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What impact do carbs have on bone health?
I am often asked about the impact of dietary nutrients on bone health, particularly as many patients with low bone density, many with a history of multiple fractures, are referred to me. Many factors affect bone density, an important predictor of fracture risk, including genetics, body weight and muscle mass, bone loading exercise, menstrual status, other hormonal factors, nutritional status, optimal absorption of dietary nutrients, and medication use.
Dietary nutrients include macronutrients (carbohydrates, proteins, fat, and fiber) and micronutrients (such as dietary minerals and vitamins). The importance of micronutrients such as calcium, phosphorus, magnesium, and vitamins C, D, and K in optimizing bone mineralization and bone formation has been well documented.
The impact of protein intake on bone health is slightly more controversial, with some studies suggesting that increased protein intake may be deleterious to bone by increasing acid load, which in turn, increases calcium loss in urine. Overall data analysis from multiple studies support the finding that a higher protein intake is modestly beneficial for bone at certain sites, such as the spine.
Though data regarding the impact of dietary carbohydrates on bone are not as robust, it’s important to understand these effects given the increasing knowledge of the deleterious impact of processed carbohydrates on weight and cardiometabolic outcomes. This leads to the growing recommendations to limit carbohydrates in diet.
Quality and quantity of carbs affect bone health
Available studies suggest that both the quality and quantity of carbohydrates that are in a diet as well as the glycemic index of food may affect bone outcomes. Glycemic index refers to the extent of blood glucose elevation that occurs after the intake of any specific food. Foods with a higher glycemic index cause a rapid increase in blood glucose, whereas those with a low glycemic index result in a slower and more gradual increase. Examples of high–glycemic index food include processed and baked foods (such as breakfast cereals [unless whole grain], pretzels, cookies, doughnuts, pastries, cake, white bread, bagels, croissants, and corn chips), sugar-sweetened beverages, white rice, fast food (such as pizza and burgers), and potatoes. Examples of low glycemic index foods include vegetables, fruits, legumes, dairy and dairy products (without added sugar), whole-grain foods (such as oat porridge), and nuts.
A high–glycemic index diet has been associated with a greater risk for obesity and cardiovascular disease, and with lower bone density, an increased risk for fracture. This has been attributed to acute increases in glucose and insulin levels after consumption of high–glycemic index food, which causes increased oxidative stress and secretion of inflammatory cytokines, such as interleukin 6 and tumor necrosis factor alpha, that activate cells in bone that increase bone loss.
Higher blood glucose concentrations induced by a higher dietary glycemic index can have deleterious effects on osteoblasts, the cells important for bone formation, and increase bone loss through production of advanced glycation end products that affect the cross linking of collagen in bone (important for bone strength), as well as calcium loss in urine. This was recently reported in a study by Garcia-Gavilan and others, in which the authors showed that high dietary glycemic index and dietary glucose load are associated with a higher risk for osteoporosis-related fractures in an older Mediterranean population who are at high risk for cardiovascular events. Similar data were reported by Nouri and coauthors in a study from Iran.
The quantity and quality of dietary carbohydrates may also have an impact on bone. The quality of carbohydrates has been assessed using the carbohydrate quality index (CQI) and the low carbohydrate diet score (LCDS). The CQI takes into account dietary fiber intake, glycemic index, intake of processed vs. whole grain, and solid vs. total carbohydrates in diet. A higher CQI diet is associated with reduced cardiovascular risk. Higher LCDS reflects lower carbohydrate and higher fat and protein intake.
Diets that are rich in refined or processed carbohydrates with added sugar are proinflammatory and increase oxidative stress, which may lead to increased bone loss, low bone density, and increased fracture risk. These foods also have a high glycemic index.
In contrast, diets that are rich in whole grains, legumes, fruits, vegetables, nuts, and olive oil have a lower glycemic index and are beneficial to bone. These diets have a higher CQI and LCDS (as reported by Nouri and coauthors) and provide a rich source of antioxidants, vitamins, minerals, and other nutrients (such as calcium, magnesium, and vitamins B, C, and K), which are all beneficial to bone. Gao and others have reported that implementing a low glycemic index pulse-based diet (lentils, peas, beans) is superior to a regular hospital diet in preventing the increase in bone loss that typically occurs during hospitalization with enforced bed rest.
Most reports of the impact of carbohydrates on bone health are from observational studies. In an interventional study, Dalskov and coauthors randomly assigned children aged 5-18 years who had parents with overweight to one of five diets (high protein/low glycemic index, high protein/high glycemic index, low protein/low glycemic index, low protein/high glycemic index, or regular) for 6 months.
Contrasting with our understanding that protein intake is overall good for bone, this study found that among patients receiving a high–glycemic index diet, those who were on a high-protein diet had greater reductions in a bone formation marker than did those on a low-protein diet, with no major changes observed with the other diets. This suggests the influence of associated dietary nutrients on bone outcomes and that protein intake may modify the effects of dietary carbohydrates on bone formation. Similarly, the fat content of food can alter the glycemic index and thus may modify the impact of dietary carbohydrates on bone.
In summary, available data suggest that the quantity and quality of carbohydrates, including the glycemic index of food, may affect bone health and that it is important to exercise moderation in the consumption of such foods. However, there are only a few studies that have examined these associations, and more studies are necessary to further clarify the impact of dietary carbohydrates on bone as well as any modifications of these effects by other associated food groups. These studies will allow us to refine our recommendations to our patients as we advance our understanding of the impact of the combined effects of various dietary nutrients on bone.
Madhusmita Misra, MD, MPH, is chief of the division of pediatric endocrinology, Mass General for Children, Boston, and serves or has served as a director, officer, partner, employee, advisor, consultant, or trustee for AbbVie, Sanofi, and Ipsen.
A version of this article first appeared on Medscape.com.
I am often asked about the impact of dietary nutrients on bone health, particularly as many patients with low bone density, many with a history of multiple fractures, are referred to me. Many factors affect bone density, an important predictor of fracture risk, including genetics, body weight and muscle mass, bone loading exercise, menstrual status, other hormonal factors, nutritional status, optimal absorption of dietary nutrients, and medication use.
Dietary nutrients include macronutrients (carbohydrates, proteins, fat, and fiber) and micronutrients (such as dietary minerals and vitamins). The importance of micronutrients such as calcium, phosphorus, magnesium, and vitamins C, D, and K in optimizing bone mineralization and bone formation has been well documented.
The impact of protein intake on bone health is slightly more controversial, with some studies suggesting that increased protein intake may be deleterious to bone by increasing acid load, which in turn, increases calcium loss in urine. Overall data analysis from multiple studies support the finding that a higher protein intake is modestly beneficial for bone at certain sites, such as the spine.
Though data regarding the impact of dietary carbohydrates on bone are not as robust, it’s important to understand these effects given the increasing knowledge of the deleterious impact of processed carbohydrates on weight and cardiometabolic outcomes. This leads to the growing recommendations to limit carbohydrates in diet.
Quality and quantity of carbs affect bone health
Available studies suggest that both the quality and quantity of carbohydrates that are in a diet as well as the glycemic index of food may affect bone outcomes. Glycemic index refers to the extent of blood glucose elevation that occurs after the intake of any specific food. Foods with a higher glycemic index cause a rapid increase in blood glucose, whereas those with a low glycemic index result in a slower and more gradual increase. Examples of high–glycemic index food include processed and baked foods (such as breakfast cereals [unless whole grain], pretzels, cookies, doughnuts, pastries, cake, white bread, bagels, croissants, and corn chips), sugar-sweetened beverages, white rice, fast food (such as pizza and burgers), and potatoes. Examples of low glycemic index foods include vegetables, fruits, legumes, dairy and dairy products (without added sugar), whole-grain foods (such as oat porridge), and nuts.
A high–glycemic index diet has been associated with a greater risk for obesity and cardiovascular disease, and with lower bone density, an increased risk for fracture. This has been attributed to acute increases in glucose and insulin levels after consumption of high–glycemic index food, which causes increased oxidative stress and secretion of inflammatory cytokines, such as interleukin 6 and tumor necrosis factor alpha, that activate cells in bone that increase bone loss.
Higher blood glucose concentrations induced by a higher dietary glycemic index can have deleterious effects on osteoblasts, the cells important for bone formation, and increase bone loss through production of advanced glycation end products that affect the cross linking of collagen in bone (important for bone strength), as well as calcium loss in urine. This was recently reported in a study by Garcia-Gavilan and others, in which the authors showed that high dietary glycemic index and dietary glucose load are associated with a higher risk for osteoporosis-related fractures in an older Mediterranean population who are at high risk for cardiovascular events. Similar data were reported by Nouri and coauthors in a study from Iran.
The quantity and quality of dietary carbohydrates may also have an impact on bone. The quality of carbohydrates has been assessed using the carbohydrate quality index (CQI) and the low carbohydrate diet score (LCDS). The CQI takes into account dietary fiber intake, glycemic index, intake of processed vs. whole grain, and solid vs. total carbohydrates in diet. A higher CQI diet is associated with reduced cardiovascular risk. Higher LCDS reflects lower carbohydrate and higher fat and protein intake.
Diets that are rich in refined or processed carbohydrates with added sugar are proinflammatory and increase oxidative stress, which may lead to increased bone loss, low bone density, and increased fracture risk. These foods also have a high glycemic index.
In contrast, diets that are rich in whole grains, legumes, fruits, vegetables, nuts, and olive oil have a lower glycemic index and are beneficial to bone. These diets have a higher CQI and LCDS (as reported by Nouri and coauthors) and provide a rich source of antioxidants, vitamins, minerals, and other nutrients (such as calcium, magnesium, and vitamins B, C, and K), which are all beneficial to bone. Gao and others have reported that implementing a low glycemic index pulse-based diet (lentils, peas, beans) is superior to a regular hospital diet in preventing the increase in bone loss that typically occurs during hospitalization with enforced bed rest.
Most reports of the impact of carbohydrates on bone health are from observational studies. In an interventional study, Dalskov and coauthors randomly assigned children aged 5-18 years who had parents with overweight to one of five diets (high protein/low glycemic index, high protein/high glycemic index, low protein/low glycemic index, low protein/high glycemic index, or regular) for 6 months.
Contrasting with our understanding that protein intake is overall good for bone, this study found that among patients receiving a high–glycemic index diet, those who were on a high-protein diet had greater reductions in a bone formation marker than did those on a low-protein diet, with no major changes observed with the other diets. This suggests the influence of associated dietary nutrients on bone outcomes and that protein intake may modify the effects of dietary carbohydrates on bone formation. Similarly, the fat content of food can alter the glycemic index and thus may modify the impact of dietary carbohydrates on bone.
In summary, available data suggest that the quantity and quality of carbohydrates, including the glycemic index of food, may affect bone health and that it is important to exercise moderation in the consumption of such foods. However, there are only a few studies that have examined these associations, and more studies are necessary to further clarify the impact of dietary carbohydrates on bone as well as any modifications of these effects by other associated food groups. These studies will allow us to refine our recommendations to our patients as we advance our understanding of the impact of the combined effects of various dietary nutrients on bone.
Madhusmita Misra, MD, MPH, is chief of the division of pediatric endocrinology, Mass General for Children, Boston, and serves or has served as a director, officer, partner, employee, advisor, consultant, or trustee for AbbVie, Sanofi, and Ipsen.
A version of this article first appeared on Medscape.com.
I am often asked about the impact of dietary nutrients on bone health, particularly as many patients with low bone density, many with a history of multiple fractures, are referred to me. Many factors affect bone density, an important predictor of fracture risk, including genetics, body weight and muscle mass, bone loading exercise, menstrual status, other hormonal factors, nutritional status, optimal absorption of dietary nutrients, and medication use.
Dietary nutrients include macronutrients (carbohydrates, proteins, fat, and fiber) and micronutrients (such as dietary minerals and vitamins). The importance of micronutrients such as calcium, phosphorus, magnesium, and vitamins C, D, and K in optimizing bone mineralization and bone formation has been well documented.
The impact of protein intake on bone health is slightly more controversial, with some studies suggesting that increased protein intake may be deleterious to bone by increasing acid load, which in turn, increases calcium loss in urine. Overall data analysis from multiple studies support the finding that a higher protein intake is modestly beneficial for bone at certain sites, such as the spine.
Though data regarding the impact of dietary carbohydrates on bone are not as robust, it’s important to understand these effects given the increasing knowledge of the deleterious impact of processed carbohydrates on weight and cardiometabolic outcomes. This leads to the growing recommendations to limit carbohydrates in diet.
Quality and quantity of carbs affect bone health
Available studies suggest that both the quality and quantity of carbohydrates that are in a diet as well as the glycemic index of food may affect bone outcomes. Glycemic index refers to the extent of blood glucose elevation that occurs after the intake of any specific food. Foods with a higher glycemic index cause a rapid increase in blood glucose, whereas those with a low glycemic index result in a slower and more gradual increase. Examples of high–glycemic index food include processed and baked foods (such as breakfast cereals [unless whole grain], pretzels, cookies, doughnuts, pastries, cake, white bread, bagels, croissants, and corn chips), sugar-sweetened beverages, white rice, fast food (such as pizza and burgers), and potatoes. Examples of low glycemic index foods include vegetables, fruits, legumes, dairy and dairy products (without added sugar), whole-grain foods (such as oat porridge), and nuts.
A high–glycemic index diet has been associated with a greater risk for obesity and cardiovascular disease, and with lower bone density, an increased risk for fracture. This has been attributed to acute increases in glucose and insulin levels after consumption of high–glycemic index food, which causes increased oxidative stress and secretion of inflammatory cytokines, such as interleukin 6 and tumor necrosis factor alpha, that activate cells in bone that increase bone loss.
Higher blood glucose concentrations induced by a higher dietary glycemic index can have deleterious effects on osteoblasts, the cells important for bone formation, and increase bone loss through production of advanced glycation end products that affect the cross linking of collagen in bone (important for bone strength), as well as calcium loss in urine. This was recently reported in a study by Garcia-Gavilan and others, in which the authors showed that high dietary glycemic index and dietary glucose load are associated with a higher risk for osteoporosis-related fractures in an older Mediterranean population who are at high risk for cardiovascular events. Similar data were reported by Nouri and coauthors in a study from Iran.
The quantity and quality of dietary carbohydrates may also have an impact on bone. The quality of carbohydrates has been assessed using the carbohydrate quality index (CQI) and the low carbohydrate diet score (LCDS). The CQI takes into account dietary fiber intake, glycemic index, intake of processed vs. whole grain, and solid vs. total carbohydrates in diet. A higher CQI diet is associated with reduced cardiovascular risk. Higher LCDS reflects lower carbohydrate and higher fat and protein intake.
Diets that are rich in refined or processed carbohydrates with added sugar are proinflammatory and increase oxidative stress, which may lead to increased bone loss, low bone density, and increased fracture risk. These foods also have a high glycemic index.
In contrast, diets that are rich in whole grains, legumes, fruits, vegetables, nuts, and olive oil have a lower glycemic index and are beneficial to bone. These diets have a higher CQI and LCDS (as reported by Nouri and coauthors) and provide a rich source of antioxidants, vitamins, minerals, and other nutrients (such as calcium, magnesium, and vitamins B, C, and K), which are all beneficial to bone. Gao and others have reported that implementing a low glycemic index pulse-based diet (lentils, peas, beans) is superior to a regular hospital diet in preventing the increase in bone loss that typically occurs during hospitalization with enforced bed rest.
Most reports of the impact of carbohydrates on bone health are from observational studies. In an interventional study, Dalskov and coauthors randomly assigned children aged 5-18 years who had parents with overweight to one of five diets (high protein/low glycemic index, high protein/high glycemic index, low protein/low glycemic index, low protein/high glycemic index, or regular) for 6 months.
Contrasting with our understanding that protein intake is overall good for bone, this study found that among patients receiving a high–glycemic index diet, those who were on a high-protein diet had greater reductions in a bone formation marker than did those on a low-protein diet, with no major changes observed with the other diets. This suggests the influence of associated dietary nutrients on bone outcomes and that protein intake may modify the effects of dietary carbohydrates on bone formation. Similarly, the fat content of food can alter the glycemic index and thus may modify the impact of dietary carbohydrates on bone.
In summary, available data suggest that the quantity and quality of carbohydrates, including the glycemic index of food, may affect bone health and that it is important to exercise moderation in the consumption of such foods. However, there are only a few studies that have examined these associations, and more studies are necessary to further clarify the impact of dietary carbohydrates on bone as well as any modifications of these effects by other associated food groups. These studies will allow us to refine our recommendations to our patients as we advance our understanding of the impact of the combined effects of various dietary nutrients on bone.
Madhusmita Misra, MD, MPH, is chief of the division of pediatric endocrinology, Mass General for Children, Boston, and serves or has served as a director, officer, partner, employee, advisor, consultant, or trustee for AbbVie, Sanofi, and Ipsen.
A version of this article first appeared on Medscape.com.
Meaningful improvement for patients like Tante Ilse
Last year, after a long delay due to COVID, my father’s ashes were finally laid to rest at Arlington National Cemetery. Among the loved ones who came was my favorite aunt, Tante Ilse, who was suffering from dementia. While she wasn’t “following” everything that was going on, she did perk up when she heard my father’s name and would comment on how she liked him and how wonderful he had been to her.
After the ceremony, our family of about 30 gathered at a restaurant where we shared stories and old pictures. Tante Ilse seemed to relish the photos and the time with family. She was doing so well that when we went back to my mom’s home after the reception, my cousins decided to bring Tante Ilse there, too. She had a great time, as evidenced by her famous total-body laugh. In the months before her death, we all commented about that day and how happy she seemed.
My aunt’s decline comes to mind as I reflect on media reports of 2 Alzheimer drugs— aducanumab and lecanemab—that have been billed by some as “gamechangers.” These new drugs are monoclonal antibodies directed at amyloid, one of several agents thought to cause Alzheimer disease. The details of aducanumab’s approval by the US Food and Drug Administration (FDA) generated a great deal of criticism—with good reason.
Two manufacturer-sponsored studies of aducanumab were halted due to futility of finding a benefit.1 The FDA’s scientific advisory panel recommended against approval due to a lack of evidence that it did anything more than remove amyloid plaque from the brain. And yet aducanumab received accelerated approval from the FDA. (This author collaborated on an additional analysis using data presented to the FDA, after its approval, which also reported no clinically meaningful effects.2) The other agent, lecanemab, also reduces markers of amyloid and was shown to be only moderately better than placebo in decreasing the rate of decline on various measures of cognition.3 Quite notably, both aducanumab and lecanemab, which are administered parenterally, cost more than $25,000 per year4,5 and cause amyloid-related imaging abnormalities (brain edema or hemorrhage).
