekend day, hot flash frequency and severity was recorded for 1 week using a mobile app, and the effect of menopausal symptoms on quality of life was measured using the vasomotor, psychosocial, physical, and sexual domains of the Menopause-Specific Quality of Life (MENQOL) questionnaire.

Equol production was also assessed in a subset of 15 intervention and 12 control participants who had urinary isoflavone concentrations measured after eating half a cup (86 g) of soybeans twice daily for 3 days. This was based on the theory that diets such as the intervention in this study “seem to foster the growth of gut bacteria capable of converting daidzein to equol,” noted the authors. The ability to produce equol is detected more frequently in individuals following vegetarian diets than in omnivores and … has been proposed as a factor in soy’s apparent health benefits.”

The study found that total hot flash frequency decreased by 78% in the intervention group (P < .001) and 39% (P < .001) in the control group (between-group P = .003), and moderate to severe hot flashes decreased by 88% versus 34%, respectively (from 5.0 to 0.6 per day, P < .001 vs. from 4.4 to 2.9 per day, P < .001; between-group P < .001). Among participants with at least seven moderate to severe hot flashes per day at baseline, moderate to severe hot flashes decreased by 93% (from 10.6 to 0.7 per day) in the intervention group (P < .001) and 36% (from 9.0 to 5.8 per day) in the control group (P = .01, between-group P < .001). The changes in hot flashes were paralleled by changes in the MENQOL findings, with significant between-group differences in the vasomotor (P = 0.004), physical (P = 0.01), and sexual (P = 0.03) domains.

Changes in frequency of severe hot flashes correlated directly with changes in fat intake, and inversely with changes in carbohydrate and fiber intake, such that “the greater the reduction in fat intake and the greater the increases in carbohydrate and fiber consumption, the greater the reduction in severe hot flashes,” noted the researchers. Mean body weight also decreased by 3.6 kg in the intervention group and 0.2 kg in the control group (P < .001). “Equol-production status had no apparent effect on hot flashes,” they added.

The study is the second phase of WAVS, which comprises two parts, the first of which showed similar results, but was conducted in the fall, raising questions about whether cooler temperatures were partly responsible for the results. Phase 2 of WAVS enrolled participants in the spring “ruling out the effect of outside temperature,” noted the authors.

“Eating a healthy diet at midlife is so important for long-term health and a sense of well-being for peri- and postmenopausal women,” said Dr Reed, but she urged caution in interpreting the findings. “This was an unblinded study,” she told this news organization. “Women were recruited to this study anticipating that they would be in a study on a soy diet. Individuals who sign up for a study are hoping for benefit from the intervention. The controls who don’t get the soy diet are often disappointed, so there is no benefit from a nonblinded control arm for their hot flashes. And that is exactly what we saw here. Blinded studies can hide what you are getting, so everyone in the study (intervention and controls) has the same anticipated benefit.  But you cannot blind a soy diet.”

Dr. Reed also noted that, while the biologic mechanism of benefit should be equol production, this was not shown – given that both equol producers and nonproducers in the soy intervention reported marked symptom reduction.

“Only prior studies with estrogen interventions have observed reductions of hot flashes of the amount reported here,” she concluded. “Hopefully future large studies will clarify the role of soy diet for decreasing hot flashes.”

Dr. Barnard writes books and articles and gives lectures related to nutrition and health and has received royalties and honoraria from these sources. Dr. Reed has no relevant disclosures.

Women eating a reduced-fat vegan diet combined with a daily serving of soybeans experienced a 78% reduction in frequency of menopausal hot flashes over 12 weeks, in a small, nonblinded, randomized-controlled trial.

“We do not fully understand yet why this combination works, but it seems that these three elements are key: avoiding animal products, reducing fat, and adding a serving of soybeans,” lead researcher Neal Barnard, MD, explained in a press release. “These new results suggest that a diet change should be considered as a first-line treatment for troublesome vasomotor symptoms, including night sweats and hot flashes,” added Dr. Barnard, who is president of the Physicians Committee for Responsible Medicine, and adjunct professor at George Washington University, Washington. 

Elliott O’Donovan Photography

But, while “the findings from this very small study complement everything we know about the benefits of an excellent diet and the health benefits of soy,” they should be interpreted with some caution, commented Susan Reed, MD, president of the North American Menopause Society, and associate program director of the women’s reproductive research program at the University of Washington, Seattle.

For the trial, called WAVS (Women’s Study for the Alleviation of Vasomotor Symptoms), the researchers randomized 84 postmenopausal women with at least two moderate to severe hot flashes daily to either the intervention or usual diet, with a total of 71 subjects completing the 12-week study, published in Menopause. Criteria for exclusion included any cause of vasomotor symptoms other than natural menopause, current use of a low-fat, vegan diet that includes daily soy products, soy allergy, and body mass index < 18.5 kg/m².

Participants in the intervention group were asked to avoid animal-derived foods, minimize their use of oils and fatty foods such as nuts and avocados, and include half a cup (86 g) of cooked soybeans daily in their diets. They were also offered 1-hour virtual group meetings each week, in which a registered dietitian or research staff provided information on food preparation and managing common dietary challenges.

Control group participants were asked to continue their usual diets and attend four 1-hour group sessions.

At baseline and then after the 12-week study period, dietary intake was self-recorded for 2 weekdays and 1 weekend day, hot flash frequency and severity was recorded for 1 week using a mobile app, and the effect of menopausal symptoms on quality of life was measured using the vasomotor, psychosocial, physical, and sexual domains of the Menopause-Specific Quality of Life (MENQOL) questionnaire.

Equol production was also assessed in a subset of 15 intervention and 12 control participants who had urinary isoflavone concentrations measured after eating half a cup (86 g) of soybeans twice daily for 3 days. This was based on the theory that diets such as the intervention in this study “seem to foster the growth of gut bacteria capable of converting daidzein to equol,” noted the authors. The ability to produce equol is detected more frequently in individuals following vegetarian diets than in omnivores and … has been proposed as a factor in soy’s apparent health benefits.”

The study found that total hot flash frequency decreased by 78% in the intervention group (P < .001) and 39% (P < .001) in the control group (between-group P = .003), and moderate to severe hot flashes decreased by 88% versus 34%, respectively (from 5.0 to 0.6 per day, P < .001 vs. from 4.4 to 2.9 per day, P < .001; between-group P < .001). Among participants with at least seven moderate to severe hot flashes per day at baseline, moderate to severe hot flashes decreased by 93% (from 10.6 to 0.7 per day) in the intervention group (P < .001) and 36% (from 9.0 to 5.8 per day) in the control group (P = .01, between-group P < .001). The changes in hot flashes were paralleled by changes in the MENQOL findings, with significant between-group differences in the vasomotor (P = 0.004), physical (P = 0.01), and sexual (P = 0.03) domains.

Changes in frequency of severe hot flashes correlated directly with changes in fat intake, and inversely with changes in carbohydrate and fiber intake, such that “the greater the reduction in fat intake and the greater the increases in carbohydrate and fiber consumption, the greater the reduction in severe hot flashes,” noted the researchers. Mean body weight also decreased by 3.6 kg in the intervention group and 0.2 kg in the control group (P < .001). “Equol-production status had no apparent effect on hot flashes,” they added.

The study is the second phase of WAVS, which comprises two parts, the first of which showed similar results, but was conducted in the fall, raising questions about whether cooler temperatures were partly responsible for the results. Phase 2 of WAVS enrolled participants in the spring “ruling out the effect of outside temperature,” noted the authors.

“Eating a healthy diet at midlife is so important for long-term health and a sense of well-being for peri- and postmenopausal women,” said Dr Reed, but she urged caution in interpreting the findings. “This was an unblinded study,” she told this news organization. “Women were recruited to this study anticipating that they would be in a study on a soy diet. Individuals who sign up for a study are hoping for benefit from the intervention. The controls who don’t get the soy diet are often disappointed, so there is no benefit from a nonblinded control arm for their hot flashes. And that is exactly what we saw here. Blinded studies can hide what you are getting, so everyone in the study (intervention and controls) has the same anticipated benefit.  But you cannot blind a soy diet.”

Dr. Reed also noted that, while the biologic mechanism of benefit should be equol production, this was not shown – given that both equol producers and nonproducers in the soy intervention reported marked symptom reduction.

“Only prior studies with estrogen interventions have observed reductions of hot flashes of the amount reported here,” she concluded. “Hopefully future large studies will clarify the role of soy diet for decreasing hot flashes.”

Dr. Barnard writes books and articles and gives lectures related to nutrition and health and has received royalties and honoraria from these sources. Dr. Reed has no relevant disclosures.

Women eating a reduced-fat vegan diet combined with a daily serving of soybeans experienced a 78% reduction in frequency of menopausal hot flashes over 12 weeks, in a small, nonblinded, randomized-controlled trial.

“We do not fully understand yet why this combination works, but it seems that these three elements are key: avoiding animal products, reducing fat, and adding a serving of soybeans,” lead researcher Neal Barnard, MD, explained in a press release. “These new results suggest that a diet change should be considered as a first-line treatment for troublesome vasomotor symptoms, including night sweats and hot flashes,” added Dr. Barnard, who is president of the Physicians Committee for Responsible Medicine, and adjunct professor at George Washington University, Washington. 

Elliott O’Donovan Photography

But, while “the findings from this very small study complement everything we know about the benefits of an excellent diet and the health benefits of soy,” they should be interpreted with some caution, commented Susan Reed, MD, president of the North American Menopause Society, and associate program director of the women’s reproductive research program at the University of Washington, Seattle.

For the trial, called WAVS (Women’s Study for the Alleviation of Vasomotor Symptoms), the researchers randomized 84 postmenopausal women with at least two moderate to severe hot flashes daily to either the intervention or usual diet, with a total of 71 subjects completing the 12-week study, published in Menopause. Criteria for exclusion included any cause of vasomotor symptoms other than natural menopause, current use of a low-fat, vegan diet that includes daily soy products, soy allergy, and body mass index < 18.5 kg/m².

Participants in the intervention group were asked to avoid animal-derived foods, minimize their use of oils and fatty foods such as nuts and avocados, and include half a cup (86 g) of cooked soybeans daily in their diets. They were also offered 1-hour virtual group meetings each week, in which a registered dietitian or research staff provided information on food preparation and managing common dietary challenges.

Control group participants were asked to continue their usual diets and attend four 1-hour group sessions.

At baseline and then after the 12-week study period, dietary intake was self-recorded for 2 weekdays and 1 weekend day, hot flash frequency and severity was recorded for 1 week using a mobile app, and the effect of menopausal symptoms on quality of life was measured using the vasomotor, psychosocial, physical, and sexual domains of the Menopause-Specific Quality of Life (MENQOL) questionnaire.

Equol production was also assessed in a subset of 15 intervention and 12 control participants who had urinary isoflavone concentrations measured after eating half a cup (86 g) of soybeans twice daily for 3 days. This was based on the theory that diets such as the intervention in this study “seem to foster the growth of gut bacteria capable of converting daidzein to equol,” noted the authors. The ability to produce equol is detected more frequently in individuals following vegetarian diets than in omnivores and … has been proposed as a factor in soy’s apparent health benefits.”

The study found that total hot flash frequency decreased by 78% in the intervention group (P < .001) and 39% (P < .001) in the control group (between-group P = .003), and moderate to severe hot flashes decreased by 88% versus 34%, respectively (from 5.0 to 0.6 per day, P < .001 vs. from 4.4 to 2.9 per day, P < .001; between-group P < .001). Among participants with at least seven moderate to severe hot flashes per day at baseline, moderate to severe hot flashes decreased by 93% (from 10.6 to 0.7 per day) in the intervention group (P < .001) and 36% (from 9.0 to 5.8 per day) in the control group (P = .01, between-group P < .001). The changes in hot flashes were paralleled by changes in the MENQOL findings, with significant between-group differences in the vasomotor (P = 0.004), physical (P = 0.01), and sexual (P = 0.03) domains.

Changes in frequency of severe hot flashes correlated directly with changes in fat intake, and inversely with changes in carbohydrate and fiber intake, such that “the greater the reduction in fat intake and the greater the increases in carbohydrate and fiber consumption, the greater the reduction in severe hot flashes,” noted the researchers. Mean body weight also decreased by 3.6 kg in the intervention group and 0.2 kg in the control group (P < .001). “Equol-production status had no apparent effect on hot flashes,” they added.

The study is the second phase of WAVS, which comprises two parts, the first of which showed similar results, but was conducted in the fall, raising questions about whether cooler temperatures were partly responsible for the results. Phase 2 of WAVS enrolled participants in the spring “ruling out the effect of outside temperature,” noted the authors.

“Eating a healthy diet at midlife is so important for long-term health and a sense of well-being for peri- and postmenopausal women,” said Dr Reed, but she urged caution in interpreting the findings. “This was an unblinded study,” she told this news organization. “Women were recruited to this study anticipating that they would be in a study on a soy diet. Individuals who sign up for a study are hoping for benefit from the intervention. The controls who don’t get the soy diet are often disappointed, so there is no benefit from a nonblinded control arm for their hot flashes. And that is exactly what we saw here. Blinded studies can hide what you are getting, so everyone in the study (intervention and controls) has the same anticipated benefit.  But you cannot blind a soy diet.”

Dr. Reed also noted that, while the biologic mechanism of benefit should be equol production, this was not shown – given that both equol producers and nonproducers in the soy intervention reported marked symptom reduction.

“Only prior studies with estrogen interventions have observed reductions of hot flashes of the amount reported here,” she concluded. “Hopefully future large studies will clarify the role of soy diet for decreasing hot flashes.”

Dr. Barnard writes books and articles and gives lectures related to nutrition and health and has received royalties and honoraria from these sources. Dr. Reed has no relevant disclosures.

The nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia) unexpectedly showed that it might protect against incident infective pneumonia and COVID-19. The finding was based on secondary analyses run on more than 13,000 people enrolled in the two pivotal trials for finerenone.

Finerenone was approved by the Food and Drug Administration in 2021 for slowing progressive renal dysfunction and preventing cardiovascular events in adults with type 2 diabetes and chronic kidney disease (CKD).
 

‘Striking reduction in the risk of pneumonia’

The “striking reduction in risk of pneumonia” in a new analysis suggests that “the propagation of pulmonary infection into lobar or bronchial consolidation may be reduced by finerenone,” write Bertram Pitt, MD, and coauthors in a report published on October 26 in JAMA Network Open.

They also suggest that if further studies confirm that finerenone treatment reduces complications from pneumonia and COVID-19, it would have “significant medical implications,” especially because of the limited treatment options now available for complications from COVID-19.

The new analyses used the FIDELITY dataset, a prespecified merging of results from the FIDELIO-DKD and FIGARO-DKD trials, which together enrolled 13,026 people with type 2 diabetes and CKD, as determined on the basis of the patients’ having a urine albumin-to-creatinine ratio of at least 30 mg/g.

The primary outcomes of these trials showed that treatment with finerenone led to significant slowing of the progression of CKD and a significant reduction in the incidence of cardiovascular events, compared with placebo during median follow-up of 3 years.

The new, secondary analyses focused on the 6.0% of participants in whom there was evidence of pneumonia and the 1.6% in whom there was evidence of having COVID-19. Pneumonia was the most common serious adverse event in the two trials, a finding consistent with the documented risk for pneumonia faced by people with CKD.
 

Finerenone linked with a 29% relative reduction in pneumonia

When analyzed by treatment, the incidence of pneumonia was 4.7% among those who received finerenone and 6.7% among those who received placebo. This translated into a significant relative risk reduction of 29% associated with finerenone treatment.

