Use of statins or other lipid-lowering drugs was associated with a lower risk of dying from colorectal cancer in a large study, investigators reported.

Use of lipid-lowering medication was linked to a 56% lower risk of colorectal cancer death among individuals with no cancer at baseline who were enrolled in the Atherosclerosis Risk in Communities (ARIC) study. The reduction in mortality risk was evident regardless of sex, race, age, or how long patients had been on lipid-lowering drugs.

Michael T. Marrone, PhD, of Johns Hopkins University, Baltimore, and colleagues detailed these findings in a poster presented at the AACR virtual meeting II.

“Definitely for those individuals at average risk for colorectal cancer, if their primary care doctor recommends a lipid-lowering medication for cardiovascular disease prevention, they should follow their doctor’s advice,” Dr. Marrone said in an interview.

“We really can’t say that they should take this specifically for colon cancer prevention, but they should just follow the recommendation for cardiovascular disease prevention,” he added.

While previous studies have linked lipid-lowering drugs, and statins in particular, to a modestly reduced risk of developing colorectal cancer, the impact on risk by factors such as sex, race, and duration of use have not been well characterized, according to Dr. Marrone.

Another motivation for this study was to determine, in participants free of cancer at baseline, the risk of actually dying from this cancer. “That endpoint has not been well studied in the literature at all,” Dr. Marrone said.

To address those gaps, Dr. Marrone and colleagues analyzed data on 14,428 patients from the ARIC study who were cancer free at study visits between 1990 and 1992. Follow-up continued through the end of 2015 or until death, whichever came first.

A total of 384 incident colorectal cancer cases and 144 deaths were seen over 290,249 person-years at risk. The patients’ mean age was 57 years, 54.9% were women, and 27.9% were black. At scheduled follow-up visits from 1996 to 1998, 22% of patients were taking lipid-lowering drugs, mostly statins.

Compared with patients who never used lipid-lowering medications, patients who had ever used a lipid-lowering drug had a lower risk of colorectal cancer incidence (hazard ratio, 0.72). The incidence of colorectal cancer was lower among all lipid-lowering drug users, including men (HR, 0.69), women (HR, 0.76), black patients (HR, 0.60), and white patients (HR, 0.77).

Similarly, colorectal cancer–related death was lower among patients who had ever used a lipid-lowering drug (HR, 0.44). That association was apparent in men (HR, 0.58), women (HR, 0.33), black patients (HR, 0.63), and white patients (HR, 0.40).

In addition, the mortality risk was lower among lipid-lowering drug users regardless of duration of use or age at first use. The HR was 0.50 for patients taking lipid-lowering drugs for less than 15 years and 0.44 for patients taking the drugs for 15 years or more. HRs by age were 0.69 for patients aged 50-59 years, 0.45 for patients aged 60-69 years, and 0.57 for patients aged 70 and older.

While results of this particular study do help “move the needle forward” in terms of characterizing the relationship between lipid-lowering drugs and colorectal cancer risk, further studies are needed to better characterize the effects of long-term statin use, said Jennifer M. Weiss, MD, of the University of Wisconsin–Madison.

Clinical studies of the impact of statins on colorectal neoplasias have produced inconsistent results, Dr. Weiss and coauthor Bryson W. Katona, MD, PhD, wrote in a review article on chemoprevention in colorectal cancer.

“I definitely think there have been some studies that showed a modestly reduced risk,” Dr. Weiss said in an interview. “Unfortunately, there are also are some studies that show an increased risk of adenomas, and then there’s some studies that show no significant change. So we just can’t unequivocally confirm that there’s a significant association between statin use and decreased risk of developing colorectal cancer or adenomas.”

This research was funded by grants from the National Cancer Institute; the National Heart, Lung, and Blood Institute; the National Program of Cancer Registries; and the American Association for Cancer Research. Dr. Marrone disclosed no conflicts of interest. Dr. Weiss was an investigator for the CPP FAP-310 trial (NCT01483144) and received no salary support for her participation in the trial.

SOURCE: Marrone MT et al. AACR 2020, Abstract 2357.

Use of statins or other lipid-lowering drugs was associated with a lower risk of dying from colorectal cancer in a large study, investigators reported.

Use of lipid-lowering medication was linked to a 56% lower risk of colorectal cancer death among individuals with no cancer at baseline who were enrolled in the Atherosclerosis Risk in Communities (ARIC) study. The reduction in mortality risk was evident regardless of sex, race, age, or how long patients had been on lipid-lowering drugs.

Michael T. Marrone, PhD, of Johns Hopkins University, Baltimore, and colleagues detailed these findings in a poster presented at the AACR virtual meeting II.

“Definitely for those individuals at average risk for colorectal cancer, if their primary care doctor recommends a lipid-lowering medication for cardiovascular disease prevention, they should follow their doctor’s advice,” Dr. Marrone said in an interview.

“We really can’t say that they should take this specifically for colon cancer prevention, but they should just follow the recommendation for cardiovascular disease prevention,” he added.

While previous studies have linked lipid-lowering drugs, and statins in particular, to a modestly reduced risk of developing colorectal cancer, the impact on risk by factors such as sex, race, and duration of use have not been well characterized, according to Dr. Marrone.

Another motivation for this study was to determine, in participants free of cancer at baseline, the risk of actually dying from this cancer. “That endpoint has not been well studied in the literature at all,” Dr. Marrone said.

To address those gaps, Dr. Marrone and colleagues analyzed data on 14,428 patients from the ARIC study who were cancer free at study visits between 1990 and 1992. Follow-up continued through the end of 2015 or until death, whichever came first.

A total of 384 incident colorectal cancer cases and 144 deaths were seen over 290,249 person-years at risk. The patients’ mean age was 57 years, 54.9% were women, and 27.9% were black. At scheduled follow-up visits from 1996 to 1998, 22% of patients were taking lipid-lowering drugs, mostly statins.

Compared with patients who never used lipid-lowering medications, patients who had ever used a lipid-lowering drug had a lower risk of colorectal cancer incidence (hazard ratio, 0.72). The incidence of colorectal cancer was lower among all lipid-lowering drug users, including men (HR, 0.69), women (HR, 0.76), black patients (HR, 0.60), and white patients (HR, 0.77).

Similarly, colorectal cancer–related death was lower among patients who had ever used a lipid-lowering drug (HR, 0.44). That association was apparent in men (HR, 0.58), women (HR, 0.33), black patients (HR, 0.63), and white patients (HR, 0.40).

In addition, the mortality risk was lower among lipid-lowering drug users regardless of duration of use or age at first use. The HR was 0.50 for patients taking lipid-lowering drugs for less than 15 years and 0.44 for patients taking the drugs for 15 years or more. HRs by age were 0.69 for patients aged 50-59 years, 0.45 for patients aged 60-69 years, and 0.57 for patients aged 70 and older.

While results of this particular study do help “move the needle forward” in terms of characterizing the relationship between lipid-lowering drugs and colorectal cancer risk, further studies are needed to better characterize the effects of long-term statin use, said Jennifer M. Weiss, MD, of the University of Wisconsin–Madison.

Clinical studies of the impact of statins on colorectal neoplasias have produced inconsistent results, Dr. Weiss and coauthor Bryson W. Katona, MD, PhD, wrote in a review article on chemoprevention in colorectal cancer.

“I definitely think there have been some studies that showed a modestly reduced risk,” Dr. Weiss said in an interview. “Unfortunately, there are also are some studies that show an increased risk of adenomas, and then there’s some studies that show no significant change. So we just can’t unequivocally confirm that there’s a significant association between statin use and decreased risk of developing colorectal cancer or adenomas.”

This research was funded by grants from the National Cancer Institute; the National Heart, Lung, and Blood Institute; the National Program of Cancer Registries; and the American Association for Cancer Research. Dr. Marrone disclosed no conflicts of interest. Dr. Weiss was an investigator for the CPP FAP-310 trial (NCT01483144) and received no salary support for her participation in the trial.

SOURCE: Marrone MT et al. AACR 2020, Abstract 2357.

Use of statins or other lipid-lowering drugs was associated with a lower risk of dying from colorectal cancer in a large study, investigators reported.

Use of lipid-lowering medication was linked to a 56% lower risk of colorectal cancer death among individuals with no cancer at baseline who were enrolled in the Atherosclerosis Risk in Communities (ARIC) study. The reduction in mortality risk was evident regardless of sex, race, age, or how long patients had been on lipid-lowering drugs.

Michael T. Marrone, PhD, of Johns Hopkins University, Baltimore, and colleagues detailed these findings in a poster presented at the AACR virtual meeting II.

“Definitely for those individuals at average risk for colorectal cancer, if their primary care doctor recommends a lipid-lowering medication for cardiovascular disease prevention, they should follow their doctor’s advice,” Dr. Marrone said in an interview.

“We really can’t say that they should take this specifically for colon cancer prevention, but they should just follow the recommendation for cardiovascular disease prevention,” he added.

While previous studies have linked lipid-lowering drugs, and statins in particular, to a modestly reduced risk of developing colorectal cancer, the impact on risk by factors such as sex, race, and duration of use have not been well characterized, according to Dr. Marrone.

Another motivation for this study was to determine, in participants free of cancer at baseline, the risk of actually dying from this cancer. “That endpoint has not been well studied in the literature at all,” Dr. Marrone said.

To address those gaps, Dr. Marrone and colleagues analyzed data on 14,428 patients from the ARIC study who were cancer free at study visits between 1990 and 1992. Follow-up continued through the end of 2015 or until death, whichever came first.

A total of 384 incident colorectal cancer cases and 144 deaths were seen over 290,249 person-years at risk. The patients’ mean age was 57 years, 54.9% were women, and 27.9% were black. At scheduled follow-up visits from 1996 to 1998, 22% of patients were taking lipid-lowering drugs, mostly statins.

Compared with patients who never used lipid-lowering medications, patients who had ever used a lipid-lowering drug had a lower risk of colorectal cancer incidence (hazard ratio, 0.72). The incidence of colorectal cancer was lower among all lipid-lowering drug users, including men (HR, 0.69), women (HR, 0.76), black patients (HR, 0.60), and white patients (HR, 0.77).

Similarly, colorectal cancer–related death was lower among patients who had ever used a lipid-lowering drug (HR, 0.44). That association was apparent in men (HR, 0.58), women (HR, 0.33), black patients (HR, 0.63), and white patients (HR, 0.40).

In addition, the mortality risk was lower among lipid-lowering drug users regardless of duration of use or age at first use. The HR was 0.50 for patients taking lipid-lowering drugs for less than 15 years and 0.44 for patients taking the drugs for 15 years or more. HRs by age were 0.69 for patients aged 50-59 years, 0.45 for patients aged 60-69 years, and 0.57 for patients aged 70 and older.

While results of this particular study do help “move the needle forward” in terms of characterizing the relationship between lipid-lowering drugs and colorectal cancer risk, further studies are needed to better characterize the effects of long-term statin use, said Jennifer M. Weiss, MD, of the University of Wisconsin–Madison.

Clinical studies of the impact of statins on colorectal neoplasias have produced inconsistent results, Dr. Weiss and coauthor Bryson W. Katona, MD, PhD, wrote in a review article on chemoprevention in colorectal cancer.

“I definitely think there have been some studies that showed a modestly reduced risk,” Dr. Weiss said in an interview. “Unfortunately, there are also are some studies that show an increased risk of adenomas, and then there’s some studies that show no significant change. So we just can’t unequivocally confirm that there’s a significant association between statin use and decreased risk of developing colorectal cancer or adenomas.”

This research was funded by grants from the National Cancer Institute; the National Heart, Lung, and Blood Institute; the National Program of Cancer Registries; and the American Association for Cancer Research. Dr. Marrone disclosed no conflicts of interest. Dr. Weiss was an investigator for the CPP FAP-310 trial (NCT01483144) and received no salary support for her participation in the trial.

SOURCE: Marrone MT et al. AACR 2020, Abstract 2357.

The Food and Drug Administration has approved oral octreotide (Mycapssa, Chiasma) delayed-release capsules for the long-term maintenance treatment of patients with acromegaly who previously responded to and tolerated octreotide or lanreotide injections.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

“People living with acromegaly experience many challenges associated with injectable therapies and are in need of new treatment options,” Jill Sisco, president of Acromegaly Community, a patient support group, said in a Chiasma press release.

“The entire acromegaly community has long awaited oral therapeutic options and it is gratifying to see that the FDA has now approved the first oral somatostatin analog (SSA) therapy with the potential to make a significant impact in the lives of people with acromegaly and their caregivers,” she added.

Acromegaly, a rare, chronic disease usually caused by a benign pituitary tumor that leads to excess production of growth hormone and insulin-like growth factor-1 (IGF-1) hormone, can be cured through the successful surgical removal of the pituitary tumor. However, management of the disease remains a lifelong challenge for many who must rely on chronic injections.

The new oral formulation of octreotide is the first and only oral somatostatin analog approved by the FDA.

The approval was based on the results of the 9-month, phase 3 pivotal CHIASMA OPTIMAL clinical trial, involving 56 adults with acromegaly controlled by injectable SSAs.

The patients, who were randomized 1:1 to octreotide capsules or placebo, were dose-titrated from 40 mg/day up to a maximum of 80 mg/day, equaling two capsules in the morning and two in the evening.

The study met its primary endpoint. Overall, 58% of patients taking octreotide maintained IGF-1 response compared with 19% of those on placebo at the end of 9 months (P = .008), according to the average of the last two IGF-1 levels that were 1 times or less the upper limit of normal, assessed at weeks 34 and 36.  

The trial also met its secondary endpoints, which included the proportion of patients who maintain growth hormone response at week 36 compared with screening; time to loss of response; and proportion of patients requiring reversion to prior treatment.

Safety data were favorable. Adverse reactions to the drug, detailed in the prescribing information, include cholelithiasis and associated complications; hyperglycemia and hypoglycemia; thyroid function abnormalities; cardiac function abnormalities; decreased vitamin B12 levels, and abnormal Schilling’s test results.

Results from the clinical trial “are encouraging for patients with acromegaly,” the study’s principal investigator, Susan Samson, MD, PhD, of Baylor College of Medicine, Houston, said in the Chiasma statement.

“Based on data from the CHIASMA OPTIMAL trial showing patients on therapy being able to maintain mean IGF-1 levels within the normal range at the end of treatment, I believe oral octreotide capsules hold meaningful promise for patients with this disease and will address a long-standing unmet treatment need,” she added.

Chiasma reports that it expects Mycapssa to be available in the fourth quarter of 2020, pending FDA approval of a planned manufacturing supplement to the approved new drug application.

The company further plans to provide patient support services including assistance with insurance providers and specialty pharmacies and support in incorporating treatment into patients’ daily routines.

Despite effective biochemical control of growth hormone, many patients with acromegaly continue to suffer symptoms, mainly because of comorbidities, so it is important that these are also adequately treated, a consensus group concluded earlier this year.

The CHIASMA OPTIMAL trial was funded by Chiasma.
 

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

The Food and Drug Administration has approved oral octreotide (Mycapssa, Chiasma) delayed-release capsules for the long-term maintenance treatment of patients with acromegaly who previously responded to and tolerated octreotide or lanreotide injections.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

“People living with acromegaly experience many challenges associated with injectable therapies and are in need of new treatment options,” Jill Sisco, president of Acromegaly Community, a patient support group, said in a Chiasma press release.

“The entire acromegaly community has long awaited oral therapeutic options and it is gratifying to see that the FDA has now approved the first oral somatostatin analog (SSA) therapy with the potential to make a significant impact in the lives of people with acromegaly and their caregivers,” she added.