Expensive agents without meaningful benefit. So far, neither of these agents has shown a reduction in things that are truly important to our patients and their families/caregivers: a reduction in caregiver burden and a reduction in the need for placement in long-term care facilities.
This is in contrast to cholinesterase inhibitors, which also slow the rate of cognitive decline.6 Among the differences that exist between these agents: Cholinesterase inhibitors are taken orally and are available as generics, which cost less than a thousand dollars per year.7 Limited data also suggest that they are associated with a lower risk for nursing home placement.8,9 (A February 2023 search of clinicaltrials.gov did not reveal any completed or planned head-to-head comparisons of monoclonal antibodies and anticholinergic agents.)
Our patients, their families, and caregivers hold out hope for something that will improve the patient’s cognition and extend the meaningful time they have with their loved ones. So far, the best we have to offer falls far short of these goals. I certainly would have hoped for something better than merely clearing amyloid for my aunt.
It’s time that the FDA adopt more rigorous standards requiring new drugs to, among other things, demonstrate meaningful clinical benefits, provide real cost savings, and be safer than currently available therapies. Other nations seem to be able to do this.10,11 It is bad enough to provide “hope in a bottle”; it is worse when what is offered is false hope.
1. Budd Haeberlein S, Aisen PS, Barkhof F, et al. Two randomized phase 3 studies of aducanumab in early Alzheimer’s disease. J Prev Alzheimers Dis. 2022;9:197-210. doi: 10.14283/jpad.2022.30
2. Ebell MH, Barry HC. Why physicians should not prescribe aducanumab for Alzheimer disease. Am Fam Physician. 2022;105:353-354.
3. van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in early Alzheimer’s disease. N Engl J Med. 2023;388:9-21. doi: 10.1056/NEJMoa2212948
4. Reardon S. FDA approves Alzheimer’s drug lecanemab amid safety concerns. Nature. 2023; 613:227-228. doi: 10.1038/d41586-023-00030-3
5. Biogen announces reduced price for Aduhelm to improve access for patients with early Alzheimer’s disease. December 20, 2021. Accessed February 20, 2023. https://investors.biogen.com/news-releases/news-release-details/biogen-announces-reduced-price-aduhelmr-improve-access-patients
6. Takramah WK, Asem L. The efficacy of pharmacological interventions to improve cognitive and behavior symptoms in people with dementia: A systematic review and meta-analysis. Health Sci Rep. 2022;5:e913. doi: 10.1002/hsr2.913
7. GoodRx. Donepezil generic Aricept. Accessed February 20, 2023. www.goodrx.com/donepezil
8. Howard R, McShane R, Lindesay J, et al. Nursing home placement in the donepezil and memantine in moderate to severe Alzheimer’s disease (DOMINO-AD) trial: secondary and post-hoc analyses. Lancet Neurol. 2015;14:1171-1181. doi: 10.1016/S1474-4422(15)00258-6
9. Geldmacher DS, Provenzano G, McRae T, et al. Donepezil is associated with delayed nursing home placement in patients with Alzheimer’s disease. J Am Geriatr Soc. 2003;51:937-944. doi: 10.1046/j.1365-2389.2003.51306.x
10. Pham C, Le K, Draves M, et al. Assessment of FDA-approved drugs not recommended for use or reimbursement in other countries, 2017-2020. JAMA Intern Med. Published online February 13, 2023. doi: 10.1001/jamainternmed.2022.6787
11. Johnston JL, Ross JS, Ramachandran R. US Food and Drug Administration approval of drugs not meeting pivotal trial primary end points, 2018-2021. JAMA Intern Med. Published online February 13, 2023. doi: 10.1001/jamainternmed.2022.6444
Last year, after a long delay due to COVID, my father’s ashes were finally laid to rest at Arlington National Cemetery. Among the loved ones who came was my favorite aunt, Tante Ilse, who was suffering from dementia. While she wasn’t “following” everything that was going on, she did perk up when she heard my father’s name and would comment on how she liked him and how wonderful he had been to her.
After the ceremony, our family of about 30 gathered at a restaurant where we shared stories and old pictures. Tante Ilse seemed to relish the photos and the time with family. She was doing so well that when we went back to my mom’s home after the reception, my cousins decided to bring Tante Ilse there, too. She had a great time, as evidenced by her famous total-body laugh. In the months before her death, we all commented about that day and how happy she seemed.
My aunt’s decline comes to mind as I reflect on media reports of 2 Alzheimer drugs— aducanumab and lecanemab—that have been billed by some as “gamechangers.” These new drugs are monoclonal antibodies directed at amyloid, one of several agents thought to cause Alzheimer disease. The details of aducanumab’s approval by the US Food and Drug Administration (FDA) generated a great deal of criticism—with good reason.
Two manufacturer-sponsored studies of aducanumab were halted due to futility of finding a benefit.1 The FDA’s scientific advisory panel recommended against approval due to a lack of evidence that it did anything more than remove amyloid plaque from the brain. And yet aducanumab received accelerated approval from the FDA. (This author collaborated on an additional analysis using data presented to the FDA, after its approval, which also reported no clinically meaningful effects.2) The other agent, lecanemab, also reduces markers of amyloid and was shown to be only moderately better than placebo in decreasing the rate of decline on various measures of cognition.3 Quite notably, both aducanumab and lecanemab, which are administered parenterally, cost more than $25,000 per year4,5 and cause amyloid-related imaging abnormalities (brain edema or hemorrhage).
Expensive agents without meaningful benefit. So far, neither of these agents has shown a reduction in things that are truly important to our patients and their families/caregivers: a reduction in caregiver burden and a reduction in the need for placement in long-term care facilities.
This is in contrast to cholinesterase inhibitors, which also slow the rate of cognitive decline.6 Among the differences that exist between these agents: Cholinesterase inhibitors are taken orally and are available as generics, which cost less than a thousand dollars per year.7 Limited data also suggest that they are associated with a lower risk for nursing home placement.8,9 (A February 2023 search of clinicaltrials.gov did not reveal any completed or planned head-to-head comparisons of monoclonal antibodies and anticholinergic agents.)
Our patients, their families, and caregivers hold out hope for something that will improve the patient’s cognition and extend the meaningful time they have with their loved ones. So far, the best we have to offer falls far short of these goals. I certainly would have hoped for something better than merely clearing amyloid for my aunt.
It’s time that the FDA adopt more rigorous standards requiring new drugs to, among other things, demonstrate meaningful clinical benefits, provide real cost savings, and be safer than currently available therapies. Other nations seem to be able to do this.10,11 It is bad enough to provide “hope in a bottle”; it is worse when what is offered is false hope.
Last year, after a long delay due to COVID, my father’s ashes were finally laid to rest at Arlington National Cemetery. Among the loved ones who came was my favorite aunt, Tante Ilse, who was suffering from dementia. While she wasn’t “following” everything that was going on, she did perk up when she heard my father’s name and would comment on how she liked him and how wonderful he had been to her.
After the ceremony, our family of about 30 gathered at a restaurant where we shared stories and old pictures. Tante Ilse seemed to relish the photos and the time with family. She was doing so well that when we went back to my mom’s home after the reception, my cousins decided to bring Tante Ilse there, too. She had a great time, as evidenced by her famous total-body laugh. In the months before her death, we all commented about that day and how happy she seemed.
My aunt’s decline comes to mind as I reflect on media reports of 2 Alzheimer drugs— aducanumab and lecanemab—that have been billed by some as “gamechangers.” These new drugs are monoclonal antibodies directed at amyloid, one of several agents thought to cause Alzheimer disease. The details of aducanumab’s approval by the US Food and Drug Administration (FDA) generated a great deal of criticism—with good reason.
Two manufacturer-sponsored studies of aducanumab were halted due to futility of finding a benefit.1 The FDA’s scientific advisory panel recommended against approval due to a lack of evidence that it did anything more than remove amyloid plaque from the brain. And yet aducanumab received accelerated approval from the FDA. (This author collaborated on an additional analysis using data presented to the FDA, after its approval, which also reported no clinically meaningful effects.2) The other agent, lecanemab, also reduces markers of amyloid and was shown to be only moderately better than placebo in decreasing the rate of decline on various measures of cognition.3 Quite notably, both aducanumab and lecanemab, which are administered parenterally, cost more than $25,000 per year4,5 and cause amyloid-related imaging abnormalities (brain edema or hemorrhage).
Expensive agents without meaningful benefit. So far, neither of these agents has shown a reduction in things that are truly important to our patients and their families/caregivers: a reduction in caregiver burden and a reduction in the need for placement in long-term care facilities.
This is in contrast to cholinesterase inhibitors, which also slow the rate of cognitive decline.6 Among the differences that exist between these agents: Cholinesterase inhibitors are taken orally and are available as generics, which cost less than a thousand dollars per year.7 Limited data also suggest that they are associated with a lower risk for nursing home placement.8,9 (A February 2023 search of clinicaltrials.gov did not reveal any completed or planned head-to-head comparisons of monoclonal antibodies and anticholinergic agents.)
Our patients, their families, and caregivers hold out hope for something that will improve the patient’s cognition and extend the meaningful time they have with their loved ones. So far, the best we have to offer falls far short of these goals. I certainly would have hoped for something better than merely clearing amyloid for my aunt.
It’s time that the FDA adopt more rigorous standards requiring new drugs to, among other things, demonstrate meaningful clinical benefits, provide real cost savings, and be safer than currently available therapies. Other nations seem to be able to do this.10,11 It is bad enough to provide “hope in a bottle”; it is worse when what is offered is false hope.
1. Budd Haeberlein S, Aisen PS, Barkhof F, et al. Two randomized phase 3 studies of aducanumab in early Alzheimer’s disease. J Prev Alzheimers Dis. 2022;9:197-210. doi: 10.14283/jpad.2022.30
2. Ebell MH, Barry HC. Why physicians should not prescribe aducanumab for Alzheimer disease. Am Fam Physician. 2022;105:353-354.
3. van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in early Alzheimer’s disease. N Engl J Med. 2023;388:9-21. doi: 10.1056/NEJMoa2212948
4. Reardon S. FDA approves Alzheimer’s drug lecanemab amid safety concerns. Nature. 2023; 613:227-228. doi: 10.1038/d41586-023-00030-3
5. Biogen announces reduced price for Aduhelm to improve access for patients with early Alzheimer’s disease. December 20, 2021. Accessed February 20, 2023. https://investors.biogen.com/news-releases/news-release-details/biogen-announces-reduced-price-aduhelmr-improve-access-patients
6. Takramah WK, Asem L. The efficacy of pharmacological interventions to improve cognitive and behavior symptoms in people with dementia: A systematic review and meta-analysis. Health Sci Rep. 2022;5:e913. doi: 10.1002/hsr2.913
7. GoodRx. Donepezil generic Aricept. Accessed February 20, 2023. www.goodrx.com/donepezil
8. Howard R, McShane R, Lindesay J, et al. Nursing home placement in the donepezil and memantine in moderate to severe Alzheimer’s disease (DOMINO-AD) trial: secondary and post-hoc analyses. Lancet Neurol. 2015;14:1171-1181. doi: 10.1016/S1474-4422(15)00258-6
9. Geldmacher DS, Provenzano G, McRae T, et al. Donepezil is associated with delayed nursing home placement in patients with Alzheimer’s disease. J Am Geriatr Soc. 2003;51:937-944. doi: 10.1046/j.1365-2389.2003.51306.x
10. Pham C, Le K, Draves M, et al. Assessment of FDA-approved drugs not recommended for use or reimbursement in other countries, 2017-2020. JAMA Intern Med. Published online February 13, 2023. doi: 10.1001/jamainternmed.2022.6787
11. Johnston JL, Ross JS, Ramachandran R. US Food and Drug Administration approval of drugs not meeting pivotal trial primary end points, 2018-2021. JAMA Intern Med. Published online February 13, 2023. doi: 10.1001/jamainternmed.2022.6444
1. Budd Haeberlein S, Aisen PS, Barkhof F, et al. Two randomized phase 3 studies of aducanumab in early Alzheimer’s disease. J Prev Alzheimers Dis. 2022;9:197-210. doi: 10.14283/jpad.2022.30
2. Ebell MH, Barry HC. Why physicians should not prescribe aducanumab for Alzheimer disease. Am Fam Physician. 2022;105:353-354.
3. van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in early Alzheimer’s disease. N Engl J Med. 2023;388:9-21. doi: 10.1056/NEJMoa2212948
4. Reardon S. FDA approves Alzheimer’s drug lecanemab amid safety concerns. Nature. 2023; 613:227-228. doi: 10.1038/d41586-023-00030-3
5. Biogen announces reduced price for Aduhelm to improve access for patients with early Alzheimer’s disease. December 20, 2021. Accessed February 20, 2023. https://investors.biogen.com/news-releases/news-release-details/biogen-announces-reduced-price-aduhelmr-improve-access-patients
6. Takramah WK, Asem L. The efficacy of pharmacological interventions to improve cognitive and behavior symptoms in people with dementia: A systematic review and meta-analysis. Health Sci Rep. 2022;5:e913. doi: 10.1002/hsr2.913
7. GoodRx. Donepezil generic Aricept. Accessed February 20, 2023. www.goodrx.com/donepezil
8. Howard R, McShane R, Lindesay J, et al. Nursing home placement in the donepezil and memantine in moderate to severe Alzheimer’s disease (DOMINO-AD) trial: secondary and post-hoc analyses. Lancet Neurol. 2015;14:1171-1181. doi: 10.1016/S1474-4422(15)00258-6
9. Geldmacher DS, Provenzano G, McRae T, et al. Donepezil is associated with delayed nursing home placement in patients with Alzheimer’s disease. J Am Geriatr Soc. 2003;51:937-944. doi: 10.1046/j.1365-2389.2003.51306.x
10. Pham C, Le K, Draves M, et al. Assessment of FDA-approved drugs not recommended for use or reimbursement in other countries, 2017-2020. JAMA Intern Med. Published online February 13, 2023. doi: 10.1001/jamainternmed.2022.6787
11. Johnston JL, Ross JS, Ramachandran R. US Food and Drug Administration approval of drugs not meeting pivotal trial primary end points, 2018-2021. JAMA Intern Med. Published online February 13, 2023. doi: 10.1001/jamainternmed.2022.6444
The SHOW UP Act Threatens VA Telehealth
In February, the US House of Representatives hurriedly passed the Stopping Home Office Work’s Unproductive Problems (SHOW UP) Act, H.R. 139, a bill that calls into question the contributions of federal employees allowed to work from home and resets telework policies to those in place in 2019. Its author, House Oversight Committee Chairman James Comer (R, Kentucky) claimed that this change was necessary because the expansion of federal telework during the COVID-19 pandemic “has crippled the ability of agencies to get their jobs done and created backlogs.” His targets included the US Department of Veterans Affairs (VA), where, he charged, “veterans have been unable…to obtain care they have earned.” He added, “it’s hard to argue that teleworking has helped the VA.”
While oversight of government programs is an authority of Congress, the SHOW UP Act is based on unsubstantiated assumptions of dereliction. It also disregards the devastating impact the proposed changes will have on veterans’ ability to receive care and inaccurately implies improving it. As the Senate considers the bill, they should take heed of these and other facts involving this often misunderstood form of labor.
COVID-19 irrevocably transformed the use of virtual care within the VA and across the world. Even as the pandemic subsides, public and private health care systems have continued to use telework-centered telehealth far above prepandemic levels, especially for mental health and primary care. Employers, including the VA, capitalize on telework for its benefits to both consumers and the workforce. For consumers, research supports the clinical effectiveness of telemental health service, as well as its cost-effectiveness and consumer satisfaction. On the workforce side, research has documented heightened productivity, lower distractibility, and higher job satisfaction among counselors who shifted to remote work.
Remote work also serves as a key tool in attracting and retaining a qualified workforce. As one VA service chief explained, “I am having enough trouble competing with the private sector, where extensive telework is now the norm. If telework options were rolled back, the private sector will have a field day picking off my best staff.” These comments are consistent with the data. McKinsey’s American Opportunity Survey shows that Americans have embraced remote work and want more of it. Recent data from Gallup show that 6 of 10 currently exclusively remote employees would be extremely likely to change companies if they lost their remote flexibility. Further, Gallup data show that when an employee’s location preference does not match their current work location, burnout rises, and engagement drops.
Between 2019 and 2023, the VA’s telework expansion is what has enabled it to meet the growing demand for mental health services. VA is keeping pace by having 2 or more clinicians rotate between home and a shared VA office. Forcing these hybrid practitioners to work full time at VA facilities would drastically reduce the number of patients they can care for. There simply are not enough offices on crammed VA grounds to house staff who telework today. The net result would be that fewer appointments would be available, creating longer wait times. And that is just for existing patients. It does not factor in the expected influx due to new veteran eligibility made possible by the toxic exposures PACT Act.
Here is another good example of crucial VA telework: With the advent of the 988 Suicide & Crisis Lifeline, VA is adding more than 1000 new Veterans Crisis Line responders. All these new positions are remote. The SHOW UP Act would inhibit this expansion of lifesaving programs.
Veterans want more, not fewer, telehealth options. At a House Committee on Veterans’ Affairs hearing this past September, the VA reported that most veterans would prefer to receive mental health services virtually than to have to commute to a VA medical center or clinic. Telehealth benefits veterans in meaningful ways, including that it reduces their travel time, travel expense, depletion of sick leave, and need for childcare. Veterans with posttraumatic stress disorder, military sexual trauma, those with mobility issues, or those who struggle with the stigma of mental health treatment may prefer the familiarity of their own homes for care. Virtual options also relieve a patient’s need to enter a hospital and be unnecessarily exposed to contagious viruses. That’s safer not only for veterans but also for VA staff.
Finally, virtual care improves treatment. Research has revealed that the likelihood of missing telehealth appointments is lower than for in-person appointments. When patients miss appointments, continuity of care is disrupted, and health care outcomes are diminished.
The pandemic is receding, but the advantages of telework-centered virtual care are greater than ever. Political representatives who want to show up for veterans should do everything in their power to expand—not cut—VA’s ability to authorize working from home.