Analysis of COVID-19 adverse events showed a 1.3% incidence among those who received finerenone and a 1.8% incidence among those in the placebo group, which translated into a significant 27% relative risk reduction linked with finerenone treatment.

In contrast, the data showed no reduced incidence of several other respiratory infections among the finerenone recipients, including nasopharyngitis, bronchitis, and influenza. The data also showed no signal that pneumonia or COVID-19 was more severe among the people who did not receive finerenone, nor did finerenone treatment appear to affect pneumonia recovery.
 

Analysis based on adverse events reports

These secondary analyses are far from definitive. The authors relied on pneumonia and COVID-19 being reported as adverse events. Each investigator diagnosed pneumonia at their discretion, and the trials did not specify diagnostic criteria. The authors also acknowledge that testing for COVID-19 was “not widespread” and that one of the two pivotal trials largely ran prior to the onset of the COVID-19 pandemic so that only 6 participants developed COVID-19 symptoms out of more than 5,700 enrolled.

The authors hypothesize that several actions of finerenone might potentially help mediate an effect on pneumonia and COVID-19: improvements in pulmonary inflammation and fibrosis, upregulation of expression of angiotensin converting enzyme 2, and amelioration of right heart pressure and pulmonary congestion. Also, antagonizing the mineralocorticoid receptor on monocytes and macrophages may block macrophage infiltration and accumulation of active macrophages, which can mediate the pulmonary tissue damage caused by COVID-19.

The FIDELIO-DKD and FIGARO-DKD trials and the FIDELITY combined database were sponsored by Bayer, the company that markets finerenone (Kerendia). Dr. Pitt has received personal fees from Bayer and personal fees and stock options from numerous other companies. Several coauthors reported having a financial relationship with Bayer, as well as with other companies.

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

The nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia) unexpectedly showed that it might protect against incident infective pneumonia and COVID-19. The finding was based on secondary analyses run on more than 13,000 people enrolled in the two pivotal trials for finerenone.

Finerenone was approved by the Food and Drug Administration in 2021 for slowing progressive renal dysfunction and preventing cardiovascular events in adults with type 2 diabetes and chronic kidney disease (CKD).
 

‘Striking reduction in the risk of pneumonia’

The “striking reduction in risk of pneumonia” in a new analysis suggests that “the propagation of pulmonary infection into lobar or bronchial consolidation may be reduced by finerenone,” write Bertram Pitt, MD, and coauthors in a report published on October 26 in JAMA Network Open.

They also suggest that if further studies confirm that finerenone treatment reduces complications from pneumonia and COVID-19, it would have “significant medical implications,” especially because of the limited treatment options now available for complications from COVID-19.

The new analyses used the FIDELITY dataset, a prespecified merging of results from the FIDELIO-DKD and FIGARO-DKD trials, which together enrolled 13,026 people with type 2 diabetes and CKD, as determined on the basis of the patients’ having a urine albumin-to-creatinine ratio of at least 30 mg/g.

The primary outcomes of these trials showed that treatment with finerenone led to significant slowing of the progression of CKD and a significant reduction in the incidence of cardiovascular events, compared with placebo during median follow-up of 3 years.

The new, secondary analyses focused on the 6.0% of participants in whom there was evidence of pneumonia and the 1.6% in whom there was evidence of having COVID-19. Pneumonia was the most common serious adverse event in the two trials, a finding consistent with the documented risk for pneumonia faced by people with CKD.
 

Finerenone linked with a 29% relative reduction in pneumonia

When analyzed by treatment, the incidence of pneumonia was 4.7% among those who received finerenone and 6.7% among those who received placebo. This translated into a significant relative risk reduction of 29% associated with finerenone treatment.

Analysis of COVID-19 adverse events showed a 1.3% incidence among those who received finerenone and a 1.8% incidence among those in the placebo group, which translated into a significant 27% relative risk reduction linked with finerenone treatment.

In contrast, the data showed no reduced incidence of several other respiratory infections among the finerenone recipients, including nasopharyngitis, bronchitis, and influenza. The data also showed no signal that pneumonia or COVID-19 was more severe among the people who did not receive finerenone, nor did finerenone treatment appear to affect pneumonia recovery.
 

Analysis based on adverse events reports

These secondary analyses are far from definitive. The authors relied on pneumonia and COVID-19 being reported as adverse events. Each investigator diagnosed pneumonia at their discretion, and the trials did not specify diagnostic criteria. The authors also acknowledge that testing for COVID-19 was “not widespread” and that one of the two pivotal trials largely ran prior to the onset of the COVID-19 pandemic so that only 6 participants developed COVID-19 symptoms out of more than 5,700 enrolled.

The authors hypothesize that several actions of finerenone might potentially help mediate an effect on pneumonia and COVID-19: improvements in pulmonary inflammation and fibrosis, upregulation of expression of angiotensin converting enzyme 2, and amelioration of right heart pressure and pulmonary congestion. Also, antagonizing the mineralocorticoid receptor on monocytes and macrophages may block macrophage infiltration and accumulation of active macrophages, which can mediate the pulmonary tissue damage caused by COVID-19.

The FIDELIO-DKD and FIGARO-DKD trials and the FIDELITY combined database were sponsored by Bayer, the company that markets finerenone (Kerendia). Dr. Pitt has received personal fees from Bayer and personal fees and stock options from numerous other companies. Several coauthors reported having a financial relationship with Bayer, as well as with other companies.

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

The nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia) unexpectedly showed that it might protect against incident infective pneumonia and COVID-19. The finding was based on secondary analyses run on more than 13,000 people enrolled in the two pivotal trials for finerenone.

Finerenone was approved by the Food and Drug Administration in 2021 for slowing progressive renal dysfunction and preventing cardiovascular events in adults with type 2 diabetes and chronic kidney disease (CKD).
 

‘Striking reduction in the risk of pneumonia’

The “striking reduction in risk of pneumonia” in a new analysis suggests that “the propagation of pulmonary infection into lobar or bronchial consolidation may be reduced by finerenone,” write Bertram Pitt, MD, and coauthors in a report published on October 26 in JAMA Network Open.

They also suggest that if further studies confirm that finerenone treatment reduces complications from pneumonia and COVID-19, it would have “significant medical implications,” especially because of the limited treatment options now available for complications from COVID-19.

The new analyses used the FIDELITY dataset, a prespecified merging of results from the FIDELIO-DKD and FIGARO-DKD trials, which together enrolled 13,026 people with type 2 diabetes and CKD, as determined on the basis of the patients’ having a urine albumin-to-creatinine ratio of at least 30 mg/g.

The primary outcomes of these trials showed that treatment with finerenone led to significant slowing of the progression of CKD and a significant reduction in the incidence of cardiovascular events, compared with placebo during median follow-up of 3 years.

The new, secondary analyses focused on the 6.0% of participants in whom there was evidence of pneumonia and the 1.6% in whom there was evidence of having COVID-19. Pneumonia was the most common serious adverse event in the two trials, a finding consistent with the documented risk for pneumonia faced by people with CKD.
 

Finerenone linked with a 29% relative reduction in pneumonia

When analyzed by treatment, the incidence of pneumonia was 4.7% among those who received finerenone and 6.7% among those who received placebo. This translated into a significant relative risk reduction of 29% associated with finerenone treatment.

Analysis of COVID-19 adverse events showed a 1.3% incidence among those who received finerenone and a 1.8% incidence among those in the placebo group, which translated into a significant 27% relative risk reduction linked with finerenone treatment.

In contrast, the data showed no reduced incidence of several other respiratory infections among the finerenone recipients, including nasopharyngitis, bronchitis, and influenza. The data also showed no signal that pneumonia or COVID-19 was more severe among the people who did not receive finerenone, nor did finerenone treatment appear to affect pneumonia recovery.
 

Analysis based on adverse events reports

These secondary analyses are far from definitive. The authors relied on pneumonia and COVID-19 being reported as adverse events. Each investigator diagnosed pneumonia at their discretion, and the trials did not specify diagnostic criteria. The authors also acknowledge that testing for COVID-19 was “not widespread” and that one of the two pivotal trials largely ran prior to the onset of the COVID-19 pandemic so that only 6 participants developed COVID-19 symptoms out of more than 5,700 enrolled.

The authors hypothesize that several actions of finerenone might potentially help mediate an effect on pneumonia and COVID-19: improvements in pulmonary inflammation and fibrosis, upregulation of expression of angiotensin converting enzyme 2, and amelioration of right heart pressure and pulmonary congestion. Also, antagonizing the mineralocorticoid receptor on monocytes and macrophages may block macrophage infiltration and accumulation of active macrophages, which can mediate the pulmonary tissue damage caused by COVID-19.

The FIDELIO-DKD and FIGARO-DKD trials and the FIDELITY combined database were sponsored by Bayer, the company that markets finerenone (Kerendia). Dr. Pitt has received personal fees from Bayer and personal fees and stock options from numerous other companies. Several coauthors reported having a financial relationship with Bayer, as well as with other companies.

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

Smokers who quit before age 35 showed a "substantial" reduction in risk, compared with people who never smoked, according to a new national study.

Researchers also quantified the benefit of quitting for those older than 35. The added risk of death associated with smoking was reduced by 90% for those who quit before age 45 and 66% for those who quit at ages 45 to 64.

“The distal nature of the health consequences for young smokers is a challenge for professionals trying to motivate quitting in younger age groups. Without a proximal goal, it is tempting for smokers to abandon a quit attempt with cognitions such as ‘I don’t really need to do it just now,’ ” John P. Pierce, PhD, director for Population Sciences at UC-San Diego’s Moores Cancer Center, wrote in a commentary. 

Current smokers were twice as likely to die from any cause during the study, compared with the group researchers called “never smokers,” who were defined as smoking fewer than 100 lifetime cigarettes. 

Published in JAMA Network Open, the study involved 551,388 U.S. participants using information collected by the CDC from 1997 to 2018. Researchers collected data for specific causes of death of participants through the end of 2019.

The results echo past findings but also established whether demographic factors such as a smoker’s race and gender impact the benefits of quitting. (In many areas of health research, a person’s race or gender is associated with varying risks.)

The researchers found that the benefits of quitting smoking in reducing risk of death are comparable across demographic groups.

“Among former smokers in each racial and ethnic group, whether male or female, quitting was associated with reductions of approximately 80% of the excess mortality associated with continued smoking,” the authors stated. “These associations were generally consistent for deaths from cancer, cardiovascular disease, and lower respiratory disease.”

The findings are also important for guiding stop-smoking efforts because while smoking nationwide has decreased, the reduction has varied across demographic groups.

“Monitoring the association of smoking with mortality by race, ethnicity, and sex is critical to understanding how the U.S. tobacco epidemic continues to evolve over time and who is most affected by the changes,” the authors stated. “Despite continued decreases in U.S. smoking prevalence in recent decades, progress has not been equal across demographic groups. Recent progress in raising the quit ratio among U.S. ever-smokers overall has been modest, and the quit ratio has been consistently lower among Black and Hispanic ever-smokers than among non-Hispanic White ever-smokers.”

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

This article was updated 10/27/22.

Smokers who quit before age 35 showed a "substantial" reduction in risk, compared with people who never smoked, according to a new national study.

Researchers also quantified the benefit of quitting for those older than 35. The added risk of death associated with smoking was reduced by 90% for those who quit before age 45 and 66% for those who quit at ages 45 to 64.

“The distal nature of the health consequences for young smokers is a challenge for professionals trying to motivate quitting in younger age groups. Without a proximal goal, it is tempting for smokers to abandon a quit attempt with cognitions such as ‘I don’t really need to do it just now,’ ” John P. Pierce, PhD, director for Population Sciences at UC-San Diego’s Moores Cancer Center, wrote in a commentary. 

Current smokers were twice as likely to die from any cause during the study, compared with the group researchers called “never smokers,” who were defined as smoking fewer than 100 lifetime cigarettes. 

Published in JAMA Network Open, the study involved 551,388 U.S. participants using information collected by the CDC from 1997 to 2018. Researchers collected data for specific causes of death of participants through the end of 2019.

The results echo past findings but also established whether demographic factors such as a smoker’s race and gender impact the benefits of quitting. (In many areas of health research, a person’s race or gender is associated with varying risks.)

The researchers found that the benefits of quitting smoking in reducing risk of death are comparable across demographic groups.

“Among former smokers in each racial and ethnic group, whether male or female, quitting was associated with reductions of approximately 80% of the excess mortality associated with continued smoking,” the authors stated. “These associations were generally consistent for deaths from cancer, cardiovascular disease, and lower respiratory disease.”

The findings are also important for guiding stop-smoking efforts because while smoking nationwide has decreased, the reduction has varied across demographic groups.

“Monitoring the association of smoking with mortality by race, ethnicity, and sex is critical to understanding how the U.S. tobacco epidemic continues to evolve over time and who is most affected by the changes,” the authors stated. “Despite continued decreases in U.S. smoking prevalence in recent decades, progress has not been equal across demographic groups. Recent progress in raising the quit ratio among U.S. ever-smokers overall has been modest, and the quit ratio has been consistently lower among Black and Hispanic ever-smokers than among non-Hispanic White ever-smokers.”

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

This article was updated 10/27/22.

Smokers who quit before age 35 showed a "substantial" reduction in risk, compared with people who never smoked, according to a new national study.

Researchers also quantified the benefit of quitting for those older than 35. The added risk of death associated with smoking was reduced by 90% for those who quit before age 45 and 66% for those who quit at ages 45 to 64.

“The distal nature of the health consequences for young smokers is a challenge for professionals trying to motivate quitting in younger age groups. Without a proximal goal, it is tempting for smokers to abandon a quit attempt with cognitions such as ‘I don’t really need to do it just now,’ ” John P. Pierce, PhD, director for Population Sciences at UC-San Diego’s Moores Cancer Center, wrote in a commentary. 

Current smokers were twice as likely to die from any cause during the study, compared with the group researchers called “never smokers,” who were defined as smoking fewer than 100 lifetime cigarettes. 

Published in JAMA Network Open, the study involved 551,388 U.S. participants using information collected by the CDC from 1997 to 2018. Researchers collected data for specific causes of death of participants through the end of 2019.

The results echo past findings but also established whether demographic factors such as a smoker’s race and gender impact the benefits of quitting. (In many areas of health research, a person’s race or gender is associated with varying risks.)

The researchers found that the benefits of quitting smoking in reducing risk of death are comparable across demographic groups.

“Among former smokers in each racial and ethnic group, whether male or female, quitting was associated with reductions of approximately 80% of the excess mortality associated with continued smoking,” the authors stated. “These associations were generally consistent for deaths from cancer, cardiovascular disease, and lower respiratory disease.”

The findings are also important for guiding stop-smoking efforts because while smoking nationwide has decreased, the reduction has varied across demographic groups.

“Monitoring the association of smoking with mortality by race, ethnicity, and sex is critical to understanding how the U.S. tobacco epidemic continues to evolve over time and who is most affected by the changes,” the authors stated. “Despite continued decreases in U.S. smoking prevalence in recent decades, progress has not been equal across demographic groups. Recent progress in raising the quit ratio among U.S. ever-smokers overall has been modest, and the quit ratio has been consistently lower among Black and Hispanic ever-smokers than among non-Hispanic White ever-smokers.”

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

This article was updated 10/27/22.

“We eat first with our eyes.” 

The Roman foodie Apicius is thought to have uttered those words in the 1st century A.D. Now, some 2,000 years later, scientists may be proving him right. 

Massachusetts Institute of Technology researchers have discovered a previously unknown part of the brain that lights up when we see food. Dubbed the “ventral food component,” this part resides in the brain’s visual cortex, in a region known to play a role in identifying faces, scenes, and words. 