Acromegaly, a rare, chronic disease usually caused by a benign pituitary tumor that leads to excess production of growth hormone and insulin-like growth factor-1 (IGF-1) hormone, can be cured through the successful surgical removal of the pituitary tumor. However, management of the disease remains a lifelong challenge for many who must rely on chronic injections.

The new oral formulation of octreotide is the first and only oral somatostatin analog approved by the FDA.

The approval was based on the results of the 9-month, phase 3 pivotal CHIASMA OPTIMAL clinical trial, involving 56 adults with acromegaly controlled by injectable SSAs.

The patients, who were randomized 1:1 to octreotide capsules or placebo, were dose-titrated from 40 mg/day up to a maximum of 80 mg/day, equaling two capsules in the morning and two in the evening.

The study met its primary endpoint. Overall, 58% of patients taking octreotide maintained IGF-1 response compared with 19% of those on placebo at the end of 9 months (P = .008), according to the average of the last two IGF-1 levels that were 1 times or less the upper limit of normal, assessed at weeks 34 and 36.  

The trial also met its secondary endpoints, which included the proportion of patients who maintain growth hormone response at week 36 compared with screening; time to loss of response; and proportion of patients requiring reversion to prior treatment.

Safety data were favorable. Adverse reactions to the drug, detailed in the prescribing information, include cholelithiasis and associated complications; hyperglycemia and hypoglycemia; thyroid function abnormalities; cardiac function abnormalities; decreased vitamin B12 levels, and abnormal Schilling’s test results.

Results from the clinical trial “are encouraging for patients with acromegaly,” the study’s principal investigator, Susan Samson, MD, PhD, of Baylor College of Medicine, Houston, said in the Chiasma statement.

“Based on data from the CHIASMA OPTIMAL trial showing patients on therapy being able to maintain mean IGF-1 levels within the normal range at the end of treatment, I believe oral octreotide capsules hold meaningful promise for patients with this disease and will address a long-standing unmet treatment need,” she added.

Chiasma reports that it expects Mycapssa to be available in the fourth quarter of 2020, pending FDA approval of a planned manufacturing supplement to the approved new drug application.

The company further plans to provide patient support services including assistance with insurance providers and specialty pharmacies and support in incorporating treatment into patients’ daily routines.

Despite effective biochemical control of growth hormone, many patients with acromegaly continue to suffer symptoms, mainly because of comorbidities, so it is important that these are also adequately treated, a consensus group concluded earlier this year.

The CHIASMA OPTIMAL trial was funded by Chiasma.
 

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

The Food and Drug Administration has approved oral octreotide (Mycapssa, Chiasma) delayed-release capsules for the long-term maintenance treatment of patients with acromegaly who previously responded to and tolerated octreotide or lanreotide injections.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

“People living with acromegaly experience many challenges associated with injectable therapies and are in need of new treatment options,” Jill Sisco, president of Acromegaly Community, a patient support group, said in a Chiasma press release.

“The entire acromegaly community has long awaited oral therapeutic options and it is gratifying to see that the FDA has now approved the first oral somatostatin analog (SSA) therapy with the potential to make a significant impact in the lives of people with acromegaly and their caregivers,” she added.

Acromegaly, a rare, chronic disease usually caused by a benign pituitary tumor that leads to excess production of growth hormone and insulin-like growth factor-1 (IGF-1) hormone, can be cured through the successful surgical removal of the pituitary tumor. However, management of the disease remains a lifelong challenge for many who must rely on chronic injections.

The new oral formulation of octreotide is the first and only oral somatostatin analog approved by the FDA.

The approval was based on the results of the 9-month, phase 3 pivotal CHIASMA OPTIMAL clinical trial, involving 56 adults with acromegaly controlled by injectable SSAs.

The patients, who were randomized 1:1 to octreotide capsules or placebo, were dose-titrated from 40 mg/day up to a maximum of 80 mg/day, equaling two capsules in the morning and two in the evening.

The study met its primary endpoint. Overall, 58% of patients taking octreotide maintained IGF-1 response compared with 19% of those on placebo at the end of 9 months (P = .008), according to the average of the last two IGF-1 levels that were 1 times or less the upper limit of normal, assessed at weeks 34 and 36.  

The trial also met its secondary endpoints, which included the proportion of patients who maintain growth hormone response at week 36 compared with screening; time to loss of response; and proportion of patients requiring reversion to prior treatment.

Safety data were favorable. Adverse reactions to the drug, detailed in the prescribing information, include cholelithiasis and associated complications; hyperglycemia and hypoglycemia; thyroid function abnormalities; cardiac function abnormalities; decreased vitamin B12 levels, and abnormal Schilling’s test results.

Results from the clinical trial “are encouraging for patients with acromegaly,” the study’s principal investigator, Susan Samson, MD, PhD, of Baylor College of Medicine, Houston, said in the Chiasma statement.

“Based on data from the CHIASMA OPTIMAL trial showing patients on therapy being able to maintain mean IGF-1 levels within the normal range at the end of treatment, I believe oral octreotide capsules hold meaningful promise for patients with this disease and will address a long-standing unmet treatment need,” she added.

Chiasma reports that it expects Mycapssa to be available in the fourth quarter of 2020, pending FDA approval of a planned manufacturing supplement to the approved new drug application.

The company further plans to provide patient support services including assistance with insurance providers and specialty pharmacies and support in incorporating treatment into patients’ daily routines.

Despite effective biochemical control of growth hormone, many patients with acromegaly continue to suffer symptoms, mainly because of comorbidities, so it is important that these are also adequately treated, a consensus group concluded earlier this year.

The CHIASMA OPTIMAL trial was funded by Chiasma.
 

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

Older adults, particularly postmenopausal women, are often advised to pursue low-impact, low-intensity exercise as a way to preserve joint health, but that approach might actually contribute to a decline in bone mineral density, researchers report.

Concerns about falls and fracture risk have led many clinicians to advise against higher-impact activities, like jumping, but that is exactly the type of activity that improves bone density and physical function, said Belinda Beck, PhD, professor at the Griffith University School of Allied Health Sciences in Southport, Australia.

“There has always been a quandary in terms of pursuing research on this,” she said in an interview. “We know from animal studies that bone only responds to high-intensity activity, but we worry about advising that for people with low bone mass, so instead we give them medications.”

“But not everyone likes to go on meds, they’re not 100% effective, and they’re not free of side effects,” said Beck, who is also the owner and director of The Bone Clinic in Brisbane, Australia.

In 2014, to assess whether high-intensity resistance and impact training (HiRIT) was a safe and effective way to improve bone mass, Beck and her colleagues conducted the LIFTMOR study of 101 postmenopausal women. The researchers showed that bone mineral density in the lumbar spine and femoral neck regions and functional performance measures were significantly better in the 49 participants randomized to HiRIT for 8 months than in the 52 randomized to low-intensity training.

Three years after the completion of LIFTMOR, the researchers looked at bone mineral density in 23 women from the HiRIT group in their retrospective observational study, the results of which were presented at the virtual American College of Sports Medicine 2020 Annual Meeting.

Ongoing gains were significantly better for the seven participants who continued with HiRIT (at least 25% compliance) than for the 16 who did not when looking at both bone mineral density of the lumbar spine (8.63% vs. 2.18%; P = .042) and femoral neck (3.67% vs. 2.85%; P = 0.14).

However, the women who discontinued HiRIT after 8 months maintained the gains in bone mineral density that they had achieved 3 years earlier.

Functional outcomes in the women who continued HiRIT were better than those in the women who did not, but the differences were not significant.

“The takeaway here is that this type of exercise appears to be a highly effective therapy to reduce risk of osteoporotic fracture, since it improves bone mass,” Beck said.

Jump more, lose less bone density

Given the widespread reluctance to suggest HiRIT-type activity to those with low bone mass, this research is significant, said Vanessa Yingling, PhD, from the Department of Kinesiology at California State University, East Bay.

“Once women hit 60, they’re somehow regarded as frail, but that becomes a self-fulfilling prophecy when we take this kinder, gentler approach to exercise,” Yingling said in an interview. “Building bone density in older adults is important, but maintaining current bone density is just as crucial. Without high-impact activity, we are likely to see decelerating density at a faster rate.”

The other key to the recent research is the functional testing, Yingling added. In addition to bone density measures, high-intensity activity can improve mobility and muscle strength, as the study noted.

This type of activity can be done in shorter bursts, making these workouts more efficient, she explained. For example, a Tabata high-intensity interval training session usually takes about 10 minutes, warm-up and cool-down included.

“A HiRIT workout even once or twice a week would likely improve function, strength, and bone density maintenance,” Beck said. “The result of that would be better fall prevention and potentially less medication usage for BMD issues.”

Both men and women can benefit from a HiRIT workout, Beck and Yingling said. Initially, supervision by a knowledgeable trainer or physical therapist is ideal, they added.

This article first appeared on Medscape.com.

Older adults, particularly postmenopausal women, are often advised to pursue low-impact, low-intensity exercise as a way to preserve joint health, but that approach might actually contribute to a decline in bone mineral density, researchers report.

Concerns about falls and fracture risk have led many clinicians to advise against higher-impact activities, like jumping, but that is exactly the type of activity that improves bone density and physical function, said Belinda Beck, PhD, professor at the Griffith University School of Allied Health Sciences in Southport, Australia.

“There has always been a quandary in terms of pursuing research on this,” she said in an interview. “We know from animal studies that bone only responds to high-intensity activity, but we worry about advising that for people with low bone mass, so instead we give them medications.”

“But not everyone likes to go on meds, they’re not 100% effective, and they’re not free of side effects,” said Beck, who is also the owner and director of The Bone Clinic in Brisbane, Australia.

In 2014, to assess whether high-intensity resistance and impact training (HiRIT) was a safe and effective way to improve bone mass, Beck and her colleagues conducted the LIFTMOR study of 101 postmenopausal women. The researchers showed that bone mineral density in the lumbar spine and femoral neck regions and functional performance measures were significantly better in the 49 participants randomized to HiRIT for 8 months than in the 52 randomized to low-intensity training.

Three years after the completion of LIFTMOR, the researchers looked at bone mineral density in 23 women from the HiRIT group in their retrospective observational study, the results of which were presented at the virtual American College of Sports Medicine 2020 Annual Meeting.

Ongoing gains were significantly better for the seven participants who continued with HiRIT (at least 25% compliance) than for the 16 who did not when looking at both bone mineral density of the lumbar spine (8.63% vs. 2.18%; P = .042) and femoral neck (3.67% vs. 2.85%; P = 0.14).

However, the women who discontinued HiRIT after 8 months maintained the gains in bone mineral density that they had achieved 3 years earlier.

Functional outcomes in the women who continued HiRIT were better than those in the women who did not, but the differences were not significant.

“The takeaway here is that this type of exercise appears to be a highly effective therapy to reduce risk of osteoporotic fracture, since it improves bone mass,” Beck said.

Jump more, lose less bone density

Given the widespread reluctance to suggest HiRIT-type activity to those with low bone mass, this research is significant, said Vanessa Yingling, PhD, from the Department of Kinesiology at California State University, East Bay.

“Once women hit 60, they’re somehow regarded as frail, but that becomes a self-fulfilling prophecy when we take this kinder, gentler approach to exercise,” Yingling said in an interview. “Building bone density in older adults is important, but maintaining current bone density is just as crucial. Without high-impact activity, we are likely to see decelerating density at a faster rate.”

The other key to the recent research is the functional testing, Yingling added. In addition to bone density measures, high-intensity activity can improve mobility and muscle strength, as the study noted.

This type of activity can be done in shorter bursts, making these workouts more efficient, she explained. For example, a Tabata high-intensity interval training session usually takes about 10 minutes, warm-up and cool-down included.

“A HiRIT workout even once or twice a week would likely improve function, strength, and bone density maintenance,” Beck said. “The result of that would be better fall prevention and potentially less medication usage for BMD issues.”

Both men and women can benefit from a HiRIT workout, Beck and Yingling said. Initially, supervision by a knowledgeable trainer or physical therapist is ideal, they added.

This article first appeared on Medscape.com.

Older adults, particularly postmenopausal women, are often advised to pursue low-impact, low-intensity exercise as a way to preserve joint health, but that approach might actually contribute to a decline in bone mineral density, researchers report.

Concerns about falls and fracture risk have led many clinicians to advise against higher-impact activities, like jumping, but that is exactly the type of activity that improves bone density and physical function, said Belinda Beck, PhD, professor at the Griffith University School of Allied Health Sciences in Southport, Australia.

“There has always been a quandary in terms of pursuing research on this,” she said in an interview. “We know from animal studies that bone only responds to high-intensity activity, but we worry about advising that for people with low bone mass, so instead we give them medications.”

“But not everyone likes to go on meds, they’re not 100% effective, and they’re not free of side effects,” said Beck, who is also the owner and director of The Bone Clinic in Brisbane, Australia.

In 2014, to assess whether high-intensity resistance and impact training (HiRIT) was a safe and effective way to improve bone mass, Beck and her colleagues conducted the LIFTMOR study of 101 postmenopausal women. The researchers showed that bone mineral density in the lumbar spine and femoral neck regions and functional performance measures were significantly better in the 49 participants randomized to HiRIT for 8 months than in the 52 randomized to low-intensity training.

Three years after the completion of LIFTMOR, the researchers looked at bone mineral density in 23 women from the HiRIT group in their retrospective observational study, the results of which were presented at the virtual American College of Sports Medicine 2020 Annual Meeting.

Ongoing gains were significantly better for the seven participants who continued with HiRIT (at least 25% compliance) than for the 16 who did not when looking at both bone mineral density of the lumbar spine (8.63% vs. 2.18%; P = .042) and femoral neck (3.67% vs. 2.85%; P = 0.14).

However, the women who discontinued HiRIT after 8 months maintained the gains in bone mineral density that they had achieved 3 years earlier.

Functional outcomes in the women who continued HiRIT were better than those in the women who did not, but the differences were not significant.

“The takeaway here is that this type of exercise appears to be a highly effective therapy to reduce risk of osteoporotic fracture, since it improves bone mass,” Beck said.

Jump more, lose less bone density

Given the widespread reluctance to suggest HiRIT-type activity to those with low bone mass, this research is significant, said Vanessa Yingling, PhD, from the Department of Kinesiology at California State University, East Bay.

“Once women hit 60, they’re somehow regarded as frail, but that becomes a self-fulfilling prophecy when we take this kinder, gentler approach to exercise,” Yingling said in an interview. “Building bone density in older adults is important, but maintaining current bone density is just as crucial. Without high-impact activity, we are likely to see decelerating density at a faster rate.”

The other key to the recent research is the functional testing, Yingling added. In addition to bone density measures, high-intensity activity can improve mobility and muscle strength, as the study noted.

This type of activity can be done in shorter bursts, making these workouts more efficient, she explained. For example, a Tabata high-intensity interval training session usually takes about 10 minutes, warm-up and cool-down included.

“A HiRIT workout even once or twice a week would likely improve function, strength, and bone density maintenance,” Beck said. “The result of that would be better fall prevention and potentially less medication usage for BMD issues.”

Both men and women can benefit from a HiRIT workout, Beck and Yingling said. Initially, supervision by a knowledgeable trainer or physical therapist is ideal, they added.

This article first appeared on Medscape.com.

It’s been about two months since I volunteered in a hospital in Brooklyn, working in an ICU taking care of patients with COVID-19. I’m back home in California now but with new perspectives, not only on the pandemic, but on those who are affected by it the most.

Courtesy Dr. Arghavan Salles

Everyone seems to have forgotten the early days of the pandemic – the time when the ICUs were overrun, we were using FEMA ventilators, and endocrinologists and psychiatrists were acting as intensivists.

