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Pancreatic cancer incidence increases among young women in U.S.
Between 2001 and 2018, there was a greater than 200% difference in the incidence trend between men and women for ages 15-34, wrote Yazan Abboud, MD, a postdoctoral research fellow in the pancreaticobiliary department of the Karsh Division of Gastroenterology and Hepatology at Cedars-Sinai Medical Center, Los Angeles, and colleagues.
“The exact cause of the trend among younger women is unclear and may be driven by sex-based disproportional exposure or response to known or yet-to-be-explored risk factors,” they wrote. “Future efforts should aim to elucidate the causes of such a trend with the goal to formulate possible preventive measures.”
Although previous studies have found increasing pancreatic cancer incidence rates, especially in younger women, the data haven’t been externally validated outside of the National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) data, they wrote. In addition, there are limited data about the contributing factors, such as race, histopathological subtype, tumor location, and stage at diagnosis.
Using SEER-excluded data from the Centers for Disease Control and Prevention’s National Program of Cancer Registries (NPCR), Dr. Abboud and colleagues conducted a population-based time-trend analysis of pancreatic cancer incidence rates from 2001 to 2018 in younger adults under age 55, including the role of demographics and tumor characteristics. They analyzed age-adjusted incidence rates (aIR), mortality rates, annual percentage change (APC), and average annual percentage change (AAPC) for ages 55 and older and ages 55 and younger. In addition, the research team evaluated the impact of incidence trends on sex-specific mortality trends in younger adults using the CDC’s National Center of Health Statistics database.
Between 2001 and 2018, 748,132 patients were diagnosed with pancreatic cancer. After excluding SEER data, 454,611 patients met the inclusion criteria. About 48.9% were women.
The overall aIR of pancreatic cancer during that time was 12.18 per 100,000 people. Women had a significantly lower aIR, at 10.69 per 100,000, compared with men at 13.95 per 100,000.
In general, pancreatic cancer aIR significantly increased during that time (AAPC = 1.17%). Sex-specific trends increased among both women (AAPC = 1.27%) and men (AAPC = 1.14%), though they showed no significant difference and were parallel.
In ages 55 and older, 401,419 patients (49.7% women) were diagnosed with pancreatic cancer. The aIR significantly increased during the study period (AAPC = 1.11%), with sex-specific aIR increasing in both women (AAPC = 1.11%) and men (AAPC = 1.17%), without a significant difference.
However, a difference appeared in the 53,051 patients (42.9% women) who were ages 55 and younger. The aIR relatively increased (AAPC = 1.29%), with faster jumps in women (AAPC = 2.36%), compared with men (AAPC = .62%). There was an absolute significant difference of 1.74%.
The trends continued in breakdowns by age. For 50,599 patients (42.2% women) between ages 35 and 54, the aIR relatively increased (AAPC = 1.10%). Sex-specific aIR increased among women (AAPC = 2.09%) but remained stable among men (AAPC = 0.54%), with an absolute significant difference of 1.55%.
In the youngest cohort of 2,452 patients (57.3% women) between ages 15 and 34, aIR relatively increased (AAPC = 4.93). Sex-specific aIR also increased in both women (AAPC = 6.45%) and men (AAPC = 2.97%), with an absolute significant difference of 3.48%.
By race, although White women under age 55 experienced increasing aIR at a greater rate than men (AAPC difference = 1.59%), an even more dramatic increase was seen in Black women, as compared to counterpart men (AAPC difference = 2.23%). Sex-specific trends in people of other races were parallel.
Based on tumor characteristics in ages 55 and younger, the pancreatic ductal adenocarcinoma histopathological subtype had an AAPC difference of 0.89%, and a tumor location in the head-of-pancreas had an AAPC difference of 1.64%.
When evaluating tumors based on stage-at-diagnosis, the AAPC difference was nonsignificant in all subgroups. However, sex-specific trends differed in tumors diagnosed at localized stages, suggesting that aIR in women may be increasing at a greater rate than in men (AAPC difference = 1.64%).
Among 64,239 patients (39.3% women) who died from pancreatic cancer under age 55, the mortality rates were unchanged in women (AAPC = –0.09%) but declined in men (AAPC = –0.64%), with an absolute significant AAPC difference of 0.54%.
“Pancreatic cancer has a very poor overall survival, accounting for 7% of cancer-related deaths. The incidence of cancers, in general, is expected to rise as life expectancy increases in the United States,” said Danny Issa, MD, a gastroenterologist at the University of California, Los Angeles, who wasn’t involved with this study.
“Recently, noncomparative studies showed a possible increase in the incidence of pancreatic cancer in younger White women and in older White men and women. These reports had limitations,” he said. “The findings of this study are monumental as they confirmed that age-adjusted incidence rates have been increasing at a higher rate in younger women compared to younger men.”
In addition, Dr. Issa said, the significant increases among Black women for adenocarcinoma and for cancers located in the head of the pancreas are notable and should be studied further.
“Over the past few decades, research studies have helped improve cancer treatment by uncovering risk factors and identifying the most affected (or protected) population,” he said. “Therefore, epidemiologic studies are crucial, especially for hard-to-treat cancers such as pancreatic cancer.”
The study was supported in part by a philanthropic grant from The Widjaja Family Fund for Pancreatic Cancer Research. The authors disclosed no conflicts of interest. Dr. Issa reported no relevant disclosures.
Between 2001 and 2018, there was a greater than 200% difference in the incidence trend between men and women for ages 15-34, wrote Yazan Abboud, MD, a postdoctoral research fellow in the pancreaticobiliary department of the Karsh Division of Gastroenterology and Hepatology at Cedars-Sinai Medical Center, Los Angeles, and colleagues.
“The exact cause of the trend among younger women is unclear and may be driven by sex-based disproportional exposure or response to known or yet-to-be-explored risk factors,” they wrote. “Future efforts should aim to elucidate the causes of such a trend with the goal to formulate possible preventive measures.”
Although previous studies have found increasing pancreatic cancer incidence rates, especially in younger women, the data haven’t been externally validated outside of the National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) data, they wrote. In addition, there are limited data about the contributing factors, such as race, histopathological subtype, tumor location, and stage at diagnosis.
Using SEER-excluded data from the Centers for Disease Control and Prevention’s National Program of Cancer Registries (NPCR), Dr. Abboud and colleagues conducted a population-based time-trend analysis of pancreatic cancer incidence rates from 2001 to 2018 in younger adults under age 55, including the role of demographics and tumor characteristics. They analyzed age-adjusted incidence rates (aIR), mortality rates, annual percentage change (APC), and average annual percentage change (AAPC) for ages 55 and older and ages 55 and younger. In addition, the research team evaluated the impact of incidence trends on sex-specific mortality trends in younger adults using the CDC’s National Center of Health Statistics database.
Between 2001 and 2018, 748,132 patients were diagnosed with pancreatic cancer. After excluding SEER data, 454,611 patients met the inclusion criteria. About 48.9% were women.
The overall aIR of pancreatic cancer during that time was 12.18 per 100,000 people. Women had a significantly lower aIR, at 10.69 per 100,000, compared with men at 13.95 per 100,000.
In general, pancreatic cancer aIR significantly increased during that time (AAPC = 1.17%). Sex-specific trends increased among both women (AAPC = 1.27%) and men (AAPC = 1.14%), though they showed no significant difference and were parallel.