The study, published in the journal Current Biology, involved using artificial intelligence (AI) technology to build a computer model of this part of the brain. Similar models are emerging across fields of research to simulate and study complex systems of the body. A computer model of the digestive system was recently used to determine the best body position for taking a pill. 

“The research is still cutting-edge,” says study author Meenakshi Khosla, PhD. “There’s a lot more to be done to understand whether this region is the same or different in different individuals, and how it is modulated by experience or familiarity with different kinds of foods.”

Pinpointing those differences could provide insights into how people choose what they eat, or even help us learn what drives eating disorders, Dr. Khosla says. 

Part of what makes this study unique was the researchers’ approach, dubbed “hypothesis neutral.” Instead of setting out to prove or disprove a firm hypothesis, they simply started exploring the data to see what they could find. The goal: To go beyond “the idiosyncratic hypotheses scientists have already thought to test,” the paper says. So, they began sifting through a public database called the Natural Scenes Dataset, an inventory of brain scans from eight volunteers viewing 56,720 images. 

As expected, the software analyzing the dataset spotted brain regions already known to be triggered by images of faces, bodies, words, and scenes. But to the researchers’ surprise, the analysis also revealed a previously unknown part of the brain that seemed to be responding to images of food. 

“Our first reaction was, ‘That’s cute and all, but it can’t possibly be true,’ ” Dr. Khosla says. 

To confirm their discovery, the researchers used the data to train a computer model of this part of the brain, a process that takes less than an hour. Then they fed the model more than 1.2 million new images. 

Sure enough, the model lit up in response to food. Color didn’t matter – even black-and-white food images triggered it, though not as strongly as color ones. And the model could tell the difference between food and objects that looked like food: a banana versus a crescent moon, or a blueberry muffin versus a puppy with a muffin-like face. 

From the human data, the researchers found that some people responded slightly more to processed foods like pizza than unprocessed foods like apples. They hope to explore how other things, such as liking or disliking a food, may affect a person’s response to that food. 

This technology could open up other areas of research as well. Dr. Khosla hopes to use it to explore how the brain responds to social cues like body language and facial expressions. 

For now, Dr. Khosla has already begun to verify the computer model in real people by scanning the brains of a new set of volunteers. “We collected pilot data in a few subjects recently and were able to localize this component,” she says. 

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

“We eat first with our eyes.” 

The Roman foodie Apicius is thought to have uttered those words in the 1st century A.D. Now, some 2,000 years later, scientists may be proving him right. 

Massachusetts Institute of Technology researchers have discovered a previously unknown part of the brain that lights up when we see food. Dubbed the “ventral food component,” this part resides in the brain’s visual cortex, in a region known to play a role in identifying faces, scenes, and words. 

The study, published in the journal Current Biology, involved using artificial intelligence (AI) technology to build a computer model of this part of the brain. Similar models are emerging across fields of research to simulate and study complex systems of the body. A computer model of the digestive system was recently used to determine the best body position for taking a pill. 

“The research is still cutting-edge,” says study author Meenakshi Khosla, PhD. “There’s a lot more to be done to understand whether this region is the same or different in different individuals, and how it is modulated by experience or familiarity with different kinds of foods.”

Pinpointing those differences could provide insights into how people choose what they eat, or even help us learn what drives eating disorders, Dr. Khosla says. 

Part of what makes this study unique was the researchers’ approach, dubbed “hypothesis neutral.” Instead of setting out to prove or disprove a firm hypothesis, they simply started exploring the data to see what they could find. The goal: To go beyond “the idiosyncratic hypotheses scientists have already thought to test,” the paper says. So, they began sifting through a public database called the Natural Scenes Dataset, an inventory of brain scans from eight volunteers viewing 56,720 images. 

As expected, the software analyzing the dataset spotted brain regions already known to be triggered by images of faces, bodies, words, and scenes. But to the researchers’ surprise, the analysis also revealed a previously unknown part of the brain that seemed to be responding to images of food. 

“Our first reaction was, ‘That’s cute and all, but it can’t possibly be true,’ ” Dr. Khosla says. 

To confirm their discovery, the researchers used the data to train a computer model of this part of the brain, a process that takes less than an hour. Then they fed the model more than 1.2 million new images. 

Sure enough, the model lit up in response to food. Color didn’t matter – even black-and-white food images triggered it, though not as strongly as color ones. And the model could tell the difference between food and objects that looked like food: a banana versus a crescent moon, or a blueberry muffin versus a puppy with a muffin-like face. 

From the human data, the researchers found that some people responded slightly more to processed foods like pizza than unprocessed foods like apples. They hope to explore how other things, such as liking or disliking a food, may affect a person’s response to that food. 

This technology could open up other areas of research as well. Dr. Khosla hopes to use it to explore how the brain responds to social cues like body language and facial expressions. 

For now, Dr. Khosla has already begun to verify the computer model in real people by scanning the brains of a new set of volunteers. “We collected pilot data in a few subjects recently and were able to localize this component,” she says. 

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

“We eat first with our eyes.” 

The Roman foodie Apicius is thought to have uttered those words in the 1st century A.D. Now, some 2,000 years later, scientists may be proving him right. 

Massachusetts Institute of Technology researchers have discovered a previously unknown part of the brain that lights up when we see food. Dubbed the “ventral food component,” this part resides in the brain’s visual cortex, in a region known to play a role in identifying faces, scenes, and words. 

The study, published in the journal Current Biology, involved using artificial intelligence (AI) technology to build a computer model of this part of the brain. Similar models are emerging across fields of research to simulate and study complex systems of the body. A computer model of the digestive system was recently used to determine the best body position for taking a pill. 

“The research is still cutting-edge,” says study author Meenakshi Khosla, PhD. “There’s a lot more to be done to understand whether this region is the same or different in different individuals, and how it is modulated by experience or familiarity with different kinds of foods.”

Pinpointing those differences could provide insights into how people choose what they eat, or even help us learn what drives eating disorders, Dr. Khosla says. 

Part of what makes this study unique was the researchers’ approach, dubbed “hypothesis neutral.” Instead of setting out to prove or disprove a firm hypothesis, they simply started exploring the data to see what they could find. The goal: To go beyond “the idiosyncratic hypotheses scientists have already thought to test,” the paper says. So, they began sifting through a public database called the Natural Scenes Dataset, an inventory of brain scans from eight volunteers viewing 56,720 images. 

As expected, the software analyzing the dataset spotted brain regions already known to be triggered by images of faces, bodies, words, and scenes. But to the researchers’ surprise, the analysis also revealed a previously unknown part of the brain that seemed to be responding to images of food. 

“Our first reaction was, ‘That’s cute and all, but it can’t possibly be true,’ ” Dr. Khosla says. 

To confirm their discovery, the researchers used the data to train a computer model of this part of the brain, a process that takes less than an hour. Then they fed the model more than 1.2 million new images. 

Sure enough, the model lit up in response to food. Color didn’t matter – even black-and-white food images triggered it, though not as strongly as color ones. And the model could tell the difference between food and objects that looked like food: a banana versus a crescent moon, or a blueberry muffin versus a puppy with a muffin-like face. 

From the human data, the researchers found that some people responded slightly more to processed foods like pizza than unprocessed foods like apples. They hope to explore how other things, such as liking or disliking a food, may affect a person’s response to that food. 

This technology could open up other areas of research as well. Dr. Khosla hopes to use it to explore how the brain responds to social cues like body language and facial expressions. 

For now, Dr. Khosla has already begun to verify the computer model in real people by scanning the brains of a new set of volunteers. “We collected pilot data in a few subjects recently and were able to localize this component,” she says. 

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

Masks can be scary on Halloween, but more so when they come with scrubs, scalpels, and God complexes. In March, Medscape readers chose their favorite characters and performers in the Hollywood health care system. As a Halloween treat, we follow up with a dozen of our favorite Evil Doctors from a deep bench (and no, Dr Evil didn’t go to medical school; neither did Dr No, for that matter). Before you see these folks who’d rather haunt than heal, we urge you to seek a second opinion.

George Harris (Richard Widmark, “Coma,” 1978)

“Medicine is now a great social force,” says Dr. George Harris (Richard Widmark), chief of surgery at Boston Memorial. Because the public trusts doctors, “we’ll make the hard decisions” – like choosing which young, healthy patients to put into an irreversible coma to harvest their organs. Harris’ audience of one here is Dr. Susan Wheeler (Genevieve Bujold), the upstart who has uncovered his plot, and whom Harris has just drugged to prepare her as his next unintentional donor. “Coma” was based on a bestseller by Robin Cook and directed by Michael Crichton, who left Harvard Medical School for a career in popular books and films, including “The Andromeda Strain” and “Jurassic Park.” Although Dr. Harris starts out as a reassuring friend and mentor to Dr. Wheeler, older moviegoers won’t forget that he launched to stardom by tossing a woman in a wheelchair down the stairs in 1947’s “Kiss of Death.”
 

Christian Szell (Laurence Olivier, “Marathon Man,” 1976)

He may look harmless, but Christian Szell (Laurence Olivier) is a sadist with a secret, a stash, and throat-slitting skills. Szell, a dentist known as the White Angel of Auschwitz for his war crimes, stops at nothing to protect the diamonds he stole from his victims in the camps. In one of Hollywood’s most infamous torture scenes, Szell tries to extract information from Babe Levy (Dustin Hoffman), an innocent grad student, plying the tools of his trade. When Szell asks, “Is it safe?” he’s not curious about whether Babe’s insurance covers anesthesia.

Orin Scrivello (Steve Martin, “Little Shop of Horrors,” 1986)

Sticking with deranged dentists, Orin Scrivello, DDS, (Steve Martin) sings and dances his way into your nightmares buoyed by copious helpings of nitrous oxide. Orin’s too-encouraging momma told him to parlay his sadistic tendencies into a career “where people will pay you to be inhumane.” Sonny listened. Moviegoers were treated to screeching sound effects of a tooth getting yanked during an Elvis-like musical number shot in part from inside a patient’s mouth. Martin makes a creepy scene more fun than a long, slow root canal.

Henry Frankenstein (Colin Clive, “Frankenstein,” 1931)

His alarming need for fresh corpses forced Henry Frankenstein (Colin Clive) to leave medical school and experiment solo in a castle. He insists to his betrothed that he hasn’t gone mad when she arrives as  he is bringing a dead body back to life during a raging lightning storm. When she and Henry’s mentor, Dr Waldman, witness him succeed, Waldman warns Henry that the former owner of the purloined brain was a notorious criminal. When Henry exclaims: “It’s alive, it’s alive !” little did he know that he created the face (Boris Karloff) that would launch a thousand sequels, a spectacular satire, and untold Halloween masks.

Dr. Gogol (Peter Lorre, “Mad Love,” 1935)

A few years after playing doctor Frankenstein, Colin Clive became the patient of a mad medic himself. A concert pianist whose hands have been mangled in a train wreck, Clive’s wife turns to Dr. Gogol (Peter Lorre, in his Hollywood debut), who promises to surgically reattach the musician’s hands. Unfortunately, Gogol is so obsessed with the wife, a star of gory stage shows, that he has created a wax figure of her. He schemes to win her in the flesh by attaching a murderer’s hands to Clive, then frame him for committing murder with those hands. Gogol utters the madman’s lament: “I have conquered science. Why can’t I conquer love?” A modern remake would surely have him asking, “Why do they swipe left?

Hannibal Lecter (Anthony Hopkins, “Silence of the Lambs,” 1991)

The FBI, hunting for a serial killer, sends trainee Clarice Starling (Jodie Foster) to seek insight into the murderer from the imprisoned Dr. Hannibal Lecter (Anthony Hopkins), a brilliant psychiatrist with a penchant for murder — and a taste for the flesh of his victims. Lecter proves to be a menace from their first meeting; the bars and glass surrounding his cell offer Clarice no protection from his gaze and ability to read her mind. In his own way, the urbane, pathologically charming Lecter takes a shine to Clarice, helping with the case while embarking on another murderous spree against men who recently wronged her. When he escapes, his plans do not include dinner with – or of – Clarice, but others, well, they’re not so lucky.

Henry Jekyll (Fredric March, “Dr. Jekyll and Mr. Hyde,” 1931)

Henry Jekyll (Fredric March) is a jumble of personalities. By day, he’s a kindly doctor in Victorian London with an American accent. But he is so determined to split good and evil personalities that he devises a potion to outsource his id. As he watches himself morph into Mr. Hyde – a hairy, cone-headed dude in serious need of an orthodontist – he exclaims, “Free! Free at last!” Free, that is, for his simian side to engage in debauchery, abuse, self-hatred, intimations of rape, and ultimately murder – all of which are explored in this pre-Code film, the first talkie version of Robert Louis Stevenson’s story.

Dr. Moreau (Charles Laughton, “Island of Lost Souls,” 1932)

“Strange-looking natives you have here,” shipwreck victim Edward Parker (Richard Arlen) tells his host, the white-suited, whip-wielding Dr Moreau. Before long, we learn that Moreau’s evil veterinary talents  have created an island population of human/beast hybrids who are forced to follow his laws – especially one forbidding them from eating meat or walking on all fours. Lawbreakers get taken to the House of Pain, a medical setting which, as its name suggests, lacks adequate analgesia. Burt Lancaster and Marlon Brando took on the Moreau role in later versions, but Laughton is the creepiest when he asks, “Do you know what it means to feel like God?” The film was banned for years in Britain, and H.G. Wells despised this take on his antivivisection tale.

Charles Nichols (Jeroen Krabbé, “The Fugitive,” 1993)

Richard Kimble, a Chicago vascular surgeon, arrives home to find that a man just brutally murdered his loving wife. The killer escapes, and Kimble falls into the frame-up. Convicted for the murder and headed to prison, Kimble breaks free in an epic escape scene. He spends the rest of the movie all but giving his right arm to find the murderer, while being pursued by a dogged U.S. Marshal played with gusto by Tommy Lee Jones. Kimble eventually discovers that his colleague, Dr. Charles Nichols (Jeroen Krabbé), is not quite the best friend a man could have – or the most ethical of clinical investigators.

Elliot and Beverly Mantle (Jeremy Irons, “Dead Ringers,” 1988)

“You’ve got to try the movie star,” fertility specialist Elliot Mantle (Jeremy Irons) implores to his identical but meek twin brother, Beverly (also Jeremy Irons), talking about an actress-patient (Genevieve Bujold) as if she were a menu item. Beverly shares a practice with Elliot, along with a soul and an easily satisfied drug addiction. Beverly is unaware that Elliot seduces patients before passing them off to his brother, including the actress. Beverly is in love with the actress, which upsets the equilibrium of their shared soul. He aims to fix this, but not without some trauma involving freakish and unsanitary operating implements.

Dean Armitage (Bradley Whitford, “Get Out,” 2017)

Neurosurgeon Dean Armitage (Bradley Whitford) was such a fan of President Obama that he would have voted for him a third time if he could. At least, that’s how he portrays himself to Chris (Daniel Kaluuya), an African American photographer and the new boyfriend of Armitage’s White daughter. The Armitage estate has plenty of people of color – on staff, anyway – but Chris finds them odd and distant. It turns out that a gathering of rich White people is in fact an auction for his eyesight. Horror ensues. The main message from this film is not unlike that of Russian operatives who fall out of favor with the Kremlin: Don’t drink the tea.