Even though things are opening up and people are taking summer vacations in a seemingly amnestic state, having witnessed multiple daily deaths remains a part of my daily consciousness. As I see the case numbers climbing juxtaposed against people being out and about without masks, my anxiety level is rising.

A virus doesn’t discriminate. It can fly through the air, landing on the next available surface. If that virus is SARS-CoV-2 and that surface is a human mucosal membrane, the virus makes itself at home. It orders furniture, buys a fancy mattress and a large high definition TV, hangs art on the walls, and settles in for the long haul. It’s not going anywhere anytime soon.

Even as an equal opportunity virus, what SARS-CoV-2 has done is to hold a mirror up to the healthcare system. It has shown us what was here all along. When people first started noticing that underrepresented minorities were more likely to contract the virus and get sick from it, I heard musings that this was likely because of their preexisting health conditions. For example, commentators on cable news were quick to point out that black people are more likely than other people to have hypertension or diabetes. So doesn’t that explain why they are more affected by this virus?

That certainly is part of the story, but it doesn’t entirely explain the discrepancies we’ve seen. For example, in New York 14% of the population is black, and 25% of those who had a COVID-related death were black patients. Similarly, 19% of the population is Hispanic or Latino, and they made up 26% of COVID-related deaths. On the other hand, 55% of the population in New York is white, and white people account for only 34% of COVID-related deaths.

Working in Brooklyn, I didn’t need to be a keen observer to notice that, out of our entire unit of about 20-25 patients, there was only one patient in a 2-week period who was neither black nor Hispanic.

As others have written, there are other factors at play. I’m not sure how many of those commentators back in March stopped to think about why black patients are more likely to have hypertension and diabetes, but the chronic stress of facing racism on a daily basis surely contributes. Beyond those medical problems, minorities are more likely to live in multigenerational housing, which means that it is harder for them to isolate from others. In addition, their living quarters tend to be further from health care centers and grocery stores, which makes it harder for them to access medical care and healthy food.

As if that weren’t enough to put their health at risk, people of color are also affected by environmental racism . Factories with toxic waste are more likely to be built in or near neighborhoods filled with people of color than in other communities. On top of that, black and Hispanic people are also more likely to be under- or uninsured, meaning they often delay seeking care in order to avoid astronomic healthcare costs.

Black and Hispanic people are also more likely than others to be working in the service industry or other essential services, which means they are less likely to be able to work from home. Consequently, they have to risk more exposures to other people and the virus than do those who have the privilege of working safely from home. They also are less likely to have available paid leave and, therefore, are more likely to work while sick.

With the deck completely stacked against them, underrepresented minorities also face systemic bias and racism when interacting with the health care system. Physicians mistakenly believe black patients experience less pain than other patients, according to some research. Black mothers have significantly worse health care outcomes than do their non-black counterparts, and the infant mortality rate for Black infants is much higher as well.

Dr. Salles is a bariatric surgeon and is currently a Scholar in Residence at Stanford (Calif.) University. Find her on Twitter @arghavan_salles.

It’s been about two months since I volunteered in a hospital in Brooklyn, working in an ICU taking care of patients with COVID-19. I’m back home in California now but with new perspectives, not only on the pandemic, but on those who are affected by it the most.

Courtesy Dr. Arghavan Salles

Everyone seems to have forgotten the early days of the pandemic – the time when the ICUs were overrun, we were using FEMA ventilators, and endocrinologists and psychiatrists were acting as intensivists.

Even though things are opening up and people are taking summer vacations in a seemingly amnestic state, having witnessed multiple daily deaths remains a part of my daily consciousness. As I see the case numbers climbing juxtaposed against people being out and about without masks, my anxiety level is rising.

A virus doesn’t discriminate. It can fly through the air, landing on the next available surface. If that virus is SARS-CoV-2 and that surface is a human mucosal membrane, the virus makes itself at home. It orders furniture, buys a fancy mattress and a large high definition TV, hangs art on the walls, and settles in for the long haul. It’s not going anywhere anytime soon.

Even as an equal opportunity virus, what SARS-CoV-2 has done is to hold a mirror up to the healthcare system. It has shown us what was here all along. When people first started noticing that underrepresented minorities were more likely to contract the virus and get sick from it, I heard musings that this was likely because of their preexisting health conditions. For example, commentators on cable news were quick to point out that black people are more likely than other people to have hypertension or diabetes. So doesn’t that explain why they are more affected by this virus?

That certainly is part of the story, but it doesn’t entirely explain the discrepancies we’ve seen. For example, in New York 14% of the population is black, and 25% of those who had a COVID-related death were black patients. Similarly, 19% of the population is Hispanic or Latino, and they made up 26% of COVID-related deaths. On the other hand, 55% of the population in New York is white, and white people account for only 34% of COVID-related deaths.

Working in Brooklyn, I didn’t need to be a keen observer to notice that, out of our entire unit of about 20-25 patients, there was only one patient in a 2-week period who was neither black nor Hispanic.

As others have written, there are other factors at play. I’m not sure how many of those commentators back in March stopped to think about why black patients are more likely to have hypertension and diabetes, but the chronic stress of facing racism on a daily basis surely contributes. Beyond those medical problems, minorities are more likely to live in multigenerational housing, which means that it is harder for them to isolate from others. In addition, their living quarters tend to be further from health care centers and grocery stores, which makes it harder for them to access medical care and healthy food.

As if that weren’t enough to put their health at risk, people of color are also affected by environmental racism . Factories with toxic waste are more likely to be built in or near neighborhoods filled with people of color than in other communities. On top of that, black and Hispanic people are also more likely to be under- or uninsured, meaning they often delay seeking care in order to avoid astronomic healthcare costs.

Black and Hispanic people are also more likely than others to be working in the service industry or other essential services, which means they are less likely to be able to work from home. Consequently, they have to risk more exposures to other people and the virus than do those who have the privilege of working safely from home. They also are less likely to have available paid leave and, therefore, are more likely to work while sick.

With the deck completely stacked against them, underrepresented minorities also face systemic bias and racism when interacting with the health care system. Physicians mistakenly believe black patients experience less pain than other patients, according to some research. Black mothers have significantly worse health care outcomes than do their non-black counterparts, and the infant mortality rate for Black infants is much higher as well.

Dr. Salles is a bariatric surgeon and is currently a Scholar in Residence at Stanford (Calif.) University. Find her on Twitter @arghavan_salles.

It’s been about two months since I volunteered in a hospital in Brooklyn, working in an ICU taking care of patients with COVID-19. I’m back home in California now but with new perspectives, not only on the pandemic, but on those who are affected by it the most.

Courtesy Dr. Arghavan Salles

Everyone seems to have forgotten the early days of the pandemic – the time when the ICUs were overrun, we were using FEMA ventilators, and endocrinologists and psychiatrists were acting as intensivists.

Even though things are opening up and people are taking summer vacations in a seemingly amnestic state, having witnessed multiple daily deaths remains a part of my daily consciousness. As I see the case numbers climbing juxtaposed against people being out and about without masks, my anxiety level is rising.

A virus doesn’t discriminate. It can fly through the air, landing on the next available surface. If that virus is SARS-CoV-2 and that surface is a human mucosal membrane, the virus makes itself at home. It orders furniture, buys a fancy mattress and a large high definition TV, hangs art on the walls, and settles in for the long haul. It’s not going anywhere anytime soon.

Even as an equal opportunity virus, what SARS-CoV-2 has done is to hold a mirror up to the healthcare system. It has shown us what was here all along. When people first started noticing that underrepresented minorities were more likely to contract the virus and get sick from it, I heard musings that this was likely because of their preexisting health conditions. For example, commentators on cable news were quick to point out that black people are more likely than other people to have hypertension or diabetes. So doesn’t that explain why they are more affected by this virus?

That certainly is part of the story, but it doesn’t entirely explain the discrepancies we’ve seen. For example, in New York 14% of the population is black, and 25% of those who had a COVID-related death were black patients. Similarly, 19% of the population is Hispanic or Latino, and they made up 26% of COVID-related deaths. On the other hand, 55% of the population in New York is white, and white people account for only 34% of COVID-related deaths.

Working in Brooklyn, I didn’t need to be a keen observer to notice that, out of our entire unit of about 20-25 patients, there was only one patient in a 2-week period who was neither black nor Hispanic.

As others have written, there are other factors at play. I’m not sure how many of those commentators back in March stopped to think about why black patients are more likely to have hypertension and diabetes, but the chronic stress of facing racism on a daily basis surely contributes. Beyond those medical problems, minorities are more likely to live in multigenerational housing, which means that it is harder for them to isolate from others. In addition, their living quarters tend to be further from health care centers and grocery stores, which makes it harder for them to access medical care and healthy food.

As if that weren’t enough to put their health at risk, people of color are also affected by environmental racism . Factories with toxic waste are more likely to be built in or near neighborhoods filled with people of color than in other communities. On top of that, black and Hispanic people are also more likely to be under- or uninsured, meaning they often delay seeking care in order to avoid astronomic healthcare costs.

Black and Hispanic people are also more likely than others to be working in the service industry or other essential services, which means they are less likely to be able to work from home. Consequently, they have to risk more exposures to other people and the virus than do those who have the privilege of working safely from home. They also are less likely to have available paid leave and, therefore, are more likely to work while sick.

With the deck completely stacked against them, underrepresented minorities also face systemic bias and racism when interacting with the health care system. Physicians mistakenly believe black patients experience less pain than other patients, according to some research. Black mothers have significantly worse health care outcomes than do their non-black counterparts, and the infant mortality rate for Black infants is much higher as well.

Dr. Salles is a bariatric surgeon and is currently a Scholar in Residence at Stanford (Calif.) University. Find her on Twitter @arghavan_salles.

Background: Rates of LDL-C reduction with statin therapy vary based on biological and genetic factors, as well as adherence. In a general primary prevention population at cardiovascular risk, little is known about the extent of this variability or its impact on outcomes.

Study design: Prospective cohort study.

Setting: Primary care practices in England and Wales.

Synopsis: Across a cohort of 183,213 patients, 51.2% had a suboptimal response, defined as a less than 40% proportional reduction in LDL-C. During more than 1 million ­person-years of follow-up, suboptimal statin response at 2 years was associated with a 20% higher hazard ratio for incident cardiovascular disease.Bottom line: Half of patients do not have a sufficient response to statins, with higher attendant future risk.

Citation: Akyea RK et al. Suboptimal cholesterol response to initiation of statins and future risk of cardiovascular disease. Heart. 2019 Apr 15;0:1-7. doi: 10.1136/heartjnl-2018-314253.

Dr. Anderson is chief, hospital medicine section, and deputy chief, medicine service, at the Veterans Affairs Eastern Colorado Health Care System, Aurora.

Background: Rates of LDL-C reduction with statin therapy vary based on biological and genetic factors, as well as adherence. In a general primary prevention population at cardiovascular risk, little is known about the extent of this variability or its impact on outcomes.

Study design: Prospective cohort study.

Setting: Primary care practices in England and Wales.

Synopsis: Across a cohort of 183,213 patients, 51.2% had a suboptimal response, defined as a less than 40% proportional reduction in LDL-C. During more than 1 million ­person-years of follow-up, suboptimal statin response at 2 years was associated with a 20% higher hazard ratio for incident cardiovascular disease.Bottom line: Half of patients do not have a sufficient response to statins, with higher attendant future risk.

Citation: Akyea RK et al. Suboptimal cholesterol response to initiation of statins and future risk of cardiovascular disease. Heart. 2019 Apr 15;0:1-7. doi: 10.1136/heartjnl-2018-314253.

Dr. Anderson is chief, hospital medicine section, and deputy chief, medicine service, at the Veterans Affairs Eastern Colorado Health Care System, Aurora.

Background: Rates of LDL-C reduction with statin therapy vary based on biological and genetic factors, as well as adherence. In a general primary prevention population at cardiovascular risk, little is known about the extent of this variability or its impact on outcomes.

Study design: Prospective cohort study.

Setting: Primary care practices in England and Wales.

Synopsis: Across a cohort of 183,213 patients, 51.2% had a suboptimal response, defined as a less than 40% proportional reduction in LDL-C. During more than 1 million ­person-years of follow-up, suboptimal statin response at 2 years was associated with a 20% higher hazard ratio for incident cardiovascular disease.Bottom line: Half of patients do not have a sufficient response to statins, with higher attendant future risk.

Citation: Akyea RK et al. Suboptimal cholesterol response to initiation of statins and future risk of cardiovascular disease. Heart. 2019 Apr 15;0:1-7. doi: 10.1136/heartjnl-2018-314253.

Dr. Anderson is chief, hospital medicine section, and deputy chief, medicine service, at the Veterans Affairs Eastern Colorado Health Care System, Aurora.

Masks should not be a political issue. It is ridiculous that they’ve become one. The pandemic, and masks, are a public health issue, and we’re in the biggest public health crisis since 1918.

Mounting data show that common mask usage reduces the spread of COVID-19. Yet many people refuse to wear masks on the grounds that it’s a matter of personal freedom.

If it were that simple, I might agree. After all, it’s your health. Like smoking and skydiving, you’re the one taking risks knowingly.

But it’s not just a single person’s health with an infectious disease. Every person with it is a vector for others to catch it, knowingly or not.

The constitution twice mentions the government’s responsibility to maintain “the general welfare,” but many apparently don’t believe it applies to the pandemic.

A large part of this is a glut of pseudo-science circulating out there, buoyed by the Internet, as well as ties to conspiracy theories and thoroughly debunked claims that the masks cause decreased oxygen, strokes, and a host of other unrelated issues. To many doctors, including myself, this is incredibly frustrating. Medicine is a science. We deal in facts, probabilities, and statistics. After spending so many years learning and trying to teach patients what is and isn’t real out there, it’s disheartening, to say the least, when they choose the meandering advice found on a Facebook or Twitter account over our hard-earned knowledge.

Here in Arizona, the governor’s stay-at-home order expired in mid-May. Although not intended as such, many treated it as a declaration of victory over coronavirus, quickly flocking back to restaurants, bars, and other public gathering places. Our case numbers have since skyrocketed. Yet the climbing numbers of cases as people associate more are ignored and belittled by many in the name of freedom.

People have donned the cloak of freedom and the Bill of Rights to take a stand against wearing masks.

In 1942, U-Boats were sinking ships off the east coast in huge numbers, with targeting made easy because they were silhouetted against cities. Black-outs were ordered to help stop this. Would these same people today have stood up then to declare “They’re my lights, and I’m free to keep them on if I want”? Would they have done the same if bombs were raining on New York like they did in London blackouts during the Blitz?

Self preservation is a powerful instinct. Every animal on Earth has it. Yet humans are the only ones that willfully ignore ways to prevent an as-yet untreatable disease.

You’d think, after all these years of civilization, scientific discovery, and research that we’d be better than this.

Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.

Masks should not be a political issue. It is ridiculous that they’ve become one. The pandemic, and masks, are a public health issue, and we’re in the biggest public health crisis since 1918.

Mounting data show that common mask usage reduces the spread of COVID-19. Yet many people refuse to wear masks on the grounds that it’s a matter of personal freedom.

If it were that simple, I might agree. After all, it’s your health. Like smoking and skydiving, you’re the one taking risks knowingly.

But it’s not just a single person’s health with an infectious disease. Every person with it is a vector for others to catch it, knowingly or not.

The constitution twice mentions the government’s responsibility to maintain “the general welfare,” but many apparently don’t believe it applies to the pandemic.