In ages 55 and older, 401,419 patients (49.7% women) were diagnosed with pancreatic cancer. The aIR significantly increased during the study period (AAPC = 1.11%), with sex-specific aIR increasing in both women (AAPC = 1.11%) and men (AAPC = 1.17%), without a significant difference.
However, a difference appeared in the 53,051 patients (42.9% women) who were ages 55 and younger. The aIR relatively increased (AAPC = 1.29%), with faster jumps in women (AAPC = 2.36%), compared with men (AAPC = .62%). There was an absolute significant difference of 1.74%.
The trends continued in breakdowns by age. For 50,599 patients (42.2% women) between ages 35 and 54, the aIR relatively increased (AAPC = 1.10%). Sex-specific aIR increased among women (AAPC = 2.09%) but remained stable among men (AAPC = 0.54%), with an absolute significant difference of 1.55%.
In the youngest cohort of 2,452 patients (57.3% women) between ages 15 and 34, aIR relatively increased (AAPC = 4.93). Sex-specific aIR also increased in both women (AAPC = 6.45%) and men (AAPC = 2.97%), with an absolute significant difference of 3.48%.
By race, although White women under age 55 experienced increasing aIR at a greater rate than men (AAPC difference = 1.59%), an even more dramatic increase was seen in Black women, as compared to counterpart men (AAPC difference = 2.23%). Sex-specific trends in people of other races were parallel.
Based on tumor characteristics in ages 55 and younger, the pancreatic ductal adenocarcinoma histopathological subtype had an AAPC difference of 0.89%, and a tumor location in the head-of-pancreas had an AAPC difference of 1.64%.
When evaluating tumors based on stage-at-diagnosis, the AAPC difference was nonsignificant in all subgroups. However, sex-specific trends differed in tumors diagnosed at localized stages, suggesting that aIR in women may be increasing at a greater rate than in men (AAPC difference = 1.64%).
Among 64,239 patients (39.3% women) who died from pancreatic cancer under age 55, the mortality rates were unchanged in women (AAPC = –0.09%) but declined in men (AAPC = –0.64%), with an absolute significant AAPC difference of 0.54%.
“Pancreatic cancer has a very poor overall survival, accounting for 7% of cancer-related deaths. The incidence of cancers, in general, is expected to rise as life expectancy increases in the United States,” said Danny Issa, MD, a gastroenterologist at the University of California, Los Angeles, who wasn’t involved with this study.
“Recently, noncomparative studies showed a possible increase in the incidence of pancreatic cancer in younger White women and in older White men and women. These reports had limitations,” he said. “The findings of this study are monumental as they confirmed that age-adjusted incidence rates have been increasing at a higher rate in younger women compared to younger men.”
In addition, Dr. Issa said, the significant increases among Black women for adenocarcinoma and for cancers located in the head of the pancreas are notable and should be studied further.
“Over the past few decades, research studies have helped improve cancer treatment by uncovering risk factors and identifying the most affected (or protected) population,” he said. “Therefore, epidemiologic studies are crucial, especially for hard-to-treat cancers such as pancreatic cancer.”
The study was supported in part by a philanthropic grant from The Widjaja Family Fund for Pancreatic Cancer Research. The authors disclosed no conflicts of interest. Dr. Issa reported no relevant disclosures.
Between 2001 and 2018, there was a greater than 200% difference in the incidence trend between men and women for ages 15-34, wrote Yazan Abboud, MD, a postdoctoral research fellow in the pancreaticobiliary department of the Karsh Division of Gastroenterology and Hepatology at Cedars-Sinai Medical Center, Los Angeles, and colleagues.
“The exact cause of the trend among younger women is unclear and may be driven by sex-based disproportional exposure or response to known or yet-to-be-explored risk factors,” they wrote. “Future efforts should aim to elucidate the causes of such a trend with the goal to formulate possible preventive measures.”
Although previous studies have found increasing pancreatic cancer incidence rates, especially in younger women, the data haven’t been externally validated outside of the National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) data, they wrote. In addition, there are limited data about the contributing factors, such as race, histopathological subtype, tumor location, and stage at diagnosis.
Using SEER-excluded data from the Centers for Disease Control and Prevention’s National Program of Cancer Registries (NPCR), Dr. Abboud and colleagues conducted a population-based time-trend analysis of pancreatic cancer incidence rates from 2001 to 2018 in younger adults under age 55, including the role of demographics and tumor characteristics. They analyzed age-adjusted incidence rates (aIR), mortality rates, annual percentage change (APC), and average annual percentage change (AAPC) for ages 55 and older and ages 55 and younger. In addition, the research team evaluated the impact of incidence trends on sex-specific mortality trends in younger adults using the CDC’s National Center of Health Statistics database.
Between 2001 and 2018, 748,132 patients were diagnosed with pancreatic cancer. After excluding SEER data, 454,611 patients met the inclusion criteria. About 48.9% were women.
The overall aIR of pancreatic cancer during that time was 12.18 per 100,000 people. Women had a significantly lower aIR, at 10.69 per 100,000, compared with men at 13.95 per 100,000.
In general, pancreatic cancer aIR significantly increased during that time (AAPC = 1.17%). Sex-specific trends increased among both women (AAPC = 1.27%) and men (AAPC = 1.14%), though they showed no significant difference and were parallel.
In ages 55 and older, 401,419 patients (49.7% women) were diagnosed with pancreatic cancer. The aIR significantly increased during the study period (AAPC = 1.11%), with sex-specific aIR increasing in both women (AAPC = 1.11%) and men (AAPC = 1.17%), without a significant difference.
However, a difference appeared in the 53,051 patients (42.9% women) who were ages 55 and younger. The aIR relatively increased (AAPC = 1.29%), with faster jumps in women (AAPC = 2.36%), compared with men (AAPC = .62%). There was an absolute significant difference of 1.74%.
The trends continued in breakdowns by age. For 50,599 patients (42.2% women) between ages 35 and 54, the aIR relatively increased (AAPC = 1.10%). Sex-specific aIR increased among women (AAPC = 2.09%) but remained stable among men (AAPC = 0.54%), with an absolute significant difference of 1.55%.
In the youngest cohort of 2,452 patients (57.3% women) between ages 15 and 34, aIR relatively increased (AAPC = 4.93). Sex-specific aIR also increased in both women (AAPC = 6.45%) and men (AAPC = 2.97%), with an absolute significant difference of 3.48%.
By race, although White women under age 55 experienced increasing aIR at a greater rate than men (AAPC difference = 1.59%), an even more dramatic increase was seen in Black women, as compared to counterpart men (AAPC difference = 2.23%). Sex-specific trends in people of other races were parallel.
Based on tumor characteristics in ages 55 and younger, the pancreatic ductal adenocarcinoma histopathological subtype had an AAPC difference of 0.89%, and a tumor location in the head-of-pancreas had an AAPC difference of 1.64%.
When evaluating tumors based on stage-at-diagnosis, the AAPC difference was nonsignificant in all subgroups. However, sex-specific trends differed in tumors diagnosed at localized stages, suggesting that aIR in women may be increasing at a greater rate than in men (AAPC difference = 1.64%).
Among 64,239 patients (39.3% women) who died from pancreatic cancer under age 55, the mortality rates were unchanged in women (AAPC = –0.09%) but declined in men (AAPC = –0.64%), with an absolute significant AAPC difference of 0.54%.