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

Masks can be scary on Halloween, but more so when they come with scrubs, scalpels, and God complexes. In March, Medscape readers chose their favorite characters and performers in the Hollywood health care system. As a Halloween treat, we follow up with a dozen of our favorite Evil Doctors from a deep bench (and no, Dr Evil didn’t go to medical school; neither did Dr No, for that matter). Before you see these folks who’d rather haunt than heal, we urge you to seek a second opinion.

George Harris (Richard Widmark, “Coma,” 1978)

“Medicine is now a great social force,” says Dr. George Harris (Richard Widmark), chief of surgery at Boston Memorial. Because the public trusts doctors, “we’ll make the hard decisions” – like choosing which young, healthy patients to put into an irreversible coma to harvest their organs. Harris’ audience of one here is Dr. Susan Wheeler (Genevieve Bujold), the upstart who has uncovered his plot, and whom Harris has just drugged to prepare her as his next unintentional donor. “Coma” was based on a bestseller by Robin Cook and directed by Michael Crichton, who left Harvard Medical School for a career in popular books and films, including “The Andromeda Strain” and “Jurassic Park.” Although Dr. Harris starts out as a reassuring friend and mentor to Dr. Wheeler, older moviegoers won’t forget that he launched to stardom by tossing a woman in a wheelchair down the stairs in 1947’s “Kiss of Death.”
 

Christian Szell (Laurence Olivier, “Marathon Man,” 1976)

He may look harmless, but Christian Szell (Laurence Olivier) is a sadist with a secret, a stash, and throat-slitting skills. Szell, a dentist known as the White Angel of Auschwitz for his war crimes, stops at nothing to protect the diamonds he stole from his victims in the camps. In one of Hollywood’s most infamous torture scenes, Szell tries to extract information from Babe Levy (Dustin Hoffman), an innocent grad student, plying the tools of his trade. When Szell asks, “Is it safe?” he’s not curious about whether Babe’s insurance covers anesthesia.

Orin Scrivello (Steve Martin, “Little Shop of Horrors,” 1986)

Sticking with deranged dentists, Orin Scrivello, DDS, (Steve Martin) sings and dances his way into your nightmares buoyed by copious helpings of nitrous oxide. Orin’s too-encouraging momma told him to parlay his sadistic tendencies into a career “where people will pay you to be inhumane.” Sonny listened. Moviegoers were treated to screeching sound effects of a tooth getting yanked during an Elvis-like musical number shot in part from inside a patient’s mouth. Martin makes a creepy scene more fun than a long, slow root canal.

Henry Frankenstein (Colin Clive, “Frankenstein,” 1931)

His alarming need for fresh corpses forced Henry Frankenstein (Colin Clive) to leave medical school and experiment solo in a castle. He insists to his betrothed that he hasn’t gone mad when she arrives as  he is bringing a dead body back to life during a raging lightning storm. When she and Henry’s mentor, Dr Waldman, witness him succeed, Waldman warns Henry that the former owner of the purloined brain was a notorious criminal. When Henry exclaims: “It’s alive, it’s alive !” little did he know that he created the face (Boris Karloff) that would launch a thousand sequels, a spectacular satire, and untold Halloween masks.

Dr. Gogol (Peter Lorre, “Mad Love,” 1935)

A few years after playing doctor Frankenstein, Colin Clive became the patient of a mad medic himself. A concert pianist whose hands have been mangled in a train wreck, Clive’s wife turns to Dr. Gogol (Peter Lorre, in his Hollywood debut), who promises to surgically reattach the musician’s hands. Unfortunately, Gogol is so obsessed with the wife, a star of gory stage shows, that he has created a wax figure of her. He schemes to win her in the flesh by attaching a murderer’s hands to Clive, then frame him for committing murder with those hands. Gogol utters the madman’s lament: “I have conquered science. Why can’t I conquer love?” A modern remake would surely have him asking, “Why do they swipe left?

Hannibal Lecter (Anthony Hopkins, “Silence of the Lambs,” 1991)

The FBI, hunting for a serial killer, sends trainee Clarice Starling (Jodie Foster) to seek insight into the murderer from the imprisoned Dr. Hannibal Lecter (Anthony Hopkins), a brilliant psychiatrist with a penchant for murder — and a taste for the flesh of his victims. Lecter proves to be a menace from their first meeting; the bars and glass surrounding his cell offer Clarice no protection from his gaze and ability to read her mind. In his own way, the urbane, pathologically charming Lecter takes a shine to Clarice, helping with the case while embarking on another murderous spree against men who recently wronged her. When he escapes, his plans do not include dinner with – or of – Clarice, but others, well, they’re not so lucky.

Henry Jekyll (Fredric March, “Dr. Jekyll and Mr. Hyde,” 1931)

Henry Jekyll (Fredric March) is a jumble of personalities. By day, he’s a kindly doctor in Victorian London with an American accent. But he is so determined to split good and evil personalities that he devises a potion to outsource his id. As he watches himself morph into Mr. Hyde – a hairy, cone-headed dude in serious need of an orthodontist – he exclaims, “Free! Free at last!” Free, that is, for his simian side to engage in debauchery, abuse, self-hatred, intimations of rape, and ultimately murder – all of which are explored in this pre-Code film, the first talkie version of Robert Louis Stevenson’s story.

Dr. Moreau (Charles Laughton, “Island of Lost Souls,” 1932)

“Strange-looking natives you have here,” shipwreck victim Edward Parker (Richard Arlen) tells his host, the white-suited, whip-wielding Dr Moreau. Before long, we learn that Moreau’s evil veterinary talents  have created an island population of human/beast hybrids who are forced to follow his laws – especially one forbidding them from eating meat or walking on all fours. Lawbreakers get taken to the House of Pain, a medical setting which, as its name suggests, lacks adequate analgesia. Burt Lancaster and Marlon Brando took on the Moreau role in later versions, but Laughton is the creepiest when he asks, “Do you know what it means to feel like God?” The film was banned for years in Britain, and H.G. Wells despised this take on his antivivisection tale.

Charles Nichols (Jeroen Krabbé, “The Fugitive,” 1993)

Richard Kimble, a Chicago vascular surgeon, arrives home to find that a man just brutally murdered his loving wife. The killer escapes, and Kimble falls into the frame-up. Convicted for the murder and headed to prison, Kimble breaks free in an epic escape scene. He spends the rest of the movie all but giving his right arm to find the murderer, while being pursued by a dogged U.S. Marshal played with gusto by Tommy Lee Jones. Kimble eventually discovers that his colleague, Dr. Charles Nichols (Jeroen Krabbé), is not quite the best friend a man could have – or the most ethical of clinical investigators.

Elliot and Beverly Mantle (Jeremy Irons, “Dead Ringers,” 1988)

“You’ve got to try the movie star,” fertility specialist Elliot Mantle (Jeremy Irons) implores to his identical but meek twin brother, Beverly (also Jeremy Irons), talking about an actress-patient (Genevieve Bujold) as if she were a menu item. Beverly shares a practice with Elliot, along with a soul and an easily satisfied drug addiction. Beverly is unaware that Elliot seduces patients before passing them off to his brother, including the actress. Beverly is in love with the actress, which upsets the equilibrium of their shared soul. He aims to fix this, but not without some trauma involving freakish and unsanitary operating implements.

Dean Armitage (Bradley Whitford, “Get Out,” 2017)

Neurosurgeon Dean Armitage (Bradley Whitford) was such a fan of President Obama that he would have voted for him a third time if he could. At least, that’s how he portrays himself to Chris (Daniel Kaluuya), an African American photographer and the new boyfriend of Armitage’s White daughter. The Armitage estate has plenty of people of color – on staff, anyway – but Chris finds them odd and distant. It turns out that a gathering of rich White people is in fact an auction for his eyesight. Horror ensues. The main message from this film is not unlike that of Russian operatives who fall out of favor with the Kremlin: Don’t drink the tea.

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

Masks can be scary on Halloween, but more so when they come with scrubs, scalpels, and God complexes. In March, Medscape readers chose their favorite characters and performers in the Hollywood health care system. As a Halloween treat, we follow up with a dozen of our favorite Evil Doctors from a deep bench (and no, Dr Evil didn’t go to medical school; neither did Dr No, for that matter). Before you see these folks who’d rather haunt than heal, we urge you to seek a second opinion.

George Harris (Richard Widmark, “Coma,” 1978)

“Medicine is now a great social force,” says Dr. George Harris (Richard Widmark), chief of surgery at Boston Memorial. Because the public trusts doctors, “we’ll make the hard decisions” – like choosing which young, healthy patients to put into an irreversible coma to harvest their organs. Harris’ audience of one here is Dr. Susan Wheeler (Genevieve Bujold), the upstart who has uncovered his plot, and whom Harris has just drugged to prepare her as his next unintentional donor. “Coma” was based on a bestseller by Robin Cook and directed by Michael Crichton, who left Harvard Medical School for a career in popular books and films, including “The Andromeda Strain” and “Jurassic Park.” Although Dr. Harris starts out as a reassuring friend and mentor to Dr. Wheeler, older moviegoers won’t forget that he launched to stardom by tossing a woman in a wheelchair down the stairs in 1947’s “Kiss of Death.”
 

Christian Szell (Laurence Olivier, “Marathon Man,” 1976)

He may look harmless, but Christian Szell (Laurence Olivier) is a sadist with a secret, a stash, and throat-slitting skills. Szell, a dentist known as the White Angel of Auschwitz for his war crimes, stops at nothing to protect the diamonds he stole from his victims in the camps. In one of Hollywood’s most infamous torture scenes, Szell tries to extract information from Babe Levy (Dustin Hoffman), an innocent grad student, plying the tools of his trade. When Szell asks, “Is it safe?” he’s not curious about whether Babe’s insurance covers anesthesia.

Orin Scrivello (Steve Martin, “Little Shop of Horrors,” 1986)

Sticking with deranged dentists, Orin Scrivello, DDS, (Steve Martin) sings and dances his way into your nightmares buoyed by copious helpings of nitrous oxide. Orin’s too-encouraging momma told him to parlay his sadistic tendencies into a career “where people will pay you to be inhumane.” Sonny listened. Moviegoers were treated to screeching sound effects of a tooth getting yanked during an Elvis-like musical number shot in part from inside a patient’s mouth. Martin makes a creepy scene more fun than a long, slow root canal.

Henry Frankenstein (Colin Clive, “Frankenstein,” 1931)

His alarming need for fresh corpses forced Henry Frankenstein (Colin Clive) to leave medical school and experiment solo in a castle. He insists to his betrothed that he hasn’t gone mad when she arrives as  he is bringing a dead body back to life during a raging lightning storm. When she and Henry’s mentor, Dr Waldman, witness him succeed, Waldman warns Henry that the former owner of the purloined brain was a notorious criminal. When Henry exclaims: “It’s alive, it’s alive !” little did he know that he created the face (Boris Karloff) that would launch a thousand sequels, a spectacular satire, and untold Halloween masks.

Dr. Gogol (Peter Lorre, “Mad Love,” 1935)

A few years after playing doctor Frankenstein, Colin Clive became the patient of a mad medic himself. A concert pianist whose hands have been mangled in a train wreck, Clive’s wife turns to Dr. Gogol (Peter Lorre, in his Hollywood debut), who promises to surgically reattach the musician’s hands. Unfortunately, Gogol is so obsessed with the wife, a star of gory stage shows, that he has created a wax figure of her. He schemes to win her in the flesh by attaching a murderer’s hands to Clive, then frame him for committing murder with those hands. Gogol utters the madman’s lament: “I have conquered science. Why can’t I conquer love?” A modern remake would surely have him asking, “Why do they swipe left?

Hannibal Lecter (Anthony Hopkins, “Silence of the Lambs,” 1991)

The FBI, hunting for a serial killer, sends trainee Clarice Starling (Jodie Foster) to seek insight into the murderer from the imprisoned Dr. Hannibal Lecter (Anthony Hopkins), a brilliant psychiatrist with a penchant for murder — and a taste for the flesh of his victims. Lecter proves to be a menace from their first meeting; the bars and glass surrounding his cell offer Clarice no protection from his gaze and ability to read her mind. In his own way, the urbane, pathologically charming Lecter takes a shine to Clarice, helping with the case while embarking on another murderous spree against men who recently wronged her. When he escapes, his plans do not include dinner with – or of – Clarice, but others, well, they’re not so lucky.

Henry Jekyll (Fredric March, “Dr. Jekyll and Mr. Hyde,” 1931)

Henry Jekyll (Fredric March) is a jumble of personalities. By day, he’s a kindly doctor in Victorian London with an American accent. But he is so determined to split good and evil personalities that he devises a potion to outsource his id. As he watches himself morph into Mr. Hyde – a hairy, cone-headed dude in serious need of an orthodontist – he exclaims, “Free! Free at last!” Free, that is, for his simian side to engage in debauchery, abuse, self-hatred, intimations of rape, and ultimately murder – all of which are explored in this pre-Code film, the first talkie version of Robert Louis Stevenson’s story.

Dr. Moreau (Charles Laughton, “Island of Lost Souls,” 1932)

“Strange-looking natives you have here,” shipwreck victim Edward Parker (Richard Arlen) tells his host, the white-suited, whip-wielding Dr Moreau. Before long, we learn that Moreau’s evil veterinary talents  have created an island population of human/beast hybrids who are forced to follow his laws – especially one forbidding them from eating meat or walking on all fours. Lawbreakers get taken to the House of Pain, a medical setting which, as its name suggests, lacks adequate analgesia. Burt Lancaster and Marlon Brando took on the Moreau role in later versions, but Laughton is the creepiest when he asks, “Do you know what it means to feel like God?” The film was banned for years in Britain, and H.G. Wells despised this take on his antivivisection tale.

Charles Nichols (Jeroen Krabbé, “The Fugitive,” 1993)

Richard Kimble, a Chicago vascular surgeon, arrives home to find that a man just brutally murdered his loving wife. The killer escapes, and Kimble falls into the frame-up. Convicted for the murder and headed to prison, Kimble breaks free in an epic escape scene. He spends the rest of the movie all but giving his right arm to find the murderer, while being pursued by a dogged U.S. Marshal played with gusto by Tommy Lee Jones. Kimble eventually discovers that his colleague, Dr. Charles Nichols (Jeroen Krabbé), is not quite the best friend a man could have – or the most ethical of clinical investigators.

Elliot and Beverly Mantle (Jeremy Irons, “Dead Ringers,” 1988)

“You’ve got to try the movie star,” fertility specialist Elliot Mantle (Jeremy Irons) implores to his identical but meek twin brother, Beverly (also Jeremy Irons), talking about an actress-patient (Genevieve Bujold) as if she were a menu item. Beverly shares a practice with Elliot, along with a soul and an easily satisfied drug addiction. Beverly is unaware that Elliot seduces patients before passing them off to his brother, including the actress. Beverly is in love with the actress, which upsets the equilibrium of their shared soul. He aims to fix this, but not without some trauma involving freakish and unsanitary operating implements.

Dean Armitage (Bradley Whitford, “Get Out,” 2017)

Neurosurgeon Dean Armitage (Bradley Whitford) was such a fan of President Obama that he would have voted for him a third time if he could. At least, that’s how he portrays himself to Chris (Daniel Kaluuya), an African American photographer and the new boyfriend of Armitage’s White daughter. The Armitage estate has plenty of people of color – on staff, anyway – but Chris finds them odd and distant. It turns out that a gathering of rich White people is in fact an auction for his eyesight. Horror ensues. The main message from this film is not unlike that of Russian operatives who fall out of favor with the Kremlin: Don’t drink the tea.

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

An “exciting” new gene-editing strategy means those born with a rare inherited disease of the immune system could be treated by repairing a fault in their cells.