A large part of this is a glut of pseudo-science circulating out there, buoyed by the Internet, as well as ties to conspiracy theories and thoroughly debunked claims that the masks cause decreased oxygen, strokes, and a host of other unrelated issues. To many doctors, including myself, this is incredibly frustrating. Medicine is a science. We deal in facts, probabilities, and statistics. After spending so many years learning and trying to teach patients what is and isn’t real out there, it’s disheartening, to say the least, when they choose the meandering advice found on a Facebook or Twitter account over our hard-earned knowledge.

Here in Arizona, the governor’s stay-at-home order expired in mid-May. Although not intended as such, many treated it as a declaration of victory over coronavirus, quickly flocking back to restaurants, bars, and other public gathering places. Our case numbers have since skyrocketed. Yet the climbing numbers of cases as people associate more are ignored and belittled by many in the name of freedom.

People have donned the cloak of freedom and the Bill of Rights to take a stand against wearing masks.

In 1942, U-Boats were sinking ships off the east coast in huge numbers, with targeting made easy because they were silhouetted against cities. Black-outs were ordered to help stop this. Would these same people today have stood up then to declare “They’re my lights, and I’m free to keep them on if I want”? Would they have done the same if bombs were raining on New York like they did in London blackouts during the Blitz?

Self preservation is a powerful instinct. Every animal on Earth has it. Yet humans are the only ones that willfully ignore ways to prevent an as-yet untreatable disease.

You’d think, after all these years of civilization, scientific discovery, and research that we’d be better than this.

Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.

Masks should not be a political issue. It is ridiculous that they’ve become one. The pandemic, and masks, are a public health issue, and we’re in the biggest public health crisis since 1918.

Mounting data show that common mask usage reduces the spread of COVID-19. Yet many people refuse to wear masks on the grounds that it’s a matter of personal freedom.

If it were that simple, I might agree. After all, it’s your health. Like smoking and skydiving, you’re the one taking risks knowingly.

But it’s not just a single person’s health with an infectious disease. Every person with it is a vector for others to catch it, knowingly or not.

The constitution twice mentions the government’s responsibility to maintain “the general welfare,” but many apparently don’t believe it applies to the pandemic.

A large part of this is a glut of pseudo-science circulating out there, buoyed by the Internet, as well as ties to conspiracy theories and thoroughly debunked claims that the masks cause decreased oxygen, strokes, and a host of other unrelated issues. To many doctors, including myself, this is incredibly frustrating. Medicine is a science. We deal in facts, probabilities, and statistics. After spending so many years learning and trying to teach patients what is and isn’t real out there, it’s disheartening, to say the least, when they choose the meandering advice found on a Facebook or Twitter account over our hard-earned knowledge.

Here in Arizona, the governor’s stay-at-home order expired in mid-May. Although not intended as such, many treated it as a declaration of victory over coronavirus, quickly flocking back to restaurants, bars, and other public gathering places. Our case numbers have since skyrocketed. Yet the climbing numbers of cases as people associate more are ignored and belittled by many in the name of freedom.

People have donned the cloak of freedom and the Bill of Rights to take a stand against wearing masks.

In 1942, U-Boats were sinking ships off the east coast in huge numbers, with targeting made easy because they were silhouetted against cities. Black-outs were ordered to help stop this. Would these same people today have stood up then to declare “They’re my lights, and I’m free to keep them on if I want”? Would they have done the same if bombs were raining on New York like they did in London blackouts during the Blitz?

Self preservation is a powerful instinct. Every animal on Earth has it. Yet humans are the only ones that willfully ignore ways to prevent an as-yet untreatable disease.

You’d think, after all these years of civilization, scientific discovery, and research that we’d be better than this.

Dr. Block has a solo neurology practice in Scottsdale, Ariz. He has no relevant disclosures.

Acne is diagnosed by examining the patient’s skin with a simple, visual inspection. In rare cases, a lesion or pustule may be swabbed or scraped for microbiological examination or culture to rule out other sources of infection.

Benefits of Virtual Visits for Acne Patients

With stay-at-home orders in effect in the United States because of the COVID-19 pandemic, many dermatology practices have transitioned from live appointments to telemedicine visits. They have found that switching from live to virtual visits is especially amenable for patients with acne, especially those with severe acne who are taking isotretinoin and must be seen every six weeks. With telemedicine visits, dermatologists can diagnose new patients with facial acne. For existing acne patients, dermatologists can provide uninterrupted care and treatment, and hear directly from patients about their progress with a specific acne treatment – just as they can with in-person visits in the clinic.

“Our practice has found that virtual acne visits can be as efficient and effective as in-person visits, namely because the evaluation of acne is very visual and the treatment is not procedural,” says Julie Harper, M.D., a dermatologist at Dermatology & Skin Care Center of Birmingham in Alabama and Galderma consultant. “We were surprised to find that telehealth visits with our acne patients in their own home even have a distinct advantage. If I ask a patient which medications they’re using to self-treat, they’ll often walk to their bathroom and show me, so I can see those products for myself.”

Challenges in Treating Truncal Acne

Although telehealth visits for patients with facial acne are typically straightforward and simple, virtual visits for patients with truncal acne can be challenging as the shoulders, back and chest aren’t typically seen on a video chat. Now that the U.S. Food and Drug Administration (FDA) has approved AKLIEF^® (trifarotene) Cream, 0.005%, for the treatment of acne vulgaris in patients age 9 years and over, clinicians should ask facial acne patients whether they are also experiencing truncal acne. AKLIEF Cream is a unique, highly targeted retinoid that has been demonstrated to reduce inflammatory lesions on the face, back, chest and shoulders and to be safe and well tolerated.³ It is the first topical treatment specifically studied and proven safe and effective to treat both facial and truncal acne. AKLIEF Cream also contains the first retinoid molecule to receive FDA approval for the treatment of acne in more than 20 years.^4,5,6

The FDA approval was supported by data from pivotal Phase 3 clinical trials of once-daily AKLIEF Cream in patients with moderate acne on the face and trunk, including two 12-week trials of efficacy and safety and one 52-week safety trial.⁴ The two identical 12-week, randomized, multicenter, parallel group, double-blind, vehicle-controlled clinical trials of 2,420 patients showed that AKLIEF Cream significantly reduced inflammatory lesions as early as two weeks on the face and four weeks on the back, shoulders and chest compared to vehicle (p<0.05). AKLIEF Cream was well tolerated when used on the face, back, shoulders and chest. The most common adverse reactions (incidence >1%) included application site irritation, application site pruritus (itching) and sunburn. For more information, visit AKLIEF.com/HCP.

Future of Telehealth in Dermatology

Virtual visits allow clinicians to provide uninterrupted care to patients with acne and offer visibility into a patient’s lifestyle and skincare regimen. “With telehealth visits, I don’t have to interrupt patient care, and with newer treatments becoming available, I can continue to offer patients innovative options that may be better suited to their needs. For example, for patients with acne on the face and trunk, I now have the option to prescribe AKLIEF Cream, which has been proven effective to treat both areas, and I can help patients achieve clearer skin from the safety of their homes,” says Dr. Harper. Given the success that many dermatology practices have had with telehealth visits during the novel coronavirus public health crisis, many plan to continue to offer virtual visits for the foreseeable future.

# # #

Important Safety Information

INDICATION: AKLIEF^® (trifarotene) Cream, 0.005% is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. ADVERSE EVENTS: The most common adverse reactions (incidence ≥ 1%) in patients treated with AKLIEF Cream were application site irritation, application site pruritus (itching), and sunburn. WARNINGS/PRECAUTIONS: Patients using AKLIEF Cream may experience erythema, scaling, dryness, and stinging/burning. Use a moisturizer from the initiation of treatment, and, if appropriate, depending upon the severity of these adverse reactions, reduce the frequency of application of AKLIEF Cream, suspend or discontinue use. Avoid application of AKLIEF Cream to cuts, abrasions or eczematous or sunburned skin. Use of “waxing” as a depilatory method should be avoided on skin treated with AKLIEF Cream. Minimize exposure to sunlight and sunlamps. Use sunscreen and protective clothing over treated areas when exposure cannot be avoided.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

©2020 Galderma Laboratories, L.P. All Rights Reserved. All trademarks are the property of their respective owners.

References:

1. American Academy of Dermatology. Acne. https://www.aad.org/media/stats-numbers. Accessed June 2, 2020.

2. Del Rosso JQ, et al. A closer look at truncal acne vulgaris: prevalence, severity, and clinical significance. J Drugs Dermatol. 2007; 6:597-600.

3. Tan J, Thiboutot D, Popp G, Gooderham M, Lynde C, et al. Randomized Phase 3 evaluation of trifarotene 50 μg/g cream treatment of moderate facial and truncal acne. J Am Acad Dermatol. 2019. DOI: https://doi.org/10.1016/j.jaad.2019.02.044.

4. British Association of Dermatologists. Topical trifarotene: a new retinoid. Br J Dermatol. 2018;179:231-232.

5. Data on File, Galderma.

6. FDA PPI, Galderma.

Acne is diagnosed by examining the patient’s skin with a simple, visual inspection. In rare cases, a lesion or pustule may be swabbed or scraped for microbiological examination or culture to rule out other sources of infection.

Benefits of Virtual Visits for Acne Patients

With stay-at-home orders in effect in the United States because of the COVID-19 pandemic, many dermatology practices have transitioned from live appointments to telemedicine visits. They have found that switching from live to virtual visits is especially amenable for patients with acne, especially those with severe acne who are taking isotretinoin and must be seen every six weeks. With telemedicine visits, dermatologists can diagnose new patients with facial acne. For existing acne patients, dermatologists can provide uninterrupted care and treatment, and hear directly from patients about their progress with a specific acne treatment – just as they can with in-person visits in the clinic.

“Our practice has found that virtual acne visits can be as efficient and effective as in-person visits, namely because the evaluation of acne is very visual and the treatment is not procedural,” says Julie Harper, M.D., a dermatologist at Dermatology & Skin Care Center of Birmingham in Alabama and Galderma consultant. “We were surprised to find that telehealth visits with our acne patients in their own home even have a distinct advantage. If I ask a patient which medications they’re using to self-treat, they’ll often walk to their bathroom and show me, so I can see those products for myself.”

Challenges in Treating Truncal Acne

Although telehealth visits for patients with facial acne are typically straightforward and simple, virtual visits for patients with truncal acne can be challenging as the shoulders, back and chest aren’t typically seen on a video chat. Now that the U.S. Food and Drug Administration (FDA) has approved AKLIEF^® (trifarotene) Cream, 0.005%, for the treatment of acne vulgaris in patients age 9 years and over, clinicians should ask facial acne patients whether they are also experiencing truncal acne. AKLIEF Cream is a unique, highly targeted retinoid that has been demonstrated to reduce inflammatory lesions on the face, back, chest and shoulders and to be safe and well tolerated.³ It is the first topical treatment specifically studied and proven safe and effective to treat both facial and truncal acne. AKLIEF Cream also contains the first retinoid molecule to receive FDA approval for the treatment of acne in more than 20 years.^4,5,6

The FDA approval was supported by data from pivotal Phase 3 clinical trials of once-daily AKLIEF Cream in patients with moderate acne on the face and trunk, including two 12-week trials of efficacy and safety and one 52-week safety trial.⁴ The two identical 12-week, randomized, multicenter, parallel group, double-blind, vehicle-controlled clinical trials of 2,420 patients showed that AKLIEF Cream significantly reduced inflammatory lesions as early as two weeks on the face and four weeks on the back, shoulders and chest compared to vehicle (p<0.05). AKLIEF Cream was well tolerated when used on the face, back, shoulders and chest. The most common adverse reactions (incidence >1%) included application site irritation, application site pruritus (itching) and sunburn. For more information, visit AKLIEF.com/HCP.

Future of Telehealth in Dermatology

Virtual visits allow clinicians to provide uninterrupted care to patients with acne and offer visibility into a patient’s lifestyle and skincare regimen. “With telehealth visits, I don’t have to interrupt patient care, and with newer treatments becoming available, I can continue to offer patients innovative options that may be better suited to their needs. For example, for patients with acne on the face and trunk, I now have the option to prescribe AKLIEF Cream, which has been proven effective to treat both areas, and I can help patients achieve clearer skin from the safety of their homes,” says Dr. Harper. Given the success that many dermatology practices have had with telehealth visits during the novel coronavirus public health crisis, many plan to continue to offer virtual visits for the foreseeable future.

# # #

Important Safety Information

INDICATION: AKLIEF^® (trifarotene) Cream, 0.005% is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. ADVERSE EVENTS: The most common adverse reactions (incidence ≥ 1%) in patients treated with AKLIEF Cream were application site irritation, application site pruritus (itching), and sunburn. WARNINGS/PRECAUTIONS: Patients using AKLIEF Cream may experience erythema, scaling, dryness, and stinging/burning. Use a moisturizer from the initiation of treatment, and, if appropriate, depending upon the severity of these adverse reactions, reduce the frequency of application of AKLIEF Cream, suspend or discontinue use. Avoid application of AKLIEF Cream to cuts, abrasions or eczematous or sunburned skin. Use of “waxing” as a depilatory method should be avoided on skin treated with AKLIEF Cream. Minimize exposure to sunlight and sunlamps. Use sunscreen and protective clothing over treated areas when exposure cannot be avoided.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

©2020 Galderma Laboratories, L.P. All Rights Reserved. All trademarks are the property of their respective owners.

References:

1. American Academy of Dermatology. Acne. https://www.aad.org/media/stats-numbers. Accessed June 2, 2020.

2. Del Rosso JQ, et al. A closer look at truncal acne vulgaris: prevalence, severity, and clinical significance. J Drugs Dermatol. 2007; 6:597-600.

3. Tan J, Thiboutot D, Popp G, Gooderham M, Lynde C, et al. Randomized Phase 3 evaluation of trifarotene 50 μg/g cream treatment of moderate facial and truncal acne. J Am Acad Dermatol. 2019. DOI: https://doi.org/10.1016/j.jaad.2019.02.044.

4. British Association of Dermatologists. Topical trifarotene: a new retinoid. Br J Dermatol. 2018;179:231-232.

5. Data on File, Galderma.

6. FDA PPI, Galderma.

Acne is diagnosed by examining the patient’s skin with a simple, visual inspection. In rare cases, a lesion or pustule may be swabbed or scraped for microbiological examination or culture to rule out other sources of infection.

Benefits of Virtual Visits for Acne Patients

With stay-at-home orders in effect in the United States because of the COVID-19 pandemic, many dermatology practices have transitioned from live appointments to telemedicine visits. They have found that switching from live to virtual visits is especially amenable for patients with acne, especially those with severe acne who are taking isotretinoin and must be seen every six weeks. With telemedicine visits, dermatologists can diagnose new patients with facial acne. For existing acne patients, dermatologists can provide uninterrupted care and treatment, and hear directly from patients about their progress with a specific acne treatment – just as they can with in-person visits in the clinic.

“Our practice has found that virtual acne visits can be as efficient and effective as in-person visits, namely because the evaluation of acne is very visual and the treatment is not procedural,” says Julie Harper, M.D., a dermatologist at Dermatology & Skin Care Center of Birmingham in Alabama and Galderma consultant. “We were surprised to find that telehealth visits with our acne patients in their own home even have a distinct advantage. If I ask a patient which medications they’re using to self-treat, they’ll often walk to their bathroom and show me, so I can see those products for myself.”