“Pancreatic cancer has a very poor overall survival, accounting for 7% of cancer-related deaths. The incidence of cancers, in general, is expected to rise as life expectancy increases in the United States,” said Danny Issa, MD, a gastroenterologist at the University of California, Los Angeles, who wasn’t involved with this study.
“Recently, noncomparative studies showed a possible increase in the incidence of pancreatic cancer in younger White women and in older White men and women. These reports had limitations,” he said. “The findings of this study are monumental as they confirmed that age-adjusted incidence rates have been increasing at a higher rate in younger women compared to younger men.”
In addition, Dr. Issa said, the significant increases among Black women for adenocarcinoma and for cancers located in the head of the pancreas are notable and should be studied further.
“Over the past few decades, research studies have helped improve cancer treatment by uncovering risk factors and identifying the most affected (or protected) population,” he said. “Therefore, epidemiologic studies are crucial, especially for hard-to-treat cancers such as pancreatic cancer.”
The study was supported in part by a philanthropic grant from The Widjaja Family Fund for Pancreatic Cancer Research. The authors disclosed no conflicts of interest. Dr. Issa reported no relevant disclosures.
FROM GASTROENTEROLOGY
Key takeaways from ACP’s new Tx guidelines for adults with major depressive disorder
In January 2023, the American College of Physicians (ACP) published updated recommendations on the treatment of adults with major depressive disorder (MDD).1 The ACP guidelines address initial treatment of patients in the acute phase of mild and moderate-to-severe MDD. Here’s what the ACP recommends, as well as 6 important takeaways.
Recommendations for initial treatment of those with mild or moderate-to-severe MDD center around cognitive behavioral therapy (CBT) and second-generation antidepressants (SGA). For patients in the acute phase of mild MDD, the recommendation is for monotherapy with CBT. However, if CBT is not an option due to cost and/or availability of services, the use of an SGA is acceptable.
For patients in the acute phase of moderate-to-severe MDD, either CBT, an SGA, or a combination of both is recommended.
If initial treatment does not work … Up to 70% of patients with moderate-to-severe MDD will not respond to the initial therapy chosen. If a patient does not respond to initial treatment with an SGA, consider 1 of the following:
- Switching to CBT
- Adding on CBT while continuing the SGA
- Changing to a different SGA
- Adding a second pharmacologic agent.
6 key takeaways. The full guideline should be read for a more complete discussion of the many clinical considerations of these treatment options. However, the most important points include:
• Employ shared clinical decision-making and consider the individual characteristics of each patient when making treatment decisions.
• Consider generic options when using an SGA; generic options appear to be as effective as more expensive brand-name products.
• Start with a low-dose SGA and increase gradually to an approved maximum dose before determining there has been no response.
• Monitor frequently for medication adverse effects.
• Monitor the patient for thoughts about self-harm for the first 2 months.
• Continue treatment for 4 to 9 months once remission is achieved.
A word about strength of evidence. While these recommendations are based on an extensive review of the best available evidence, most are based on low-certainty evidence—illustrating the amount of clinical research still needed on this topic. The exceptions are monotherapy with either CBT or SGA for initial treatment of moderate-to-severe MDD, both of which are based on moderate-strength evidence and received a strong recommendation. The panel felt there was insufficient evidence to assess complementary and alternative interventions including exercise and omega-3 fatty acids.
1. Qaseem A, Owens D, Etxeandia-Ikobaltzeta I, et al; Clinical Guidelines Committee of the American College of Physicians. Nonpharmacologic and pharmacologic treatments of adults in the acute phase of major depressive disorder: a living clinical guideline from the American College of Physicians. Ann Intern Med. Published online January 24, 2023. doi: 10.7326/M22-2056
In January 2023, the American College of Physicians (ACP) published updated recommendations on the treatment of adults with major depressive disorder (MDD).1 The ACP guidelines address initial treatment of patients in the acute phase of mild and moderate-to-severe MDD. Here’s what the ACP recommends, as well as 6 important takeaways.
Recommendations for initial treatment of those with mild or moderate-to-severe MDD center around cognitive behavioral therapy (CBT) and second-generation antidepressants (SGA). For patients in the acute phase of mild MDD, the recommendation is for monotherapy with CBT. However, if CBT is not an option due to cost and/or availability of services, the use of an SGA is acceptable.
For patients in the acute phase of moderate-to-severe MDD, either CBT, an SGA, or a combination of both is recommended.
If initial treatment does not work … Up to 70% of patients with moderate-to-severe MDD will not respond to the initial therapy chosen. If a patient does not respond to initial treatment with an SGA, consider 1 of the following:
- Switching to CBT
- Adding on CBT while continuing the SGA
- Changing to a different SGA
- Adding a second pharmacologic agent.
6 key takeaways. The full guideline should be read for a more complete discussion of the many clinical considerations of these treatment options. However, the most important points include:
• Employ shared clinical decision-making and consider the individual characteristics of each patient when making treatment decisions.
• Consider generic options when using an SGA; generic options appear to be as effective as more expensive brand-name products.
• Start with a low-dose SGA and increase gradually to an approved maximum dose before determining there has been no response.
• Monitor frequently for medication adverse effects.
• Monitor the patient for thoughts about self-harm for the first 2 months.
• Continue treatment for 4 to 9 months once remission is achieved.
A word about strength of evidence. While these recommendations are based on an extensive review of the best available evidence, most are based on low-certainty evidence—illustrating the amount of clinical research still needed on this topic. The exceptions are monotherapy with either CBT or SGA for initial treatment of moderate-to-severe MDD, both of which are based on moderate-strength evidence and received a strong recommendation. The panel felt there was insufficient evidence to assess complementary and alternative interventions including exercise and omega-3 fatty acids.
In January 2023, the American College of Physicians (ACP) published updated recommendations on the treatment of adults with major depressive disorder (MDD).1 The ACP guidelines address initial treatment of patients in the acute phase of mild and moderate-to-severe MDD. Here’s what the ACP recommends, as well as 6 important takeaways.
Recommendations for initial treatment of those with mild or moderate-to-severe MDD center around cognitive behavioral therapy (CBT) and second-generation antidepressants (SGA). For patients in the acute phase of mild MDD, the recommendation is for monotherapy with CBT. However, if CBT is not an option due to cost and/or availability of services, the use of an SGA is acceptable.
For patients in the acute phase of moderate-to-severe MDD, either CBT, an SGA, or a combination of both is recommended.
If initial treatment does not work … Up to 70% of patients with moderate-to-severe MDD will not respond to the initial therapy chosen. If a patient does not respond to initial treatment with an SGA, consider 1 of the following:
- Switching to CBT
- Adding on CBT while continuing the SGA
- Changing to a different SGA
- Adding a second pharmacologic agent.
6 key takeaways. The full guideline should be read for a more complete discussion of the many clinical considerations of these treatment options. However, the most important points include:
• Employ shared clinical decision-making and consider the individual characteristics of each patient when making treatment decisions.
• Consider generic options when using an SGA; generic options appear to be as effective as more expensive brand-name products.
• Start with a low-dose SGA and increase gradually to an approved maximum dose before determining there has been no response.
• Monitor frequently for medication adverse effects.
• Monitor the patient for thoughts about self-harm for the first 2 months.