Scientists have hailed new research that found faulty cells responsible for the immune system disease CTLA-4 insufficiency can be repaired with a pioneering gene editing technique.

CTLA-4 is a protein produced by T cells that helps to control the activity of the immune system. Most people carry two working copies of the gene responsible for producing CTLA-4, but those who have only one functional copy produce too little of the protein to sufficiently regulate the immune system.

For patients with the condition, CTLA-4 insufficiency causes regulatory T cells to function abnormally, leading to severe autoimmunity. The authors explained that the condition also affects effector T cells and thereby “hampers their immune system’s ‘memory,’ ” meaning patients can “struggle to fight off recurring infections by the same viruses and bacteria.” In some cases, it can also lead to lymphomas.
 

Gene editing to ‘cut’ out faulty genes and ‘paste’ in ‘corrected’ ones

The research, published in Science Translational Medicine, and led by scientists from University College London, demonstrated in human cells and in mice that the cell fault can be repaired.

The scientists used “cut-and-paste” gene-editing techniques. First, they used the CRISPR/Cas9 system to target the faulty gene in human T cells taken from patients with CTLA-4 insufficiency, and then snip the faulty CTLA-4 gene in two. Then, to repair the errors a corrected sequence of DNA – delivered to the cell using a modified virus – was pasted over the faulty part of the gene using a cellular DNA repair mechanism known as homology-directed repair.

The authors explained that this allowed them to “preserve” important sequences within the CTLA-4 gene – known as the intron – that allow it to be switched on and off by the cell only when needed. 

The outcome was “restored levels of CTLA-4 in the cells to those seen in healthy T cells,” the authors said.

Claire Booth, PhD, Mahboubian professor of gene therapy and pediatric immunology, UCL Great Ormond Street Institute of Child Health, and co–senior author, said that it was “really exciting” to think about taking this treatment forward to patients. “If we can improve their symptoms and reduce their risk of getting lymphoproliferative disease this will be a major step forward.”

In addition, the researchers were also able to improve symptoms of the disease in mice with CTLA-4 insufficiency by giving them injections of gene-edited T cells.
 

Technique may help tackle many conditions

The current standard treatment for CTLA-4 insufficiency is a bone marrow transplant to replace the stem cells responsible for producing T cells. However, “transplants are risky” and require high doses of chemotherapy and many weeks in hospital, the authors explained. “Older patients with CTLA-4 insufficiency are typically not well enough to tolerate the transplant procedure.”

Dr. Booth highlighted that the approach has many “positive aspects”. By correcting the patient’s T cells, “we think it can improve many of the symptoms of the disease”, she said, and added that this new approach is much less toxic than a bone marrow transplant. “Collecting the T cells is easier and correcting the T cells is easier. With this approach the amount of time in hospital the patients would need would be far less.”

Emma Morris, PhD, professor of clinical cell and gene therapy and director of UCL’s division of infection and immunity, and co–senior author, said: “Genes that play critical roles in controlling immune responses are not switched on all the time and are very tightly regulated. The technique we have used allows us to leave the natural (endogenous) mechanisms controlling gene expression intact, at the same time as correcting the mistake in the gene itself.”

The researchers explained that, although CTLA-4 insufficiency is rare, the gene editing therapy could be a proof of principle of their approach that could be adapted to tackle other conditions. 

“It’s a way of correcting genetic mutations that could potentially be applicable for other diseases,” suggested Dr. Morris. “The bigger picture is it allows us to correct genes that are dysregulated or overactive, but also allows us to understand much more about gene expression and gene regulation.”

The study was funded by the Wellcome Trust, the Association for Moleculary Pathology, the Medical Research Council, Alzheimer’s Research UK, and the UCLH/UCL NIHR Biomedical Research Centre. Dr. Morris is a founder sharehold of Quell Therapeutics and has received honoraria from Orchard Therapeutics, GlaxoSmithKline, and AstraZeneca. Dr. Booth has performed ad hoc consulting in the past 3 years for SOBI and Novartis and educational material production for SOBI and Chiesi. A patent on the intronic gene editing approach has been filed in the UK. The other authors declared that they have no completing interests.

A version of this article first appeared on Medscape UK.

An “exciting” new gene-editing strategy means those born with a rare inherited disease of the immune system could be treated by repairing a fault in their cells.

Scientists have hailed new research that found faulty cells responsible for the immune system disease CTLA-4 insufficiency can be repaired with a pioneering gene editing technique.

CTLA-4 is a protein produced by T cells that helps to control the activity of the immune system. Most people carry two working copies of the gene responsible for producing CTLA-4, but those who have only one functional copy produce too little of the protein to sufficiently regulate the immune system.

For patients with the condition, CTLA-4 insufficiency causes regulatory T cells to function abnormally, leading to severe autoimmunity. The authors explained that the condition also affects effector T cells and thereby “hampers their immune system’s ‘memory,’ ” meaning patients can “struggle to fight off recurring infections by the same viruses and bacteria.” In some cases, it can also lead to lymphomas.
 

Gene editing to ‘cut’ out faulty genes and ‘paste’ in ‘corrected’ ones

The research, published in Science Translational Medicine, and led by scientists from University College London, demonstrated in human cells and in mice that the cell fault can be repaired.

The scientists used “cut-and-paste” gene-editing techniques. First, they used the CRISPR/Cas9 system to target the faulty gene in human T cells taken from patients with CTLA-4 insufficiency, and then snip the faulty CTLA-4 gene in two. Then, to repair the errors a corrected sequence of DNA – delivered to the cell using a modified virus – was pasted over the faulty part of the gene using a cellular DNA repair mechanism known as homology-directed repair.

The authors explained that this allowed them to “preserve” important sequences within the CTLA-4 gene – known as the intron – that allow it to be switched on and off by the cell only when needed. 

The outcome was “restored levels of CTLA-4 in the cells to those seen in healthy T cells,” the authors said.

Claire Booth, PhD, Mahboubian professor of gene therapy and pediatric immunology, UCL Great Ormond Street Institute of Child Health, and co–senior author, said that it was “really exciting” to think about taking this treatment forward to patients. “If we can improve their symptoms and reduce their risk of getting lymphoproliferative disease this will be a major step forward.”

In addition, the researchers were also able to improve symptoms of the disease in mice with CTLA-4 insufficiency by giving them injections of gene-edited T cells.
 

Technique may help tackle many conditions

The current standard treatment for CTLA-4 insufficiency is a bone marrow transplant to replace the stem cells responsible for producing T cells. However, “transplants are risky” and require high doses of chemotherapy and many weeks in hospital, the authors explained. “Older patients with CTLA-4 insufficiency are typically not well enough to tolerate the transplant procedure.”

Dr. Booth highlighted that the approach has many “positive aspects”. By correcting the patient’s T cells, “we think it can improve many of the symptoms of the disease”, she said, and added that this new approach is much less toxic than a bone marrow transplant. “Collecting the T cells is easier and correcting the T cells is easier. With this approach the amount of time in hospital the patients would need would be far less.”

Emma Morris, PhD, professor of clinical cell and gene therapy and director of UCL’s division of infection and immunity, and co–senior author, said: “Genes that play critical roles in controlling immune responses are not switched on all the time and are very tightly regulated. The technique we have used allows us to leave the natural (endogenous) mechanisms controlling gene expression intact, at the same time as correcting the mistake in the gene itself.”

The researchers explained that, although CTLA-4 insufficiency is rare, the gene editing therapy could be a proof of principle of their approach that could be adapted to tackle other conditions. 

“It’s a way of correcting genetic mutations that could potentially be applicable for other diseases,” suggested Dr. Morris. “The bigger picture is it allows us to correct genes that are dysregulated or overactive, but also allows us to understand much more about gene expression and gene regulation.”

The study was funded by the Wellcome Trust, the Association for Moleculary Pathology, the Medical Research Council, Alzheimer’s Research UK, and the UCLH/UCL NIHR Biomedical Research Centre. Dr. Morris is a founder sharehold of Quell Therapeutics and has received honoraria from Orchard Therapeutics, GlaxoSmithKline, and AstraZeneca. Dr. Booth has performed ad hoc consulting in the past 3 years for SOBI and Novartis and educational material production for SOBI and Chiesi. A patent on the intronic gene editing approach has been filed in the UK. The other authors declared that they have no completing interests.

A version of this article first appeared on Medscape UK.

An “exciting” new gene-editing strategy means those born with a rare inherited disease of the immune system could be treated by repairing a fault in their cells.

Scientists have hailed new research that found faulty cells responsible for the immune system disease CTLA-4 insufficiency can be repaired with a pioneering gene editing technique.

CTLA-4 is a protein produced by T cells that helps to control the activity of the immune system. Most people carry two working copies of the gene responsible for producing CTLA-4, but those who have only one functional copy produce too little of the protein to sufficiently regulate the immune system.

For patients with the condition, CTLA-4 insufficiency causes regulatory T cells to function abnormally, leading to severe autoimmunity. The authors explained that the condition also affects effector T cells and thereby “hampers their immune system’s ‘memory,’ ” meaning patients can “struggle to fight off recurring infections by the same viruses and bacteria.” In some cases, it can also lead to lymphomas.
 

Gene editing to ‘cut’ out faulty genes and ‘paste’ in ‘corrected’ ones

The research, published in Science Translational Medicine, and led by scientists from University College London, demonstrated in human cells and in mice that the cell fault can be repaired.

The scientists used “cut-and-paste” gene-editing techniques. First, they used the CRISPR/Cas9 system to target the faulty gene in human T cells taken from patients with CTLA-4 insufficiency, and then snip the faulty CTLA-4 gene in two. Then, to repair the errors a corrected sequence of DNA – delivered to the cell using a modified virus – was pasted over the faulty part of the gene using a cellular DNA repair mechanism known as homology-directed repair.

The authors explained that this allowed them to “preserve” important sequences within the CTLA-4 gene – known as the intron – that allow it to be switched on and off by the cell only when needed. 

The outcome was “restored levels of CTLA-4 in the cells to those seen in healthy T cells,” the authors said.

Claire Booth, PhD, Mahboubian professor of gene therapy and pediatric immunology, UCL Great Ormond Street Institute of Child Health, and co–senior author, said that it was “really exciting” to think about taking this treatment forward to patients. “If we can improve their symptoms and reduce their risk of getting lymphoproliferative disease this will be a major step forward.”

In addition, the researchers were also able to improve symptoms of the disease in mice with CTLA-4 insufficiency by giving them injections of gene-edited T cells.
 

Technique may help tackle many conditions

The current standard treatment for CTLA-4 insufficiency is a bone marrow transplant to replace the stem cells responsible for producing T cells. However, “transplants are risky” and require high doses of chemotherapy and many weeks in hospital, the authors explained. “Older patients with CTLA-4 insufficiency are typically not well enough to tolerate the transplant procedure.”

Dr. Booth highlighted that the approach has many “positive aspects”. By correcting the patient’s T cells, “we think it can improve many of the symptoms of the disease”, she said, and added that this new approach is much less toxic than a bone marrow transplant. “Collecting the T cells is easier and correcting the T cells is easier. With this approach the amount of time in hospital the patients would need would be far less.”

Emma Morris, PhD, professor of clinical cell and gene therapy and director of UCL’s division of infection and immunity, and co–senior author, said: “Genes that play critical roles in controlling immune responses are not switched on all the time and are very tightly regulated. The technique we have used allows us to leave the natural (endogenous) mechanisms controlling gene expression intact, at the same time as correcting the mistake in the gene itself.”

The researchers explained that, although CTLA-4 insufficiency is rare, the gene editing therapy could be a proof of principle of their approach that could be adapted to tackle other conditions. 

“It’s a way of correcting genetic mutations that could potentially be applicable for other diseases,” suggested Dr. Morris. “The bigger picture is it allows us to correct genes that are dysregulated or overactive, but also allows us to understand much more about gene expression and gene regulation.”

The study was funded by the Wellcome Trust, the Association for Moleculary Pathology, the Medical Research Council, Alzheimer’s Research UK, and the UCLH/UCL NIHR Biomedical Research Centre. Dr. Morris is a founder sharehold of Quell Therapeutics and has received honoraria from Orchard Therapeutics, GlaxoSmithKline, and AstraZeneca. Dr. Booth has performed ad hoc consulting in the past 3 years for SOBI and Novartis and educational material production for SOBI and Chiesi. A patent on the intronic gene editing approach has been filed in the UK. The other authors declared that they have no completing interests.

A version of this article first appeared on Medscape UK.

In the era of Ebola, COVID-19, and even Legionnaires, technicians and other staff working behind the scenes to ensure provider and patient safety continue to face a long-recognized but under addressed challenge: splashes and airborne droplets.

Granted, National Institute for Occupational Safety and Health (NIOSH) standards, industry standards, and professional guidelines are all in place to prevent unintentional exposure to pathogens. However, findings from a newly published study in the American Journal of Infection Control suggest they fall short.

In the study, researchers found that simulated manual cleaning of medical devices generated a drenching splash throughout the process with droplet dispersal exceeding 7 feet (2.1 meters).

“The guidelines say that droplets stop at 3 or 4 feet, and they don’t,” Cori L. Ofstead, MSPH, lead author and president/CEO of Ofstead & Associates, Bloomington, Minn., told this news organization. “That’s the problem with having standards and guidelines that are not based on relevant evidence, [which] in this case, is a single study that was done in an intensive care area where they had an infection outbreak.”

Ms. Ofstead was referring to a report in the journal Infection Control and Hospital Epidemiology, detailing a Canadian investigation involving a multidrug-resistant Pseudomonas aeruginosa outbreak in an ICU. The report implicated the faucets over the hand hygiene sinks, with fluorescent dye showing droplet dispersal roughly 3 feet away from the sinks.

“Somehow it [the 3-feet rule] got implemented in guidelines in sterile processing decontamination areas, which are not the same as hand hygiene,’’ Ms. Ofstead explained.

With a goal of providing more current evidence on droplet generation and dispersal, as well as personal protection equipment (PPE) exposure/effectiveness, she and her colleagues simulated manual cleaning of a decommissioned colonoscope and transvaginal ultrasound probe, using for the study location a new academic sterile processing unit.

To detect droplet generation and dispersal as well as splash following common technician activities (for example, colonoscope brushing, scrubbing, rinsing and transport to an automated endoscope reprocessor [AER] for sterilization), the researchers affixed blue moisture-detection paper to environmental surfaces, on carts positioned 4 feet (1.2 meters) from the sink (to simulate observers), and along a 15-foot pathway between the sink and AER.

They observed droplets everywhere.

Technician activities such as running the faucet and rinsing the probe under running water generated substantial splashing overall. Instrument rinsing in particular produced small and large droplets and confluent puddles of water around the sink and in the broad area surrounding the workspace. Droplets were also dispersed on the floor 7.25 feet (2.2 meters) away and along the entire 15-foot path from the sink to the AER.

At the sink, the technician risked drenching exposure from head to toe during most activities, and even observers positioned 3-4 feet away were found to have droplets on their gowns. In addition, saturated shoe covers reportedly tracked moisture away from the sink to the unit door – a distance of 13 feet (4 meters) – and 2 feet (0.6 meters) farther out into the PPE foyer for donning and doffing.

Although PPE gowns effectively repelled moisture during cleaning of a single device, Ms. Ofstead emphasized that technicians typically handle up to 10 instruments during a normal, 2-hour shift, further increasing exposure risk with each subsequent cleaning.

However, perhaps one of the most surprising findings was that despite an optimal unit design, including physical separation of clean and dirty activities and pressurized air flow to protect workers, droplets were still broadly dispersed.

Current efforts, however well-intentioned, might not be offering the degree of protection (and consideration) that sterile processing technicians need.