Challenges in Treating Truncal Acne

Although telehealth visits for patients with facial acne are typically straightforward and simple, virtual visits for patients with truncal acne can be challenging as the shoulders, back and chest aren’t typically seen on a video chat. Now that the U.S. Food and Drug Administration (FDA) has approved AKLIEF^® (trifarotene) Cream, 0.005%, for the treatment of acne vulgaris in patients age 9 years and over, clinicians should ask facial acne patients whether they are also experiencing truncal acne. AKLIEF Cream is a unique, highly targeted retinoid that has been demonstrated to reduce inflammatory lesions on the face, back, chest and shoulders and to be safe and well tolerated.³ It is the first topical treatment specifically studied and proven safe and effective to treat both facial and truncal acne. AKLIEF Cream also contains the first retinoid molecule to receive FDA approval for the treatment of acne in more than 20 years.^4,5,6

The FDA approval was supported by data from pivotal Phase 3 clinical trials of once-daily AKLIEF Cream in patients with moderate acne on the face and trunk, including two 12-week trials of efficacy and safety and one 52-week safety trial.⁴ The two identical 12-week, randomized, multicenter, parallel group, double-blind, vehicle-controlled clinical trials of 2,420 patients showed that AKLIEF Cream significantly reduced inflammatory lesions as early as two weeks on the face and four weeks on the back, shoulders and chest compared to vehicle (p<0.05). AKLIEF Cream was well tolerated when used on the face, back, shoulders and chest. The most common adverse reactions (incidence >1%) included application site irritation, application site pruritus (itching) and sunburn. For more information, visit AKLIEF.com/HCP.

Future of Telehealth in Dermatology

Virtual visits allow clinicians to provide uninterrupted care to patients with acne and offer visibility into a patient’s lifestyle and skincare regimen. “With telehealth visits, I don’t have to interrupt patient care, and with newer treatments becoming available, I can continue to offer patients innovative options that may be better suited to their needs. For example, for patients with acne on the face and trunk, I now have the option to prescribe AKLIEF Cream, which has been proven effective to treat both areas, and I can help patients achieve clearer skin from the safety of their homes,” says Dr. Harper. Given the success that many dermatology practices have had with telehealth visits during the novel coronavirus public health crisis, many plan to continue to offer virtual visits for the foreseeable future.

# # #

Important Safety Information

INDICATION: AKLIEF^® (trifarotene) Cream, 0.005% is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. ADVERSE EVENTS: The most common adverse reactions (incidence ≥ 1%) in patients treated with AKLIEF Cream were application site irritation, application site pruritus (itching), and sunburn. WARNINGS/PRECAUTIONS: Patients using AKLIEF Cream may experience erythema, scaling, dryness, and stinging/burning. Use a moisturizer from the initiation of treatment, and, if appropriate, depending upon the severity of these adverse reactions, reduce the frequency of application of AKLIEF Cream, suspend or discontinue use. Avoid application of AKLIEF Cream to cuts, abrasions or eczematous or sunburned skin. Use of “waxing” as a depilatory method should be avoided on skin treated with AKLIEF Cream. Minimize exposure to sunlight and sunlamps. Use sunscreen and protective clothing over treated areas when exposure cannot be avoided.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

©2020 Galderma Laboratories, L.P. All Rights Reserved. All trademarks are the property of their respective owners.

References:

1. American Academy of Dermatology. Acne. https://www.aad.org/media/stats-numbers. Accessed June 2, 2020.

2. Del Rosso JQ, et al. A closer look at truncal acne vulgaris: prevalence, severity, and clinical significance. J Drugs Dermatol. 2007; 6:597-600.

3. Tan J, Thiboutot D, Popp G, Gooderham M, Lynde C, et al. Randomized Phase 3 evaluation of trifarotene 50 μg/g cream treatment of moderate facial and truncal acne. J Am Acad Dermatol. 2019. DOI: https://doi.org/10.1016/j.jaad.2019.02.044.

4. British Association of Dermatologists. Topical trifarotene: a new retinoid. Br J Dermatol. 2018;179:231-232.

5. Data on File, Galderma.

6. FDA PPI, Galderma.

For the first 10 months of Christine’s gender transition, a progressive LGBT health clinic in Boston made getting on hormones easy. But after a year or so on estrogen and a testosterone-blocker, she found herself in financial trouble. She had just recently moved to the city, where she was unable to find a job, and her savings were starting to wear thin.

Finding employment as a transgender person, she says, was overwhelmingly difficult: “I was turned down for more jobs than I can count — 20 or 40 different positions in a couple of months.” She would land an interview, then wouldn’t hear back, she says, which she suspects happened because the company noticed she was “not like their other potential hires.”

Christine, a transgender woman, had been enrolled in the state’s Medicaid program, MassHealth, for four months, and her copay for hormone therapy was only $5. But without a job, she found herself torn between food, rent, and medication. For a while, she juggled all three expenses with donations from friends. But after several months, she felt guilty about asking for help and stopped treatment. (Undark has agreed to use only Christine's chosen name because she said she feared both online and in-person harassment for sharing her story.)

At first, Christine didn’t mind being off hormones. She marched in political protests alongside older trans people who assured her that starting and stopping hormones was a normal part of the trans experience. But eventually, Christine felt her body reverting back to the way it had been before her transition; her chest flattened and her fat moved from her hips to her stomach. She stopped wearing dresses and makeup.

“I wasn't looking at myself in the mirror anymore,” she says. “I existed for 10 months, and then I was gone.”

People who are visibly transgender often have trouble finding a job. Nearly a third live in poverty. Many don’t have health insurance, and those who do may have a plan that doesn’t cover hormones. Although testosterone and estrogen only cost $5 to $30 a month for patients with an insurance plan (and typically less than $100 per month for the uninsured), doctors often require consistent therapy and blood work, which ratchets up the cost. Even when trans people have the money, finding doctors willing to treat them can prove impossible. Trans people are also likely to have had bad experiences with the health care system and want to avoid it altogether.

Without access to quality medical care, trans people around the world are seeking hormones from friends or through illegal online markets, even when the cost exceeds what it would through insurance. Although rare, others are resorting to self-surgery by cutting off their own penis and testicles or breasts.

Even with a doctor’s oversight, the health risks of transgender hormone therapy remain unclear, but without formal medical care, the do-it-yourself transition may be downright dangerous. To minimize these risks, some experts suggest health care reforms such as making it easier for primary care physicians to assess trans patients and prescribe hormones or creating specialized clinics where doctors prescribe hormones on demand.

But those solutions aren’t available to most people who are seeking DIY treatments right now. Many doctors aren’t even aware that DIY transitioning exists, although the few experts who are following the community aren’t surprised. Self-treatment is “the reality for most trans people in the world,” says Ayden Scheim, an epidemiologist focusing on transgender health at Drexel University who is trans himself.

While there isn’t a lot of other existing research on DIY hormone treatment, and some of it may be outdated, the available studies suggest it is fairly common and researchers may in fact be underestimating the prevalence of DIY hormone use because they miss people who avoid the medical system completely. In 2014, researchers in the U.K. found that at the time of their first gender clinic visit, 17 percent of transgender people were already taking hormones that they had bought online or from a friend. In Canada, a quarter of trans people on hormones had self-medicated, according to a 2013 study in the American Journal of Public Health. And in a survey of trans people in Washington, D.C. in 2000, 58 percent said they used non-prescribed hormones.

People cite all sorts of reasons for ordering the drugs online or acquiring them by other means. In addition to distrust of doctors and a lack of insurance or access to health care, some simply don’t want to endure long waits for medications. That’s the case for Emma, a trans woman in college in the Netherlands, where it can take two to three years to receive a physician prescription. (Emma is only using her first name to avoid online harassment, which she says she’s experienced in the past.)

As for surgery, far fewer people turn to DIY versions compared to those who try hormones. A 2012 study in the Journal of Sexual Medicine reported that only 109 cases of self-castration or self-mutilation of the genitals appear in the scientific literature, and not all are related to gender identity. “But one is too many,” Scheim says. “No one should be in a position where they feel like they need to do that.”

The individual cases reveal a practice that is dangerous and devastating. In Hangzhou, China, a 30-year-old transgender woman feared rejection from her family, so she hid her true gender, according to a 2019 Amnesty International report. She also tried to transition in secret. At first, the woman tried putting ice on her genitals to stop them from functioning. When that didn’t work, she booked an appointment with a black-market surgeon, but the doctor was arrested before her session. She attempted surgery on herself, the report says, and after losing a profuse amount of blood, hailed a taxi to the emergency room. There, she asked the doctor to tell her family she had been in an accident.

When it comes to self-surgery, the dangers of DIY transitioning are obvious. The dangers of DIY hormones are more far-ranging, from “not ideal to serious,” Scheim says. Some DIY users take a more-is-better approach, but taking too much testosterone too quickly can fry the vocal cords. Even buying hormones from an online pharmacy is risky. In 2010, more than half of all treatments from illicit websites — not only of hormones, but of any drug — were counterfeit, according to a bulletin from the World Health Organization.

Still, Charley isn’t worried about the legitimacy of the drugs he’s taking. The packaging his estrogen comes in matches what he would get from a pharmacy with a doctor’s prescription, he says. He’s also unconcerned about the side effects. “I just did a metric century” — a 100-kilometer bike ride — “in under four hours and walked away from it feeling great. I’m healthy,” he says. “So, yeah, there might be a few side effects. But I know where the local hospital is.”

Yet waiting to see if a seemingly minor side effect leads to a health emergency may mean a patient gets help too late. “I don’t want to say that the risks are incredibly high and there is a high mortality,” Metastasio says. “I am saying, though, that this is a procedure best to be monitored.” Metastasio and others recommend seeing a doctor regularly to catch any health issues that arise as quickly as possible.

But even when doctors prescribe the drugs, the risks are unclear because of a lack of research on trans health, says Scheim: “There’s so much we don’t know about hormone use.”

Researchers do know a little bit, though. Even when a doctor weighs in on the proper dosages, there is an increased risk of heart attack. Taking testosterone increases the chances of developing acne, headaches and migraines, and anger and irritability, according to the Trans Care Project, a program of the Transcend Transgender Support and Education Society and Vancouver Coastal Health’s Transgender Health Program in Canada. Testosterone also increases the risk of having abnormally high levels of red blood cells, or polycythemia, which thickens the blood and can lead to clotting. Meanwhile, studies suggest estrogen can up the risk for breast cancer, stroke, blood clots, gallstones, and a range of heart issues. And the most common testosterone-blocker, spironolactone, can cause dehydration and weaken the kidneys.

All of these risks make it especially important for trans people to have the support of a medical provider, Metastasio says. Specialists are in short supply, but general practitioners and family doctors should be able to fill the gap. After all, they already sign off on the hormone medications for cisgender people for birth control and conditions such as menopause and male pattern baldness — which come with similar side effects and warnings as when trans people use them.

Some doctors have already realized the connection. “People can increasingly get hormone therapy from their pre-existing family doctor,” Scheim says, “which is really ideal because people should be able to have a sort of continuity of health care.”

Zil Goldstein, associate medical director for transgender and gender non-binary health at the Callen-Lorde Community Health Center in New York City, would like to see more of this. Treating gender dysphoria, she says, should be just like treating a patient for any other condition. “It wouldn't be acceptable for someone to come into a primary care provider’s office with diabetes” and for the doctor to say “‘I can't actually treat you. Please leave,’” she says. Primary care providers need to see transgender care, she adds, “as a regular part of their practice.”

Another way to increase access to hormones is through informed consent, a system which received a green light from the newest WPATH guidelines. That’s how Christine received her hormones from Fenway Health before she moved from Boston to Cape Cod. Under informed consent, if someone has a blood test to assess personal health risks of treatment, they can receive a diagnosis of gender dysphoria, sign off on knowing the risks and benefits of hormone therapy, and get a prescription — all in one day.

And Jaime Lynn Gilmour, a trans woman using the full name she chose to match her gender identity, turned to informed consent after struggling to find DIY hormones. In 2017, Jaime realized she was trans while serving in the military, and says she felt she had to keep her gender a secret. When her service ended, she was ready to start taking hormones right away. So she tried to find them online, but her order wouldn’t go through on three different websites. Instead, she visited a Planned Parenthood clinic. After blood work and a few questions, she walked out with three months of estrogen and spironolactone.

But Goldstein says even informed consent doesn’t go far enough: “If I have someone who's diabetic, I don't make them sign a document eliciting their informed consent before starting insulin.”

For trans people, hormone treatments “are life-saving therapies,” Goldstein adds, “and we shouldn’t delay or stigmatize.”

For now Christine still lives with her parents in Cape Cod. She’s also still off hormones. But she found a job. After she stashes a bit more cash in the bank, she plans to move closer to Boston and find a physician.

Despite the positive shifts in her life, it’s been a difficult few months. After moving to Cape Cod, Christine lost most of her social life and support system — particularly since her parents don’t understand or accept her gender identity. Though she has reconnected with a few friends in the past several weeks, she says she’s in a tough place emotionally. In public, she typically dresses and styles herself to look more masculine to avoid rude stares, and she is experiencing self-hatred that she fears won’t go away when she restarts treatment. Transitioning again isn’t going to be easy, as she explained to Undark in a private message on Facebook: “I've been beaten down enough that now I don't wanna get back up most of the time.”

Even worse is the fear that she might not be able to restart treatment at all. Earlier this year, Christine suffered two health emergencies within the span of a week, in which she says her blood pressure spiked, potentially causing organ damage. Christine has had one similar episode in the past and her family has a history of heart issues.

Christine may not be able to get back on estrogen despite the hard work she’s done to be able to afford it, she says, since it can increase the risk of heart attack and stroke. Because she has so far resisted trying DIY treatments again, she may have saved herself from additional health problems.

But Christine doesn’t see it that way. “Even if it was unsafe, even if I risked health concerns making myself a guinea pig, I wish I followed through,” she wrote. “Being off hormones is hell. And now that I face potentially never taking them again, I wish I had.”

Tara Santora is a science journalist based out of Denver. They have written for Psychology Today, Live Science, Fatherly, Audubon, and more.

This article was originally published on Undark. Read the original article.

For the first 10 months of Christine’s gender transition, a progressive LGBT health clinic in Boston made getting on hormones easy. But after a year or so on estrogen and a testosterone-blocker, she found herself in financial trouble. She had just recently moved to the city, where she was unable to find a job, and her savings were starting to wear thin.

Finding employment as a transgender person, she says, was overwhelmingly difficult: “I was turned down for more jobs than I can count — 20 or 40 different positions in a couple of months.” She would land an interview, then wouldn’t hear back, she says, which she suspects happened because the company noticed she was “not like their other potential hires.”

Christine, a transgender woman, had been enrolled in the state’s Medicaid program, MassHealth, for four months, and her copay for hormone therapy was only $5. But without a job, she found herself torn between food, rent, and medication. For a while, she juggled all three expenses with donations from friends. But after several months, she felt guilty about asking for help and stopped treatment. (Undark has agreed to use only Christine's chosen name because she said she feared both online and in-person harassment for sharing her story.)

At first, Christine didn’t mind being off hormones. She marched in political protests alongside older trans people who assured her that starting and stopping hormones was a normal part of the trans experience. But eventually, Christine felt her body reverting back to the way it had been before her transition; her chest flattened and her fat moved from her hips to her stomach. She stopped wearing dresses and makeup.

“I wasn't looking at myself in the mirror anymore,” she says. “I existed for 10 months, and then I was gone.”

People who are visibly transgender often have trouble finding a job. Nearly a third live in poverty. Many don’t have health insurance, and those who do may have a plan that doesn’t cover hormones. Although testosterone and estrogen only cost $5 to $30 a month for patients with an insurance plan (and typically less than $100 per month for the uninsured), doctors often require consistent therapy and blood work, which ratchets up the cost. Even when trans people have the money, finding doctors willing to treat them can prove impossible. Trans people are also likely to have had bad experiences with the health care system and want to avoid it altogether.