• Continue treatment for 4 to 9 months once remission is achieved.
A word about strength of evidence. While these recommendations are based on an extensive review of the best available evidence, most are based on low-certainty evidence—illustrating the amount of clinical research still needed on this topic. The exceptions are monotherapy with either CBT or SGA for initial treatment of moderate-to-severe MDD, both of which are based on moderate-strength evidence and received a strong recommendation. The panel felt there was insufficient evidence to assess complementary and alternative interventions including exercise and omega-3 fatty acids.
1. Qaseem A, Owens D, Etxeandia-Ikobaltzeta I, et al; Clinical Guidelines Committee of the American College of Physicians. Nonpharmacologic and pharmacologic treatments of adults in the acute phase of major depressive disorder: a living clinical guideline from the American College of Physicians. Ann Intern Med. Published online January 24, 2023. doi: 10.7326/M22-2056
1. Qaseem A, Owens D, Etxeandia-Ikobaltzeta I, et al; Clinical Guidelines Committee of the American College of Physicians. Nonpharmacologic and pharmacologic treatments of adults in the acute phase of major depressive disorder: a living clinical guideline from the American College of Physicians. Ann Intern Med. Published online January 24, 2023. doi: 10.7326/M22-2056
Scientific advances and dietary measures to slow down aging
These findings are closer than ever to being applied in older adults. Currently, diet is the most accessible form of intervention, but it is appropriate to clarify current myths and realities.
An article published in Cell in 2013 summarized for the first time the molecular indicators of aging in mammals. The article had a great impact and served as a knowledge map about aging. Now the authors have updated and extended this knowledge in the same journal.
A barometer of interest in the topic is that approximately 300,000 articles on aging have been published since 2013, which is as many as were published during the previous century. In addition, almost 80 experiments have been conducted with mammals, including humans, that confirm that interventions in the aging process can prevent, delay, and even avoid age-related diseases such as cancer.
María A. Blasco, MD, scientific director of the National Cancer Research Center, an international leader in telomere research and coauthor of the study, noted on the institution’s website, “The spectacular advances in recent years to increase the longevity of model organisms, including in mammals, indicate that it will be important to develop rational strategies to intervene in human aging.”
Eighty experimental interventions
The new article verifies the conclusions of the analysis carried out a decade ago. “Now there is much more investment, and we are closer to applying basic knowledge to new ways of treating diseases,” said Dr. Blasco. The researchers identified nine indicators of aging – molecular signatures that mark the progress of the process and on which it was possible to act to prolong life.
They also point to four primary causes of aging: genomic instability, shortening of telomeres, epigenetic alterations, and imbalance between protein synthesis and degradation. These are strongly interconnected processes. Aging results from their joint action, which is why there are multiple ways to act on the physiologic process of aging. The new study includes a table with almost 80 recent experimental interventions with mammals (mostly mice) that suggest that it is possible to prolong life or treat age-associated diseases. Some of those studies concern humans; others investigate how to delay aging through diet. “Acting on the diet is one of the most accessible ways to intervene in human aging,” according to the researchers.
Nutrient sensors
Dietary interventions are related to a key indicator of aging: the dysregulation of the nutrient sensing mechanism. This mechanism is the sophisticated network of molecular signals that alert all mammals that food is available.
“Nutrient sensors are therapeutic targets for potential anti-longevity drugs, but health benefits and lifespan extension could also be achieved through dietary interventions. However, the results obtained in this line in our species are still unclear: Clinical trials based on dietary restriction in humans become complicated due to poor compliance, although they suggest positive effects on immunity and inflammation,” wrote the researchers.
Diet and disease
Javier Gómez Pavón, MD, head of geriatrics at Red Cross Hospital in Madrid and member of the leadership team of the Spanish Society of Geriatrics and Gerontology, told this news organization, “Currently, the evidence we have indicates that certain types of diet in population cohort studies are associated with a lower incidence and prevalence of certain diseases.”
Dr. Gómez mentioned contrasting examples. “The Mediterranean diet has been shown in different studies to be associated with a lower cardiovascular risk (stroke, ischemic heart disease, dyslipidemia) and a lower risk of cognitive impairment, especially due to its vascular component.”
Eating nuts (e.g., almonds, walnuts) is associated with a less dyslipidemia. A diet rich in fiber is also associated with less colonic digestive pathology, such as constipation and especially colon cancer. In addition, a diet low in fatty meats and rich in fruits and vegetables is associated with less prostate, breast, and colon disease. A diet with adequate protein intake is related to better muscle mass at all ages, and a diet rich in calcium products, such as nuts and dairy products, is linked to better bone mass and less osteoporosis and its consequences.
“At the moment, there is no study that links any type of diet with greater longevity, although in view of these data, it seems logical that a Mediterranean diet rich in fruits, vegetables, vegetables with proteins of animal origin, preferably fish or white meat, avoiding excess red meat and its calcium component in the form of nuts and dairy products would be associated with better disease-free aging,” said Dr. Gómez.
Aging indicators
The article expands the aging indicators from 9 to 12 (genomic instability, telomere wear, epigenetic alterations, loss of proteostasis, inactivated macroautophagy, dysregulation of nutrient sensing, mitochondrial dysfunction, cellular senescence, depletion of hematopoietic progenitor cells, alteration of intercellular communication, chronic inflammation, and imbalances in the microbiome), which are measurable processes that change with the aging of the organism and which, when manipulated experimentally, induce an acceleration or, on the contrary, an interruption, even a regression, of aging.
“Each of these indicators should be considered an entry point for future exploration of the aging process, as well as for the development of new antiaging drugs,” the researchers concluded.
A decade ago, it was recognized that telomere shortening was at the origin of age-related diseases, said Dr. Blasco. “It is now emphasized that the generation of mouse models with short telomeres has shown that telomeric wasting is at the origin of prevalent age-associated diseases, such as pulmonary and renal fibrosis.”
The recent study reviews new interventions to delay aging and age-related diseases that act on telomeres. “For example, the activation of telomerase through a gene therapy strategy has shown therapeutic effects in mouse models of pulmonary fibrosis and aplastic anemia,” Dr. Blasco added.
Food fact and fiction
Since diet is currently the most easily accessible element to slow down aging, Dr. Gómez refutes the most widespread myths that are circulating about food and longevity. First, regarding dairy products, it is said that yogurt is not useful for the elderly, since the elderly do not have adequate enzymes to digest yogurt and that it is only for children or young people who are growing. “It is not true. Dairy products are not important for their proteins but for their calcium and vitamin D content. [These are] fundamental elements at all ages, but especially in aging, where there is bone loss secondary to aging itself and an increased risk of osteoporosis and associated fractures. Especially in the elderly, the tragic hip fracture is associated with high morbidity and mortality.”
Another myth is that it is not good to eat fruit with meals. “Due to its rich content in antioxidants and vitamins, it is a fundamental food of the Mediterranean diet. Antioxidants of any type (nuts, vegetables, fruits, etc.) are undoubtedly the most important components against pathological aging (stroke, myocardial infarction, dementia, etc.). It may be true that they can be more easily digested if they are eaten outside of meals, but the important thing is that they be eaten whenever.”