“The study was conducted in a new sterile processing area that had an extra excellent kind of distancing and three separate rooms, something that I think most of our hospitals are working toward,” Stella Hines, MD, associate professor at the University of Maryland School of Medicine, Baltimore, explained. Dr. Hines was not directly involved in the study.

“But it also really kind of highlighted what’s happening to workers potentially,” she added. “For example, we want to know if that spray or splatter has a live microbe it in that could cause a problem or ... in a highly wet environment, if that water has some kind of chemical in it that could pose an occupational hazard to the worker based on skin or mucous membrane exposure.”

Ms. Ofstead agreed. “We need to be thinking about the exposure of critically important workers and the environment in an era where we are worried about aerosol-generating procedures and superbugs,” she explained.

Dr. Hines and Ms. Ofstead also noted that the majority of staff involved in front-line patient care have never actually ventured into the sterile processing units nor do they recognize the risks that technicians working in these units face on a daily, or even hourly, basis.

“The people who run these operations are very well trained and knowledgeable. I think that it would be helpful for them to know that they’re appreciated and for the people upstairs on the front lines using the equipment to see what goes on downstairs and all of the painstaking steps that need to be in place for the equipment to come out of sterile processing and be ready to go,” said Dr. Hines.

In the meantime, hospital leaders need to address the challenges and danger posed by migrating infectious droplets, especially for workers involved in processes that stir them up in the first place – workers who by the end of their shifts are unavoidably drenched with infectious blood and tissue secretions.

“I think that it’s going to take a much bigger kind of worldview from hospital leadership,” Dr. Hines said.

The study was supported in part by a grant from Healthmark Industries. Ms. Ofstead reports research grants or consulting fees through her organization with 3M Company, Ambu, Boston Scientific, Cleanis, Fortive/Advanced Sterilization Products, Healthmark Industries, Pentax, and Steris/Cantel/Medviators. Dr. Hines reports no relevant financial relationships.

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

In the era of Ebola, COVID-19, and even Legionnaires, technicians and other staff working behind the scenes to ensure provider and patient safety continue to face a long-recognized but under addressed challenge: splashes and airborne droplets.

Granted, National Institute for Occupational Safety and Health (NIOSH) standards, industry standards, and professional guidelines are all in place to prevent unintentional exposure to pathogens. However, findings from a newly published study in the American Journal of Infection Control suggest they fall short.

In the study, researchers found that simulated manual cleaning of medical devices generated a drenching splash throughout the process with droplet dispersal exceeding 7 feet (2.1 meters).

“The guidelines say that droplets stop at 3 or 4 feet, and they don’t,” Cori L. Ofstead, MSPH, lead author and president/CEO of Ofstead & Associates, Bloomington, Minn., told this news organization. “That’s the problem with having standards and guidelines that are not based on relevant evidence, [which] in this case, is a single study that was done in an intensive care area where they had an infection outbreak.”

Ms. Ofstead was referring to a report in the journal Infection Control and Hospital Epidemiology, detailing a Canadian investigation involving a multidrug-resistant Pseudomonas aeruginosa outbreak in an ICU. The report implicated the faucets over the hand hygiene sinks, with fluorescent dye showing droplet dispersal roughly 3 feet away from the sinks.

“Somehow it [the 3-feet rule] got implemented in guidelines in sterile processing decontamination areas, which are not the same as hand hygiene,’’ Ms. Ofstead explained.

With a goal of providing more current evidence on droplet generation and dispersal, as well as personal protection equipment (PPE) exposure/effectiveness, she and her colleagues simulated manual cleaning of a decommissioned colonoscope and transvaginal ultrasound probe, using for the study location a new academic sterile processing unit.

To detect droplet generation and dispersal as well as splash following common technician activities (for example, colonoscope brushing, scrubbing, rinsing and transport to an automated endoscope reprocessor [AER] for sterilization), the researchers affixed blue moisture-detection paper to environmental surfaces, on carts positioned 4 feet (1.2 meters) from the sink (to simulate observers), and along a 15-foot pathway between the sink and AER.

They observed droplets everywhere.

Technician activities such as running the faucet and rinsing the probe under running water generated substantial splashing overall. Instrument rinsing in particular produced small and large droplets and confluent puddles of water around the sink and in the broad area surrounding the workspace. Droplets were also dispersed on the floor 7.25 feet (2.2 meters) away and along the entire 15-foot path from the sink to the AER.

At the sink, the technician risked drenching exposure from head to toe during most activities, and even observers positioned 3-4 feet away were found to have droplets on their gowns. In addition, saturated shoe covers reportedly tracked moisture away from the sink to the unit door – a distance of 13 feet (4 meters) – and 2 feet (0.6 meters) farther out into the PPE foyer for donning and doffing.

Although PPE gowns effectively repelled moisture during cleaning of a single device, Ms. Ofstead emphasized that technicians typically handle up to 10 instruments during a normal, 2-hour shift, further increasing exposure risk with each subsequent cleaning.

However, perhaps one of the most surprising findings was that despite an optimal unit design, including physical separation of clean and dirty activities and pressurized air flow to protect workers, droplets were still broadly dispersed.

Current efforts, however well-intentioned, might not be offering the degree of protection (and consideration) that sterile processing technicians need.

“The study was conducted in a new sterile processing area that had an extra excellent kind of distancing and three separate rooms, something that I think most of our hospitals are working toward,” Stella Hines, MD, associate professor at the University of Maryland School of Medicine, Baltimore, explained. Dr. Hines was not directly involved in the study.

“But it also really kind of highlighted what’s happening to workers potentially,” she added. “For example, we want to know if that spray or splatter has a live microbe it in that could cause a problem or ... in a highly wet environment, if that water has some kind of chemical in it that could pose an occupational hazard to the worker based on skin or mucous membrane exposure.”

Ms. Ofstead agreed. “We need to be thinking about the exposure of critically important workers and the environment in an era where we are worried about aerosol-generating procedures and superbugs,” she explained.

Dr. Hines and Ms. Ofstead also noted that the majority of staff involved in front-line patient care have never actually ventured into the sterile processing units nor do they recognize the risks that technicians working in these units face on a daily, or even hourly, basis.

“The people who run these operations are very well trained and knowledgeable. I think that it would be helpful for them to know that they’re appreciated and for the people upstairs on the front lines using the equipment to see what goes on downstairs and all of the painstaking steps that need to be in place for the equipment to come out of sterile processing and be ready to go,” said Dr. Hines.

In the meantime, hospital leaders need to address the challenges and danger posed by migrating infectious droplets, especially for workers involved in processes that stir them up in the first place – workers who by the end of their shifts are unavoidably drenched with infectious blood and tissue secretions.

“I think that it’s going to take a much bigger kind of worldview from hospital leadership,” Dr. Hines said.

The study was supported in part by a grant from Healthmark Industries. Ms. Ofstead reports research grants or consulting fees through her organization with 3M Company, Ambu, Boston Scientific, Cleanis, Fortive/Advanced Sterilization Products, Healthmark Industries, Pentax, and Steris/Cantel/Medviators. Dr. Hines reports no relevant financial relationships.

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

In the era of Ebola, COVID-19, and even Legionnaires, technicians and other staff working behind the scenes to ensure provider and patient safety continue to face a long-recognized but under addressed challenge: splashes and airborne droplets.

Granted, National Institute for Occupational Safety and Health (NIOSH) standards, industry standards, and professional guidelines are all in place to prevent unintentional exposure to pathogens. However, findings from a newly published study in the American Journal of Infection Control suggest they fall short.

In the study, researchers found that simulated manual cleaning of medical devices generated a drenching splash throughout the process with droplet dispersal exceeding 7 feet (2.1 meters).

“The guidelines say that droplets stop at 3 or 4 feet, and they don’t,” Cori L. Ofstead, MSPH, lead author and president/CEO of Ofstead & Associates, Bloomington, Minn., told this news organization. “That’s the problem with having standards and guidelines that are not based on relevant evidence, [which] in this case, is a single study that was done in an intensive care area where they had an infection outbreak.”

Ms. Ofstead was referring to a report in the journal Infection Control and Hospital Epidemiology, detailing a Canadian investigation involving a multidrug-resistant Pseudomonas aeruginosa outbreak in an ICU. The report implicated the faucets over the hand hygiene sinks, with fluorescent dye showing droplet dispersal roughly 3 feet away from the sinks.

“Somehow it [the 3-feet rule] got implemented in guidelines in sterile processing decontamination areas, which are not the same as hand hygiene,’’ Ms. Ofstead explained.

With a goal of providing more current evidence on droplet generation and dispersal, as well as personal protection equipment (PPE) exposure/effectiveness, she and her colleagues simulated manual cleaning of a decommissioned colonoscope and transvaginal ultrasound probe, using for the study location a new academic sterile processing unit.

To detect droplet generation and dispersal as well as splash following common technician activities (for example, colonoscope brushing, scrubbing, rinsing and transport to an automated endoscope reprocessor [AER] for sterilization), the researchers affixed blue moisture-detection paper to environmental surfaces, on carts positioned 4 feet (1.2 meters) from the sink (to simulate observers), and along a 15-foot pathway between the sink and AER.

They observed droplets everywhere.

Technician activities such as running the faucet and rinsing the probe under running water generated substantial splashing overall. Instrument rinsing in particular produced small and large droplets and confluent puddles of water around the sink and in the broad area surrounding the workspace. Droplets were also dispersed on the floor 7.25 feet (2.2 meters) away and along the entire 15-foot path from the sink to the AER.

At the sink, the technician risked drenching exposure from head to toe during most activities, and even observers positioned 3-4 feet away were found to have droplets on their gowns. In addition, saturated shoe covers reportedly tracked moisture away from the sink to the unit door – a distance of 13 feet (4 meters) – and 2 feet (0.6 meters) farther out into the PPE foyer for donning and doffing.

Although PPE gowns effectively repelled moisture during cleaning of a single device, Ms. Ofstead emphasized that technicians typically handle up to 10 instruments during a normal, 2-hour shift, further increasing exposure risk with each subsequent cleaning.

However, perhaps one of the most surprising findings was that despite an optimal unit design, including physical separation of clean and dirty activities and pressurized air flow to protect workers, droplets were still broadly dispersed.

Current efforts, however well-intentioned, might not be offering the degree of protection (and consideration) that sterile processing technicians need.

“The study was conducted in a new sterile processing area that had an extra excellent kind of distancing and three separate rooms, something that I think most of our hospitals are working toward,” Stella Hines, MD, associate professor at the University of Maryland School of Medicine, Baltimore, explained. Dr. Hines was not directly involved in the study.

“But it also really kind of highlighted what’s happening to workers potentially,” she added. “For example, we want to know if that spray or splatter has a live microbe it in that could cause a problem or ... in a highly wet environment, if that water has some kind of chemical in it that could pose an occupational hazard to the worker based on skin or mucous membrane exposure.”

Ms. Ofstead agreed. “We need to be thinking about the exposure of critically important workers and the environment in an era where we are worried about aerosol-generating procedures and superbugs,” she explained.

Dr. Hines and Ms. Ofstead also noted that the majority of staff involved in front-line patient care have never actually ventured into the sterile processing units nor do they recognize the risks that technicians working in these units face on a daily, or even hourly, basis.

“The people who run these operations are very well trained and knowledgeable. I think that it would be helpful for them to know that they’re appreciated and for the people upstairs on the front lines using the equipment to see what goes on downstairs and all of the painstaking steps that need to be in place for the equipment to come out of sterile processing and be ready to go,” said Dr. Hines.

In the meantime, hospital leaders need to address the challenges and danger posed by migrating infectious droplets, especially for workers involved in processes that stir them up in the first place – workers who by the end of their shifts are unavoidably drenched with infectious blood and tissue secretions.

“I think that it’s going to take a much bigger kind of worldview from hospital leadership,” Dr. Hines said.

The study was supported in part by a grant from Healthmark Industries. Ms. Ofstead reports research grants or consulting fees through her organization with 3M Company, Ambu, Boston Scientific, Cleanis, Fortive/Advanced Sterilization Products, Healthmark Industries, Pentax, and Steris/Cantel/Medviators. Dr. Hines reports no relevant financial relationships.

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

Josie Tenore, MD, and Paul Hinds were introduced by a mutual friend in 2017 and hadn’t been going out long when she laid down the law: He had to get a physical.

“I don’t date people who don’t take care of their health,” said Dr. Tenore, who practices cosmetic dermatology and functional medicine in suburban Chicago.

One of Mr. Hinds’ blood tests that summer came back with an alarming result: His prostate-specific antigen (PSA), level was very high. A biopsy confirmed he had advanced prostate cancer.

There aren’t a lot of comfortable alternatives for treating prostate cancer, which generally progresses as long as testosterone levels remain high. Marijuana appears to lower testosterone levels, so after his diagnosis, he dosed a liquid form of cannabis for several weeks. That cut his PSA in half, but Mr. Hinds, a cybersecurity expert who likes yoga and bicycling, “was stoned out of his mind and couldn’t function,” Dr. Tenore recalled.

With Dr. Tenore guiding his decisions, Mr. Hinds next tried high-frequency ultrasound treatment, but it failed. And in the summer of 2019 doctors removed his prostate gland. Still, the PSA levels climbed again, and doctors assessed that the cancer had metastasized. The only alternative was to drastically lower Mr. Hinds’ testosterone levels – either via surgery or drugs that block all testosterone. In May 2021, he got his first intramuscular shot of Lupron Depot, a brand name for leuprolide, designed to suppress the prostate gland’s release of the hormone for 3 months. That August, he got his second shot.

And then the bills came.

The patient: Paul Hinds, now 60, is covered by United Healthcare through a COBRA plan from his former employer.

Medical service: Two 3-month Lupron Depot injections for metastatic prostate cancer.

Service provider: University of Chicago Medicine, a 900-physician nonprofit system that includes an 811-bed medical center, a suburban hospital, the Pritzker School of Medicine, and outpatient clinics and physician offices throughout the Chicago area.

Total bill: $73,812 for the two shots ($35,414 for the first, $38,398 for the second), including lab work and physician charges. United Healthcare’s negotiated rate for the two shots plus associated fees was $27,568, of which the insurer paid $19,567. After Mr. Hinds haggled with the hospital and insurer for more than a year, his share of the bills was determined to be nearly $7,000.

What gives: The first issue is unrelenting price increases on old drugs that have remained branded as manufacturers find ways to extend patents for decades and maintain sales through marketing.

Though Lupron was invented in 1973, its manufacturer got patent extensions in 1989 by offering a slow-release version. Drugmakers commonly use this tactic to extend their exclusive rights to sell a product.

The development of Lupron Depot as an intramuscular shot that suppressed testosterone for months at a time improved patient compliance and also enabled its maker, Abbott Laboratories, and its Japanese partner, Takeda, to extend their patents on the drug into the 2000s, said Gerald Weisberg, MD, a former Abbott scientist who has been critical of the company’s pricing policies.

In subsequent years, Abbott and Takeda, in a joint venture called TAP Pharmaceuticals, steadily marked up the price of their slow-release product. In 2000, the average wholesale U.S. price for a 3-month shot was $1,245; currently that figure is $5,866. (It is manufactured in the United States by AbbVie now.)

In the United Kingdom, where health care is generally free and Takeda sells the drug under the name Prostap, all physicians can purchase a 3-month dose for about $260.

It’s likely that Chicago Medicine, where Mr. Hinds got his shots, paid something close to the British price. That’s because the health system’s hospital on Chicago’s South Side participates in a federal program called 340B, which allows hospitals that serve low-income populations to purchase drugs at deep discounts.