In February, the US House of Representatives hurriedly passed the Stopping Home Office Work’s Unproductive Problems (SHOW UP) Act, H.R. 139, a bill that calls into question the contributions of federal employees allowed to work from home and resets telework policies to those in place in 2019. Its author, House Oversight Committee Chairman James Comer (R, Kentucky) claimed that this change was necessary because the expansion of federal telework during the COVID-19 pandemic “has crippled the ability of agencies to get their jobs done and created backlogs.” His targets included the US Department of Veterans Affairs (VA), where, he charged, “veterans have been unable…to obtain care they have earned.” He added, “it’s hard to argue that teleworking has helped the VA.”
While oversight of government programs is an authority of Congress, the SHOW UP Act is based on unsubstantiated assumptions of dereliction. It also disregards the devastating impact the proposed changes will have on veterans’ ability to receive care and inaccurately implies improving it. As the Senate considers the bill, they should take heed of these and other facts involving this often misunderstood form of labor.
COVID-19 irrevocably transformed the use of virtual care within the VA and across the world. Even as the pandemic subsides, public and private health care systems have continued to use telework-centered telehealth far above prepandemic levels, especially for mental health and primary care. Employers, including the VA, capitalize on telework for its benefits to both consumers and the workforce. For consumers, research supports the clinical effectiveness of telemental health service, as well as its cost-effectiveness and consumer satisfaction. On the workforce side, research has documented heightened productivity, lower distractibility, and higher job satisfaction among counselors who shifted to remote work.
Remote work also serves as a key tool in attracting and retaining a qualified workforce. As one VA service chief explained, “I am having enough trouble competing with the private sector, where extensive telework is now the norm. If telework options were rolled back, the private sector will have a field day picking off my best staff.” These comments are consistent with the data. McKinsey’s American Opportunity Survey shows that Americans have embraced remote work and want more of it. Recent data from Gallup show that 6 of 10 currently exclusively remote employees would be extremely likely to change companies if they lost their remote flexibility. Further, Gallup data show that when an employee’s location preference does not match their current work location, burnout rises, and engagement drops.
Between 2019 and 2023, the VA’s telework expansion is what has enabled it to meet the growing demand for mental health services. VA is keeping pace by having 2 or more clinicians rotate between home and a shared VA office. Forcing these hybrid practitioners to work full time at VA facilities would drastically reduce the number of patients they can care for. There simply are not enough offices on crammed VA grounds to house staff who telework today. The net result would be that fewer appointments would be available, creating longer wait times. And that is just for existing patients. It does not factor in the expected influx due to new veteran eligibility made possible by the toxic exposures PACT Act.
Here is another good example of crucial VA telework: With the advent of the 988 Suicide & Crisis Lifeline, VA is adding more than 1000 new Veterans Crisis Line responders. All these new positions are remote. The SHOW UP Act would inhibit this expansion of lifesaving programs.
Veterans want more, not fewer, telehealth options. At a House Committee on Veterans’ Affairs hearing this past September, the VA reported that most veterans would prefer to receive mental health services virtually than to have to commute to a VA medical center or clinic. Telehealth benefits veterans in meaningful ways, including that it reduces their travel time, travel expense, depletion of sick leave, and need for childcare. Veterans with posttraumatic stress disorder, military sexual trauma, those with mobility issues, or those who struggle with the stigma of mental health treatment may prefer the familiarity of their own homes for care. Virtual options also relieve a patient’s need to enter a hospital and be unnecessarily exposed to contagious viruses. That’s safer not only for veterans but also for VA staff.
Finally, virtual care improves treatment. Research has revealed that the likelihood of missing telehealth appointments is lower than for in-person appointments. When patients miss appointments, continuity of care is disrupted, and health care outcomes are diminished.
The pandemic is receding, but the advantages of telework-centered virtual care are greater than ever. Political representatives who want to show up for veterans should do everything in their power to expand—not cut—VA’s ability to authorize working from home.
In February, the US House of Representatives hurriedly passed the Stopping Home Office Work’s Unproductive Problems (SHOW UP) Act, H.R. 139, a bill that calls into question the contributions of federal employees allowed to work from home and resets telework policies to those in place in 2019. Its author, House Oversight Committee Chairman James Comer (R, Kentucky) claimed that this change was necessary because the expansion of federal telework during the COVID-19 pandemic “has crippled the ability of agencies to get their jobs done and created backlogs.” His targets included the US Department of Veterans Affairs (VA), where, he charged, “veterans have been unable…to obtain care they have earned.” He added, “it’s hard to argue that teleworking has helped the VA.”
While oversight of government programs is an authority of Congress, the SHOW UP Act is based on unsubstantiated assumptions of dereliction. It also disregards the devastating impact the proposed changes will have on veterans’ ability to receive care and inaccurately implies improving it. As the Senate considers the bill, they should take heed of these and other facts involving this often misunderstood form of labor.
COVID-19 irrevocably transformed the use of virtual care within the VA and across the world. Even as the pandemic subsides, public and private health care systems have continued to use telework-centered telehealth far above prepandemic levels, especially for mental health and primary care. Employers, including the VA, capitalize on telework for its benefits to both consumers and the workforce. For consumers, research supports the clinical effectiveness of telemental health service, as well as its cost-effectiveness and consumer satisfaction. On the workforce side, research has documented heightened productivity, lower distractibility, and higher job satisfaction among counselors who shifted to remote work.
Remote work also serves as a key tool in attracting and retaining a qualified workforce. As one VA service chief explained, “I am having enough trouble competing with the private sector, where extensive telework is now the norm. If telework options were rolled back, the private sector will have a field day picking off my best staff.” These comments are consistent with the data. McKinsey’s American Opportunity Survey shows that Americans have embraced remote work and want more of it. Recent data from Gallup show that 6 of 10 currently exclusively remote employees would be extremely likely to change companies if they lost their remote flexibility. Further, Gallup data show that when an employee’s location preference does not match their current work location, burnout rises, and engagement drops.
Between 2019 and 2023, the VA’s telework expansion is what has enabled it to meet the growing demand for mental health services. VA is keeping pace by having 2 or more clinicians rotate between home and a shared VA office. Forcing these hybrid practitioners to work full time at VA facilities would drastically reduce the number of patients they can care for. There simply are not enough offices on crammed VA grounds to house staff who telework today. The net result would be that fewer appointments would be available, creating longer wait times. And that is just for existing patients. It does not factor in the expected influx due to new veteran eligibility made possible by the toxic exposures PACT Act.
Here is another good example of crucial VA telework: With the advent of the 988 Suicide & Crisis Lifeline, VA is adding more than 1000 new Veterans Crisis Line responders. All these new positions are remote. The SHOW UP Act would inhibit this expansion of lifesaving programs.
Veterans want more, not fewer, telehealth options. At a House Committee on Veterans’ Affairs hearing this past September, the VA reported that most veterans would prefer to receive mental health services virtually than to have to commute to a VA medical center or clinic. Telehealth benefits veterans in meaningful ways, including that it reduces their travel time, travel expense, depletion of sick leave, and need for childcare. Veterans with posttraumatic stress disorder, military sexual trauma, those with mobility issues, or those who struggle with the stigma of mental health treatment may prefer the familiarity of their own homes for care. Virtual options also relieve a patient’s need to enter a hospital and be unnecessarily exposed to contagious viruses. That’s safer not only for veterans but also for VA staff.
Finally, virtual care improves treatment. Research has revealed that the likelihood of missing telehealth appointments is lower than for in-person appointments. When patients miss appointments, continuity of care is disrupted, and health care outcomes are diminished.
The pandemic is receding, but the advantages of telework-centered virtual care are greater than ever. Political representatives who want to show up for veterans should do everything in their power to expand—not cut—VA’s ability to authorize working from home.
Inequity, Bias, Racism, and Physician Burnout: Staying Connected to Purpose and Identity as an Antidote
“Where are you really from?”
When I tell patients I am from Casper, Wyoming—wh ere I have lived the majority of my life—it’smet with disbelief. The subtext: YOU can’t be from THERE.
I didn’t used to think much of comments like this, but as I have continued to hear them, I find myself feeling tired—tired of explaining myself, tired of being treated differently than my colleagues, and tired of justifying myself. My experiences as a woman of color sadly are not uncommon in medicine.
Sara Martinez-Garcia, BA
Racial bias and racism are steeped in the culture of medicine—from the medical school admissions process1,2 to the medical training itself.3 More than half of medical students who identify as underrepresented in medicine (UIM) experience microaggressions.4 Experiencing racism and sexism in the learning environment can lead to burnout, and microaggressions promote feelings of self-doubt and isolation. Medical students who experience microaggressions are more likely to report feelings of burnout and impaired learning.4 These experiences can leave one feeling as if “You do not belong” and “You are unworthy of being in this position.”
Addressing physician burnout already is complex, and addressing burnout caused by inequity, bias, and racism is even more so. In an ideal world, we would eliminate inequity, bias, and racism in medicine through institutional and individual actions. There has been movement to do so. For example, the Accreditation Council for Graduate Medical Education (ACGME), which oversees standards for US resident and fellow training, launched ACGME Equity Matters (https://www.acgme.org/what-we-do/diversity-equity-and-inclusion/ACGME-Equity-Matters/), an initiative aimed to improve diversity, equity, and antiracism practices within graduate medical eduation. However, we know that education alone isn’t enough to fix this monumental problem. Traditional diversity training as we have known it has never been demonstrated to contribute to lasting changes in behavior; it takes much more extensive and complex interventions to meaningfully reduce bias.5 In the meantime, we need action. As a medical community, we need to be better about not turning the other way when we see these things happening in our classrooms and in our hospitals. As individuals, we must self-reflect on the role that we each play in contributing to or combatting injustices and seek out bystander training to empower us to speak out against acts of bias such as sexism or racism. Whether it is supporting a fellow colleague or speaking out against an inappropriate interaction, we can all do our part. A very brief list of actions and resources to support our UIM students and colleagues are listed in the Table; those interested in more in-depth resources are encouraged to explore the Association of American Medical Colleges Diversity and Inclusion Toolkit (https://www.aamc.org/professional-development/affinity-groups/cfas/diversity-inclusion-toolkit/resources).
We can’t change the culture of medicine quickly or even in our lifetime. In the meantime, those who are UIM will continue to experience these events that erode our well-being. They will continue to need support. Discussing mental health has long been stigmatized, and physicians are no exception. Many physicians are hesitant to discuss mental health issues out of fear of judgement and perceived or even real repercussions on their careers.10 However, times are changing and evolving with the current generation of medical students. It’s no secret that medicine is stressful. Most medical schools provide free counseling services, which lowers the barrier for discussions of mental health from the beginning. Making talk about mental health just as normal as talking about other aspects of health takes away the fear that “something is wrong with me” if someone seeks out counseling and mental health services. Faculty should actively check in and maintain open lines of communication, which can be invaluable for UIM students and their training experience. Creating an environment where trainees can be real and honest about the struggles they face in and out of the classroom can make everyone feel like they are not alone.
Addressing burnout in medicine is going to require an all-hands-on-deck approach. At an institutional level, there is a lot of room for improvement—improving systems for physicians so they are able to operate at their highest level (eg, addressing the burdens of prior authorizations and the electronic medical record), setting reasonable expectations around productivity, and creating work structures that respect work-life balance.11 But what can we do for ourselves? We believe that one of the most important ways to protect ourselves from burnout is to remember why. As a medical student, there is enormous pressure—pressure to learn an enormous volume of information, pass examinations, get involved in extracurricular activities, make connections, and seek research opportunities, while also cooking healthy food, grocery shopping, maintaining relationships with loved ones, and generally taking care of oneself. At times it can feel as if our lives outside of medical school are not important enough or valuable enough to make time for, but the pieces of our identity outside of medicine are what shape us into who we are today and are the roots of our purpose in medicine. Sometimes you can feel the most motivated, valued, and supported when you make time to have dinner with friends, call a family member, or simply spend time alone in the outdoors. Who you are and how you got to this point in your life are your identity. Reminding yourself of that can help when experiencing microaggressions or when that voice tries to tell you that you are not worthy. As you progress further in your career, maintaining that relationship with who you are outside of medicine can be your armor against burnout.
- Capers Q IV, Clinchot D, McDougle L, et al. Implicit racial bias in medical school admissions. Acad Med. 2017;92:365-369.
- Lucey CR, Saguil A. The consequences of structural racism on MCAT scores and medical school admissions: the past is prologue. Acad Med. 2020;95:351-356.
- Nguemeni Tiako MJ, South EC, Ray V. Medical schools as racialized organizations: a primer. Ann Intern Med. 2021;174:1143-1144.
- Chisholm LP, Jackson KR, Davidson HA, et al. Evaluation of racial microaggressions experienced during medical school training and the effect on medical student education and burnout: a validation study. J Natl Med Assoc. 2021;113:310-314.
- Dobbin F, Kalev A. Why doesn’t diversity training work? the challenge for industry and academia. Anthropology Now. 2018;10:48-55.
- Okoye GA. Supporting underrepresented minority women in academic dermatology. Int J Womens Dermatol. 2020;6:57-60.
- Hackworth JM, Kotagal M, Bignall ONR, et al. Microaggressions: privileged observers’ duty to act and what they can do [published online December 1, 2021]. Pediatrics. doi:10.1542/peds.2021-052758.
- Wheeler DJ, Zapata J, Davis D, et al. Twelve tips for responding to microaggressions and overt discrimination: when the patient offends the learner. Med Teach. 2019;41:1112-1117.
- Scott K. Just Work: How to Root Out Bias, Prejudice, and Bullying to Build a Kick-Ass Culture of Inclusivity. St. Martin’s Press; 2021.
- Center C, Davis M, Detre T, et al. Confronting depression and suicide in physicians: a consensus statement. JAMA. 2003;289:3161-3166.
- West CP, Dyrbye LN, Shanafelt TD. Physician burnout: contributors, consequences and solutions. J Intern Med. 2018;283:516-529.
“Where are you really from?”
When I tell patients I am from Casper, Wyoming—wh ere I have lived the majority of my life—it’smet with disbelief. The subtext: YOU can’t be from THERE.
I didn’t used to think much of comments like this, but as I have continued to hear them, I find myself feeling tired—tired of explaining myself, tired of being treated differently than my colleagues, and tired of justifying myself. My experiences as a woman of color sadly are not uncommon in medicine.
Sara Martinez-Garcia, BA
Racial bias and racism are steeped in the culture of medicine—from the medical school admissions process1,2 to the medical training itself.3 More than half of medical students who identify as underrepresented in medicine (UIM) experience microaggressions.4 Experiencing racism and sexism in the learning environment can lead to burnout, and microaggressions promote feelings of self-doubt and isolation. Medical students who experience microaggressions are more likely to report feelings of burnout and impaired learning.4 These experiences can leave one feeling as if “You do not belong” and “You are unworthy of being in this position.”
Addressing physician burnout already is complex, and addressing burnout caused by inequity, bias, and racism is even more so. In an ideal world, we would eliminate inequity, bias, and racism in medicine through institutional and individual actions. There has been movement to do so. For example, the Accreditation Council for Graduate Medical Education (ACGME), which oversees standards for US resident and fellow training, launched ACGME Equity Matters (https://www.acgme.org/what-we-do/diversity-equity-and-inclusion/ACGME-Equity-Matters/), an initiative aimed to improve diversity, equity, and antiracism practices within graduate medical eduation. However, we know that education alone isn’t enough to fix this monumental problem. Traditional diversity training as we have known it has never been demonstrated to contribute to lasting changes in behavior; it takes much more extensive and complex interventions to meaningfully reduce bias.5 In the meantime, we need action. As a medical community, we need to be better about not turning the other way when we see these things happening in our classrooms and in our hospitals. As individuals, we must self-reflect on the role that we each play in contributing to or combatting injustices and seek out bystander training to empower us to speak out against acts of bias such as sexism or racism. Whether it is supporting a fellow colleague or speaking out against an inappropriate interaction, we can all do our part. A very brief list of actions and resources to support our UIM students and colleagues are listed in the Table; those interested in more in-depth resources are encouraged to explore the Association of American Medical Colleges Diversity and Inclusion Toolkit (https://www.aamc.org/professional-development/affinity-groups/cfas/diversity-inclusion-toolkit/resources).
We can’t change the culture of medicine quickly or even in our lifetime. In the meantime, those who are UIM will continue to experience these events that erode our well-being. They will continue to need support. Discussing mental health has long been stigmatized, and physicians are no exception. Many physicians are hesitant to discuss mental health issues out of fear of judgement and perceived or even real repercussions on their careers.10 However, times are changing and evolving with the current generation of medical students. It’s no secret that medicine is stressful. Most medical schools provide free counseling services, which lowers the barrier for discussions of mental health from the beginning. Making talk about mental health just as normal as talking about other aspects of health takes away the fear that “something is wrong with me” if someone seeks out counseling and mental health services. Faculty should actively check in and maintain open lines of communication, which can be invaluable for UIM students and their training experience. Creating an environment where trainees can be real and honest about the struggles they face in and out of the classroom can make everyone feel like they are not alone.
Addressing burnout in medicine is going to require an all-hands-on-deck approach. At an institutional level, there is a lot of room for improvement—improving systems for physicians so they are able to operate at their highest level (eg, addressing the burdens of prior authorizations and the electronic medical record), setting reasonable expectations around productivity, and creating work structures that respect work-life balance.11 But what can we do for ourselves? We believe that one of the most important ways to protect ourselves from burnout is to remember why. As a medical student, there is enormous pressure—pressure to learn an enormous volume of information, pass examinations, get involved in extracurricular activities, make connections, and seek research opportunities, while also cooking healthy food, grocery shopping, maintaining relationships with loved ones, and generally taking care of oneself. At times it can feel as if our lives outside of medical school are not important enough or valuable enough to make time for, but the pieces of our identity outside of medicine are what shape us into who we are today and are the roots of our purpose in medicine. Sometimes you can feel the most motivated, valued, and supported when you make time to have dinner with friends, call a family member, or simply spend time alone in the outdoors. Who you are and how you got to this point in your life are your identity. Reminding yourself of that can help when experiencing microaggressions or when that voice tries to tell you that you are not worthy. As you progress further in your career, maintaining that relationship with who you are outside of medicine can be your armor against burnout.
“Where are you really from?”
When I tell patients I am from Casper, Wyoming—wh ere I have lived the majority of my life—it’smet with disbelief. The subtext: YOU can’t be from THERE.
I didn’t used to think much of comments like this, but as I have continued to hear them, I find myself feeling tired—tired of explaining myself, tired of being treated differently than my colleagues, and tired of justifying myself. My experiences as a woman of color sadly are not uncommon in medicine.