Sugars and meat
“Regarding the ‘fact’ that the sugars in legumes and bread are harmful, it is not true. In addition to sugar, legumes contain fiber and other very important antioxidants, just like bread. The difference is the amount, as in all food. On the contrary, refined sugars, such as pastries, sugary drinks, etc., should be avoided, since they are directly related to cardiovascular disease and obesity,” added Dr. Gómez.
“As for the popular saying, ‘Do not even try meat,’ it is not sound, since red meat and fish, including oily fish, are rich in protein and vitamin B as well as iron and, therefore, are necessary.
“As always, it is the amount that should be limited, especially red meat, not so much oily fish. I would recommend reducing red meat and replacing it with white meat, since the former are rich in saturated fats that produce more cholesterol,” added Dr. Gómez.
Another phrase that circulates around is that wine is food. “Careful. Wine in small quantities, a glass at lunch and dinner, is beneficial due to its antioxidant power, but at more than these amounts, the negative power of alcohol predominates over its benefits,” concluded Dr. Gómez.
Dr. Gómez has disclosed no relevant financial relationships.
This article was translated from the Medscape Spanish edition. A version of this article appeared on Medscape.com.
These findings are closer than ever to being applied in older adults. Currently, diet is the most accessible form of intervention, but it is appropriate to clarify current myths and realities.
An article published in Cell in 2013 summarized for the first time the molecular indicators of aging in mammals. The article had a great impact and served as a knowledge map about aging. Now the authors have updated and extended this knowledge in the same journal.
A barometer of interest in the topic is that approximately 300,000 articles on aging have been published since 2013, which is as many as were published during the previous century. In addition, almost 80 experiments have been conducted with mammals, including humans, that confirm that interventions in the aging process can prevent, delay, and even avoid age-related diseases such as cancer.
María A. Blasco, MD, scientific director of the National Cancer Research Center, an international leader in telomere research and coauthor of the study, noted on the institution’s website, “The spectacular advances in recent years to increase the longevity of model organisms, including in mammals, indicate that it will be important to develop rational strategies to intervene in human aging.”
Eighty experimental interventions
The new article verifies the conclusions of the analysis carried out a decade ago. “Now there is much more investment, and we are closer to applying basic knowledge to new ways of treating diseases,” said Dr. Blasco. The researchers identified nine indicators of aging – molecular signatures that mark the progress of the process and on which it was possible to act to prolong life.
They also point to four primary causes of aging: genomic instability, shortening of telomeres, epigenetic alterations, and imbalance between protein synthesis and degradation. These are strongly interconnected processes. Aging results from their joint action, which is why there are multiple ways to act on the physiologic process of aging. The new study includes a table with almost 80 recent experimental interventions with mammals (mostly mice) that suggest that it is possible to prolong life or treat age-associated diseases. Some of those studies concern humans; others investigate how to delay aging through diet. “Acting on the diet is one of the most accessible ways to intervene in human aging,” according to the researchers.
Nutrient sensors
Dietary interventions are related to a key indicator of aging: the dysregulation of the nutrient sensing mechanism. This mechanism is the sophisticated network of molecular signals that alert all mammals that food is available.
“Nutrient sensors are therapeutic targets for potential anti-longevity drugs, but health benefits and lifespan extension could also be achieved through dietary interventions. However, the results obtained in this line in our species are still unclear: Clinical trials based on dietary restriction in humans become complicated due to poor compliance, although they suggest positive effects on immunity and inflammation,” wrote the researchers.
Diet and disease
Javier Gómez Pavón, MD, head of geriatrics at Red Cross Hospital in Madrid and member of the leadership team of the Spanish Society of Geriatrics and Gerontology, told this news organization, “Currently, the evidence we have indicates that certain types of diet in population cohort studies are associated with a lower incidence and prevalence of certain diseases.”
Dr. Gómez mentioned contrasting examples. “The Mediterranean diet has been shown in different studies to be associated with a lower cardiovascular risk (stroke, ischemic heart disease, dyslipidemia) and a lower risk of cognitive impairment, especially due to its vascular component.”
Eating nuts (e.g., almonds, walnuts) is associated with a less dyslipidemia. A diet rich in fiber is also associated with less colonic digestive pathology, such as constipation and especially colon cancer. In addition, a diet low in fatty meats and rich in fruits and vegetables is associated with less prostate, breast, and colon disease. A diet with adequate protein intake is related to better muscle mass at all ages, and a diet rich in calcium products, such as nuts and dairy products, is linked to better bone mass and less osteoporosis and its consequences.
“At the moment, there is no study that links any type of diet with greater longevity, although in view of these data, it seems logical that a Mediterranean diet rich in fruits, vegetables, vegetables with proteins of animal origin, preferably fish or white meat, avoiding excess red meat and its calcium component in the form of nuts and dairy products would be associated with better disease-free aging,” said Dr. Gómez.
Aging indicators
The article expands the aging indicators from 9 to 12 (genomic instability, telomere wear, epigenetic alterations, loss of proteostasis, inactivated macroautophagy, dysregulation of nutrient sensing, mitochondrial dysfunction, cellular senescence, depletion of hematopoietic progenitor cells, alteration of intercellular communication, chronic inflammation, and imbalances in the microbiome), which are measurable processes that change with the aging of the organism and which, when manipulated experimentally, induce an acceleration or, on the contrary, an interruption, even a regression, of aging.
“Each of these indicators should be considered an entry point for future exploration of the aging process, as well as for the development of new antiaging drugs,” the researchers concluded.
A decade ago, it was recognized that telomere shortening was at the origin of age-related diseases, said Dr. Blasco. “It is now emphasized that the generation of mouse models with short telomeres has shown that telomeric wasting is at the origin of prevalent age-associated diseases, such as pulmonary and renal fibrosis.”
The recent study reviews new interventions to delay aging and age-related diseases that act on telomeres. “For example, the activation of telomerase through a gene therapy strategy has shown therapeutic effects in mouse models of pulmonary fibrosis and aplastic anemia,” Dr. Blasco added.
Food fact and fiction
Since diet is currently the most easily accessible element to slow down aging, Dr. Gómez refutes the most widespread myths that are circulating about food and longevity. First, regarding dairy products, it is said that yogurt is not useful for the elderly, since the elderly do not have adequate enzymes to digest yogurt and that it is only for children or young people who are growing. “It is not true. Dairy products are not important for their proteins but for their calcium and vitamin D content. [These are] fundamental elements at all ages, but especially in aging, where there is bone loss secondary to aging itself and an increased risk of osteoporosis and associated fractures. Especially in the elderly, the tragic hip fracture is associated with high morbidity and mortality.”
Another myth is that it is not good to eat fruit with meals. “Due to its rich content in antioxidants and vitamins, it is a fundamental food of the Mediterranean diet. Antioxidants of any type (nuts, vegetables, fruits, etc.) are undoubtedly the most important components against pathological aging (stroke, myocardial infarction, dementia, etc.). It may be true that they can be more easily digested if they are eaten outside of meals, but the important thing is that they be eaten whenever.”
Sugars and meat
“Regarding the ‘fact’ that the sugars in legumes and bread are harmful, it is not true. In addition to sugar, legumes contain fiber and other very important antioxidants, just like bread. The difference is the amount, as in all food. On the contrary, refined sugars, such as pastries, sugary drinks, etc., should be avoided, since they are directly related to cardiovascular disease and obesity,” added Dr. Gómez.