Without access to quality medical care, trans people around the world are seeking hormones from friends or through illegal online markets, even when the cost exceeds what it would through insurance. Although rare, others are resorting to self-surgery by cutting off their own penis and testicles or breasts.

Even with a doctor’s oversight, the health risks of transgender hormone therapy remain unclear, but without formal medical care, the do-it-yourself transition may be downright dangerous. To minimize these risks, some experts suggest health care reforms such as making it easier for primary care physicians to assess trans patients and prescribe hormones or creating specialized clinics where doctors prescribe hormones on demand.

But those solutions aren’t available to most people who are seeking DIY treatments right now. Many doctors aren’t even aware that DIY transitioning exists, although the few experts who are following the community aren’t surprised. Self-treatment is “the reality for most trans people in the world,” says Ayden Scheim, an epidemiologist focusing on transgender health at Drexel University who is trans himself.

While there isn’t a lot of other existing research on DIY hormone treatment, and some of it may be outdated, the available studies suggest it is fairly common and researchers may in fact be underestimating the prevalence of DIY hormone use because they miss people who avoid the medical system completely. In 2014, researchers in the U.K. found that at the time of their first gender clinic visit, 17 percent of transgender people were already taking hormones that they had bought online or from a friend. In Canada, a quarter of trans people on hormones had self-medicated, according to a 2013 study in the American Journal of Public Health. And in a survey of trans people in Washington, D.C. in 2000, 58 percent said they used non-prescribed hormones.

People cite all sorts of reasons for ordering the drugs online or acquiring them by other means. In addition to distrust of doctors and a lack of insurance or access to health care, some simply don’t want to endure long waits for medications. That’s the case for Emma, a trans woman in college in the Netherlands, where it can take two to three years to receive a physician prescription. (Emma is only using her first name to avoid online harassment, which she says she’s experienced in the past.)

As for surgery, far fewer people turn to DIY versions compared to those who try hormones. A 2012 study in the Journal of Sexual Medicine reported that only 109 cases of self-castration or self-mutilation of the genitals appear in the scientific literature, and not all are related to gender identity. “But one is too many,” Scheim says. “No one should be in a position where they feel like they need to do that.”

The individual cases reveal a practice that is dangerous and devastating. In Hangzhou, China, a 30-year-old transgender woman feared rejection from her family, so she hid her true gender, according to a 2019 Amnesty International report. She also tried to transition in secret. At first, the woman tried putting ice on her genitals to stop them from functioning. When that didn’t work, she booked an appointment with a black-market surgeon, but the doctor was arrested before her session. She attempted surgery on herself, the report says, and after losing a profuse amount of blood, hailed a taxi to the emergency room. There, she asked the doctor to tell her family she had been in an accident.

When it comes to self-surgery, the dangers of DIY transitioning are obvious. The dangers of DIY hormones are more far-ranging, from “not ideal to serious,” Scheim says. Some DIY users take a more-is-better approach, but taking too much testosterone too quickly can fry the vocal cords. Even buying hormones from an online pharmacy is risky. In 2010, more than half of all treatments from illicit websites — not only of hormones, but of any drug — were counterfeit, according to a bulletin from the World Health Organization.

Still, Charley isn’t worried about the legitimacy of the drugs he’s taking. The packaging his estrogen comes in matches what he would get from a pharmacy with a doctor’s prescription, he says. He’s also unconcerned about the side effects. “I just did a metric century” — a 100-kilometer bike ride — “in under four hours and walked away from it feeling great. I’m healthy,” he says. “So, yeah, there might be a few side effects. But I know where the local hospital is.”

Yet waiting to see if a seemingly minor side effect leads to a health emergency may mean a patient gets help too late. “I don’t want to say that the risks are incredibly high and there is a high mortality,” Metastasio says. “I am saying, though, that this is a procedure best to be monitored.” Metastasio and others recommend seeing a doctor regularly to catch any health issues that arise as quickly as possible.

But even when doctors prescribe the drugs, the risks are unclear because of a lack of research on trans health, says Scheim: “There’s so much we don’t know about hormone use.”

Researchers do know a little bit, though. Even when a doctor weighs in on the proper dosages, there is an increased risk of heart attack. Taking testosterone increases the chances of developing acne, headaches and migraines, and anger and irritability, according to the Trans Care Project, a program of the Transcend Transgender Support and Education Society and Vancouver Coastal Health’s Transgender Health Program in Canada. Testosterone also increases the risk of having abnormally high levels of red blood cells, or polycythemia, which thickens the blood and can lead to clotting. Meanwhile, studies suggest estrogen can up the risk for breast cancer, stroke, blood clots, gallstones, and a range of heart issues. And the most common testosterone-blocker, spironolactone, can cause dehydration and weaken the kidneys.

All of these risks make it especially important for trans people to have the support of a medical provider, Metastasio says. Specialists are in short supply, but general practitioners and family doctors should be able to fill the gap. After all, they already sign off on the hormone medications for cisgender people for birth control and conditions such as menopause and male pattern baldness — which come with similar side effects and warnings as when trans people use them.

Some doctors have already realized the connection. “People can increasingly get hormone therapy from their pre-existing family doctor,” Scheim says, “which is really ideal because people should be able to have a sort of continuity of health care.”

Zil Goldstein, associate medical director for transgender and gender non-binary health at the Callen-Lorde Community Health Center in New York City, would like to see more of this. Treating gender dysphoria, she says, should be just like treating a patient for any other condition. “It wouldn't be acceptable for someone to come into a primary care provider’s office with diabetes” and for the doctor to say “‘I can't actually treat you. Please leave,’” she says. Primary care providers need to see transgender care, she adds, “as a regular part of their practice.”

Another way to increase access to hormones is through informed consent, a system which received a green light from the newest WPATH guidelines. That’s how Christine received her hormones from Fenway Health before she moved from Boston to Cape Cod. Under informed consent, if someone has a blood test to assess personal health risks of treatment, they can receive a diagnosis of gender dysphoria, sign off on knowing the risks and benefits of hormone therapy, and get a prescription — all in one day.

And Jaime Lynn Gilmour, a trans woman using the full name she chose to match her gender identity, turned to informed consent after struggling to find DIY hormones. In 2017, Jaime realized she was trans while serving in the military, and says she felt she had to keep her gender a secret. When her service ended, she was ready to start taking hormones right away. So she tried to find them online, but her order wouldn’t go through on three different websites. Instead, she visited a Planned Parenthood clinic. After blood work and a few questions, she walked out with three months of estrogen and spironolactone.

But Goldstein says even informed consent doesn’t go far enough: “If I have someone who's diabetic, I don't make them sign a document eliciting their informed consent before starting insulin.”

For trans people, hormone treatments “are life-saving therapies,” Goldstein adds, “and we shouldn’t delay or stigmatize.”

For now Christine still lives with her parents in Cape Cod. She’s also still off hormones. But she found a job. After she stashes a bit more cash in the bank, she plans to move closer to Boston and find a physician.

Despite the positive shifts in her life, it’s been a difficult few months. After moving to Cape Cod, Christine lost most of her social life and support system — particularly since her parents don’t understand or accept her gender identity. Though she has reconnected with a few friends in the past several weeks, she says she’s in a tough place emotionally. In public, she typically dresses and styles herself to look more masculine to avoid rude stares, and she is experiencing self-hatred that she fears won’t go away when she restarts treatment. Transitioning again isn’t going to be easy, as she explained to Undark in a private message on Facebook: “I've been beaten down enough that now I don't wanna get back up most of the time.”

Even worse is the fear that she might not be able to restart treatment at all. Earlier this year, Christine suffered two health emergencies within the span of a week, in which she says her blood pressure spiked, potentially causing organ damage. Christine has had one similar episode in the past and her family has a history of heart issues.

Christine may not be able to get back on estrogen despite the hard work she’s done to be able to afford it, she says, since it can increase the risk of heart attack and stroke. Because she has so far resisted trying DIY treatments again, she may have saved herself from additional health problems.

But Christine doesn’t see it that way. “Even if it was unsafe, even if I risked health concerns making myself a guinea pig, I wish I followed through,” she wrote. “Being off hormones is hell. And now that I face potentially never taking them again, I wish I had.”

Tara Santora is a science journalist based out of Denver. They have written for Psychology Today, Live Science, Fatherly, Audubon, and more.

This article was originally published on Undark. Read the original article.

For the first 10 months of Christine’s gender transition, a progressive LGBT health clinic in Boston made getting on hormones easy. But after a year or so on estrogen and a testosterone-blocker, she found herself in financial trouble. She had just recently moved to the city, where she was unable to find a job, and her savings were starting to wear thin.

Finding employment as a transgender person, she says, was overwhelmingly difficult: “I was turned down for more jobs than I can count — 20 or 40 different positions in a couple of months.” She would land an interview, then wouldn’t hear back, she says, which she suspects happened because the company noticed she was “not like their other potential hires.”

Christine, a transgender woman, had been enrolled in the state’s Medicaid program, MassHealth, for four months, and her copay for hormone therapy was only $5. But without a job, she found herself torn between food, rent, and medication. For a while, she juggled all three expenses with donations from friends. But after several months, she felt guilty about asking for help and stopped treatment. (Undark has agreed to use only Christine's chosen name because she said she feared both online and in-person harassment for sharing her story.)

At first, Christine didn’t mind being off hormones. She marched in political protests alongside older trans people who assured her that starting and stopping hormones was a normal part of the trans experience. But eventually, Christine felt her body reverting back to the way it had been before her transition; her chest flattened and her fat moved from her hips to her stomach. She stopped wearing dresses and makeup.

“I wasn't looking at myself in the mirror anymore,” she says. “I existed for 10 months, and then I was gone.”

People who are visibly transgender often have trouble finding a job. Nearly a third live in poverty. Many don’t have health insurance, and those who do may have a plan that doesn’t cover hormones. Although testosterone and estrogen only cost $5 to $30 a month for patients with an insurance plan (and typically less than $100 per month for the uninsured), doctors often require consistent therapy and blood work, which ratchets up the cost. Even when trans people have the money, finding doctors willing to treat them can prove impossible. Trans people are also likely to have had bad experiences with the health care system and want to avoid it altogether.

Without access to quality medical care, trans people around the world are seeking hormones from friends or through illegal online markets, even when the cost exceeds what it would through insurance. Although rare, others are resorting to self-surgery by cutting off their own penis and testicles or breasts.

Even with a doctor’s oversight, the health risks of transgender hormone therapy remain unclear, but without formal medical care, the do-it-yourself transition may be downright dangerous. To minimize these risks, some experts suggest health care reforms such as making it easier for primary care physicians to assess trans patients and prescribe hormones or creating specialized clinics where doctors prescribe hormones on demand.

But those solutions aren’t available to most people who are seeking DIY treatments right now. Many doctors aren’t even aware that DIY transitioning exists, although the few experts who are following the community aren’t surprised. Self-treatment is “the reality for most trans people in the world,” says Ayden Scheim, an epidemiologist focusing on transgender health at Drexel University who is trans himself.

While there isn’t a lot of other existing research on DIY hormone treatment, and some of it may be outdated, the available studies suggest it is fairly common and researchers may in fact be underestimating the prevalence of DIY hormone use because they miss people who avoid the medical system completely. In 2014, researchers in the U.K. found that at the time of their first gender clinic visit, 17 percent of transgender people were already taking hormones that they had bought online or from a friend. In Canada, a quarter of trans people on hormones had self-medicated, according to a 2013 study in the American Journal of Public Health. And in a survey of trans people in Washington, D.C. in 2000, 58 percent said they used non-prescribed hormones.

People cite all sorts of reasons for ordering the drugs online or acquiring them by other means. In addition to distrust of doctors and a lack of insurance or access to health care, some simply don’t want to endure long waits for medications. That’s the case for Emma, a trans woman in college in the Netherlands, where it can take two to three years to receive a physician prescription. (Emma is only using her first name to avoid online harassment, which she says she’s experienced in the past.)

As for surgery, far fewer people turn to DIY versions compared to those who try hormones. A 2012 study in the Journal of Sexual Medicine reported that only 109 cases of self-castration or self-mutilation of the genitals appear in the scientific literature, and not all are related to gender identity. “But one is too many,” Scheim says. “No one should be in a position where they feel like they need to do that.”

The individual cases reveal a practice that is dangerous and devastating. In Hangzhou, China, a 30-year-old transgender woman feared rejection from her family, so she hid her true gender, according to a 2019 Amnesty International report. She also tried to transition in secret. At first, the woman tried putting ice on her genitals to stop them from functioning. When that didn’t work, she booked an appointment with a black-market surgeon, but the doctor was arrested before her session. She attempted surgery on herself, the report says, and after losing a profuse amount of blood, hailed a taxi to the emergency room. There, she asked the doctor to tell her family she had been in an accident.

When it comes to self-surgery, the dangers of DIY transitioning are obvious. The dangers of DIY hormones are more far-ranging, from “not ideal to serious,” Scheim says. Some DIY users take a more-is-better approach, but taking too much testosterone too quickly can fry the vocal cords. Even buying hormones from an online pharmacy is risky. In 2010, more than half of all treatments from illicit websites — not only of hormones, but of any drug — were counterfeit, according to a bulletin from the World Health Organization.

Still, Charley isn’t worried about the legitimacy of the drugs he’s taking. The packaging his estrogen comes in matches what he would get from a pharmacy with a doctor’s prescription, he says. He’s also unconcerned about the side effects. “I just did a metric century” — a 100-kilometer bike ride — “in under four hours and walked away from it feeling great. I’m healthy,” he says. “So, yeah, there might be a few side effects. But I know where the local hospital is.”

Yet waiting to see if a seemingly minor side effect leads to a health emergency may mean a patient gets help too late. “I don’t want to say that the risks are incredibly high and there is a high mortality,” Metastasio says. “I am saying, though, that this is a procedure best to be monitored.” Metastasio and others recommend seeing a doctor regularly to catch any health issues that arise as quickly as possible.

But even when doctors prescribe the drugs, the risks are unclear because of a lack of research on trans health, says Scheim: “There’s so much we don’t know about hormone use.”

Researchers do know a little bit, though. Even when a doctor weighs in on the proper dosages, there is an increased risk of heart attack. Taking testosterone increases the chances of developing acne, headaches and migraines, and anger and irritability, according to the Trans Care Project, a program of the Transcend Transgender Support and Education Society and Vancouver Coastal Health’s Transgender Health Program in Canada. Testosterone also increases the risk of having abnormally high levels of red blood cells, or polycythemia, which thickens the blood and can lead to clotting. Meanwhile, studies suggest estrogen can up the risk for breast cancer, stroke, blood clots, gallstones, and a range of heart issues. And the most common testosterone-blocker, spironolactone, can cause dehydration and weaken the kidneys.

All of these risks make it especially important for trans people to have the support of a medical provider, Metastasio says. Specialists are in short supply, but general practitioners and family doctors should be able to fill the gap. After all, they already sign off on the hormone medications for cisgender people for birth control and conditions such as menopause and male pattern baldness — which come with similar side effects and warnings as when trans people use them.

Some doctors have already realized the connection. “People can increasingly get hormone therapy from their pre-existing family doctor,” Scheim says, “which is really ideal because people should be able to have a sort of continuity of health care.”

Zil Goldstein, associate medical director for transgender and gender non-binary health at the Callen-Lorde Community Health Center in New York City, would like to see more of this. Treating gender dysphoria, she says, should be just like treating a patient for any other condition. “It wouldn't be acceptable for someone to come into a primary care provider’s office with diabetes” and for the doctor to say “‘I can't actually treat you. Please leave,’” she says. Primary care providers need to see transgender care, she adds, “as a regular part of their practice.”