Sara Martinez-Garcia, BA
Racial bias and racism are steeped in the culture of medicine—from the medical school admissions process1,2 to the medical training itself.3 More than half of medical students who identify as underrepresented in medicine (UIM) experience microaggressions.4 Experiencing racism and sexism in the learning environment can lead to burnout, and microaggressions promote feelings of self-doubt and isolation. Medical students who experience microaggressions are more likely to report feelings of burnout and impaired learning.4 These experiences can leave one feeling as if “You do not belong” and “You are unworthy of being in this position.”
Addressing physician burnout already is complex, and addressing burnout caused by inequity, bias, and racism is even more so. In an ideal world, we would eliminate inequity, bias, and racism in medicine through institutional and individual actions. There has been movement to do so. For example, the Accreditation Council for Graduate Medical Education (ACGME), which oversees standards for US resident and fellow training, launched ACGME Equity Matters (https://www.acgme.org/what-we-do/diversity-equity-and-inclusion/ACGME-Equity-Matters/), an initiative aimed to improve diversity, equity, and antiracism practices within graduate medical eduation. However, we know that education alone isn’t enough to fix this monumental problem. Traditional diversity training as we have known it has never been demonstrated to contribute to lasting changes in behavior; it takes much more extensive and complex interventions to meaningfully reduce bias.5 In the meantime, we need action. As a medical community, we need to be better about not turning the other way when we see these things happening in our classrooms and in our hospitals. As individuals, we must self-reflect on the role that we each play in contributing to or combatting injustices and seek out bystander training to empower us to speak out against acts of bias such as sexism or racism. Whether it is supporting a fellow colleague or speaking out against an inappropriate interaction, we can all do our part. A very brief list of actions and resources to support our UIM students and colleagues are listed in the Table; those interested in more in-depth resources are encouraged to explore the Association of American Medical Colleges Diversity and Inclusion Toolkit (https://www.aamc.org/professional-development/affinity-groups/cfas/diversity-inclusion-toolkit/resources).
We can’t change the culture of medicine quickly or even in our lifetime. In the meantime, those who are UIM will continue to experience these events that erode our well-being. They will continue to need support. Discussing mental health has long been stigmatized, and physicians are no exception. Many physicians are hesitant to discuss mental health issues out of fear of judgement and perceived or even real repercussions on their careers.10 However, times are changing and evolving with the current generation of medical students. It’s no secret that medicine is stressful. Most medical schools provide free counseling services, which lowers the barrier for discussions of mental health from the beginning. Making talk about mental health just as normal as talking about other aspects of health takes away the fear that “something is wrong with me” if someone seeks out counseling and mental health services. Faculty should actively check in and maintain open lines of communication, which can be invaluable for UIM students and their training experience. Creating an environment where trainees can be real and honest about the struggles they face in and out of the classroom can make everyone feel like they are not alone.
Addressing burnout in medicine is going to require an all-hands-on-deck approach. At an institutional level, there is a lot of room for improvement—improving systems for physicians so they are able to operate at their highest level (eg, addressing the burdens of prior authorizations and the electronic medical record), setting reasonable expectations around productivity, and creating work structures that respect work-life balance.11 But what can we do for ourselves? We believe that one of the most important ways to protect ourselves from burnout is to remember why. As a medical student, there is enormous pressure—pressure to learn an enormous volume of information, pass examinations, get involved in extracurricular activities, make connections, and seek research opportunities, while also cooking healthy food, grocery shopping, maintaining relationships with loved ones, and generally taking care of oneself. At times it can feel as if our lives outside of medical school are not important enough or valuable enough to make time for, but the pieces of our identity outside of medicine are what shape us into who we are today and are the roots of our purpose in medicine. Sometimes you can feel the most motivated, valued, and supported when you make time to have dinner with friends, call a family member, or simply spend time alone in the outdoors. Who you are and how you got to this point in your life are your identity. Reminding yourself of that can help when experiencing microaggressions or when that voice tries to tell you that you are not worthy. As you progress further in your career, maintaining that relationship with who you are outside of medicine can be your armor against burnout.
- Capers Q IV, Clinchot D, McDougle L, et al. Implicit racial bias in medical school admissions. Acad Med. 2017;92:365-369.
- Lucey CR, Saguil A. The consequences of structural racism on MCAT scores and medical school admissions: the past is prologue. Acad Med. 2020;95:351-356.
- Nguemeni Tiako MJ, South EC, Ray V. Medical schools as racialized organizations: a primer. Ann Intern Med. 2021;174:1143-1144.
- Chisholm LP, Jackson KR, Davidson HA, et al. Evaluation of racial microaggressions experienced during medical school training and the effect on medical student education and burnout: a validation study. J Natl Med Assoc. 2021;113:310-314.
- Dobbin F, Kalev A. Why doesn’t diversity training work? the challenge for industry and academia. Anthropology Now. 2018;10:48-55.
- Okoye GA. Supporting underrepresented minority women in academic dermatology. Int J Womens Dermatol. 2020;6:57-60.
- Hackworth JM, Kotagal M, Bignall ONR, et al. Microaggressions: privileged observers’ duty to act and what they can do [published online December 1, 2021]. Pediatrics. doi:10.1542/peds.2021-052758.
- Wheeler DJ, Zapata J, Davis D, et al. Twelve tips for responding to microaggressions and overt discrimination: when the patient offends the learner. Med Teach. 2019;41:1112-1117.
- Scott K. Just Work: How to Root Out Bias, Prejudice, and Bullying to Build a Kick-Ass Culture of Inclusivity. St. Martin’s Press; 2021.
- Center C, Davis M, Detre T, et al. Confronting depression and suicide in physicians: a consensus statement. JAMA. 2003;289:3161-3166.
- West CP, Dyrbye LN, Shanafelt TD. Physician burnout: contributors, consequences and solutions. J Intern Med. 2018;283:516-529.
- Capers Q IV, Clinchot D, McDougle L, et al. Implicit racial bias in medical school admissions. Acad Med. 2017;92:365-369.
- Lucey CR, Saguil A. The consequences of structural racism on MCAT scores and medical school admissions: the past is prologue. Acad Med. 2020;95:351-356.
- Nguemeni Tiako MJ, South EC, Ray V. Medical schools as racialized organizations: a primer. Ann Intern Med. 2021;174:1143-1144.
- Chisholm LP, Jackson KR, Davidson HA, et al. Evaluation of racial microaggressions experienced during medical school training and the effect on medical student education and burnout: a validation study. J Natl Med Assoc. 2021;113:310-314.
- Dobbin F, Kalev A. Why doesn’t diversity training work? the challenge for industry and academia. Anthropology Now. 2018;10:48-55.
- Okoye GA. Supporting underrepresented minority women in academic dermatology. Int J Womens Dermatol. 2020;6:57-60.
- Hackworth JM, Kotagal M, Bignall ONR, et al. Microaggressions: privileged observers’ duty to act and what they can do [published online December 1, 2021]. Pediatrics. doi:10.1542/peds.2021-052758.
- Wheeler DJ, Zapata J, Davis D, et al. Twelve tips for responding to microaggressions and overt discrimination: when the patient offends the learner. Med Teach. 2019;41:1112-1117.
- Scott K. Just Work: How to Root Out Bias, Prejudice, and Bullying to Build a Kick-Ass Culture of Inclusivity. St. Martin’s Press; 2021.
- Center C, Davis M, Detre T, et al. Confronting depression and suicide in physicians: a consensus statement. JAMA. 2003;289:3161-3166.
- West CP, Dyrbye LN, Shanafelt TD. Physician burnout: contributors, consequences and solutions. J Intern Med. 2018;283:516-529.
Robotic peritoneal vaginoplasty
When the Food and Drug Administration first approved the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, Calif.) for adult use in 2000, it altered the face of minimally invasive surgery across a multitude of specialties. Improved three-dimensional visualization and enhanced instrument articulation facilitates complex dissections and intracorporeal suturing. While the standard of care for gender-affirming vaginoplasty remains the single-stage penile inversion vaginoplasty, robotic procedures are quickly emerging as alternative options for both primary and revisional surgeries.
The single-stage penile inversion vaginoplasty requires an adequate amount of penoscrotal tissue not only to line a neovaginal canal that measures 12-15 cm, but also to create external vulvar structures. While this is often sufficient in most candidates, there is an increasing number of patients who are receiving puberty blockers, resulting in penoscrotal hypoplasia.
Alternatively, there are patients who experience loss of vaginal depth and vaginal stenosis who seek revisional surgeries. Additional donor sites for skin grafting are available and include the lower abdomen and thighs, although patients may not want these donor site scars. With these donor sites, there is also concern about graft contracture, which could lead to recurrent vaginal stenosis.1 Robotic peritoneal vaginoplasty and robotic enteric vaginoplasty can serve as additional options for patients seeking revisional surgery or who have insufficient genital skin. One benefit of using peritoneal flaps is that they are hairless and are well vascularized with minimal donor site morbidity.1 Currently, there are two predominant techniques that utilize peritoneal flaps: the modified Davydov procedure and the tubularized urachus-peritoneal hinge flap.
The modified Davydov technique, which originated in the treatment of congenital vaginal agenesis in cisgender women, involves the creation of anterior and posterior peritoneal flaps. This type of peritoneal vaginoplasty is more commonly utilized for primary cases.
Ideally, there is a robotic surgeon (typically a urologist) working in tandem with the perineal surgeon. The robotic surgeon makes a horizontal incision along the peritoneal ridge at the rectovesical junction and continues the dissection within Denonvilliers fascia, between the prostate and rectum, to the pelvic floor. This dissection is like that performed in a robot-assisted laparoscopic prostatectomy.
Simultaneously, the perineal surgeon will break through the pelvic floor with assistance of the robotic view. Peritoneal flaps are raised from the anterior rectum and posterior bladder.2,3 In primary cases, the penoscrotal flap is introduced into the abdomen from the perineum and sutured to the anterior and posterior peritoneum to create a circumferential canal. At the apex of the neovagina, these anterior and posterior flaps are then sutured together.2,3
The tubularized urachus-peritoneal hinge flap technique is predominantly used for revision cases in patients who experienced neovaginal shortening and desire increased neovaginal depth. As peritoneal reach is limited, candidates for this procedure must have both adequate width and neovaginal canal depth.4 Once intra-abdominal access is achieved, an anterior peritoneal flap is mobilized to the level of the bladder and rotated 180 degrees inferiorly.4 The superior aspect of the flap is flipped is mobilized and is sutured to the peritoneum at the apex of the neovaginal canal.
The main benefit of these procedures, compared with traditional techniques, is increased neovaginal depth. The average vaginal length in patients undergoing peritoneal vaginoplasties is 14.2 cm, compared with 11.6 cm achieved in those using skin grafts.1,3 However, many surgeons report achieving 14-15 cm of depth with the traditional vaginoplasty. There are insufficient short- and long-term data for the peritoneal technique to recommend this as a first-line procedure.
Complications for peritoneal vaginoplasty procedures are similar to those of single-stage penile inversion vaginoplasty cases but with additional operative risks associated with laparoscopic/robotic surgery. These risks include injury to viscera and major vessels during initial intra-abdominal access, intra-abdominal adhesions, port site hernias, need to convert to an open procedure, and equipment malfunction.2 Additional postoperative risks include pelvic abscess formation, dehiscence of the peritoneal-vaginal incision, and peritoneal perforation during dilation.2,3 Surgeons and institutions must also weigh the cost of using the robot versus the cost of additional revisional surgical procedures. While initial studies evaluating robotic peritoneal vaginoplasty procedures have yielded promising preliminary results, additional studies are warranted.
Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.
References
1. Salibian AA et al. Plast Reconstr Surg. 2021;147(4):634e-43e.
2. Dy GW et al. In: Nikolavsky D and Blakely SA, eds. Urological care for the transgender patient: A comprehensive guide. Switzerland: Springer, 2021:237-48.
3. Jacoby A et al. J Urol. 2019;201(6):1171-5.
4. Smith SM et al. J Sex Med. 2022;10(6):100572.
When the Food and Drug Administration first approved the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, Calif.) for adult use in 2000, it altered the face of minimally invasive surgery across a multitude of specialties. Improved three-dimensional visualization and enhanced instrument articulation facilitates complex dissections and intracorporeal suturing. While the standard of care for gender-affirming vaginoplasty remains the single-stage penile inversion vaginoplasty, robotic procedures are quickly emerging as alternative options for both primary and revisional surgeries.
The single-stage penile inversion vaginoplasty requires an adequate amount of penoscrotal tissue not only to line a neovaginal canal that measures 12-15 cm, but also to create external vulvar structures. While this is often sufficient in most candidates, there is an increasing number of patients who are receiving puberty blockers, resulting in penoscrotal hypoplasia.
Alternatively, there are patients who experience loss of vaginal depth and vaginal stenosis who seek revisional surgeries. Additional donor sites for skin grafting are available and include the lower abdomen and thighs, although patients may not want these donor site scars. With these donor sites, there is also concern about graft contracture, which could lead to recurrent vaginal stenosis.1 Robotic peritoneal vaginoplasty and robotic enteric vaginoplasty can serve as additional options for patients seeking revisional surgery or who have insufficient genital skin. One benefit of using peritoneal flaps is that they are hairless and are well vascularized with minimal donor site morbidity.1 Currently, there are two predominant techniques that utilize peritoneal flaps: the modified Davydov procedure and the tubularized urachus-peritoneal hinge flap.
The modified Davydov technique, which originated in the treatment of congenital vaginal agenesis in cisgender women, involves the creation of anterior and posterior peritoneal flaps. This type of peritoneal vaginoplasty is more commonly utilized for primary cases.
Ideally, there is a robotic surgeon (typically a urologist) working in tandem with the perineal surgeon. The robotic surgeon makes a horizontal incision along the peritoneal ridge at the rectovesical junction and continues the dissection within Denonvilliers fascia, between the prostate and rectum, to the pelvic floor. This dissection is like that performed in a robot-assisted laparoscopic prostatectomy.
Simultaneously, the perineal surgeon will break through the pelvic floor with assistance of the robotic view. Peritoneal flaps are raised from the anterior rectum and posterior bladder.2,3 In primary cases, the penoscrotal flap is introduced into the abdomen from the perineum and sutured to the anterior and posterior peritoneum to create a circumferential canal. At the apex of the neovagina, these anterior and posterior flaps are then sutured together.2,3
The tubularized urachus-peritoneal hinge flap technique is predominantly used for revision cases in patients who experienced neovaginal shortening and desire increased neovaginal depth. As peritoneal reach is limited, candidates for this procedure must have both adequate width and neovaginal canal depth.4 Once intra-abdominal access is achieved, an anterior peritoneal flap is mobilized to the level of the bladder and rotated 180 degrees inferiorly.4 The superior aspect of the flap is flipped is mobilized and is sutured to the peritoneum at the apex of the neovaginal canal.
The main benefit of these procedures, compared with traditional techniques, is increased neovaginal depth. The average vaginal length in patients undergoing peritoneal vaginoplasties is 14.2 cm, compared with 11.6 cm achieved in those using skin grafts.1,3 However, many surgeons report achieving 14-15 cm of depth with the traditional vaginoplasty. There are insufficient short- and long-term data for the peritoneal technique to recommend this as a first-line procedure.
Complications for peritoneal vaginoplasty procedures are similar to those of single-stage penile inversion vaginoplasty cases but with additional operative risks associated with laparoscopic/robotic surgery. These risks include injury to viscera and major vessels during initial intra-abdominal access, intra-abdominal adhesions, port site hernias, need to convert to an open procedure, and equipment malfunction.2 Additional postoperative risks include pelvic abscess formation, dehiscence of the peritoneal-vaginal incision, and peritoneal perforation during dilation.2,3 Surgeons and institutions must also weigh the cost of using the robot versus the cost of additional revisional surgical procedures. While initial studies evaluating robotic peritoneal vaginoplasty procedures have yielded promising preliminary results, additional studies are warranted.
Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.
References
1. Salibian AA et al. Plast Reconstr Surg. 2021;147(4):634e-43e.
2. Dy GW et al. In: Nikolavsky D and Blakely SA, eds. Urological care for the transgender patient: A comprehensive guide. Switzerland: Springer, 2021:237-48.
3. Jacoby A et al. J Urol. 2019;201(6):1171-5.
4. Smith SM et al. J Sex Med. 2022;10(6):100572.
When the Food and Drug Administration first approved the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, Calif.) for adult use in 2000, it altered the face of minimally invasive surgery across a multitude of specialties. Improved three-dimensional visualization and enhanced instrument articulation facilitates complex dissections and intracorporeal suturing. While the standard of care for gender-affirming vaginoplasty remains the single-stage penile inversion vaginoplasty, robotic procedures are quickly emerging as alternative options for both primary and revisional surgeries.
The single-stage penile inversion vaginoplasty requires an adequate amount of penoscrotal tissue not only to line a neovaginal canal that measures 12-15 cm, but also to create external vulvar structures. While this is often sufficient in most candidates, there is an increasing number of patients who are receiving puberty blockers, resulting in penoscrotal hypoplasia.
Alternatively, there are patients who experience loss of vaginal depth and vaginal stenosis who seek revisional surgeries. Additional donor sites for skin grafting are available and include the lower abdomen and thighs, although patients may not want these donor site scars. With these donor sites, there is also concern about graft contracture, which could lead to recurrent vaginal stenosis.1 Robotic peritoneal vaginoplasty and robotic enteric vaginoplasty can serve as additional options for patients seeking revisional surgery or who have insufficient genital skin. One benefit of using peritoneal flaps is that they are hairless and are well vascularized with minimal donor site morbidity.1 Currently, there are two predominant techniques that utilize peritoneal flaps: the modified Davydov procedure and the tubularized urachus-peritoneal hinge flap.
The modified Davydov technique, which originated in the treatment of congenital vaginal agenesis in cisgender women, involves the creation of anterior and posterior peritoneal flaps. This type of peritoneal vaginoplasty is more commonly utilized for primary cases.
Ideally, there is a robotic surgeon (typically a urologist) working in tandem with the perineal surgeon. The robotic surgeon makes a horizontal incision along the peritoneal ridge at the rectovesical junction and continues the dissection within Denonvilliers fascia, between the prostate and rectum, to the pelvic floor. This dissection is like that performed in a robot-assisted laparoscopic prostatectomy.