“As for the popular saying, ‘Do not even try meat,’ it is not sound, since red meat and fish, including oily fish, are rich in protein and vitamin B as well as iron and, therefore, are necessary.
“As always, it is the amount that should be limited, especially red meat, not so much oily fish. I would recommend reducing red meat and replacing it with white meat, since the former are rich in saturated fats that produce more cholesterol,” added Dr. Gómez.
Another phrase that circulates around is that wine is food. “Careful. Wine in small quantities, a glass at lunch and dinner, is beneficial due to its antioxidant power, but at more than these amounts, the negative power of alcohol predominates over its benefits,” concluded Dr. Gómez.
Dr. Gómez has disclosed no relevant financial relationships.
This article was translated from the Medscape Spanish edition. A version of this article appeared on Medscape.com.
These findings are closer than ever to being applied in older adults. Currently, diet is the most accessible form of intervention, but it is appropriate to clarify current myths and realities.
An article published in Cell in 2013 summarized for the first time the molecular indicators of aging in mammals. The article had a great impact and served as a knowledge map about aging. Now the authors have updated and extended this knowledge in the same journal.
A barometer of interest in the topic is that approximately 300,000 articles on aging have been published since 2013, which is as many as were published during the previous century. In addition, almost 80 experiments have been conducted with mammals, including humans, that confirm that interventions in the aging process can prevent, delay, and even avoid age-related diseases such as cancer.
María A. Blasco, MD, scientific director of the National Cancer Research Center, an international leader in telomere research and coauthor of the study, noted on the institution’s website, “The spectacular advances in recent years to increase the longevity of model organisms, including in mammals, indicate that it will be important to develop rational strategies to intervene in human aging.”
Eighty experimental interventions
The new article verifies the conclusions of the analysis carried out a decade ago. “Now there is much more investment, and we are closer to applying basic knowledge to new ways of treating diseases,” said Dr. Blasco. The researchers identified nine indicators of aging – molecular signatures that mark the progress of the process and on which it was possible to act to prolong life.
They also point to four primary causes of aging: genomic instability, shortening of telomeres, epigenetic alterations, and imbalance between protein synthesis and degradation. These are strongly interconnected processes. Aging results from their joint action, which is why there are multiple ways to act on the physiologic process of aging. The new study includes a table with almost 80 recent experimental interventions with mammals (mostly mice) that suggest that it is possible to prolong life or treat age-associated diseases. Some of those studies concern humans; others investigate how to delay aging through diet. “Acting on the diet is one of the most accessible ways to intervene in human aging,” according to the researchers.
Nutrient sensors
Dietary interventions are related to a key indicator of aging: the dysregulation of the nutrient sensing mechanism. This mechanism is the sophisticated network of molecular signals that alert all mammals that food is available.
“Nutrient sensors are therapeutic targets for potential anti-longevity drugs, but health benefits and lifespan extension could also be achieved through dietary interventions. However, the results obtained in this line in our species are still unclear: Clinical trials based on dietary restriction in humans become complicated due to poor compliance, although they suggest positive effects on immunity and inflammation,” wrote the researchers.
Diet and disease
Javier Gómez Pavón, MD, head of geriatrics at Red Cross Hospital in Madrid and member of the leadership team of the Spanish Society of Geriatrics and Gerontology, told this news organization, “Currently, the evidence we have indicates that certain types of diet in population cohort studies are associated with a lower incidence and prevalence of certain diseases.”
Dr. Gómez mentioned contrasting examples. “The Mediterranean diet has been shown in different studies to be associated with a lower cardiovascular risk (stroke, ischemic heart disease, dyslipidemia) and a lower risk of cognitive impairment, especially due to its vascular component.”
Eating nuts (e.g., almonds, walnuts) is associated with a less dyslipidemia. A diet rich in fiber is also associated with less colonic digestive pathology, such as constipation and especially colon cancer. In addition, a diet low in fatty meats and rich in fruits and vegetables is associated with less prostate, breast, and colon disease. A diet with adequate protein intake is related to better muscle mass at all ages, and a diet rich in calcium products, such as nuts and dairy products, is linked to better bone mass and less osteoporosis and its consequences.
“At the moment, there is no study that links any type of diet with greater longevity, although in view of these data, it seems logical that a Mediterranean diet rich in fruits, vegetables, vegetables with proteins of animal origin, preferably fish or white meat, avoiding excess red meat and its calcium component in the form of nuts and dairy products would be associated with better disease-free aging,” said Dr. Gómez.
Aging indicators
The article expands the aging indicators from 9 to 12 (genomic instability, telomere wear, epigenetic alterations, loss of proteostasis, inactivated macroautophagy, dysregulation of nutrient sensing, mitochondrial dysfunction, cellular senescence, depletion of hematopoietic progenitor cells, alteration of intercellular communication, chronic inflammation, and imbalances in the microbiome), which are measurable processes that change with the aging of the organism and which, when manipulated experimentally, induce an acceleration or, on the contrary, an interruption, even a regression, of aging.
“Each of these indicators should be considered an entry point for future exploration of the aging process, as well as for the development of new antiaging drugs,” the researchers concluded.
A decade ago, it was recognized that telomere shortening was at the origin of age-related diseases, said Dr. Blasco. “It is now emphasized that the generation of mouse models with short telomeres has shown that telomeric wasting is at the origin of prevalent age-associated diseases, such as pulmonary and renal fibrosis.”
The recent study reviews new interventions to delay aging and age-related diseases that act on telomeres. “For example, the activation of telomerase through a gene therapy strategy has shown therapeutic effects in mouse models of pulmonary fibrosis and aplastic anemia,” Dr. Blasco added.
Food fact and fiction
Since diet is currently the most easily accessible element to slow down aging, Dr. Gómez refutes the most widespread myths that are circulating about food and longevity. First, regarding dairy products, it is said that yogurt is not useful for the elderly, since the elderly do not have adequate enzymes to digest yogurt and that it is only for children or young people who are growing. “It is not true. Dairy products are not important for their proteins but for their calcium and vitamin D content. [These are] fundamental elements at all ages, but especially in aging, where there is bone loss secondary to aging itself and an increased risk of osteoporosis and associated fractures. Especially in the elderly, the tragic hip fracture is associated with high morbidity and mortality.”
Another myth is that it is not good to eat fruit with meals. “Due to its rich content in antioxidants and vitamins, it is a fundamental food of the Mediterranean diet. Antioxidants of any type (nuts, vegetables, fruits, etc.) are undoubtedly the most important components against pathological aging (stroke, myocardial infarction, dementia, etc.). It may be true that they can be more easily digested if they are eaten outside of meals, but the important thing is that they be eaten whenever.”
Sugars and meat
“Regarding the ‘fact’ that the sugars in legumes and bread are harmful, it is not true. In addition to sugar, legumes contain fiber and other very important antioxidants, just like bread. The difference is the amount, as in all food. On the contrary, refined sugars, such as pastries, sugary drinks, etc., should be avoided, since they are directly related to cardiovascular disease and obesity,” added Dr. Gómez.
“As for the popular saying, ‘Do not even try meat,’ it is not sound, since red meat and fish, including oily fish, are rich in protein and vitamin B as well as iron and, therefore, are necessary.
“As always, it is the amount that should be limited, especially red meat, not so much oily fish. I would recommend reducing red meat and replacing it with white meat, since the former are rich in saturated fats that produce more cholesterol,” added Dr. Gómez.