Another way to increase access to hormones is through informed consent, a system which received a green light from the newest WPATH guidelines. That’s how Christine received her hormones from Fenway Health before she moved from Boston to Cape Cod. Under informed consent, if someone has a blood test to assess personal health risks of treatment, they can receive a diagnosis of gender dysphoria, sign off on knowing the risks and benefits of hormone therapy, and get a prescription — all in one day.

And Jaime Lynn Gilmour, a trans woman using the full name she chose to match her gender identity, turned to informed consent after struggling to find DIY hormones. In 2017, Jaime realized she was trans while serving in the military, and says she felt she had to keep her gender a secret. When her service ended, she was ready to start taking hormones right away. So she tried to find them online, but her order wouldn’t go through on three different websites. Instead, she visited a Planned Parenthood clinic. After blood work and a few questions, she walked out with three months of estrogen and spironolactone.

But Goldstein says even informed consent doesn’t go far enough: “If I have someone who's diabetic, I don't make them sign a document eliciting their informed consent before starting insulin.”

For trans people, hormone treatments “are life-saving therapies,” Goldstein adds, “and we shouldn’t delay or stigmatize.”

For now Christine still lives with her parents in Cape Cod. She’s also still off hormones. But she found a job. After she stashes a bit more cash in the bank, she plans to move closer to Boston and find a physician.

Despite the positive shifts in her life, it’s been a difficult few months. After moving to Cape Cod, Christine lost most of her social life and support system — particularly since her parents don’t understand or accept her gender identity. Though she has reconnected with a few friends in the past several weeks, she says she’s in a tough place emotionally. In public, she typically dresses and styles herself to look more masculine to avoid rude stares, and she is experiencing self-hatred that she fears won’t go away when she restarts treatment. Transitioning again isn’t going to be easy, as she explained to Undark in a private message on Facebook: “I've been beaten down enough that now I don't wanna get back up most of the time.”

Even worse is the fear that she might not be able to restart treatment at all. Earlier this year, Christine suffered two health emergencies within the span of a week, in which she says her blood pressure spiked, potentially causing organ damage. Christine has had one similar episode in the past and her family has a history of heart issues.

Christine may not be able to get back on estrogen despite the hard work she’s done to be able to afford it, she says, since it can increase the risk of heart attack and stroke. Because she has so far resisted trying DIY treatments again, she may have saved herself from additional health problems.

But Christine doesn’t see it that way. “Even if it was unsafe, even if I risked health concerns making myself a guinea pig, I wish I followed through,” she wrote. “Being off hormones is hell. And now that I face potentially never taking them again, I wish I had.”

Tara Santora is a science journalist based out of Denver. They have written for Psychology Today, Live Science, Fatherly, Audubon, and more.

This article was originally published on Undark. Read the original article.

A striking clinical feature of illness from SARS-CoV-2 is a marked increase in thrombotic and microvascular complications, or COVID-19–associated coagulopathy (CAC).

A new study suggests endothelial cell injury plays a major role in the pathogenesis of CAC, and blood levels of soluble thrombomodulin correlate with mortality.

George Goshua, MD, of Yale University, New Haven, Conn., presented this study as a late-breaking abstract at the virtual annual congress of the European Hematology Association.

Dr. Goshua cited past research showing CAC to be highly prevalent among hospitalized patients. Venous thromboembolism was found in 17% to 69% of patients, despite thromboprophylaxis.^1-4 Arterial thrombosis has been seen in 3.6% to 4.0% of patients,^1-3 and autopsy findings have shown microvascular thrombosis in as many as 87% of patients.^5-7

For their study, Dr. Goshua and colleagues assessed endothelial cell damage, platelet activation, and hemostatic and fibrinolytic cascade effects of CAC.

The investigators measured markers of endothelial cell injury and platelet activation, plasminogen activation inhibitor 1 (PAI-1), and coagulation factors in stable and critically ill patients hospitalized with COVID-19. In addition, the team sought to identify biomarkers of mortality in hospitalized patients.

Dr. Goshua and colleagues studied 68 adults hospitalized for suspected COVID-19 – 48 in the ICU and 20 outside the ICU. Patients in the ICU received mechanical ventilation, while the non-ICU patients required supplemental oxygen (≤3 L/min per nasal cannula).

There were more men than women (69% vs. 31%) in the ICU population but not in the non-ICU population (40% vs. 60%). There were no statistically significant differences in age or comorbid conditions between the ICU and non-ICU patients.
 

Results and interpretation

Consistent with augmentation of the coagulation cascade – and as expected – D-dimer and thrombin-antithrombin levels were high in both the ICU and non-ICU populations, but levels were significantly higher (P < .001) among the ICU patients.

Endogenous anticoagulants (antithrombin and proteins C and S) and fibrinolytic enzymes (alpha 2-antiplasmin) were preserved, verifying that CAC is distinct from disseminated intravascular coagulation. Classic fibrinolysis did not occur, as PAI-1 was high in ICU and non-ICU patients, and lysis-30 was normal in nearly all ICU patients (96%).

Von Willebrand factor antigen and activity levels and factor VIII levels were markedly elevated in non-ICU and ICU patients, but they were significantly higher (P < .001) in the ICU cohort. This supports the hypothesis that endothelial cell damage and platelet activation play major roles in CAC.

Similarly, soluble P-selectin, which is shed from endothelial cells and platelets, was dramatically elevated in ICU patients in comparison with controls and non-ICU patients (P < .001 for both comparisons).

Levels of soluble thrombomodulin, which is released from endothelial cells, were not significantly different in ICU patients and controls. However, given thrombomodulin’s significant role in the coagulation cascade, Dr. Goshua and colleagues plotted receiver operating curves to see if soluble thrombomodulin levels were predictive of mortality.

The results showed that soluble thrombomodulin correlated with the probability of survival, both overall and in ICU patients. Soluble thrombomodulin levels greater than 3.26 ng/mL were associated with significantly worse survival in all patients (P = .0087) and ICU patients (P = .0309).
 

Influence on therapy

Laboratory perturbations were detected in both ICU and non-ICU patients, and otherwise healthy outpatients have exhibited potentially life-threatening CAC, according to Dr. Goshua.

These findings suggest the prothrombotic state occurs early in the pathogenesis of SARS-CoV-2 infection, is driven by platelet activation and endotheliopathy, and becomes more pronounced with worsening severity of infection.

The results of this study prompted a change in how Yale–New Haven Hospital manages COVID-19 patients. Patients without a clinical contraindication now receive aspirin at 81 mg daily in addition to the anticoagulation regimen typically used for all hospitalized COVID-19 patients.

Investigations regarding other medications that can influence platelet-endothelial cell interactions and modulate endothelial cell damage in CAC – such as dipyridamole, defibrotide, and eculizumab – are planned.
 

Challenges and unanswered questions

Virchow’s triad was described by the eminent German physician, Rudolf Virchow, MD, in the 19th century. It refers to the three broad categories of factors that can predispose patients to thrombosis — circulatory stasis, hypercoagulability, and endothelial injury.

Although all of these elements could be operative in CAC, the current study suggests platelet activation and endothelial cell injury in CAC may be of primary importance.

Because of the limited ability to test critically ill patients and concerns regarding exposure of additional hospital personnel to COVID-19 patients, the current report lacked clarity about the relationship of the detected laboratory abnormalities to confirmed thrombotic events.

It is unknown whether endothelial cells in different organs are damaged uniformly. It is also unclear if the laboratory abnormalities identified in this analysis can be used to monitor response to therapy, to guide follow-up management of discharged patients with CAC, or to identify infected outpatients who should receive prophylactic anticoagulation.

The mechanism by which SARS-CoV-2 injures endothelial cells is not explained by these data. Neutrophil defensins and other prothrombotic peptides or markers of inflammation could play key roles in pathogenesis, assessment of disease severity, or monitoring for therapeutic efficacy.

Today, we have more sophisticated diagnostic tools than Dr. Virchow had. We also have the ability to record and rapidly disseminate information globally. Still, with regard to the COVID-19 pandemic, clinicians face many of the same challenges that confronted Dr. Virchow in his era.

The analysis conducted by Dr. Goshua and colleagues goes a long way toward elucidating some of the mechanisms and therapeutic targets to meet these challenges.

Dr. Goshua disclosed no conflicts of interest.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

SOURCE: Goshua G et al. EHA Congress. Abstract LB2605.

References

1. Klok FA et al. Confirmation of the high cumulative incidence of thrombotic complications in critically ill ICU patients with COVID-19: An updated analysis. Thromb Res. 2020;191:148-50. doi: 10.1016/j.thromres.2020.04.041.

2. Thomas W et al. Thrombotic complications of patients admitted to intensive care with COVID-19 at a teaching hospital in the United Kingdom. Thromb Res. 2020;191:76-7. doi: 10.1016/j.thromres.2020.04.028

3. Lodigiani C et al. Venous and arterial thromboembolic complications in COVID-19 patients admitted to an academic hospital in Milan, Italy. Thromb Res. 2020;191:9-14. doi: 10.1016/j.thromres.2020.04.024

4. Llitjos JF et al. High incidence of venous thromboembolic events in anticoagulated severe COVID-19 patients [published online ahead of print, 2020 Apr 22]. J Thromb Haemost. 2020;10.1111/jth.14869. doi: 10.1111/jth.14869

5. Carsana L et al. Pulmonary post-mortem findings in a large series of COVID-19 cases from Northern Italy. medRxiv 2020.04.19.20054262; doi: 10.1101/2020.04.19.20054262v1.

6. Menter T et al. Post-mortem examination of COVID19 patients reveals diffuse alveolar damage with severe capillary congestion and variegated findings of lungs and other organs suggesting vascular dysfunction [published online ahead of print, 2020 May 4]. Histopathology. 2020;10.1111/his.14134. doi: 10.1111/his.14134

7. Lax SF, et al. Pulmonary arterial thrombosis in COVID-19 with fatal outcome: Results from a prospective, single-center, clinicopathologic case series [published online ahead of print, 2020 May 14]. Ann Intern Med. 2020;M20-2566. doi: 10.7326/M20-2566.

A striking clinical feature of illness from SARS-CoV-2 is a marked increase in thrombotic and microvascular complications, or COVID-19–associated coagulopathy (CAC).

A new study suggests endothelial cell injury plays a major role in the pathogenesis of CAC, and blood levels of soluble thrombomodulin correlate with mortality.

George Goshua, MD, of Yale University, New Haven, Conn., presented this study as a late-breaking abstract at the virtual annual congress of the European Hematology Association.

Dr. Goshua cited past research showing CAC to be highly prevalent among hospitalized patients. Venous thromboembolism was found in 17% to 69% of patients, despite thromboprophylaxis.^1-4 Arterial thrombosis has been seen in 3.6% to 4.0% of patients,^1-3 and autopsy findings have shown microvascular thrombosis in as many as 87% of patients.^5-7

For their study, Dr. Goshua and colleagues assessed endothelial cell damage, platelet activation, and hemostatic and fibrinolytic cascade effects of CAC.

The investigators measured markers of endothelial cell injury and platelet activation, plasminogen activation inhibitor 1 (PAI-1), and coagulation factors in stable and critically ill patients hospitalized with COVID-19. In addition, the team sought to identify biomarkers of mortality in hospitalized patients.

Dr. Goshua and colleagues studied 68 adults hospitalized for suspected COVID-19 – 48 in the ICU and 20 outside the ICU. Patients in the ICU received mechanical ventilation, while the non-ICU patients required supplemental oxygen (≤3 L/min per nasal cannula).

There were more men than women (69% vs. 31%) in the ICU population but not in the non-ICU population (40% vs. 60%). There were no statistically significant differences in age or comorbid conditions between the ICU and non-ICU patients.
 

Results and interpretation

Consistent with augmentation of the coagulation cascade – and as expected – D-dimer and thrombin-antithrombin levels were high in both the ICU and non-ICU populations, but levels were significantly higher (P < .001) among the ICU patients.

Endogenous anticoagulants (antithrombin and proteins C and S) and fibrinolytic enzymes (alpha 2-antiplasmin) were preserved, verifying that CAC is distinct from disseminated intravascular coagulation. Classic fibrinolysis did not occur, as PAI-1 was high in ICU and non-ICU patients, and lysis-30 was normal in nearly all ICU patients (96%).

Von Willebrand factor antigen and activity levels and factor VIII levels were markedly elevated in non-ICU and ICU patients, but they were significantly higher (P < .001) in the ICU cohort. This supports the hypothesis that endothelial cell damage and platelet activation play major roles in CAC.

Similarly, soluble P-selectin, which is shed from endothelial cells and platelets, was dramatically elevated in ICU patients in comparison with controls and non-ICU patients (P < .001 for both comparisons).

Levels of soluble thrombomodulin, which is released from endothelial cells, were not significantly different in ICU patients and controls. However, given thrombomodulin’s significant role in the coagulation cascade, Dr. Goshua and colleagues plotted receiver operating curves to see if soluble thrombomodulin levels were predictive of mortality.

The results showed that soluble thrombomodulin correlated with the probability of survival, both overall and in ICU patients. Soluble thrombomodulin levels greater than 3.26 ng/mL were associated with significantly worse survival in all patients (P = .0087) and ICU patients (P = .0309).
 

Influence on therapy

Laboratory perturbations were detected in both ICU and non-ICU patients, and otherwise healthy outpatients have exhibited potentially life-threatening CAC, according to Dr. Goshua.

These findings suggest the prothrombotic state occurs early in the pathogenesis of SARS-CoV-2 infection, is driven by platelet activation and endotheliopathy, and becomes more pronounced with worsening severity of infection.

The results of this study prompted a change in how Yale–New Haven Hospital manages COVID-19 patients. Patients without a clinical contraindication now receive aspirin at 81 mg daily in addition to the anticoagulation regimen typically used for all hospitalized COVID-19 patients.

Investigations regarding other medications that can influence platelet-endothelial cell interactions and modulate endothelial cell damage in CAC – such as dipyridamole, defibrotide, and eculizumab – are planned.
 

Challenges and unanswered questions

Virchow’s triad was described by the eminent German physician, Rudolf Virchow, MD, in the 19th century. It refers to the three broad categories of factors that can predispose patients to thrombosis — circulatory stasis, hypercoagulability, and endothelial injury.

Although all of these elements could be operative in CAC, the current study suggests platelet activation and endothelial cell injury in CAC may be of primary importance.

Because of the limited ability to test critically ill patients and concerns regarding exposure of additional hospital personnel to COVID-19 patients, the current report lacked clarity about the relationship of the detected laboratory abnormalities to confirmed thrombotic events.

It is unknown whether endothelial cells in different organs are damaged uniformly. It is also unclear if the laboratory abnormalities identified in this analysis can be used to monitor response to therapy, to guide follow-up management of discharged patients with CAC, or to identify infected outpatients who should receive prophylactic anticoagulation.

The mechanism by which SARS-CoV-2 injures endothelial cells is not explained by these data. Neutrophil defensins and other prothrombotic peptides or markers of inflammation could play key roles in pathogenesis, assessment of disease severity, or monitoring for therapeutic efficacy.

Today, we have more sophisticated diagnostic tools than Dr. Virchow had. We also have the ability to record and rapidly disseminate information globally. Still, with regard to the COVID-19 pandemic, clinicians face many of the same challenges that confronted Dr. Virchow in his era.

The analysis conducted by Dr. Goshua and colleagues goes a long way toward elucidating some of the mechanisms and therapeutic targets to meet these challenges.

Dr. Goshua disclosed no conflicts of interest.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

SOURCE: Goshua G et al. EHA Congress. Abstract LB2605.