Simultaneously, the perineal surgeon will break through the pelvic floor with assistance of the robotic view. Peritoneal flaps are raised from the anterior rectum and posterior bladder.2,3 In primary cases, the penoscrotal flap is introduced into the abdomen from the perineum and sutured to the anterior and posterior peritoneum to create a circumferential canal. At the apex of the neovagina, these anterior and posterior flaps are then sutured together.2,3
The tubularized urachus-peritoneal hinge flap technique is predominantly used for revision cases in patients who experienced neovaginal shortening and desire increased neovaginal depth. As peritoneal reach is limited, candidates for this procedure must have both adequate width and neovaginal canal depth.4 Once intra-abdominal access is achieved, an anterior peritoneal flap is mobilized to the level of the bladder and rotated 180 degrees inferiorly.4 The superior aspect of the flap is flipped is mobilized and is sutured to the peritoneum at the apex of the neovaginal canal.
The main benefit of these procedures, compared with traditional techniques, is increased neovaginal depth. The average vaginal length in patients undergoing peritoneal vaginoplasties is 14.2 cm, compared with 11.6 cm achieved in those using skin grafts.1,3 However, many surgeons report achieving 14-15 cm of depth with the traditional vaginoplasty. There are insufficient short- and long-term data for the peritoneal technique to recommend this as a first-line procedure.
Complications for peritoneal vaginoplasty procedures are similar to those of single-stage penile inversion vaginoplasty cases but with additional operative risks associated with laparoscopic/robotic surgery. These risks include injury to viscera and major vessels during initial intra-abdominal access, intra-abdominal adhesions, port site hernias, need to convert to an open procedure, and equipment malfunction.2 Additional postoperative risks include pelvic abscess formation, dehiscence of the peritoneal-vaginal incision, and peritoneal perforation during dilation.2,3 Surgeons and institutions must also weigh the cost of using the robot versus the cost of additional revisional surgical procedures. While initial studies evaluating robotic peritoneal vaginoplasty procedures have yielded promising preliminary results, additional studies are warranted.
Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.
References
1. Salibian AA et al. Plast Reconstr Surg. 2021;147(4):634e-43e.
2. Dy GW et al. In: Nikolavsky D and Blakely SA, eds. Urological care for the transgender patient: A comprehensive guide. Switzerland: Springer, 2021:237-48.
3. Jacoby A et al. J Urol. 2019;201(6):1171-5.
4. Smith SM et al. J Sex Med. 2022;10(6):100572.
U.S. vs. French guidelines for osteoporosis treatment
Lille, France – Bernard Cortet, MD, PhD, chairperson of the Osteoporosis Research and Information Group and head of the rheumatology department at Lille (France) University Hospital, has agreed to compare the new U.S. guidelines to the 2018 French recommendations written under the aegis of the French Society for Rheumatology and GRIO. Dr. Cortet participated in drafting the French recommendations.
Question: The ACP “strongly” recommends initial pharmacologic treatment with bisphosphonate antiresorptive drugs (alendronate, ibandronate, risedronate, zoledronate) in postmenopausal females diagnosed with primary osteoporosis. Isn’t this what the SFR–GRIO have been recommending for many years?
Answer: The ACP reinforces its stance by arguing that in postmenopausal females with primary osteoporosis, bisphosphonates have the most favorable balance between benefits, harms, patient values and preferences, and cost among the drug classes that were evaluated. In addition to net clinical benefits, bisphosphonates are much cheaper than other pharmacologic treatments and are available in generic oral and injectable formulations.
Our French recommendations specify the choice of drug based on the type of fracture in women and on their bone mineral density (BMD). However, bisphosphonates are definitely given pride of place. When treatment for osteoporosis needs to be started, most of the time, a bisphosphonate is the treatment of choice.
Nevertheless, as also highlighted by the ACP, a more “aggressive” approach must be considered for more severe cases.
In the case of a severe fracture, the French recommendations indicate that all treatments can be prescribed. However, zoledronic acid should be favored as first-line treatment for a hip fracture. In other cases – with or without a nonsevere fracture – the therapeutic indication depends on the BMD values, and in difficult cases, on tools such as FRAX [the Fracture Risk Assessment Tool].
Our guidance strongly recommends opting for an injection in other contexts, such as significant decrease in bone density, presence of comorbidities, poor treatment compliance, brain function disorders, and polymedication.
Q. But it’s not really as simple as prescribing a bisphosphonate, is it?
A. You’re right, many people find the idea of taking bisphosphonates worrying because of associated jaw problems – osteonecrosis of the jaw – or atypical femoral fractures, based on what they’ve read on the Internet, where these serious adverse events are on display front and center with no mention of how often they actually happen and, often, failing to mention how effective bisphosphonates truly are.
These complications are real, but fortunately rare, especially during the first 5 years of treatment. To put this into context, for bisphosphonates, there’s one case of osteonecrosis of the jaw for every 10,000. And for denosumab, there are five cases for every 10,000. For atypical fractures, there’s one case for every 30,000 to 50,000.
Q. The U.S. guidelines also recommend that clinicians use a RANK ligand inhibitor – denosumab, also an antiresorptive drug – as second-line medical treatment. This is to reduce the risk of fractures in postmenopausal women diagnosed with primary osteoporosis and presenting with contraindications or side effects of bisphosphonates. Do you support the use of denosumab as second-line treatment?
A. French legislation classifies it as a second-line treatment, after bisphosphonates. However, there are arguments in favor of prescribing it as first-line treatment in some contexts. If denosumab is to be prescribed – via a twice-yearly subcutaneous injection – full compliance must be observed. If a patient is to stop taking denosumab, an opinion from a medical professional is required before treatment can be discontinued, and then treatment with bisphosphonates must be prescribed.
Q. The ACP recommends that clinicians use either a sclerostin inhibitor – romosozumab – or recombinant human parathyroid hormone – teriparatide – two anabolic agents, followed by a bisphosphonate, with the aim of reducing the risk of fractures. This is only used in women with primary osteoporosis who are at a very high risk of fracture. As romosozumab is not available in France, it’s not really worth discussing its use. Does this strategy seem advisable to you, though?
A. The main issue is what is understood by “women at a very high risk of fracture.” There’s no consensus on the definition of what constitutes a woman at a very high risk of fracture, but we can assume that it involves the combination of low BMD and at least one severe fracture.
The role of anabolic bone treatment, as [the ACP] has defined it, seems logical to me, because in cases of severe osteoporosis with fracture, the risk of recurrence is very high in the next 2-3 years. In a study comparing risedronate and teriparatide in cases of severe osteoporosis, teriparatide was more effective in reducing the recurrence of vertebral fractures.
The favorable opinion of the French National Authority for Health in relation to medical coverage for romosozumab in the treatment of severe postmenopausal osteoporosis in women under the age of 75 years with a history of severe fractures, a T-score less than –2.5, and no previous history of coronary artery disease dates to 2021. This is because medical coverage for this specific group was not listed in the marketing authorization (MA) description for this drug.
But the review by the Economic Committee for Health Products failed to reach a consensus regarding the price. Today, in theory, romosozumab can be dispensed in France by hospital pharmacies, because it is approved for use in public hospitals. Romosozumab is a very interesting drug for relatively young women, especially those with multiple vertebral fractures. This injectable treatment is more effective than teriparatide in increasing BMD values and more effective than alendronate in preventing the recurrence of fractures.
Regarding medical coverage, as it stands, in cases where patients have a T-score less than or equal to –3, the 2018 SFR–GRIO recommends starting treatment even if the patient has no fractures. In cases with severe fractures combined with very low BMD (T-score ≤ –3), injectable treatments may be used to reach a bone density target (T-score > –2.5 to –2 for the hip) at the end of the treatment plan. [These treatments include] zoledronic acid, denosumab (in case of bisphosphonate failure or intolerance), or a treatment plan with teriparatide (covered by medical insurance if the patient has at least two vertebral fractures) followed by an antiresorptive drug (bisphosphonate or denosumab).
Romosozumab is a humanized monoclonal antibody (IgG2) that binds to sclerostin and acts as an inhibitor. This increases bone formation because of the activation of [bone lining cells], the production of bone matrix by osteoblasts, and the recruitment of osteochondroprogenitor cells. Moreover, romosozumab causes changes in the expression of osteoclast mediators, which decreases bone resorption. Together, these two effects that increase bone formation and decrease bone resorption lead to the rapid increase of trabecular and cortical bone mass, as well as improvements in bone structure and strength.
Women treated with a bone anabolic agent must take an antiresorptive agent at the end of their treatment so that the benefits from the treatment remain in the long term. The French and U.S. guidelines line up on this point.
In patients with two prevalent vertebral fractures, the U.S. guidelines state that teriparatide can be prescribed as first-line treatment at diagnosis in the absence of any contraindications. We agree on this point as well.
Moreover, in women under the age of 70 years with osteoporosis requiring treatment, French experts recommend prescribing raloxifene, a selective estrogen-receptor modulator. This is if the risk of nonvertebral fracture is low, as defined by the absence of the following criteria: low hip T-score, risk of falling, and history of nonvertebral fracture. Opportunities for its use are limited, and it doesn’t even figure among the U.S. recommendations.
Q. The ACP recommends that clinicians adopt an individualized approach regarding whether to start medical treatment with a bisphosphonate in women over age 65 years with low bone mass (osteopenia) to reduce the risk of fractures. If treatment is started, they›re of the opinion that a bisphosphonate must be used. What are the recommendations in France?
A. It should be noted that this recommendation by the ACP is conditional because of the low-certainty evidence.
Here’s a brief reminder of important things to note: a T-score between –2.5 and –1 indicates osteopenia; a T-score less than or equal to –2.5 indicates osteoporosis; a T-score less than or equal to –2.5 with one or several fractures indicates severe osteoporosis. The French recommendations state that treatment is not justified if a patient’s T-score is higher than –2 and there’s no presence of fractures, even with risk factors (and/or multiple falls). For T-scores less than or equal to –2 and higher than –3, the decision to prescribe depends on the specialist.
Q. The ACP recommends that clinicians use bisphosphonates for the initial medical treatment to reduce the risk of fractures in men diagnosed with primary osteoporosis.
A. The ACP recommends that clinicians use a RANK ligand inhibitor – denosumab – as second-line medical treatment to reduce the risk of fractures in men diagnosed with primary osteoporosis who present with contraindications or who are experiencing side effects of bisphosphonates. This treatment is not covered by health insurance for men in France.
Between 20% and 25% of clinical osteoporotic fractures occur in men. After age 50 years, men are roughly 20% more likely to experience an osteoporotic fracture in their lifetime. The French recommendations regarding the management and treatment of osteoporosis in men were published in 2021.
In the case of severe fractures (vertebrae, pelvis, upper end of the femur, distal femur, proximal humerus) attributable to bone fragility, osteoporosis treatment is recommended if one of the T-scores is less than or equal to –1.
In the case of nonsevere fractures (particularly wrist and ankle) attributable to bone fragility, osteoporosis treatment is recommended if one of the T-scores is less than or equal to –2. If there are no fractures, osteoporosis treatment is recommended in men at risk of bone fragility or of falling and if one of the T-scores is less than or equal to –3. In patients who had a fracture of the upper end of the femur attributable to bone fragility, zoledronic acid is recommended as first-line treatment.
For men with a severe nonvertebral fracture, single vertebral fracture, or nonsevere fracture, two treatments are indicated and covered by health insurance in France: zoledronic acid and risedronate. In men with at least two vertebral fractures, the following treatments are indicated and covered by health insurance in France: teriparatide and risedronate. In this case, teriparatide is prescribed for a period of 18 months. It must be followed by a prescription of oral or intravenous bisphosphonates.
Q. What is your take on the HAS update to the proper use of osteoporosis medication that’s just been published?
A. Like in the 2018 SFR–GRIO guidelines, no update has been made to the section on postmenopausal osteoporosis, except for the HAS introduction to the proper use of romosozumab, even though it’s not covered by health insurance in France.
In accordance with the MA, it doesn’t make sense to include this drug on the list of treatment options available for women with and without fractures, as it’s not included in the HAS-selected list of drugs covered by health insurance in France.
But I’m glad that the HAS has adopted the GRIO and SFR recommendations regarding corticosteroid-induced osteoporosis. Preventive treatment for corticosteroid-induced osteoporosis must be considered as soon as the daily dose of corticosteroids reaches or exceeds the equivalent of 7.5 mg of prednisone and when the estimated duration of corticosteroid therapy exceeds 3 months.
In summary, in women and men over the age of 50 years, the intake of the equivalent of 7.5 mg/day or more of prednisone or a history of a low-trauma fracture or being age 70 years or older, even with a T-score less than or equal to –2.5 for one of the two sites, indicates prescribing a bisphosphonate. Teriparatide is indicated if the patient has two vertebral fractures.
This article was translated from Medscape’s French edition.
A version of this article first appeared on Medscape.com.
Lille, France – Bernard Cortet, MD, PhD, chairperson of the Osteoporosis Research and Information Group and head of the rheumatology department at Lille (France) University Hospital, has agreed to compare the new U.S. guidelines to the 2018 French recommendations written under the aegis of the French Society for Rheumatology and GRIO. Dr. Cortet participated in drafting the French recommendations.
Question: The ACP “strongly” recommends initial pharmacologic treatment with bisphosphonate antiresorptive drugs (alendronate, ibandronate, risedronate, zoledronate) in postmenopausal females diagnosed with primary osteoporosis. Isn’t this what the SFR–GRIO have been recommending for many years?
Answer: The ACP reinforces its stance by arguing that in postmenopausal females with primary osteoporosis, bisphosphonates have the most favorable balance between benefits, harms, patient values and preferences, and cost among the drug classes that were evaluated. In addition to net clinical benefits, bisphosphonates are much cheaper than other pharmacologic treatments and are available in generic oral and injectable formulations.
Our French recommendations specify the choice of drug based on the type of fracture in women and on their bone mineral density (BMD). However, bisphosphonates are definitely given pride of place. When treatment for osteoporosis needs to be started, most of the time, a bisphosphonate is the treatment of choice.
Nevertheless, as also highlighted by the ACP, a more “aggressive” approach must be considered for more severe cases.
In the case of a severe fracture, the French recommendations indicate that all treatments can be prescribed. However, zoledronic acid should be favored as first-line treatment for a hip fracture. In other cases – with or without a nonsevere fracture – the therapeutic indication depends on the BMD values, and in difficult cases, on tools such as FRAX [the Fracture Risk Assessment Tool].
Our guidance strongly recommends opting for an injection in other contexts, such as significant decrease in bone density, presence of comorbidities, poor treatment compliance, brain function disorders, and polymedication.
Q. But it’s not really as simple as prescribing a bisphosphonate, is it?
A. You’re right, many people find the idea of taking bisphosphonates worrying because of associated jaw problems – osteonecrosis of the jaw – or atypical femoral fractures, based on what they’ve read on the Internet, where these serious adverse events are on display front and center with no mention of how often they actually happen and, often, failing to mention how effective bisphosphonates truly are.
These complications are real, but fortunately rare, especially during the first 5 years of treatment. To put this into context, for bisphosphonates, there’s one case of osteonecrosis of the jaw for every 10,000. And for denosumab, there are five cases for every 10,000. For atypical fractures, there’s one case for every 30,000 to 50,000.
Q. The U.S. guidelines also recommend that clinicians use a RANK ligand inhibitor – denosumab, also an antiresorptive drug – as second-line medical treatment. This is to reduce the risk of fractures in postmenopausal women diagnosed with primary osteoporosis and presenting with contraindications or side effects of bisphosphonates. Do you support the use of denosumab as second-line treatment?
A. French legislation classifies it as a second-line treatment, after bisphosphonates. However, there are arguments in favor of prescribing it as first-line treatment in some contexts. If denosumab is to be prescribed – via a twice-yearly subcutaneous injection – full compliance must be observed. If a patient is to stop taking denosumab, an opinion from a medical professional is required before treatment can be discontinued, and then treatment with bisphosphonates must be prescribed.
Q. The ACP recommends that clinicians use either a sclerostin inhibitor – romosozumab – or recombinant human parathyroid hormone – teriparatide – two anabolic agents, followed by a bisphosphonate, with the aim of reducing the risk of fractures. This is only used in women with primary osteoporosis who are at a very high risk of fracture. As romosozumab is not available in France, it’s not really worth discussing its use. Does this strategy seem advisable to you, though?
A. The main issue is what is understood by “women at a very high risk of fracture.” There’s no consensus on the definition of what constitutes a woman at a very high risk of fracture, but we can assume that it involves the combination of low BMD and at least one severe fracture.
The role of anabolic bone treatment, as [the ACP] has defined it, seems logical to me, because in cases of severe osteoporosis with fracture, the risk of recurrence is very high in the next 2-3 years. In a study comparing risedronate and teriparatide in cases of severe osteoporosis, teriparatide was more effective in reducing the recurrence of vertebral fractures.
The favorable opinion of the French National Authority for Health in relation to medical coverage for romosozumab in the treatment of severe postmenopausal osteoporosis in women under the age of 75 years with a history of severe fractures, a T-score less than –2.5, and no previous history of coronary artery disease dates to 2021. This is because medical coverage for this specific group was not listed in the marketing authorization (MA) description for this drug.
But the review by the Economic Committee for Health Products failed to reach a consensus regarding the price. Today, in theory, romosozumab can be dispensed in France by hospital pharmacies, because it is approved for use in public hospitals. Romosozumab is a very interesting drug for relatively young women, especially those with multiple vertebral fractures. This injectable treatment is more effective than teriparatide in increasing BMD values and more effective than alendronate in preventing the recurrence of fractures.
Regarding medical coverage, as it stands, in cases where patients have a T-score less than or equal to –3, the 2018 SFR–GRIO recommends starting treatment even if the patient has no fractures. In cases with severe fractures combined with very low BMD (T-score ≤ –3), injectable treatments may be used to reach a bone density target (T-score > –2.5 to –2 for the hip) at the end of the treatment plan. [These treatments include] zoledronic acid, denosumab (in case of bisphosphonate failure or intolerance), or a treatment plan with teriparatide (covered by medical insurance if the patient has at least two vertebral fractures) followed by an antiresorptive drug (bisphosphonate or denosumab).
Romosozumab is a humanized monoclonal antibody (IgG2) that binds to sclerostin and acts as an inhibitor. This increases bone formation because of the activation of [bone lining cells], the production of bone matrix by osteoblasts, and the recruitment of osteochondroprogenitor cells. Moreover, romosozumab causes changes in the expression of osteoclast mediators, which decreases bone resorption. Together, these two effects that increase bone formation and decrease bone resorption lead to the rapid increase of trabecular and cortical bone mass, as well as improvements in bone structure and strength.