Lupron Depot is given as a simple injection into the muscle. It takes minutes for a nurse or doctor to administer. Yet hospital systems like Chicago Medicine can and typically do charge lavishly for such services, to enhance revenue, said Morgan Henderson, principal data scientist at the Hilltop Institute at the University of Maryland-Baltimore County. Chicago Medicine declined to say what it paid for the drug.

While U.S. drugmakers can price their drugs however they please, TAP has gotten into trouble for its Lupron sales policies in the past. In 2001, after a Justice Department probe, it paid an $875 million settlement for illegally stimulating sales by giving urologists free and discounted vials of the drug while enabling them to charge Medicare full price.

Since then, many other drugs aimed at lowering testosterone levels have entered the market, including a pill, relugolix (Orgovyx). So why wouldn’t a patient use them?

Lupron Depot is long acting, is easy to prepare and store, and employs a small needle, which some patients prefer, said Brian McNeil, MD, chief of urology at University Hospital of Brooklyn. Orgovyx is convenient, but “a patient has to be very compliant. They have to take it every day around the same time,” he said. “Some people just forget.”

But there is another important factor that may well explain Lupron Depot’s ongoing popularity among medical providers: Doctors and hospitals can earn tens of thousands of dollars each visit by marking up its price and administration fees – as they did with Mr. Hinds. If they merely write a prescription for a drug that can be taken at home, they earn nothing.

Asked about this high patient charge and the possibility of using alternatives, United spokesperson Maria Gordon Shydlo said payment was “appropriately based on the hospital’s contract and the member’s benefit plan,” adding that the insurer encourages customers to shop around for the best quality and price.

Resolution: In addition to leaving Mr. Hinds listless, the Lupron Depot shots were, literally, a pain in the rear end. “Each time he was miserable for 2 weeks,” Dr. Tenore said. After looking over his first bill for the Lupron shot, Dr. Tenore told Mr. Hinds he should ask his doctor whether there was a less expensive drug that was easier to take.

After the second shot, in August 2021, a pharmacist told him he could instead receive the pill. His doctor prescribed Mr. Hinds 3 months’ worth of Orgovyx last November, for which he paid $216 and the insurer paid over $6,000. The drug’s list price is about $2,700 a month. There is evidence that Orgovyx works a little better than leuprolide.

Orgovyx was a “no-brainer,” Mr. Hinds said. “Why would you want a sore ass for two weeks when you can take a pill that kicks in sooner, functions the same way, and clears your body of testosterone faster?”

While Orgovyx is increasingly used for prostate cancer, Lupron and other injections usually remain the standard of care, hospital spokesperson Ashley Heher said. Clinicians “work with patients to determine what treatments are the most medically effective and, when necessary, to find reasonable alternatives that may be less financially burdensome due to insurance coverage limitations.”

Mr. Hinds was baffled by the size of the charges. During months of phone calls and emails, the hospital reversed and then reapplied part of the charge, and then in July agreed to a $666.34 monthly payment plan. After Hinds had made two payments, however, the hospital announced Aug. 29 it was canceling the agreement and sending the remainder of his bill to a collection agency. Two weeks later, the hospital reinstated the payment plan – after KHN asked about the cancellation.

As for Mr. Hinds, he remains active, though his bike rides have been shortened from 50 or 60 miles to about 30, he said.

He’s grateful to have Dr. Tenore as a free consultant and empathizes with those who lack a knowledgeable guide through their disease and health care’s financial maze.

“I’ve got Dr. Josie as an advocate who knows the system,” Mr. Hinds said.

The takeaway: First tip: If you are prescribed an infusion or injection, ask your physician if there are cheaper oral medications to treat your condition. Also, many drugs that are given by injection – ones that are given “subcutaneously,” rather than into a muscle – can be administered by a patient at home, avoiding hefty administration fees. Drugs like Dupixent for eczema fall into this category.

Keep in mind that where you get treatment could make a big difference in your charges: A study found that leading U.S. cancer centers charge enormous markups to private insurers for drug injections or infusions. Another study found that hospital systems charge an average of 86% more than private clinics for cancer drug infusions. And the percentage of cancer infusions done in hospital-operated clinics increased from 6% in 2004 to 43% in 2014, and has grown since.

Under a law that took effect in 2021, hospitals are required to list their charges, though they currently do so in a way that is not user friendly. But it’s worth taking a look at the price list – the hospital chargemaster – to try to decipher the pricing and markup for your medicine. If you’re about to get an injection, infusion, or procedure done in a hospital system, ask ahead of time for an estimate of what you will owe.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Josie Tenore, MD, and Paul Hinds were introduced by a mutual friend in 2017 and hadn’t been going out long when she laid down the law: He had to get a physical.

“I don’t date people who don’t take care of their health,” said Dr. Tenore, who practices cosmetic dermatology and functional medicine in suburban Chicago.

One of Mr. Hinds’ blood tests that summer came back with an alarming result: His prostate-specific antigen (PSA), level was very high. A biopsy confirmed he had advanced prostate cancer.

There aren’t a lot of comfortable alternatives for treating prostate cancer, which generally progresses as long as testosterone levels remain high. Marijuana appears to lower testosterone levels, so after his diagnosis, he dosed a liquid form of cannabis for several weeks. That cut his PSA in half, but Mr. Hinds, a cybersecurity expert who likes yoga and bicycling, “was stoned out of his mind and couldn’t function,” Dr. Tenore recalled.

With Dr. Tenore guiding his decisions, Mr. Hinds next tried high-frequency ultrasound treatment, but it failed. And in the summer of 2019 doctors removed his prostate gland. Still, the PSA levels climbed again, and doctors assessed that the cancer had metastasized. The only alternative was to drastically lower Mr. Hinds’ testosterone levels – either via surgery or drugs that block all testosterone. In May 2021, he got his first intramuscular shot of Lupron Depot, a brand name for leuprolide, designed to suppress the prostate gland’s release of the hormone for 3 months. That August, he got his second shot.

And then the bills came.

The patient: Paul Hinds, now 60, is covered by United Healthcare through a COBRA plan from his former employer.

Medical service: Two 3-month Lupron Depot injections for metastatic prostate cancer.

Service provider: University of Chicago Medicine, a 900-physician nonprofit system that includes an 811-bed medical center, a suburban hospital, the Pritzker School of Medicine, and outpatient clinics and physician offices throughout the Chicago area.

Total bill: $73,812 for the two shots ($35,414 for the first, $38,398 for the second), including lab work and physician charges. United Healthcare’s negotiated rate for the two shots plus associated fees was $27,568, of which the insurer paid $19,567. After Mr. Hinds haggled with the hospital and insurer for more than a year, his share of the bills was determined to be nearly $7,000.

What gives: The first issue is unrelenting price increases on old drugs that have remained branded as manufacturers find ways to extend patents for decades and maintain sales through marketing.

Though Lupron was invented in 1973, its manufacturer got patent extensions in 1989 by offering a slow-release version. Drugmakers commonly use this tactic to extend their exclusive rights to sell a product.

The development of Lupron Depot as an intramuscular shot that suppressed testosterone for months at a time improved patient compliance and also enabled its maker, Abbott Laboratories, and its Japanese partner, Takeda, to extend their patents on the drug into the 2000s, said Gerald Weisberg, MD, a former Abbott scientist who has been critical of the company’s pricing policies.

In subsequent years, Abbott and Takeda, in a joint venture called TAP Pharmaceuticals, steadily marked up the price of their slow-release product. In 2000, the average wholesale U.S. price for a 3-month shot was $1,245; currently that figure is $5,866. (It is manufactured in the United States by AbbVie now.)

In the United Kingdom, where health care is generally free and Takeda sells the drug under the name Prostap, all physicians can purchase a 3-month dose for about $260.

It’s likely that Chicago Medicine, where Mr. Hinds got his shots, paid something close to the British price. That’s because the health system’s hospital on Chicago’s South Side participates in a federal program called 340B, which allows hospitals that serve low-income populations to purchase drugs at deep discounts.

Lupron Depot is given as a simple injection into the muscle. It takes minutes for a nurse or doctor to administer. Yet hospital systems like Chicago Medicine can and typically do charge lavishly for such services, to enhance revenue, said Morgan Henderson, principal data scientist at the Hilltop Institute at the University of Maryland-Baltimore County. Chicago Medicine declined to say what it paid for the drug.

While U.S. drugmakers can price their drugs however they please, TAP has gotten into trouble for its Lupron sales policies in the past. In 2001, after a Justice Department probe, it paid an $875 million settlement for illegally stimulating sales by giving urologists free and discounted vials of the drug while enabling them to charge Medicare full price.

Since then, many other drugs aimed at lowering testosterone levels have entered the market, including a pill, relugolix (Orgovyx). So why wouldn’t a patient use them?

Lupron Depot is long acting, is easy to prepare and store, and employs a small needle, which some patients prefer, said Brian McNeil, MD, chief of urology at University Hospital of Brooklyn. Orgovyx is convenient, but “a patient has to be very compliant. They have to take it every day around the same time,” he said. “Some people just forget.”

But there is another important factor that may well explain Lupron Depot’s ongoing popularity among medical providers: Doctors and hospitals can earn tens of thousands of dollars each visit by marking up its price and administration fees – as they did with Mr. Hinds. If they merely write a prescription for a drug that can be taken at home, they earn nothing.

Asked about this high patient charge and the possibility of using alternatives, United spokesperson Maria Gordon Shydlo said payment was “appropriately based on the hospital’s contract and the member’s benefit plan,” adding that the insurer encourages customers to shop around for the best quality and price.

Resolution: In addition to leaving Mr. Hinds listless, the Lupron Depot shots were, literally, a pain in the rear end. “Each time he was miserable for 2 weeks,” Dr. Tenore said. After looking over his first bill for the Lupron shot, Dr. Tenore told Mr. Hinds he should ask his doctor whether there was a less expensive drug that was easier to take.

After the second shot, in August 2021, a pharmacist told him he could instead receive the pill. His doctor prescribed Mr. Hinds 3 months’ worth of Orgovyx last November, for which he paid $216 and the insurer paid over $6,000. The drug’s list price is about $2,700 a month. There is evidence that Orgovyx works a little better than leuprolide.

Orgovyx was a “no-brainer,” Mr. Hinds said. “Why would you want a sore ass for two weeks when you can take a pill that kicks in sooner, functions the same way, and clears your body of testosterone faster?”

While Orgovyx is increasingly used for prostate cancer, Lupron and other injections usually remain the standard of care, hospital spokesperson Ashley Heher said. Clinicians “work with patients to determine what treatments are the most medically effective and, when necessary, to find reasonable alternatives that may be less financially burdensome due to insurance coverage limitations.”

Mr. Hinds was baffled by the size of the charges. During months of phone calls and emails, the hospital reversed and then reapplied part of the charge, and then in July agreed to a $666.34 monthly payment plan. After Hinds had made two payments, however, the hospital announced Aug. 29 it was canceling the agreement and sending the remainder of his bill to a collection agency. Two weeks later, the hospital reinstated the payment plan – after KHN asked about the cancellation.

As for Mr. Hinds, he remains active, though his bike rides have been shortened from 50 or 60 miles to about 30, he said.

He’s grateful to have Dr. Tenore as a free consultant and empathizes with those who lack a knowledgeable guide through their disease and health care’s financial maze.

“I’ve got Dr. Josie as an advocate who knows the system,” Mr. Hinds said.

The takeaway: First tip: If you are prescribed an infusion or injection, ask your physician if there are cheaper oral medications to treat your condition. Also, many drugs that are given by injection – ones that are given “subcutaneously,” rather than into a muscle – can be administered by a patient at home, avoiding hefty administration fees. Drugs like Dupixent for eczema fall into this category.

Keep in mind that where you get treatment could make a big difference in your charges: A study found that leading U.S. cancer centers charge enormous markups to private insurers for drug injections or infusions. Another study found that hospital systems charge an average of 86% more than private clinics for cancer drug infusions. And the percentage of cancer infusions done in hospital-operated clinics increased from 6% in 2004 to 43% in 2014, and has grown since.

Under a law that took effect in 2021, hospitals are required to list their charges, though they currently do so in a way that is not user friendly. But it’s worth taking a look at the price list – the hospital chargemaster – to try to decipher the pricing and markup for your medicine. If you’re about to get an injection, infusion, or procedure done in a hospital system, ask ahead of time for an estimate of what you will owe.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Josie Tenore, MD, and Paul Hinds were introduced by a mutual friend in 2017 and hadn’t been going out long when she laid down the law: He had to get a physical.

“I don’t date people who don’t take care of their health,” said Dr. Tenore, who practices cosmetic dermatology and functional medicine in suburban Chicago.

One of Mr. Hinds’ blood tests that summer came back with an alarming result: His prostate-specific antigen (PSA), level was very high. A biopsy confirmed he had advanced prostate cancer.

There aren’t a lot of comfortable alternatives for treating prostate cancer, which generally progresses as long as testosterone levels remain high. Marijuana appears to lower testosterone levels, so after his diagnosis, he dosed a liquid form of cannabis for several weeks. That cut his PSA in half, but Mr. Hinds, a cybersecurity expert who likes yoga and bicycling, “was stoned out of his mind and couldn’t function,” Dr. Tenore recalled.

With Dr. Tenore guiding his decisions, Mr. Hinds next tried high-frequency ultrasound treatment, but it failed. And in the summer of 2019 doctors removed his prostate gland. Still, the PSA levels climbed again, and doctors assessed that the cancer had metastasized. The only alternative was to drastically lower Mr. Hinds’ testosterone levels – either via surgery or drugs that block all testosterone. In May 2021, he got his first intramuscular shot of Lupron Depot, a brand name for leuprolide, designed to suppress the prostate gland’s release of the hormone for 3 months. That August, he got his second shot.

And then the bills came.

The patient: Paul Hinds, now 60, is covered by United Healthcare through a COBRA plan from his former employer.

Medical service: Two 3-month Lupron Depot injections for metastatic prostate cancer.

Service provider: University of Chicago Medicine, a 900-physician nonprofit system that includes an 811-bed medical center, a suburban hospital, the Pritzker School of Medicine, and outpatient clinics and physician offices throughout the Chicago area.

Total bill: $73,812 for the two shots ($35,414 for the first, $38,398 for the second), including lab work and physician charges. United Healthcare’s negotiated rate for the two shots plus associated fees was $27,568, of which the insurer paid $19,567. After Mr. Hinds haggled with the hospital and insurer for more than a year, his share of the bills was determined to be nearly $7,000.

What gives: The first issue is unrelenting price increases on old drugs that have remained branded as manufacturers find ways to extend patents for decades and maintain sales through marketing.

Though Lupron was invented in 1973, its manufacturer got patent extensions in 1989 by offering a slow-release version. Drugmakers commonly use this tactic to extend their exclusive rights to sell a product.

The development of Lupron Depot as an intramuscular shot that suppressed testosterone for months at a time improved patient compliance and also enabled its maker, Abbott Laboratories, and its Japanese partner, Takeda, to extend their patents on the drug into the 2000s, said Gerald Weisberg, MD, a former Abbott scientist who has been critical of the company’s pricing policies.

In subsequent years, Abbott and Takeda, in a joint venture called TAP Pharmaceuticals, steadily marked up the price of their slow-release product. In 2000, the average wholesale U.S. price for a 3-month shot was $1,245; currently that figure is $5,866. (It is manufactured in the United States by AbbVie now.)

In the United Kingdom, where health care is generally free and Takeda sells the drug under the name Prostap, all physicians can purchase a 3-month dose for about $260.