Another phrase that circulates around is that wine is food. “Careful. Wine in small quantities, a glass at lunch and dinner, is beneficial due to its antioxidant power, but at more than these amounts, the negative power of alcohol predominates over its benefits,” concluded Dr. Gómez.
Dr. Gómez has disclosed no relevant financial relationships.
This article was translated from the Medscape Spanish edition. A version of this article appeared on Medscape.com.
FROM CELL
Higher dementia risk in women explained?
a study suggests.
Prior research has found a higher lifetime dementia risk in women, and one explanation cited has been that women tend to live longer than men.
However, this new analysis of data from nearly 30,000 people in 18 countries found almost no evidence of sex differences in most known risk factors for dementia, including age.
The risk of dementia among women was significantly higher in poorer countries, pointing to economic disadvantages as a possible explanation.
“In general, we found that the greater dementia risk found in women compared to men was more pronounced in poorer countries, which points to the need for greater efforts to narrow the gaps in health disparities between women and men in these countries,” lead investigator Jessica Gong, MSc, a doctoral student at the George Institute for Global Health, Newtown, Australia, told this news organization. “It is likely that socioeconomic factors are potentially more important than biological factors when assessing dementia risk.”
The findings were published online in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association.
Global data
Most previous studies that examined sex differences in dementia risk were conducted in high-income countries, Ms. Gong noted, leaving a gap in the literature on risk in low- and middle-income countries.
To address this issue, researchers conducted an individual participant meta-analysis of 21 studies from the Cohort Studies of Memory in an International Consortium. Data analysis included information on 29,850 people from 18 countries on six continents. None of the participants had dementia at baseline, and the average age was 71.6 years.
Over a median of 4.6 years, incident dementia was reported in 2,089 people, 66% of whom were women.
Overall, women had higher dementia risk (hazard ratio, 1.12; 95% confidence interval, 1.02-1.23) than men, but the rates were highest in low- to middle-income economies (HR, 1.73; P = .03).
Dementia risk in women was higher than in men in 14 countries. Risk was highest in Nigeria, where dementia risk was more than double in women (aHR, 2.11; 95% CI, 1.46-3.04), and lowest in Brazil, where risk was 46% lower in women than in men (aHR, 0.54; 95% CI, 0.29-1.00).
In the United States, dementia risk was 7% higher in women than men (aHR, 1.07; 0.73-1.57).
Similar risk factors
In both women and men, older age, diabetes, depression, hearing impairment, and apo E–epsilon 4 carriage were associated with a greater risk of dementia, and more years of education, higher hip circumference, current alcohol use (vs. never), and high physical activity (vs. none to minimal) were associated with a lower risk of dementia.
Among all these risk factors, sex differences were only significant for longer education and former alcohol use, with both demonstrating a stronger association in men than women.
Global dementia rates are expected to triple over the next 25 years unless steps are taken to reduce risk factors. A 2020 report found that dementia risk could be reduced by addressing 12 modifiable risk factors, including obesity, air pollution, diabetes, social isolation, and hypertension. All of these risk factors are more common in low- to middle-income countries, Ms. Gong noted.
“These findings justify ongoing efforts to support programs to improve sex and gender equity in brain health, particularly in underrepresented and underserved populations, in turn to narrow the gaps within and between country,” Ms. Gong said.
Understanding the puzzle
Commenting on the findings for Medscape Medical News, Heather Snyder, PhD, Alzheimer’s Association vice president of medical and scientific relations, said the findings add to the body of work about sex differences in dementia risk.
“This is an interesting study looking at risk factors for dementia and suggests that, while some risk factors are more pronounced in men than in women, women may be more at risk of progressing to dementia,” Dr. Snyder said. “The findings outline the importance of understanding how the underlying biology, particularly biology that differs in males and females, may be contributing to risk.”
Data on the country and geographical variations highlighted in the study also point to a potential risk influencer, she said.
“Studying geography-specific risk factors is important because it helps us understand the ‘why’ behind geographic differences in dementia risk,” Dr. Snyder said. “This type of collaboration among countries and researchers is essential for us to understand these puzzle pieces.”
Funding for the study was provided by the U.K. Medical Research Council Skills Development Fellowship, Australian National Health and Medical Research Council Investigator Grant, National Institute on Aging, among others. See the original article for full funding sources. Ms. Gong reported no relevant financial conflicts. Dr. Snyder is employed by the Alzheimer’s Association.
A version of this article originally appeared on Medscape.com.
a study suggests.
Prior research has found a higher lifetime dementia risk in women, and one explanation cited has been that women tend to live longer than men.
However, this new analysis of data from nearly 30,000 people in 18 countries found almost no evidence of sex differences in most known risk factors for dementia, including age.
The risk of dementia among women was significantly higher in poorer countries, pointing to economic disadvantages as a possible explanation.
“In general, we found that the greater dementia risk found in women compared to men was more pronounced in poorer countries, which points to the need for greater efforts to narrow the gaps in health disparities between women and men in these countries,” lead investigator Jessica Gong, MSc, a doctoral student at the George Institute for Global Health, Newtown, Australia, told this news organization. “It is likely that socioeconomic factors are potentially more important than biological factors when assessing dementia risk.”
The findings were published online in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association.
Global data
Most previous studies that examined sex differences in dementia risk were conducted in high-income countries, Ms. Gong noted, leaving a gap in the literature on risk in low- and middle-income countries.
To address this issue, researchers conducted an individual participant meta-analysis of 21 studies from the Cohort Studies of Memory in an International Consortium. Data analysis included information on 29,850 people from 18 countries on six continents. None of the participants had dementia at baseline, and the average age was 71.6 years.
Over a median of 4.6 years, incident dementia was reported in 2,089 people, 66% of whom were women.
Overall, women had higher dementia risk (hazard ratio, 1.12; 95% confidence interval, 1.02-1.23) than men, but the rates were highest in low- to middle-income economies (HR, 1.73; P = .03).
Dementia risk in women was higher than in men in 14 countries. Risk was highest in Nigeria, where dementia risk was more than double in women (aHR, 2.11; 95% CI, 1.46-3.04), and lowest in Brazil, where risk was 46% lower in women than in men (aHR, 0.54; 95% CI, 0.29-1.00).
In the United States, dementia risk was 7% higher in women than men (aHR, 1.07; 0.73-1.57).
Similar risk factors
In both women and men, older age, diabetes, depression, hearing impairment, and apo E–epsilon 4 carriage were associated with a greater risk of dementia, and more years of education, higher hip circumference, current alcohol use (vs. never), and high physical activity (vs. none to minimal) were associated with a lower risk of dementia.
Among all these risk factors, sex differences were only significant for longer education and former alcohol use, with both demonstrating a stronger association in men than women.
Global dementia rates are expected to triple over the next 25 years unless steps are taken to reduce risk factors. A 2020 report found that dementia risk could be reduced by addressing 12 modifiable risk factors, including obesity, air pollution, diabetes, social isolation, and hypertension. All of these risk factors are more common in low- to middle-income countries, Ms. Gong noted.
“These findings justify ongoing efforts to support programs to improve sex and gender equity in brain health, particularly in underrepresented and underserved populations, in turn to narrow the gaps within and between country,” Ms. Gong said.