Women treated with a bone anabolic agent must take an antiresorptive agent at the end of their treatment so that the benefits from the treatment remain in the long term. The French and U.S. guidelines line up on this point.
In patients with two prevalent vertebral fractures, the U.S. guidelines state that teriparatide can be prescribed as first-line treatment at diagnosis in the absence of any contraindications. We agree on this point as well.
Moreover, in women under the age of 70 years with osteoporosis requiring treatment, French experts recommend prescribing raloxifene, a selective estrogen-receptor modulator. This is if the risk of nonvertebral fracture is low, as defined by the absence of the following criteria: low hip T-score, risk of falling, and history of nonvertebral fracture. Opportunities for its use are limited, and it doesn’t even figure among the U.S. recommendations.
Q. The ACP recommends that clinicians adopt an individualized approach regarding whether to start medical treatment with a bisphosphonate in women over age 65 years with low bone mass (osteopenia) to reduce the risk of fractures. If treatment is started, they›re of the opinion that a bisphosphonate must be used. What are the recommendations in France?
A. It should be noted that this recommendation by the ACP is conditional because of the low-certainty evidence.
Here’s a brief reminder of important things to note: a T-score between –2.5 and –1 indicates osteopenia; a T-score less than or equal to –2.5 indicates osteoporosis; a T-score less than or equal to –2.5 with one or several fractures indicates severe osteoporosis. The French recommendations state that treatment is not justified if a patient’s T-score is higher than –2 and there’s no presence of fractures, even with risk factors (and/or multiple falls). For T-scores less than or equal to –2 and higher than –3, the decision to prescribe depends on the specialist.
Q. The ACP recommends that clinicians use bisphosphonates for the initial medical treatment to reduce the risk of fractures in men diagnosed with primary osteoporosis.
A. The ACP recommends that clinicians use a RANK ligand inhibitor – denosumab – as second-line medical treatment to reduce the risk of fractures in men diagnosed with primary osteoporosis who present with contraindications or who are experiencing side effects of bisphosphonates. This treatment is not covered by health insurance for men in France.
Between 20% and 25% of clinical osteoporotic fractures occur in men. After age 50 years, men are roughly 20% more likely to experience an osteoporotic fracture in their lifetime. The French recommendations regarding the management and treatment of osteoporosis in men were published in 2021.
In the case of severe fractures (vertebrae, pelvis, upper end of the femur, distal femur, proximal humerus) attributable to bone fragility, osteoporosis treatment is recommended if one of the T-scores is less than or equal to –1.
In the case of nonsevere fractures (particularly wrist and ankle) attributable to bone fragility, osteoporosis treatment is recommended if one of the T-scores is less than or equal to –2. If there are no fractures, osteoporosis treatment is recommended in men at risk of bone fragility or of falling and if one of the T-scores is less than or equal to –3. In patients who had a fracture of the upper end of the femur attributable to bone fragility, zoledronic acid is recommended as first-line treatment.
For men with a severe nonvertebral fracture, single vertebral fracture, or nonsevere fracture, two treatments are indicated and covered by health insurance in France: zoledronic acid and risedronate. In men with at least two vertebral fractures, the following treatments are indicated and covered by health insurance in France: teriparatide and risedronate. In this case, teriparatide is prescribed for a period of 18 months. It must be followed by a prescription of oral or intravenous bisphosphonates.
Q. What is your take on the HAS update to the proper use of osteoporosis medication that’s just been published?
A. Like in the 2018 SFR–GRIO guidelines, no update has been made to the section on postmenopausal osteoporosis, except for the HAS introduction to the proper use of romosozumab, even though it’s not covered by health insurance in France.
In accordance with the MA, it doesn’t make sense to include this drug on the list of treatment options available for women with and without fractures, as it’s not included in the HAS-selected list of drugs covered by health insurance in France.
But I’m glad that the HAS has adopted the GRIO and SFR recommendations regarding corticosteroid-induced osteoporosis. Preventive treatment for corticosteroid-induced osteoporosis must be considered as soon as the daily dose of corticosteroids reaches or exceeds the equivalent of 7.5 mg of prednisone and when the estimated duration of corticosteroid therapy exceeds 3 months.
In summary, in women and men over the age of 50 years, the intake of the equivalent of 7.5 mg/day or more of prednisone or a history of a low-trauma fracture or being age 70 years or older, even with a T-score less than or equal to –2.5 for one of the two sites, indicates prescribing a bisphosphonate. Teriparatide is indicated if the patient has two vertebral fractures.
This article was translated from Medscape’s French edition.
A version of this article first appeared on Medscape.com.
Lille, France – Bernard Cortet, MD, PhD, chairperson of the Osteoporosis Research and Information Group and head of the rheumatology department at Lille (France) University Hospital, has agreed to compare the new U.S. guidelines to the 2018 French recommendations written under the aegis of the French Society for Rheumatology and GRIO. Dr. Cortet participated in drafting the French recommendations.
Question: The ACP “strongly” recommends initial pharmacologic treatment with bisphosphonate antiresorptive drugs (alendronate, ibandronate, risedronate, zoledronate) in postmenopausal females diagnosed with primary osteoporosis. Isn’t this what the SFR–GRIO have been recommending for many years?
Answer: The ACP reinforces its stance by arguing that in postmenopausal females with primary osteoporosis, bisphosphonates have the most favorable balance between benefits, harms, patient values and preferences, and cost among the drug classes that were evaluated. In addition to net clinical benefits, bisphosphonates are much cheaper than other pharmacologic treatments and are available in generic oral and injectable formulations.
Our French recommendations specify the choice of drug based on the type of fracture in women and on their bone mineral density (BMD). However, bisphosphonates are definitely given pride of place. When treatment for osteoporosis needs to be started, most of the time, a bisphosphonate is the treatment of choice.
Nevertheless, as also highlighted by the ACP, a more “aggressive” approach must be considered for more severe cases.
In the case of a severe fracture, the French recommendations indicate that all treatments can be prescribed. However, zoledronic acid should be favored as first-line treatment for a hip fracture. In other cases – with or without a nonsevere fracture – the therapeutic indication depends on the BMD values, and in difficult cases, on tools such as FRAX [the Fracture Risk Assessment Tool].
Our guidance strongly recommends opting for an injection in other contexts, such as significant decrease in bone density, presence of comorbidities, poor treatment compliance, brain function disorders, and polymedication.
Q. But it’s not really as simple as prescribing a bisphosphonate, is it?
A. You’re right, many people find the idea of taking bisphosphonates worrying because of associated jaw problems – osteonecrosis of the jaw – or atypical femoral fractures, based on what they’ve read on the Internet, where these serious adverse events are on display front and center with no mention of how often they actually happen and, often, failing to mention how effective bisphosphonates truly are.
These complications are real, but fortunately rare, especially during the first 5 years of treatment. To put this into context, for bisphosphonates, there’s one case of osteonecrosis of the jaw for every 10,000. And for denosumab, there are five cases for every 10,000. For atypical fractures, there’s one case for every 30,000 to 50,000.
Q. The U.S. guidelines also recommend that clinicians use a RANK ligand inhibitor – denosumab, also an antiresorptive drug – as second-line medical treatment. This is to reduce the risk of fractures in postmenopausal women diagnosed with primary osteoporosis and presenting with contraindications or side effects of bisphosphonates. Do you support the use of denosumab as second-line treatment?
A. French legislation classifies it as a second-line treatment, after bisphosphonates. However, there are arguments in favor of prescribing it as first-line treatment in some contexts. If denosumab is to be prescribed – via a twice-yearly subcutaneous injection – full compliance must be observed. If a patient is to stop taking denosumab, an opinion from a medical professional is required before treatment can be discontinued, and then treatment with bisphosphonates must be prescribed.
Q. The ACP recommends that clinicians use either a sclerostin inhibitor – romosozumab – or recombinant human parathyroid hormone – teriparatide – two anabolic agents, followed by a bisphosphonate, with the aim of reducing the risk of fractures. This is only used in women with primary osteoporosis who are at a very high risk of fracture. As romosozumab is not available in France, it’s not really worth discussing its use. Does this strategy seem advisable to you, though?
A. The main issue is what is understood by “women at a very high risk of fracture.” There’s no consensus on the definition of what constitutes a woman at a very high risk of fracture, but we can assume that it involves the combination of low BMD and at least one severe fracture.
The role of anabolic bone treatment, as [the ACP] has defined it, seems logical to me, because in cases of severe osteoporosis with fracture, the risk of recurrence is very high in the next 2-3 years. In a study comparing risedronate and teriparatide in cases of severe osteoporosis, teriparatide was more effective in reducing the recurrence of vertebral fractures.
The favorable opinion of the French National Authority for Health in relation to medical coverage for romosozumab in the treatment of severe postmenopausal osteoporosis in women under the age of 75 years with a history of severe fractures, a T-score less than –2.5, and no previous history of coronary artery disease dates to 2021. This is because medical coverage for this specific group was not listed in the marketing authorization (MA) description for this drug.
But the review by the Economic Committee for Health Products failed to reach a consensus regarding the price. Today, in theory, romosozumab can be dispensed in France by hospital pharmacies, because it is approved for use in public hospitals. Romosozumab is a very interesting drug for relatively young women, especially those with multiple vertebral fractures. This injectable treatment is more effective than teriparatide in increasing BMD values and more effective than alendronate in preventing the recurrence of fractures.
Regarding medical coverage, as it stands, in cases where patients have a T-score less than or equal to –3, the 2018 SFR–GRIO recommends starting treatment even if the patient has no fractures. In cases with severe fractures combined with very low BMD (T-score ≤ –3), injectable treatments may be used to reach a bone density target (T-score > –2.5 to –2 for the hip) at the end of the treatment plan. [These treatments include] zoledronic acid, denosumab (in case of bisphosphonate failure or intolerance), or a treatment plan with teriparatide (covered by medical insurance if the patient has at least two vertebral fractures) followed by an antiresorptive drug (bisphosphonate or denosumab).
Romosozumab is a humanized monoclonal antibody (IgG2) that binds to sclerostin and acts as an inhibitor. This increases bone formation because of the activation of [bone lining cells], the production of bone matrix by osteoblasts, and the recruitment of osteochondroprogenitor cells. Moreover, romosozumab causes changes in the expression of osteoclast mediators, which decreases bone resorption. Together, these two effects that increase bone formation and decrease bone resorption lead to the rapid increase of trabecular and cortical bone mass, as well as improvements in bone structure and strength.
Women treated with a bone anabolic agent must take an antiresorptive agent at the end of their treatment so that the benefits from the treatment remain in the long term. The French and U.S. guidelines line up on this point.
In patients with two prevalent vertebral fractures, the U.S. guidelines state that teriparatide can be prescribed as first-line treatment at diagnosis in the absence of any contraindications. We agree on this point as well.
Moreover, in women under the age of 70 years with osteoporosis requiring treatment, French experts recommend prescribing raloxifene, a selective estrogen-receptor modulator. This is if the risk of nonvertebral fracture is low, as defined by the absence of the following criteria: low hip T-score, risk of falling, and history of nonvertebral fracture. Opportunities for its use are limited, and it doesn’t even figure among the U.S. recommendations.
Q. The ACP recommends that clinicians adopt an individualized approach regarding whether to start medical treatment with a bisphosphonate in women over age 65 years with low bone mass (osteopenia) to reduce the risk of fractures. If treatment is started, they›re of the opinion that a bisphosphonate must be used. What are the recommendations in France?
A. It should be noted that this recommendation by the ACP is conditional because of the low-certainty evidence.
Here’s a brief reminder of important things to note: a T-score between –2.5 and –1 indicates osteopenia; a T-score less than or equal to –2.5 indicates osteoporosis; a T-score less than or equal to –2.5 with one or several fractures indicates severe osteoporosis. The French recommendations state that treatment is not justified if a patient’s T-score is higher than –2 and there’s no presence of fractures, even with risk factors (and/or multiple falls). For T-scores less than or equal to –2 and higher than –3, the decision to prescribe depends on the specialist.
Q. The ACP recommends that clinicians use bisphosphonates for the initial medical treatment to reduce the risk of fractures in men diagnosed with primary osteoporosis.
A. The ACP recommends that clinicians use a RANK ligand inhibitor – denosumab – as second-line medical treatment to reduce the risk of fractures in men diagnosed with primary osteoporosis who present with contraindications or who are experiencing side effects of bisphosphonates. This treatment is not covered by health insurance for men in France.
Between 20% and 25% of clinical osteoporotic fractures occur in men. After age 50 years, men are roughly 20% more likely to experience an osteoporotic fracture in their lifetime. The French recommendations regarding the management and treatment of osteoporosis in men were published in 2021.
In the case of severe fractures (vertebrae, pelvis, upper end of the femur, distal femur, proximal humerus) attributable to bone fragility, osteoporosis treatment is recommended if one of the T-scores is less than or equal to –1.
In the case of nonsevere fractures (particularly wrist and ankle) attributable to bone fragility, osteoporosis treatment is recommended if one of the T-scores is less than or equal to –2. If there are no fractures, osteoporosis treatment is recommended in men at risk of bone fragility or of falling and if one of the T-scores is less than or equal to –3. In patients who had a fracture of the upper end of the femur attributable to bone fragility, zoledronic acid is recommended as first-line treatment.
For men with a severe nonvertebral fracture, single vertebral fracture, or nonsevere fracture, two treatments are indicated and covered by health insurance in France: zoledronic acid and risedronate. In men with at least two vertebral fractures, the following treatments are indicated and covered by health insurance in France: teriparatide and risedronate. In this case, teriparatide is prescribed for a period of 18 months. It must be followed by a prescription of oral or intravenous bisphosphonates.
Q. What is your take on the HAS update to the proper use of osteoporosis medication that’s just been published?
A. Like in the 2018 SFR–GRIO guidelines, no update has been made to the section on postmenopausal osteoporosis, except for the HAS introduction to the proper use of romosozumab, even though it’s not covered by health insurance in France.
In accordance with the MA, it doesn’t make sense to include this drug on the list of treatment options available for women with and without fractures, as it’s not included in the HAS-selected list of drugs covered by health insurance in France.
But I’m glad that the HAS has adopted the GRIO and SFR recommendations regarding corticosteroid-induced osteoporosis. Preventive treatment for corticosteroid-induced osteoporosis must be considered as soon as the daily dose of corticosteroids reaches or exceeds the equivalent of 7.5 mg of prednisone and when the estimated duration of corticosteroid therapy exceeds 3 months.
In summary, in women and men over the age of 50 years, the intake of the equivalent of 7.5 mg/day or more of prednisone or a history of a low-trauma fracture or being age 70 years or older, even with a T-score less than or equal to –2.5 for one of the two sites, indicates prescribing a bisphosphonate. Teriparatide is indicated if the patient has two vertebral fractures.
This article was translated from Medscape’s French edition.
A version of this article first appeared on Medscape.com.
Emergency birth on a plane: Two doctors earn their wings
Emergencies happen anywhere, anytime, and sometimes medical professionals find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a series telling these stories.
In December 2017, I was a second-year urology resident at Cleveland Clinic. I’d gone to New Delhi to attend my best friend’s wedding. My flight back was New Delhi to Paris to JFK via Air France. I didn’t sleep on the first flight. So, on the second, I wanted to get some rest, because I had to go back to work the next day. I put on a movie and tried to snooze. As the saying goes in residency, you sleep when you can.
About 3 hours later, a flight attendant made an announcement in French, but I didn’t really hear it. Then they announced in English that they needed a physician. I noticed some flight attendants walking frantically around the economy cabin asking, “Is there a doctor on the plane?” Turns out there were two – the woman sitting next to me happened to be a pediatrician with Doctors Without Borders. I volunteered.
The flight attendant told me a woman was having abdominal pain. I thought it would be something straightforward. Usually, medical emergencies on planes involve chest pain or a panic attack or a vasovagal syncopal episode. Well, I was in for a ride that day.
She said she was 37 or 38 weeks in. I said, “Okay, if you’re having this significant abdominal pain, then I need to examine you.” So we decided to move her to the first-class cabin, which was empty (I never did ask why – but it was good we had room to work).
Next step, I went back to my seat and asked the pediatrician if she could assist. My plan was to simply get the passenger through the flight, and as soon as we landed, she would go to the hospital.
There was room to lie down in first class. The pediatrician and I examined her, and she appeared fine. She was traveling with her 4-year-old daughter, and the flight attendants were taking care of her. Everything was okay.
The pilot came back and asked if we would need an emergency landing. I asked him how far it was to JFK – 4 hours. He said the closest place to land would be the Azores Islands, which is Portuguese territory, 2 hours away.
The problem: Even if we made it to the Azores, the hospital there was a very basic facility with no obstetric care available. And by the time the ambulance picked her up and got her there, it would still be 2 or 3 hours total. I said, “No, let’s just observe and continue our course.” Inside my head, I was hoping and praying to God that was the right decision.
Within an hour, everything changed.
The woman’s pain got worse, and she started having contractions. Then her water broke.
Things progressed quickly from there. The contractions progressively got worse and worse. The interval between them got smaller and smaller. The next time we examined her, we could see the baby’s head beginning to crown.
At that point, we had to decide – are we going to deliver? We were in the middle of the North Atlantic Ocean. There was nothing around us. We were 35,000 feet in the air, surrounded by blue.
The crew wanted us to sign a Good Samaritan agreement. So, we did that. And then I said, “Okay, let’s just go for it.”
We got the plane’s medical kit. They had IV fluids, so I started an IV. I was able to monitor the woman’s blood pressure. They had the usual drugs for doing ACLS [advanced cardiac life support], running the code, and things like that. But they didn’t have a suturing kit or a laceration kit. They didn’t have a scalpel. There was nothing else.
Honestly, there was a lot of panic going through my head. I started thinking about what could go wrong. I’d done an ob.gyn. rotation in medical school and delivered seven babies before it was over. But a plane – even the first-class cabin – is in no way, shape, or form like a delivery room. I was really scared she would hemorrhage out or something.
So, internally, I was having a meltdown. Sij, you have to keep it together right now, because there’s no one else that’s going to do this. Just give it your best shot. And that’s what I did.
I asked the pilot to go to an altitude that would minimize any turbulence, and we were very lucky that the notorious North Atlantic air wasn’t choppy.