It’s likely that Chicago Medicine, where Mr. Hinds got his shots, paid something close to the British price. That’s because the health system’s hospital on Chicago’s South Side participates in a federal program called 340B, which allows hospitals that serve low-income populations to purchase drugs at deep discounts.

Lupron Depot is given as a simple injection into the muscle. It takes minutes for a nurse or doctor to administer. Yet hospital systems like Chicago Medicine can and typically do charge lavishly for such services, to enhance revenue, said Morgan Henderson, principal data scientist at the Hilltop Institute at the University of Maryland-Baltimore County. Chicago Medicine declined to say what it paid for the drug.

While U.S. drugmakers can price their drugs however they please, TAP has gotten into trouble for its Lupron sales policies in the past. In 2001, after a Justice Department probe, it paid an $875 million settlement for illegally stimulating sales by giving urologists free and discounted vials of the drug while enabling them to charge Medicare full price.

Since then, many other drugs aimed at lowering testosterone levels have entered the market, including a pill, relugolix (Orgovyx). So why wouldn’t a patient use them?

Lupron Depot is long acting, is easy to prepare and store, and employs a small needle, which some patients prefer, said Brian McNeil, MD, chief of urology at University Hospital of Brooklyn. Orgovyx is convenient, but “a patient has to be very compliant. They have to take it every day around the same time,” he said. “Some people just forget.”

But there is another important factor that may well explain Lupron Depot’s ongoing popularity among medical providers: Doctors and hospitals can earn tens of thousands of dollars each visit by marking up its price and administration fees – as they did with Mr. Hinds. If they merely write a prescription for a drug that can be taken at home, they earn nothing.

Asked about this high patient charge and the possibility of using alternatives, United spokesperson Maria Gordon Shydlo said payment was “appropriately based on the hospital’s contract and the member’s benefit plan,” adding that the insurer encourages customers to shop around for the best quality and price.

Resolution: In addition to leaving Mr. Hinds listless, the Lupron Depot shots were, literally, a pain in the rear end. “Each time he was miserable for 2 weeks,” Dr. Tenore said. After looking over his first bill for the Lupron shot, Dr. Tenore told Mr. Hinds he should ask his doctor whether there was a less expensive drug that was easier to take.

After the second shot, in August 2021, a pharmacist told him he could instead receive the pill. His doctor prescribed Mr. Hinds 3 months’ worth of Orgovyx last November, for which he paid $216 and the insurer paid over $6,000. The drug’s list price is about $2,700 a month. There is evidence that Orgovyx works a little better than leuprolide.

Orgovyx was a “no-brainer,” Mr. Hinds said. “Why would you want a sore ass for two weeks when you can take a pill that kicks in sooner, functions the same way, and clears your body of testosterone faster?”

While Orgovyx is increasingly used for prostate cancer, Lupron and other injections usually remain the standard of care, hospital spokesperson Ashley Heher said. Clinicians “work with patients to determine what treatments are the most medically effective and, when necessary, to find reasonable alternatives that may be less financially burdensome due to insurance coverage limitations.”

Mr. Hinds was baffled by the size of the charges. During months of phone calls and emails, the hospital reversed and then reapplied part of the charge, and then in July agreed to a $666.34 monthly payment plan. After Hinds had made two payments, however, the hospital announced Aug. 29 it was canceling the agreement and sending the remainder of his bill to a collection agency. Two weeks later, the hospital reinstated the payment plan – after KHN asked about the cancellation.

As for Mr. Hinds, he remains active, though his bike rides have been shortened from 50 or 60 miles to about 30, he said.

He’s grateful to have Dr. Tenore as a free consultant and empathizes with those who lack a knowledgeable guide through their disease and health care’s financial maze.

“I’ve got Dr. Josie as an advocate who knows the system,” Mr. Hinds said.

The takeaway: First tip: If you are prescribed an infusion or injection, ask your physician if there are cheaper oral medications to treat your condition. Also, many drugs that are given by injection – ones that are given “subcutaneously,” rather than into a muscle – can be administered by a patient at home, avoiding hefty administration fees. Drugs like Dupixent for eczema fall into this category.

Keep in mind that where you get treatment could make a big difference in your charges: A study found that leading U.S. cancer centers charge enormous markups to private insurers for drug injections or infusions. Another study found that hospital systems charge an average of 86% more than private clinics for cancer drug infusions. And the percentage of cancer infusions done in hospital-operated clinics increased from 6% in 2004 to 43% in 2014, and has grown since.

Under a law that took effect in 2021, hospitals are required to list their charges, though they currently do so in a way that is not user friendly. But it’s worth taking a look at the price list – the hospital chargemaster – to try to decipher the pricing and markup for your medicine. If you’re about to get an injection, infusion, or procedure done in a hospital system, ask ahead of time for an estimate of what you will owe.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

In a survey taken before the Supreme Court’s Dobbs ruling regarding abortion rights, two-thirds of assisted reproduction technology (ART) physicians who don’t offer mifepristone/misoprostol to patients with early pregnancy loss (EPL) reported that they lack access to the drugs.

The numbers are likely higher now. In the wake of the court ruling, some physicians in states with new abortion restrictions fear they won’t be able to properly treat women with miscarriages. Access to mifepristone, a component of medication abortions along with misoprostol, is at the center of their concerns.

“These restrictions that were put in place to restrict abortion care have far-reaching implications regarding miscarriages and early pregnancy loss and the assisted reproduction community is not immune,” obstetrics and gynecology specialist Zachary Anderson, MD, a resident physician at the University of Southern California, Los Angeles, said in an interview. He presented the findings at the American Society for Reproductive Medicine’s 2022 meeting.

Early pregnancy loss – defined as a miscarriage within 12 weeks and 6 days of conception – is common in all pregnancies and affects an estimated 15% of those who rely on in vitro fertilization (IVF). In women who conceive through intrauterine insemination or IVF, “an abnormal karyotype embryo/fetus is the cause of miscarriage in more than two-thirds of cases,” Mark P. Trolice, MD, director of the IVF Center and professor of obstetrics and gynecology at the University of Central Florida, Orlando, said in an interview. “The options of management are observation – with no ability to determine when passage of the products of conception will occur – vs. mifepristone/misoprostol or suction D&C.”

Dr. Trolice added that “most woman select the medical treatment protocol, which is 200 mg mifepristone orally followed by 800 mcg misoprostol vaginally 24 hours later. If no signs of heavy bleeding occur after 3 hours following misoprostol, the patient should repeat the dose of 800 micrograms vaginally.”

According to the Reuters news service, some abortion bans target mifepristone. In October 2022, the American College of Obstetricians and Gynecologists asked the Food and Drug Administration to approve mifepristone for use in miscarriage management; such use is now off label, although it is approved to end early pregnancies in conjunction with misoprostol.

For the new study, researchers sent anonymous surveys to 826 members of the Society of Reproductive Endocrinology and Infertility and received 101 responses (12% response rate, 51% women, 86% non-Hispanic White, average age 52, 52% urban, and 51% in private practice).

More than two-thirds (70%) said they diagnosed early pregnancy loss at least once a week; 47% prefer treatment with misoprostol alone, 18% surgery in an operating room, 15% expectant management (monitoring a miscarriage as it occurs without medical intervention), 10% surgery in the office, and 3% mifepristone-misoprostol.

Of those who don’t offer mifepristone-misoprostol, 68% said they lack access, and 26% said they lack familiarity with the treatment.

Study coauthor Brian T. Nguyen, MD, MSc, assistant professor of obstetrics and gynecology at USC, said in an interview that mifepristone, a highly effective drug, is treated differently from other medications “for no good reason.”

Dr. Anderson, who led the study, urged colleagues to get the appropriate certification to prescribe mifepristone. “Providers overestimate how difficult it is to become certified to prescribe it,” he said.

Dr. Trolice, who is familiar with the study findings, said the response rate is low, and the results might be biased because those with preconceived opinions may be more likely to respond.

However, he said, “The results are not surprising in that medication is more commonly preferred (nearly 50%) given the devastation of a miscarriage and the desire to expedite resolution. Approximately one-third prefer surgical management, which would allow for genetic testing of the embryo/fetus to potentially determine a cause of the pregnancy loss.”

As for the medications used to treat early pregnancy loss, many ART physicians “treat pregnancy loss with misoprostol both pre- and post Dobbs,” he said. “The difficulty in obtaining mifepristone remains.”

The study authors and Dr. Trolice report no disclosures.

In a survey taken before the Supreme Court’s Dobbs ruling regarding abortion rights, two-thirds of assisted reproduction technology (ART) physicians who don’t offer mifepristone/misoprostol to patients with early pregnancy loss (EPL) reported that they lack access to the drugs.

The numbers are likely higher now. In the wake of the court ruling, some physicians in states with new abortion restrictions fear they won’t be able to properly treat women with miscarriages. Access to mifepristone, a component of medication abortions along with misoprostol, is at the center of their concerns.

“These restrictions that were put in place to restrict abortion care have far-reaching implications regarding miscarriages and early pregnancy loss and the assisted reproduction community is not immune,” obstetrics and gynecology specialist Zachary Anderson, MD, a resident physician at the University of Southern California, Los Angeles, said in an interview. He presented the findings at the American Society for Reproductive Medicine’s 2022 meeting.

Early pregnancy loss – defined as a miscarriage within 12 weeks and 6 days of conception – is common in all pregnancies and affects an estimated 15% of those who rely on in vitro fertilization (IVF). In women who conceive through intrauterine insemination or IVF, “an abnormal karyotype embryo/fetus is the cause of miscarriage in more than two-thirds of cases,” Mark P. Trolice, MD, director of the IVF Center and professor of obstetrics and gynecology at the University of Central Florida, Orlando, said in an interview. “The options of management are observation – with no ability to determine when passage of the products of conception will occur – vs. mifepristone/misoprostol or suction D&C.”

Dr. Trolice added that “most woman select the medical treatment protocol, which is 200 mg mifepristone orally followed by 800 mcg misoprostol vaginally 24 hours later. If no signs of heavy bleeding occur after 3 hours following misoprostol, the patient should repeat the dose of 800 micrograms vaginally.”

According to the Reuters news service, some abortion bans target mifepristone. In October 2022, the American College of Obstetricians and Gynecologists asked the Food and Drug Administration to approve mifepristone for use in miscarriage management; such use is now off label, although it is approved to end early pregnancies in conjunction with misoprostol.

For the new study, researchers sent anonymous surveys to 826 members of the Society of Reproductive Endocrinology and Infertility and received 101 responses (12% response rate, 51% women, 86% non-Hispanic White, average age 52, 52% urban, and 51% in private practice).

More than two-thirds (70%) said they diagnosed early pregnancy loss at least once a week; 47% prefer treatment with misoprostol alone, 18% surgery in an operating room, 15% expectant management (monitoring a miscarriage as it occurs without medical intervention), 10% surgery in the office, and 3% mifepristone-misoprostol.

Of those who don’t offer mifepristone-misoprostol, 68% said they lack access, and 26% said they lack familiarity with the treatment.

Study coauthor Brian T. Nguyen, MD, MSc, assistant professor of obstetrics and gynecology at USC, said in an interview that mifepristone, a highly effective drug, is treated differently from other medications “for no good reason.”

Dr. Anderson, who led the study, urged colleagues to get the appropriate certification to prescribe mifepristone. “Providers overestimate how difficult it is to become certified to prescribe it,” he said.

Dr. Trolice, who is familiar with the study findings, said the response rate is low, and the results might be biased because those with preconceived opinions may be more likely to respond.

However, he said, “The results are not surprising in that medication is more commonly preferred (nearly 50%) given the devastation of a miscarriage and the desire to expedite resolution. Approximately one-third prefer surgical management, which would allow for genetic testing of the embryo/fetus to potentially determine a cause of the pregnancy loss.”

As for the medications used to treat early pregnancy loss, many ART physicians “treat pregnancy loss with misoprostol both pre- and post Dobbs,” he said. “The difficulty in obtaining mifepristone remains.”

The study authors and Dr. Trolice report no disclosures.

In a survey taken before the Supreme Court’s Dobbs ruling regarding abortion rights, two-thirds of assisted reproduction technology (ART) physicians who don’t offer mifepristone/misoprostol to patients with early pregnancy loss (EPL) reported that they lack access to the drugs.

The numbers are likely higher now. In the wake of the court ruling, some physicians in states with new abortion restrictions fear they won’t be able to properly treat women with miscarriages. Access to mifepristone, a component of medication abortions along with misoprostol, is at the center of their concerns.

“These restrictions that were put in place to restrict abortion care have far-reaching implications regarding miscarriages and early pregnancy loss and the assisted reproduction community is not immune,” obstetrics and gynecology specialist Zachary Anderson, MD, a resident physician at the University of Southern California, Los Angeles, said in an interview. He presented the findings at the American Society for Reproductive Medicine’s 2022 meeting.

Early pregnancy loss – defined as a miscarriage within 12 weeks and 6 days of conception – is common in all pregnancies and affects an estimated 15% of those who rely on in vitro fertilization (IVF). In women who conceive through intrauterine insemination or IVF, “an abnormal karyotype embryo/fetus is the cause of miscarriage in more than two-thirds of cases,” Mark P. Trolice, MD, director of the IVF Center and professor of obstetrics and gynecology at the University of Central Florida, Orlando, said in an interview. “The options of management are observation – with no ability to determine when passage of the products of conception will occur – vs. mifepristone/misoprostol or suction D&C.”

Dr. Trolice added that “most woman select the medical treatment protocol, which is 200 mg mifepristone orally followed by 800 mcg misoprostol vaginally 24 hours later. If no signs of heavy bleeding occur after 3 hours following misoprostol, the patient should repeat the dose of 800 micrograms vaginally.”

According to the Reuters news service, some abortion bans target mifepristone. In October 2022, the American College of Obstetricians and Gynecologists asked the Food and Drug Administration to approve mifepristone for use in miscarriage management; such use is now off label, although it is approved to end early pregnancies in conjunction with misoprostol.

For the new study, researchers sent anonymous surveys to 826 members of the Society of Reproductive Endocrinology and Infertility and received 101 responses (12% response rate, 51% women, 86% non-Hispanic White, average age 52, 52% urban, and 51% in private practice).

More than two-thirds (70%) said they diagnosed early pregnancy loss at least once a week; 47% prefer treatment with misoprostol alone, 18% surgery in an operating room, 15% expectant management (monitoring a miscarriage as it occurs without medical intervention), 10% surgery in the office, and 3% mifepristone-misoprostol.

Of those who don’t offer mifepristone-misoprostol, 68% said they lack access, and 26% said they lack familiarity with the treatment.

Study coauthor Brian T. Nguyen, MD, MSc, assistant professor of obstetrics and gynecology at USC, said in an interview that mifepristone, a highly effective drug, is treated differently from other medications “for no good reason.”

Dr. Anderson, who led the study, urged colleagues to get the appropriate certification to prescribe mifepristone. “Providers overestimate how difficult it is to become certified to prescribe it,” he said.

Dr. Trolice, who is familiar with the study findings, said the response rate is low, and the results might be biased because those with preconceived opinions may be more likely to respond.

However, he said, “The results are not surprising in that medication is more commonly preferred (nearly 50%) given the devastation of a miscarriage and the desire to expedite resolution. Approximately one-third prefer surgical management, which would allow for genetic testing of the embryo/fetus to potentially determine a cause of the pregnancy loss.”

As for the medications used to treat early pregnancy loss, many ART physicians “treat pregnancy loss with misoprostol both pre- and post Dobbs,” he said. “The difficulty in obtaining mifepristone remains.”

The study authors and Dr. Trolice report no disclosures.