References

1. Klok FA et al. Confirmation of the high cumulative incidence of thrombotic complications in critically ill ICU patients with COVID-19: An updated analysis. Thromb Res. 2020;191:148-50. doi: 10.1016/j.thromres.2020.04.041.

2. Thomas W et al. Thrombotic complications of patients admitted to intensive care with COVID-19 at a teaching hospital in the United Kingdom. Thromb Res. 2020;191:76-7. doi: 10.1016/j.thromres.2020.04.028

3. Lodigiani C et al. Venous and arterial thromboembolic complications in COVID-19 patients admitted to an academic hospital in Milan, Italy. Thromb Res. 2020;191:9-14. doi: 10.1016/j.thromres.2020.04.024

4. Llitjos JF et al. High incidence of venous thromboembolic events in anticoagulated severe COVID-19 patients [published online ahead of print, 2020 Apr 22]. J Thromb Haemost. 2020;10.1111/jth.14869. doi: 10.1111/jth.14869

5. Carsana L et al. Pulmonary post-mortem findings in a large series of COVID-19 cases from Northern Italy. medRxiv 2020.04.19.20054262; doi: 10.1101/2020.04.19.20054262v1.

6. Menter T et al. Post-mortem examination of COVID19 patients reveals diffuse alveolar damage with severe capillary congestion and variegated findings of lungs and other organs suggesting vascular dysfunction [published online ahead of print, 2020 May 4]. Histopathology. 2020;10.1111/his.14134. doi: 10.1111/his.14134

7. Lax SF, et al. Pulmonary arterial thrombosis in COVID-19 with fatal outcome: Results from a prospective, single-center, clinicopathologic case series [published online ahead of print, 2020 May 14]. Ann Intern Med. 2020;M20-2566. doi: 10.7326/M20-2566.

A striking clinical feature of illness from SARS-CoV-2 is a marked increase in thrombotic and microvascular complications, or COVID-19–associated coagulopathy (CAC).

A new study suggests endothelial cell injury plays a major role in the pathogenesis of CAC, and blood levels of soluble thrombomodulin correlate with mortality.

George Goshua, MD, of Yale University, New Haven, Conn., presented this study as a late-breaking abstract at the virtual annual congress of the European Hematology Association.

Dr. Goshua cited past research showing CAC to be highly prevalent among hospitalized patients. Venous thromboembolism was found in 17% to 69% of patients, despite thromboprophylaxis.^1-4 Arterial thrombosis has been seen in 3.6% to 4.0% of patients,^1-3 and autopsy findings have shown microvascular thrombosis in as many as 87% of patients.^5-7

For their study, Dr. Goshua and colleagues assessed endothelial cell damage, platelet activation, and hemostatic and fibrinolytic cascade effects of CAC.

The investigators measured markers of endothelial cell injury and platelet activation, plasminogen activation inhibitor 1 (PAI-1), and coagulation factors in stable and critically ill patients hospitalized with COVID-19. In addition, the team sought to identify biomarkers of mortality in hospitalized patients.

Dr. Goshua and colleagues studied 68 adults hospitalized for suspected COVID-19 – 48 in the ICU and 20 outside the ICU. Patients in the ICU received mechanical ventilation, while the non-ICU patients required supplemental oxygen (≤3 L/min per nasal cannula).

There were more men than women (69% vs. 31%) in the ICU population but not in the non-ICU population (40% vs. 60%). There were no statistically significant differences in age or comorbid conditions between the ICU and non-ICU patients.
 

Results and interpretation

Consistent with augmentation of the coagulation cascade – and as expected – D-dimer and thrombin-antithrombin levels were high in both the ICU and non-ICU populations, but levels were significantly higher (P < .001) among the ICU patients.

Endogenous anticoagulants (antithrombin and proteins C and S) and fibrinolytic enzymes (alpha 2-antiplasmin) were preserved, verifying that CAC is distinct from disseminated intravascular coagulation. Classic fibrinolysis did not occur, as PAI-1 was high in ICU and non-ICU patients, and lysis-30 was normal in nearly all ICU patients (96%).

Von Willebrand factor antigen and activity levels and factor VIII levels were markedly elevated in non-ICU and ICU patients, but they were significantly higher (P < .001) in the ICU cohort. This supports the hypothesis that endothelial cell damage and platelet activation play major roles in CAC.

Similarly, soluble P-selectin, which is shed from endothelial cells and platelets, was dramatically elevated in ICU patients in comparison with controls and non-ICU patients (P < .001 for both comparisons).

Levels of soluble thrombomodulin, which is released from endothelial cells, were not significantly different in ICU patients and controls. However, given thrombomodulin’s significant role in the coagulation cascade, Dr. Goshua and colleagues plotted receiver operating curves to see if soluble thrombomodulin levels were predictive of mortality.

The results showed that soluble thrombomodulin correlated with the probability of survival, both overall and in ICU patients. Soluble thrombomodulin levels greater than 3.26 ng/mL were associated with significantly worse survival in all patients (P = .0087) and ICU patients (P = .0309).
 

Influence on therapy

Laboratory perturbations were detected in both ICU and non-ICU patients, and otherwise healthy outpatients have exhibited potentially life-threatening CAC, according to Dr. Goshua.

These findings suggest the prothrombotic state occurs early in the pathogenesis of SARS-CoV-2 infection, is driven by platelet activation and endotheliopathy, and becomes more pronounced with worsening severity of infection.

The results of this study prompted a change in how Yale–New Haven Hospital manages COVID-19 patients. Patients without a clinical contraindication now receive aspirin at 81 mg daily in addition to the anticoagulation regimen typically used for all hospitalized COVID-19 patients.

Investigations regarding other medications that can influence platelet-endothelial cell interactions and modulate endothelial cell damage in CAC – such as dipyridamole, defibrotide, and eculizumab – are planned.
 

Challenges and unanswered questions

Virchow’s triad was described by the eminent German physician, Rudolf Virchow, MD, in the 19th century. It refers to the three broad categories of factors that can predispose patients to thrombosis — circulatory stasis, hypercoagulability, and endothelial injury.

Although all of these elements could be operative in CAC, the current study suggests platelet activation and endothelial cell injury in CAC may be of primary importance.

Because of the limited ability to test critically ill patients and concerns regarding exposure of additional hospital personnel to COVID-19 patients, the current report lacked clarity about the relationship of the detected laboratory abnormalities to confirmed thrombotic events.

It is unknown whether endothelial cells in different organs are damaged uniformly. It is also unclear if the laboratory abnormalities identified in this analysis can be used to monitor response to therapy, to guide follow-up management of discharged patients with CAC, or to identify infected outpatients who should receive prophylactic anticoagulation.

The mechanism by which SARS-CoV-2 injures endothelial cells is not explained by these data. Neutrophil defensins and other prothrombotic peptides or markers of inflammation could play key roles in pathogenesis, assessment of disease severity, or monitoring for therapeutic efficacy.

Today, we have more sophisticated diagnostic tools than Dr. Virchow had. We also have the ability to record and rapidly disseminate information globally. Still, with regard to the COVID-19 pandemic, clinicians face many of the same challenges that confronted Dr. Virchow in his era.

The analysis conducted by Dr. Goshua and colleagues goes a long way toward elucidating some of the mechanisms and therapeutic targets to meet these challenges.

Dr. Goshua disclosed no conflicts of interest.

Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

SOURCE: Goshua G et al. EHA Congress. Abstract LB2605.

References

1. Klok FA et al. Confirmation of the high cumulative incidence of thrombotic complications in critically ill ICU patients with COVID-19: An updated analysis. Thromb Res. 2020;191:148-50. doi: 10.1016/j.thromres.2020.04.041.

2. Thomas W et al. Thrombotic complications of patients admitted to intensive care with COVID-19 at a teaching hospital in the United Kingdom. Thromb Res. 2020;191:76-7. doi: 10.1016/j.thromres.2020.04.028

3. Lodigiani C et al. Venous and arterial thromboembolic complications in COVID-19 patients admitted to an academic hospital in Milan, Italy. Thromb Res. 2020;191:9-14. doi: 10.1016/j.thromres.2020.04.024

4. Llitjos JF et al. High incidence of venous thromboembolic events in anticoagulated severe COVID-19 patients [published online ahead of print, 2020 Apr 22]. J Thromb Haemost. 2020;10.1111/jth.14869. doi: 10.1111/jth.14869

5. Carsana L et al. Pulmonary post-mortem findings in a large series of COVID-19 cases from Northern Italy. medRxiv 2020.04.19.20054262; doi: 10.1101/2020.04.19.20054262v1.

6. Menter T et al. Post-mortem examination of COVID19 patients reveals diffuse alveolar damage with severe capillary congestion and variegated findings of lungs and other organs suggesting vascular dysfunction [published online ahead of print, 2020 May 4]. Histopathology. 2020;10.1111/his.14134. doi: 10.1111/his.14134

7. Lax SF, et al. Pulmonary arterial thrombosis in COVID-19 with fatal outcome: Results from a prospective, single-center, clinicopathologic case series [published online ahead of print, 2020 May 14]. Ann Intern Med. 2020;M20-2566. doi: 10.7326/M20-2566.

Early plans for prioritizing vaccination when a COVID-19 vaccine becomes available include placing critical health care workers in the first tier, according to Sarah Mbaeyi, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.

A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.

“Preparing for vaccination during a pandemic has long been a priority of the CDC and the U.S. government,” said Dr. Mbaeyi. The work group is building on a tiered approach to vaccination that was updated in 2018 after the H1N1 flu pandemic, with occupational and high-risk populations placed in the highest-priority groups, Dr. Mbaeyi said.

There are important differences between COVID-19 and influenza, Dr. Mbaeyi said. “Vaccine prioritization is challenging due to incomplete information on COVID-19 epidemiology and vaccines, including characteristics, timing, and number of doses.”

However, guidance for vaccine prioritization developed after the H1N1 outbreak in 2018 can be adapted for COVID-19.

To help inform ACIP deliberations, the work group reviewed the epidemiology of COVID-19. A large proportion of the population remains susceptible, and prioritizations should be based on data to date and continually refined, she said.

The work group defined the objectives of the COVID-19 vaccine program as follows: “Ensure safety and effectiveness of COVID-19 vaccines; reduce transmission, morbidity, and mortality in the population; help minimize disruption to society and economy, including maintaining health care capacity; and ensure equity in vaccine allocation and distribution.”

Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.

Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said.

However, vaccines will not be administered until safety and efficacy have been demonstrated, she emphasized. The timing and number of vaccine doses are unknown, and subprioritization may be needed, assuming the vaccine becomes available in incremental quantities over several months.

Next steps for the work group are refinement of priority groups based on ACIP feedback, and assignment of tiers to other groups such as children, pregnant women, and racial/ethnic groups at high risk, Dr. Mbaeyi said.

The goal of the work group is to have a prioritization framework for COVID-19 vaccination to present at the next ACIP meeting.

Committee member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn., emphasized that “one of the things we need to know is how is the virus [is] transmitted and who is transmitting,” and that this information will be key to developing strategies for vaccination.

Sarah E. Oliver, MD, an epidemiologist at the National Center for Immunization and Respiratory Diseases, responded that household transmission studies are in progress that will help inform the prioritization process.

Dr. Mbaeyi and Dr. Oliver had no financial conflicts to disclose.

Early plans for prioritizing vaccination when a COVID-19 vaccine becomes available include placing critical health care workers in the first tier, according to Sarah Mbaeyi, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.

A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.

“Preparing for vaccination during a pandemic has long been a priority of the CDC and the U.S. government,” said Dr. Mbaeyi. The work group is building on a tiered approach to vaccination that was updated in 2018 after the H1N1 flu pandemic, with occupational and high-risk populations placed in the highest-priority groups, Dr. Mbaeyi said.

There are important differences between COVID-19 and influenza, Dr. Mbaeyi said. “Vaccine prioritization is challenging due to incomplete information on COVID-19 epidemiology and vaccines, including characteristics, timing, and number of doses.”

However, guidance for vaccine prioritization developed after the H1N1 outbreak in 2018 can be adapted for COVID-19.

To help inform ACIP deliberations, the work group reviewed the epidemiology of COVID-19. A large proportion of the population remains susceptible, and prioritizations should be based on data to date and continually refined, she said.

The work group defined the objectives of the COVID-19 vaccine program as follows: “Ensure safety and effectiveness of COVID-19 vaccines; reduce transmission, morbidity, and mortality in the population; help minimize disruption to society and economy, including maintaining health care capacity; and ensure equity in vaccine allocation and distribution.”

Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.

Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said.

However, vaccines will not be administered until safety and efficacy have been demonstrated, she emphasized. The timing and number of vaccine doses are unknown, and subprioritization may be needed, assuming the vaccine becomes available in incremental quantities over several months.

Next steps for the work group are refinement of priority groups based on ACIP feedback, and assignment of tiers to other groups such as children, pregnant women, and racial/ethnic groups at high risk, Dr. Mbaeyi said.

The goal of the work group is to have a prioritization framework for COVID-19 vaccination to present at the next ACIP meeting.

Committee member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn., emphasized that “one of the things we need to know is how is the virus [is] transmitted and who is transmitting,” and that this information will be key to developing strategies for vaccination.

Sarah E. Oliver, MD, an epidemiologist at the National Center for Immunization and Respiratory Diseases, responded that household transmission studies are in progress that will help inform the prioritization process.

Dr. Mbaeyi and Dr. Oliver had no financial conflicts to disclose.

Early plans for prioritizing vaccination when a COVID-19 vaccine becomes available include placing critical health care workers in the first tier, according to Sarah Mbaeyi, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.

A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.

“Preparing for vaccination during a pandemic has long been a priority of the CDC and the U.S. government,” said Dr. Mbaeyi. The work group is building on a tiered approach to vaccination that was updated in 2018 after the H1N1 flu pandemic, with occupational and high-risk populations placed in the highest-priority groups, Dr. Mbaeyi said.

There are important differences between COVID-19 and influenza, Dr. Mbaeyi said. “Vaccine prioritization is challenging due to incomplete information on COVID-19 epidemiology and vaccines, including characteristics, timing, and number of doses.”

However, guidance for vaccine prioritization developed after the H1N1 outbreak in 2018 can be adapted for COVID-19.

To help inform ACIP deliberations, the work group reviewed the epidemiology of COVID-19. A large proportion of the population remains susceptible, and prioritizations should be based on data to date and continually refined, she said.

The work group defined the objectives of the COVID-19 vaccine program as follows: “Ensure safety and effectiveness of COVID-19 vaccines; reduce transmission, morbidity, and mortality in the population; help minimize disruption to society and economy, including maintaining health care capacity; and ensure equity in vaccine allocation and distribution.”

Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.

Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said.

However, vaccines will not be administered until safety and efficacy have been demonstrated, she emphasized. The timing and number of vaccine doses are unknown, and subprioritization may be needed, assuming the vaccine becomes available in incremental quantities over several months.

Next steps for the work group are refinement of priority groups based on ACIP feedback, and assignment of tiers to other groups such as children, pregnant women, and racial/ethnic groups at high risk, Dr. Mbaeyi said.

The goal of the work group is to have a prioritization framework for COVID-19 vaccination to present at the next ACIP meeting.

Committee member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn., emphasized that “one of the things we need to know is how is the virus [is] transmitted and who is transmitting,” and that this information will be key to developing strategies for vaccination.

Sarah E. Oliver, MD, an epidemiologist at the National Center for Immunization and Respiratory Diseases, responded that household transmission studies are in progress that will help inform the prioritization process.

Dr. Mbaeyi and Dr. Oliver had no financial conflicts to disclose.