More luck: This was the passenger’s second baby, and I was counting on second deliveries being easier. The pediatrician, the flight attendants, and I came together as a team. Two flight attendants had given birth before, so they held the patient’s hand and guided her to push. I was “downstairs” waiting to catch.
She was in some pain. At this point, usually people get an epidural. I kept thinking about what drugs were safe in pregnancy, but I wasn’t sure. I don’t know if they even had morphine or anything on the plane. We gave her some Tylenol.
It didn’t take long. After about 30 minutes, the baby’s head emerged. I was able to navigate it out, avoiding any shoulder dystocia. There’s a certain technique that you learn in medical school, which thankfully came back to me. I caught it – it was a boy born right there in a first-class seat.
I gave him to the pediatrician, and she did the Apgar score, calculating his breathing and appearance. Then my job was to make sure there were no postpartum complications.
I ended up using a piece of string in the kit to tie around the umbilical cord, and then I cut it with scissors. After that, the woman was able to deliver the placenta. She did have some vaginal bleeding, but that resolved by just holding pressure.
The baby was fine. Mom was doing great. No complications. It was a miracle. I was the right person at the right place at the right time. I just think it was something from God.
The pilot made an announcement, “We’re en route to JFK, and there’s an additional passenger on this plane now.”
When we landed, I had very little time because I had to catch my flight to Cleveland. I didn’t even process what had happened.
A few days later, I got this package from Air France with a very expensive bottle of champagne along with a travel voucher. I heard from the mom by email – she and baby were doing fine.
Eventually, the media relations people at Cleveland Clinic heard about the incident, and it became a story that went viral. That was very weird, because I’m usually someone who’s private. All through my residency, people would introduce me with, “Remember that guy who delivered a baby on a plane? That’s him.”
I’m so thankful for everyone who was on that team. It was very beautiful because it was people from different cultures, backgrounds, and faiths who came together to achieve something so miraculous. The patient was Nigerian. The flight attendants were French. The pediatrician and I were American.
That just shows you the power of teamwork and how humanity can come together. Medicine, surgery – everything, in fact – is a team sport.
Sij Hemal, MD, graduated from urology residency at the Cleveland Clinic and is currently a robotic urologic oncology and minimally invasive surgery fellow at the University of Southern California, Los Angeles.
A version of this article originally appeared on Medscape.com.
Emergencies happen anywhere, anytime, and sometimes medical professionals find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a series telling these stories.
In December 2017, I was a second-year urology resident at Cleveland Clinic. I’d gone to New Delhi to attend my best friend’s wedding. My flight back was New Delhi to Paris to JFK via Air France. I didn’t sleep on the first flight. So, on the second, I wanted to get some rest, because I had to go back to work the next day. I put on a movie and tried to snooze. As the saying goes in residency, you sleep when you can.
About 3 hours later, a flight attendant made an announcement in French, but I didn’t really hear it. Then they announced in English that they needed a physician. I noticed some flight attendants walking frantically around the economy cabin asking, “Is there a doctor on the plane?” Turns out there were two – the woman sitting next to me happened to be a pediatrician with Doctors Without Borders. I volunteered.
The flight attendant told me a woman was having abdominal pain. I thought it would be something straightforward. Usually, medical emergencies on planes involve chest pain or a panic attack or a vasovagal syncopal episode. Well, I was in for a ride that day.
She said she was 37 or 38 weeks in. I said, “Okay, if you’re having this significant abdominal pain, then I need to examine you.” So we decided to move her to the first-class cabin, which was empty (I never did ask why – but it was good we had room to work).
Next step, I went back to my seat and asked the pediatrician if she could assist. My plan was to simply get the passenger through the flight, and as soon as we landed, she would go to the hospital.
There was room to lie down in first class. The pediatrician and I examined her, and she appeared fine. She was traveling with her 4-year-old daughter, and the flight attendants were taking care of her. Everything was okay.
The pilot came back and asked if we would need an emergency landing. I asked him how far it was to JFK – 4 hours. He said the closest place to land would be the Azores Islands, which is Portuguese territory, 2 hours away.
The problem: Even if we made it to the Azores, the hospital there was a very basic facility with no obstetric care available. And by the time the ambulance picked her up and got her there, it would still be 2 or 3 hours total. I said, “No, let’s just observe and continue our course.” Inside my head, I was hoping and praying to God that was the right decision.
Within an hour, everything changed.
The woman’s pain got worse, and she started having contractions. Then her water broke.
Things progressed quickly from there. The contractions progressively got worse and worse. The interval between them got smaller and smaller. The next time we examined her, we could see the baby’s head beginning to crown.
At that point, we had to decide – are we going to deliver? We were in the middle of the North Atlantic Ocean. There was nothing around us. We were 35,000 feet in the air, surrounded by blue.
The crew wanted us to sign a Good Samaritan agreement. So, we did that. And then I said, “Okay, let’s just go for it.”
We got the plane’s medical kit. They had IV fluids, so I started an IV. I was able to monitor the woman’s blood pressure. They had the usual drugs for doing ACLS [advanced cardiac life support], running the code, and things like that. But they didn’t have a suturing kit or a laceration kit. They didn’t have a scalpel. There was nothing else.
Honestly, there was a lot of panic going through my head. I started thinking about what could go wrong. I’d done an ob.gyn. rotation in medical school and delivered seven babies before it was over. But a plane – even the first-class cabin – is in no way, shape, or form like a delivery room. I was really scared she would hemorrhage out or something.
So, internally, I was having a meltdown. Sij, you have to keep it together right now, because there’s no one else that’s going to do this. Just give it your best shot. And that’s what I did.
I asked the pilot to go to an altitude that would minimize any turbulence, and we were very lucky that the notorious North Atlantic air wasn’t choppy.
More luck: This was the passenger’s second baby, and I was counting on second deliveries being easier. The pediatrician, the flight attendants, and I came together as a team. Two flight attendants had given birth before, so they held the patient’s hand and guided her to push. I was “downstairs” waiting to catch.
She was in some pain. At this point, usually people get an epidural. I kept thinking about what drugs were safe in pregnancy, but I wasn’t sure. I don’t know if they even had morphine or anything on the plane. We gave her some Tylenol.
It didn’t take long. After about 30 minutes, the baby’s head emerged. I was able to navigate it out, avoiding any shoulder dystocia. There’s a certain technique that you learn in medical school, which thankfully came back to me. I caught it – it was a boy born right there in a first-class seat.
I gave him to the pediatrician, and she did the Apgar score, calculating his breathing and appearance. Then my job was to make sure there were no postpartum complications.
I ended up using a piece of string in the kit to tie around the umbilical cord, and then I cut it with scissors. After that, the woman was able to deliver the placenta. She did have some vaginal bleeding, but that resolved by just holding pressure.
The baby was fine. Mom was doing great. No complications. It was a miracle. I was the right person at the right place at the right time. I just think it was something from God.
The pilot made an announcement, “We’re en route to JFK, and there’s an additional passenger on this plane now.”
When we landed, I had very little time because I had to catch my flight to Cleveland. I didn’t even process what had happened.
A few days later, I got this package from Air France with a very expensive bottle of champagne along with a travel voucher. I heard from the mom by email – she and baby were doing fine.
Eventually, the media relations people at Cleveland Clinic heard about the incident, and it became a story that went viral. That was very weird, because I’m usually someone who’s private. All through my residency, people would introduce me with, “Remember that guy who delivered a baby on a plane? That’s him.”
I’m so thankful for everyone who was on that team. It was very beautiful because it was people from different cultures, backgrounds, and faiths who came together to achieve something so miraculous. The patient was Nigerian. The flight attendants were French. The pediatrician and I were American.
That just shows you the power of teamwork and how humanity can come together. Medicine, surgery – everything, in fact – is a team sport.
Sij Hemal, MD, graduated from urology residency at the Cleveland Clinic and is currently a robotic urologic oncology and minimally invasive surgery fellow at the University of Southern California, Los Angeles.
A version of this article originally appeared on Medscape.com.
Emergencies happen anywhere, anytime, and sometimes medical professionals find themselves in situations where they are the only ones who can help. Is There a Doctor in the House? is a series telling these stories.
In December 2017, I was a second-year urology resident at Cleveland Clinic. I’d gone to New Delhi to attend my best friend’s wedding. My flight back was New Delhi to Paris to JFK via Air France. I didn’t sleep on the first flight. So, on the second, I wanted to get some rest, because I had to go back to work the next day. I put on a movie and tried to snooze. As the saying goes in residency, you sleep when you can.
About 3 hours later, a flight attendant made an announcement in French, but I didn’t really hear it. Then they announced in English that they needed a physician. I noticed some flight attendants walking frantically around the economy cabin asking, “Is there a doctor on the plane?” Turns out there were two – the woman sitting next to me happened to be a pediatrician with Doctors Without Borders. I volunteered.
The flight attendant told me a woman was having abdominal pain. I thought it would be something straightforward. Usually, medical emergencies on planes involve chest pain or a panic attack or a vasovagal syncopal episode. Well, I was in for a ride that day.
She said she was 37 or 38 weeks in. I said, “Okay, if you’re having this significant abdominal pain, then I need to examine you.” So we decided to move her to the first-class cabin, which was empty (I never did ask why – but it was good we had room to work).
Next step, I went back to my seat and asked the pediatrician if she could assist. My plan was to simply get the passenger through the flight, and as soon as we landed, she would go to the hospital.
There was room to lie down in first class. The pediatrician and I examined her, and she appeared fine. She was traveling with her 4-year-old daughter, and the flight attendants were taking care of her. Everything was okay.
The pilot came back and asked if we would need an emergency landing. I asked him how far it was to JFK – 4 hours. He said the closest place to land would be the Azores Islands, which is Portuguese territory, 2 hours away.
The problem: Even if we made it to the Azores, the hospital there was a very basic facility with no obstetric care available. And by the time the ambulance picked her up and got her there, it would still be 2 or 3 hours total. I said, “No, let’s just observe and continue our course.” Inside my head, I was hoping and praying to God that was the right decision.
Within an hour, everything changed.
The woman’s pain got worse, and she started having contractions. Then her water broke.
Things progressed quickly from there. The contractions progressively got worse and worse. The interval between them got smaller and smaller. The next time we examined her, we could see the baby’s head beginning to crown.
At that point, we had to decide – are we going to deliver? We were in the middle of the North Atlantic Ocean. There was nothing around us. We were 35,000 feet in the air, surrounded by blue.
The crew wanted us to sign a Good Samaritan agreement. So, we did that. And then I said, “Okay, let’s just go for it.”
We got the plane’s medical kit. They had IV fluids, so I started an IV. I was able to monitor the woman’s blood pressure. They had the usual drugs for doing ACLS [advanced cardiac life support], running the code, and things like that. But they didn’t have a suturing kit or a laceration kit. They didn’t have a scalpel. There was nothing else.
Honestly, there was a lot of panic going through my head. I started thinking about what could go wrong. I’d done an ob.gyn. rotation in medical school and delivered seven babies before it was over. But a plane – even the first-class cabin – is in no way, shape, or form like a delivery room. I was really scared she would hemorrhage out or something.
So, internally, I was having a meltdown. Sij, you have to keep it together right now, because there’s no one else that’s going to do this. Just give it your best shot. And that’s what I did.
I asked the pilot to go to an altitude that would minimize any turbulence, and we were very lucky that the notorious North Atlantic air wasn’t choppy.
More luck: This was the passenger’s second baby, and I was counting on second deliveries being easier. The pediatrician, the flight attendants, and I came together as a team. Two flight attendants had given birth before, so they held the patient’s hand and guided her to push. I was “downstairs” waiting to catch.
She was in some pain. At this point, usually people get an epidural. I kept thinking about what drugs were safe in pregnancy, but I wasn’t sure. I don’t know if they even had morphine or anything on the plane. We gave her some Tylenol.
It didn’t take long. After about 30 minutes, the baby’s head emerged. I was able to navigate it out, avoiding any shoulder dystocia. There’s a certain technique that you learn in medical school, which thankfully came back to me. I caught it – it was a boy born right there in a first-class seat.
I gave him to the pediatrician, and she did the Apgar score, calculating his breathing and appearance. Then my job was to make sure there were no postpartum complications.
I ended up using a piece of string in the kit to tie around the umbilical cord, and then I cut it with scissors. After that, the woman was able to deliver the placenta. She did have some vaginal bleeding, but that resolved by just holding pressure.
The baby was fine. Mom was doing great. No complications. It was a miracle. I was the right person at the right place at the right time. I just think it was something from God.
The pilot made an announcement, “We’re en route to JFK, and there’s an additional passenger on this plane now.”
When we landed, I had very little time because I had to catch my flight to Cleveland. I didn’t even process what had happened.
A few days later, I got this package from Air France with a very expensive bottle of champagne along with a travel voucher. I heard from the mom by email – she and baby were doing fine.
Eventually, the media relations people at Cleveland Clinic heard about the incident, and it became a story that went viral. That was very weird, because I’m usually someone who’s private. All through my residency, people would introduce me with, “Remember that guy who delivered a baby on a plane? That’s him.”
I’m so thankful for everyone who was on that team. It was very beautiful because it was people from different cultures, backgrounds, and faiths who came together to achieve something so miraculous. The patient was Nigerian. The flight attendants were French. The pediatrician and I were American.
That just shows you the power of teamwork and how humanity can come together. Medicine, surgery – everything, in fact – is a team sport.
Sij Hemal, MD, graduated from urology residency at the Cleveland Clinic and is currently a robotic urologic oncology and minimally invasive surgery fellow at the University of Southern California, Los Angeles.
A version of this article originally appeared on Medscape.com.
Back pain: Red flags and when to image
This transcript has been edited for clarity.
Matthew F. Watto, MD: Welcome back to The Curbsiders. On tonight’s episode, we are going to be talking about back pain. I’ll use one of my famous teaching techniques: If the patient has any kind of back pain, they should just not move. Right?
Paul N. Williams, MD: That’s right, Matt – we should recommend bedrest until they get better for anyone who has any back pain? No. For back pain, early activity and exercise are great. Patients are often concerned that physical therapy will make their pain worse, so they don’t exercise. This misunderstanding is not surprising. They believe that if they are experiencing pain, it’s facilitating more damage, which is not necessarily the case. It will get better, and a little bit of anticipatory guidance goes a long way in terms of managing patient expectations related to early mobilization, early exercise, and physical therapy.
Dr. Watto: Absolutely. One of the goals of treatment is symptom relief to the extent that we’re able to achieve. We’re not expecting the pain to go to zero. That just doesn’t happen, especially if someone’s on a medication long term. Another goal is return to function. We want them sleeping. We want them to be able to tolerate movement.
We have medications – NSAIDs and muscle relaxants, which are actually tranquilizers. But most therapy for back pain doesn’t involve medications. It involves active movement, so we have to find movement that the patient enjoys doing. Passive treatments, things being done to patients, just don’t work as well.
Dr. Williams: We should be clear – we’re talking primarily about chronic back pain here. For acute back pain, we actually have some decent medications, but acute back pain tends to improve no matter what you do. We don’t have much to offer pharmacologically for chronic low back pain. The best modalities usually involve physical activity of some kind.
Dr. Watto: Let’s discuss the evaluation of back pain. Something that always comes up: Should we order imaging, and is there a right time to get it? Dr. Baraki was very clear about when to do imaging. Two big buckets of patients might need imaging.
First, a patient who has a serious underlying condition and you’re using imaging to try to diagnose it; or in a chronic setting, a patient who needs surgery, and imaging is part of the presurgical evaluation. We talked about red flags.
The red flags are major trauma, where we have reason to believe there might be something going on – if we strongly suspect infection, or the patient is injecting drugs. If the patient has a history of cancer, we would be worried that they might have a recurrence. Those are some of the main red flags. With a patient who has osteoporosis or is on chronic steroids, you might even be able to get by with plain films instead of an MRI to look for fracture.
The other thing I wanted to ask you about is, when should we get imaging? Are there any pitfalls we need to worry about?
Dr. Williams: I always like podcasts I’m not on because I enjoy listening to them much more. Dr. Baraki talked about the very specific language that is used in radiology reports, such as spondylitis, spondylolysis, and multilevel degenerative disease. They sound bad, but if they are just reframed as age-related degenerative changes, that sounds so much more benign. When discussing with patients, we should avoid medical jargon and say that we saw some changes that we would expect for someone of your age. That sounds so much better than saying we saw multilevel degenerative disease, which sounds like an alarming pathology if you’re not a physician. Without being inaccurate, we should frame the discussion such that we aren’t providing a very specific diagnosis, because that is rarely the case with chronic low back pain. Typically, many things are going on and you may never identify a single unifying diagnosis, which doesn’t tend to help anyway.
Dr. Watto: There’s evidence showing that if the radiology report uses clinical terminology that both clinician and patient think of as less serious, they are less likely to proceed to more invasive treatments. Calling an episode of back pain a “lumbar strain” helps the patient understand that this is a pretty common thing. Almost everyone is going to have an episode of back pain at some point in their life, and almost all of them will get better. Most of the time there’s no serious underlying condition.
This was a great discussion with Dr. Baraki. Click on Back Pain Update with Dr Austin Baraki to hear the full discussion. Until next time, I’ve been Dr. Matthew Frank Watto.
Dr. Williams: And I’m Dr. Paul Nelson Williams.
Dr. Watto is Clinical Assistant Professor, Department of Medicine, University of Pennsylvania, Philadelphia. Dr. Williams is Associate Professor of Clinical Medicine, Department of General Internal Medicine, Temple University, Philadelphia. Neither reported any conflicts of interest.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Matthew F. Watto, MD: Welcome back to The Curbsiders. On tonight’s episode, we are going to be talking about back pain. I’ll use one of my famous teaching techniques: If the patient has any kind of back pain, they should just not move. Right?
Paul N. Williams, MD: That’s right, Matt – we should recommend bedrest until they get better for anyone who has any back pain? No. For back pain, early activity and exercise are great. Patients are often concerned that physical therapy will make their pain worse, so they don’t exercise. This misunderstanding is not surprising. They believe that if they are experiencing pain, it’s facilitating more damage, which is not necessarily the case. It will get better, and a little bit of anticipatory guidance goes a long way in terms of managing patient expectations related to early mobilization, early exercise, and physical therapy.
Dr. Watto: Absolutely. One of the goals of treatment is symptom relief to the extent that we’re able to achieve. We’re not expecting the pain to go to zero. That just doesn’t happen, especially if someone’s on a medication long term. Another goal is return to function. We want them sleeping. We want them to be able to tolerate movement.
We have medications – NSAIDs and muscle relaxants, which are actually tranquilizers. But most therapy for back pain doesn’t involve medications. It involves active movement, so we have to find movement that the patient enjoys doing. Passive treatments, things being done to patients, just don’t work as well.
Dr. Williams: We should be clear – we’re talking primarily about chronic back pain here. For acute back pain, we actually have some decent medications, but acute back pain tends to improve no matter what you do. We don’t have much to offer pharmacologically for chronic low back pain. The best modalities usually involve physical activity of some kind.
Dr. Watto: Let’s discuss the evaluation of back pain. Something that always comes up: Should we order imaging, and is there a right time to get it? Dr. Baraki was very clear about when to do imaging. Two big buckets of patients might need imaging.
First, a patient who has a serious underlying condition and you’re using imaging to try to diagnose it; or in a chronic setting, a patient who needs surgery, and imaging is part of the presurgical evaluation. We talked about red flags.
The red flags are major trauma, where we have reason to believe there might be something going on – if we strongly suspect infection, or the patient is injecting drugs. If the patient has a history of cancer, we would be worried that they might have a recurrence. Those are some of the main red flags. With a patient who has osteoporosis or is on chronic steroids, you might even be able to get by with plain films instead of an MRI to look for fracture.
The other thing I wanted to ask you about is, when should we get imaging? Are there any pitfalls we need to worry about?
Dr. Williams: I always like podcasts I’m not on because I enjoy listening to them much more. Dr. Baraki talked about the very specific language that is used in radiology reports, such as spondylitis, spondylolysis, and multilevel degenerative disease. They sound bad, but if they are just reframed as age-related degenerative changes, that sounds so much more benign. When discussing with patients, we should avoid medical jargon and say that we saw some changes that we would expect for someone of your age. That sounds so much better than saying we saw multilevel degenerative disease, which sounds like an alarming pathology if you’re not a physician. Without being inaccurate, we should frame the discussion such that we aren’t providing a very specific diagnosis, because that is rarely the case with chronic low back pain. Typically, many things are going on and you may never identify a single unifying diagnosis, which doesn’t tend to help anyway.
Dr. Watto: There’s evidence showing that if the radiology report uses clinical terminology that both clinician and patient think of as less serious, they are less likely to proceed to more invasive treatments. Calling an episode of back pain a “lumbar strain” helps the patient understand that this is a pretty common thing. Almost everyone is going to have an episode of back pain at some point in their life, and almost all of them will get better. Most of the time there’s no serious underlying condition.
This was a great discussion with Dr. Baraki. Click on Back Pain Update with Dr Austin Baraki to hear the full discussion. Until next time, I’ve been Dr. Matthew Frank Watto.
Dr. Williams: And I’m Dr. Paul Nelson Williams.
Dr. Watto is Clinical Assistant Professor, Department of Medicine, University of Pennsylvania, Philadelphia. Dr. Williams is Associate Professor of Clinical Medicine, Department of General Internal Medicine, Temple University, Philadelphia. Neither reported any conflicts of interest.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Matthew F. Watto, MD: Welcome back to The Curbsiders. On tonight’s episode, we are going to be talking about back pain. I’ll use one of my famous teaching techniques: If the patient has any kind of back pain, they should just not move. Right?
Paul N. Williams, MD: That’s right, Matt – we should recommend bedrest until they get better for anyone who has any back pain? No. For back pain, early activity and exercise are great. Patients are often concerned that physical therapy will make their pain worse, so they don’t exercise. This misunderstanding is not surprising. They believe that if they are experiencing pain, it’s facilitating more damage, which is not necessarily the case. It will get better, and a little bit of anticipatory guidance goes a long way in terms of managing patient expectations related to early mobilization, early exercise, and physical therapy.
Dr. Watto: Absolutely. One of the goals of treatment is symptom relief to the extent that we’re able to achieve. We’re not expecting the pain to go to zero. That just doesn’t happen, especially if someone’s on a medication long term. Another goal is return to function. We want them sleeping. We want them to be able to tolerate movement.
We have medications – NSAIDs and muscle relaxants, which are actually tranquilizers. But most therapy for back pain doesn’t involve medications. It involves active movement, so we have to find movement that the patient enjoys doing. Passive treatments, things being done to patients, just don’t work as well.
Dr. Williams: We should be clear – we’re talking primarily about chronic back pain here. For acute back pain, we actually have some decent medications, but acute back pain tends to improve no matter what you do. We don’t have much to offer pharmacologically for chronic low back pain. The best modalities usually involve physical activity of some kind.
Dr. Watto: Let’s discuss the evaluation of back pain. Something that always comes up: Should we order imaging, and is there a right time to get it? Dr. Baraki was very clear about when to do imaging. Two big buckets of patients might need imaging.
First, a patient who has a serious underlying condition and you’re using imaging to try to diagnose it; or in a chronic setting, a patient who needs surgery, and imaging is part of the presurgical evaluation. We talked about red flags.
The red flags are major trauma, where we have reason to believe there might be something going on – if we strongly suspect infection, or the patient is injecting drugs. If the patient has a history of cancer, we would be worried that they might have a recurrence. Those are some of the main red flags. With a patient who has osteoporosis or is on chronic steroids, you might even be able to get by with plain films instead of an MRI to look for fracture.
The other thing I wanted to ask you about is, when should we get imaging? Are there any pitfalls we need to worry about?
Dr. Williams: I always like podcasts I’m not on because I enjoy listening to them much more. Dr. Baraki talked about the very specific language that is used in radiology reports, such as spondylitis, spondylolysis, and multilevel degenerative disease. They sound bad, but if they are just reframed as age-related degenerative changes, that sounds so much more benign. When discussing with patients, we should avoid medical jargon and say that we saw some changes that we would expect for someone of your age. That sounds so much better than saying we saw multilevel degenerative disease, which sounds like an alarming pathology if you’re not a physician. Without being inaccurate, we should frame the discussion such that we aren’t providing a very specific diagnosis, because that is rarely the case with chronic low back pain. Typically, many things are going on and you may never identify a single unifying diagnosis, which doesn’t tend to help anyway.
Dr. Watto: There’s evidence showing that if the radiology report uses clinical terminology that both clinician and patient think of as less serious, they are less likely to proceed to more invasive treatments. Calling an episode of back pain a “lumbar strain” helps the patient understand that this is a pretty common thing. Almost everyone is going to have an episode of back pain at some point in their life, and almost all of them will get better. Most of the time there’s no serious underlying condition.
This was a great discussion with Dr. Baraki. Click on Back Pain Update with Dr Austin Baraki to hear the full discussion. Until next time, I’ve been Dr. Matthew Frank Watto.
Dr. Williams: And I’m Dr. Paul Nelson Williams.
Dr. Watto is Clinical Assistant Professor, Department of Medicine, University of Pennsylvania, Philadelphia. Dr. Williams is Associate Professor of Clinical Medicine, Department of General Internal Medicine, Temple University, Philadelphia. Neither reported any conflicts of interest.
A version of this article first appeared on Medscape.com.
ESMO guidelines provide ‘clear blueprint’ for managing immunotherapy toxicities
This transcript has been edited for clarity.
I’m David Kerr, professor of cancer medicine at the University of Oxford. I’d like to talk to you today about something specific and generic around guidelines.
It’s around the management of toxicities from immunotherapy, and it’s the ESMO Clinical Practice Guideline for diagnosis, treatment, and follow-up, delivered by Dr. Haanen and, of course, a number of colleagues on behalf of the wider committee.
Have a look at it. I’m not going to talk about the details of it. It’s very well written. It’s very clear and evidence based, of course. There are many helpful hints and a very clear blueprint as to how we should better manage the myriad of potential side effects from immunotherapy.
It tells us a little about the basis of the science, some of the mechanistic work that’s going on in allowing us to understand why some people react in such different ways, almost as if the immune systems are primed to overreact. It gives a very helpful, stepwise look at how we best diagnose, manage, and, in the longer term, follow up patients who have problems with these very important drugs.
All of us recognize the extraordinary impact they’ve made across a wide range of different tumor types, and therefore, as practicing oncologists and health care professionals in the field, all of us need to understand better the details as to how we better care for our patients on these drugs.
Have a look at it. It’s well written and useful, and I think it’s a document that I’ll turn to when I’m looking for a refresher or advice in the future.
The generic focus is about guidelines. Many years ago, I was one of the architects of the British National Cancer Plan, and for me, there were four simple principles at that stage in our development of how we would improve the delivery of cancer control in the United Kingdom. It was around site specialization, particularly of our surgical colleagues who embraced this with vigor. God bless them.
It was using guidelines to help level up the quality of treatment that we were giving, of course underpinned by research, and using – one would hope – modern IT and telecommunications to improve the networking that we use to deliver multidisciplinary cancer care, one of the key elements. Guidelines were embedded in that.
A couple of years ago, we did a survey of cancer physicians around the world. Almost 30 different countries were represented, and we asked which guidelines were most used. It was a very interesting set of responses. The three dominant guidelines – this will surprise no one – are the NCCN (National Comprehensive Cancer Network) guidelines, the ESMO guidelines, and the ASCO (American Society of Clinical Oncology) guidelines.
Rather than selecting one and one being completely dominant, what seemed to be the case is that our colleagues around the world dipped in and used all three. They may prefer NCCN for some particular tumor type or some particular aspect of how they’re structured, but at the same time, we would dip into the ESMO guidelines for specific bits of help, as well as the ASCO guidelines.
I find this fascinating. I assume that in different regions, depending on how they were affiliated in terms of additional training or links to Europe or links to the United States, that one or other of these guideline groups would predominate, but no. In each country, in each region, given the large data bank that we have of guidelines now, it’s a sort of pick-and-mix situation.
I was initially surprised but then took comfort from it. There’s nothing I hate more than the wasted energy of reduplication and saying, well come on, if there is one guideline set that does truly command the attention of the world, then the other should stop. It’s wasted energy, which is something that none of us can afford.
The fact that each of these trusted, evidence-based, beautifully presented guidelines is used in different ways was important. A message to the guideline groups from me is: “Thank you for your professionalism, for the hard work of hundreds of cancer specialists from all different specialties, and for their contribution to developing these guidelines.”
It’s worth it, it’s working, people are using them, and they’re making a difference. It’s all about leveling up the quality of cancer care that we deliver.
Specifically, have a look at the ESMO immune guidelines. They are great. I hope you find them helpful. Generically, thanks to all of you who are contributing and working so hard to make these data available to improve the quality of cancer care around the world.
Thanks for listening, as always. I’m interested in any comments that you might have, but for the time being, Medscapers, ahoy.
David J. Kerr, CBE, MD, DSc, is a professor of cancer medicine at the University of Oxford. He reported conflicts of interest with Celleron Therapeutics, Oxford Cancer Biomarkers, Afrox, GlaxoSmithKline, Bayer, Genomic Health, and Merck Serono.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
I’m David Kerr, professor of cancer medicine at the University of Oxford. I’d like to talk to you today about something specific and generic around guidelines.
It’s around the management of toxicities from immunotherapy, and it’s the ESMO Clinical Practice Guideline for diagnosis, treatment, and follow-up, delivered by Dr. Haanen and, of course, a number of colleagues on behalf of the wider committee.
Have a look at it. I’m not going to talk about the details of it. It’s very well written. It’s very clear and evidence based, of course. There are many helpful hints and a very clear blueprint as to how we should better manage the myriad of potential side effects from immunotherapy.
It tells us a little about the basis of the science, some of the mechanistic work that’s going on in allowing us to understand why some people react in such different ways, almost as if the immune systems are primed to overreact. It gives a very helpful, stepwise look at how we best diagnose, manage, and, in the longer term, follow up patients who have problems with these very important drugs.
All of us recognize the extraordinary impact they’ve made across a wide range of different tumor types, and therefore, as practicing oncologists and health care professionals in the field, all of us need to understand better the details as to how we better care for our patients on these drugs.
Have a look at it. It’s well written and useful, and I think it’s a document that I’ll turn to when I’m looking for a refresher or advice in the future.
The generic focus is about guidelines. Many years ago, I was one of the architects of the British National Cancer Plan, and for me, there were four simple principles at that stage in our development of how we would improve the delivery of cancer control in the United Kingdom. It was around site specialization, particularly of our surgical colleagues who embraced this with vigor. God bless them.
It was using guidelines to help level up the quality of treatment that we were giving, of course underpinned by research, and using – one would hope – modern IT and telecommunications to improve the networking that we use to deliver multidisciplinary cancer care, one of the key elements. Guidelines were embedded in that.
A couple of years ago, we did a survey of cancer physicians around the world. Almost 30 different countries were represented, and we asked which guidelines were most used. It was a very interesting set of responses. The three dominant guidelines – this will surprise no one – are the NCCN (National Comprehensive Cancer Network) guidelines, the ESMO guidelines, and the ASCO (American Society of Clinical Oncology) guidelines.
Rather than selecting one and one being completely dominant, what seemed to be the case is that our colleagues around the world dipped in and used all three. They may prefer NCCN for some particular tumor type or some particular aspect of how they’re structured, but at the same time, we would dip into the ESMO guidelines for specific bits of help, as well as the ASCO guidelines.
I find this fascinating. I assume that in different regions, depending on how they were affiliated in terms of additional training or links to Europe or links to the United States, that one or other of these guideline groups would predominate, but no. In each country, in each region, given the large data bank that we have of guidelines now, it’s a sort of pick-and-mix situation.
I was initially surprised but then took comfort from it. There’s nothing I hate more than the wasted energy of reduplication and saying, well come on, if there is one guideline set that does truly command the attention of the world, then the other should stop. It’s wasted energy, which is something that none of us can afford.
The fact that each of these trusted, evidence-based, beautifully presented guidelines is used in different ways was important. A message to the guideline groups from me is: “Thank you for your professionalism, for the hard work of hundreds of cancer specialists from all different specialties, and for their contribution to developing these guidelines.”
It’s worth it, it’s working, people are using them, and they’re making a difference. It’s all about leveling up the quality of cancer care that we deliver.
Specifically, have a look at the ESMO immune guidelines. They are great. I hope you find them helpful. Generically, thanks to all of you who are contributing and working so hard to make these data available to improve the quality of cancer care around the world.
Thanks for listening, as always. I’m interested in any comments that you might have, but for the time being, Medscapers, ahoy.
David J. Kerr, CBE, MD, DSc, is a professor of cancer medicine at the University of Oxford. He reported conflicts of interest with Celleron Therapeutics, Oxford Cancer Biomarkers, Afrox, GlaxoSmithKline, Bayer, Genomic Health, and Merck Serono.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
I’m David Kerr, professor of cancer medicine at the University of Oxford. I’d like to talk to you today about something specific and generic around guidelines.
It’s around the management of toxicities from immunotherapy, and it’s the ESMO Clinical Practice Guideline for diagnosis, treatment, and follow-up, delivered by Dr. Haanen and, of course, a number of colleagues on behalf of the wider committee.
Have a look at it. I’m not going to talk about the details of it. It’s very well written. It’s very clear and evidence based, of course. There are many helpful hints and a very clear blueprint as to how we should better manage the myriad of potential side effects from immunotherapy.
It tells us a little about the basis of the science, some of the mechanistic work that’s going on in allowing us to understand why some people react in such different ways, almost as if the immune systems are primed to overreact. It gives a very helpful, stepwise look at how we best diagnose, manage, and, in the longer term, follow up patients who have problems with these very important drugs.
All of us recognize the extraordinary impact they’ve made across a wide range of different tumor types, and therefore, as practicing oncologists and health care professionals in the field, all of us need to understand better the details as to how we better care for our patients on these drugs.
Have a look at it. It’s well written and useful, and I think it’s a document that I’ll turn to when I’m looking for a refresher or advice in the future.
The generic focus is about guidelines. Many years ago, I was one of the architects of the British National Cancer Plan, and for me, there were four simple principles at that stage in our development of how we would improve the delivery of cancer control in the United Kingdom. It was around site specialization, particularly of our surgical colleagues who embraced this with vigor. God bless them.
It was using guidelines to help level up the quality of treatment that we were giving, of course underpinned by research, and using – one would hope – modern IT and telecommunications to improve the networking that we use to deliver multidisciplinary cancer care, one of the key elements. Guidelines were embedded in that.
A couple of years ago, we did a survey of cancer physicians around the world. Almost 30 different countries were represented, and we asked which guidelines were most used. It was a very interesting set of responses. The three dominant guidelines – this will surprise no one – are the NCCN (National Comprehensive Cancer Network) guidelines, the ESMO guidelines, and the ASCO (American Society of Clinical Oncology) guidelines.
Rather than selecting one and one being completely dominant, what seemed to be the case is that our colleagues around the world dipped in and used all three. They may prefer NCCN for some particular tumor type or some particular aspect of how they’re structured, but at the same time, we would dip into the ESMO guidelines for specific bits of help, as well as the ASCO guidelines.
I find this fascinating. I assume that in different regions, depending on how they were affiliated in terms of additional training or links to Europe or links to the United States, that one or other of these guideline groups would predominate, but no. In each country, in each region, given the large data bank that we have of guidelines now, it’s a sort of pick-and-mix situation.
I was initially surprised but then took comfort from it. There’s nothing I hate more than the wasted energy of reduplication and saying, well come on, if there is one guideline set that does truly command the attention of the world, then the other should stop. It’s wasted energy, which is something that none of us can afford.
The fact that each of these trusted, evidence-based, beautifully presented guidelines is used in different ways was important. A message to the guideline groups from me is: “Thank you for your professionalism, for the hard work of hundreds of cancer specialists from all different specialties, and for their contribution to developing these guidelines.”
It’s worth it, it’s working, people are using them, and they’re making a difference. It’s all about leveling up the quality of cancer care that we deliver.
Specifically, have a look at the ESMO immune guidelines. They are great. I hope you find them helpful. Generically, thanks to all of you who are contributing and working so hard to make these data available to improve the quality of cancer care around the world.
Thanks for listening, as always. I’m interested in any comments that you might have, but for the time being, Medscapers, ahoy.
David J. Kerr, CBE, MD, DSc, is a professor of cancer medicine at the University of Oxford. He reported conflicts of interest with Celleron Therapeutics, Oxford Cancer Biomarkers, Afrox, GlaxoSmithKline, Bayer, Genomic Health, and Merck Serono.
A version of this article first appeared on Medscape.com.