Understanding the puzzle
Commenting on the findings for Medscape Medical News, Heather Snyder, PhD, Alzheimer’s Association vice president of medical and scientific relations, said the findings add to the body of work about sex differences in dementia risk.
“This is an interesting study looking at risk factors for dementia and suggests that, while some risk factors are more pronounced in men than in women, women may be more at risk of progressing to dementia,” Dr. Snyder said. “The findings outline the importance of understanding how the underlying biology, particularly biology that differs in males and females, may be contributing to risk.”
Data on the country and geographical variations highlighted in the study also point to a potential risk influencer, she said.
“Studying geography-specific risk factors is important because it helps us understand the ‘why’ behind geographic differences in dementia risk,” Dr. Snyder said. “This type of collaboration among countries and researchers is essential for us to understand these puzzle pieces.”
Funding for the study was provided by the U.K. Medical Research Council Skills Development Fellowship, Australian National Health and Medical Research Council Investigator Grant, National Institute on Aging, among others. See the original article for full funding sources. Ms. Gong reported no relevant financial conflicts. Dr. Snyder is employed by the Alzheimer’s Association.
A version of this article originally appeared on Medscape.com.
a study suggests.
Prior research has found a higher lifetime dementia risk in women, and one explanation cited has been that women tend to live longer than men.
However, this new analysis of data from nearly 30,000 people in 18 countries found almost no evidence of sex differences in most known risk factors for dementia, including age.
The risk of dementia among women was significantly higher in poorer countries, pointing to economic disadvantages as a possible explanation.
“In general, we found that the greater dementia risk found in women compared to men was more pronounced in poorer countries, which points to the need for greater efforts to narrow the gaps in health disparities between women and men in these countries,” lead investigator Jessica Gong, MSc, a doctoral student at the George Institute for Global Health, Newtown, Australia, told this news organization. “It is likely that socioeconomic factors are potentially more important than biological factors when assessing dementia risk.”
The findings were published online in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association.
Global data
Most previous studies that examined sex differences in dementia risk were conducted in high-income countries, Ms. Gong noted, leaving a gap in the literature on risk in low- and middle-income countries.
To address this issue, researchers conducted an individual participant meta-analysis of 21 studies from the Cohort Studies of Memory in an International Consortium. Data analysis included information on 29,850 people from 18 countries on six continents. None of the participants had dementia at baseline, and the average age was 71.6 years.
Over a median of 4.6 years, incident dementia was reported in 2,089 people, 66% of whom were women.
Overall, women had higher dementia risk (hazard ratio, 1.12; 95% confidence interval, 1.02-1.23) than men, but the rates were highest in low- to middle-income economies (HR, 1.73; P = .03).
Dementia risk in women was higher than in men in 14 countries. Risk was highest in Nigeria, where dementia risk was more than double in women (aHR, 2.11; 95% CI, 1.46-3.04), and lowest in Brazil, where risk was 46% lower in women than in men (aHR, 0.54; 95% CI, 0.29-1.00).
In the United States, dementia risk was 7% higher in women than men (aHR, 1.07; 0.73-1.57).
Similar risk factors
In both women and men, older age, diabetes, depression, hearing impairment, and apo E–epsilon 4 carriage were associated with a greater risk of dementia, and more years of education, higher hip circumference, current alcohol use (vs. never), and high physical activity (vs. none to minimal) were associated with a lower risk of dementia.
Among all these risk factors, sex differences were only significant for longer education and former alcohol use, with both demonstrating a stronger association in men than women.
Global dementia rates are expected to triple over the next 25 years unless steps are taken to reduce risk factors. A 2020 report found that dementia risk could be reduced by addressing 12 modifiable risk factors, including obesity, air pollution, diabetes, social isolation, and hypertension. All of these risk factors are more common in low- to middle-income countries, Ms. Gong noted.
“These findings justify ongoing efforts to support programs to improve sex and gender equity in brain health, particularly in underrepresented and underserved populations, in turn to narrow the gaps within and between country,” Ms. Gong said.
Understanding the puzzle
Commenting on the findings for Medscape Medical News, Heather Snyder, PhD, Alzheimer’s Association vice president of medical and scientific relations, said the findings add to the body of work about sex differences in dementia risk.
“This is an interesting study looking at risk factors for dementia and suggests that, while some risk factors are more pronounced in men than in women, women may be more at risk of progressing to dementia,” Dr. Snyder said. “The findings outline the importance of understanding how the underlying biology, particularly biology that differs in males and females, may be contributing to risk.”
Data on the country and geographical variations highlighted in the study also point to a potential risk influencer, she said.
“Studying geography-specific risk factors is important because it helps us understand the ‘why’ behind geographic differences in dementia risk,” Dr. Snyder said. “This type of collaboration among countries and researchers is essential for us to understand these puzzle pieces.”
Funding for the study was provided by the U.K. Medical Research Council Skills Development Fellowship, Australian National Health and Medical Research Council Investigator Grant, National Institute on Aging, among others. See the original article for full funding sources. Ms. Gong reported no relevant financial conflicts. Dr. Snyder is employed by the Alzheimer’s Association.
A version of this article originally appeared on Medscape.com.
FROM ALZHEIMER’S & DEMENTIA
Myths about smoking, diet, alcohol, and cancer persist
FRANCE – Conducted every 5 years since 2005, the Cancer Survey documents the knowledge, perceptions, and way of life of the French people in relation to cancer. The researchers analyzed responses to telephone interviews of a representative sample of almost 5,000 individuals aged 15-85 years.
This study shows how thinking has changed over time and how difficult it is to alter preconceived notions.
Is cancer hereditary?
The report shows that 67.7% of respondents believe that cancer is a hereditary disease. Respondents were asked to explain their answer. “Data show that medical practices for cancer treatment substantiate this belief [that cancer is hereditary],” wrote the authors of the report.
“Indeed, health care professionals almost systematically ask questions about family history of breast cancer and, when a family member has been diagnosed with cancer, medical monitoring of other family members is often sought out, thus reinforcing the belief that cancer is hereditary,” they said.
Furthermore, there seems to be confusion regarding the role of genes in the development of cancer. A person can inherit cancer-predisposing genes, not cancer itself. The authors highlighted their concern that this confusion may “lead people to think that prevention measures are unnecessary because cancer is inherited.”
Misconceptions about smoking
About 41% of smokers think that the length of time one has been smoking is the biggest determining factor for developing cancer; 58.1% think the number of cigarettes smoked per day has a bigger impact.
Experts at InCA and SPF put the debate to rest, stating that prolonged exposure to carcinogenic substances is far more toxic. As for the danger threshold concerning the number of cigarettes smoked per day, respondents believed this to be 9.2 cigarettes per day, on average. They believed that the danger threshold for the number of years as an active smoker is 13.4, on average.
“The [survey] respondents clearly understand that smoking carries a risk, but many smokers think that light smoking or smoking for a short period of time doesn’t carry any risks.” Yet it is understood that even occasional tobacco consumption increases mortality.
This was not the only misconception regarding smoking and its relationship with cancer. About 34% of survey respondents agreed with the following statement: “Smoking doesn’t cause cancer unless you’re a heavy smoker and have smoked for a long time.” Furthermore, 43.3% agreed with the statement, “Pollution is more likely to cause cancer than smoking,” 54.6% think that “exercising cleans your lungs of tobacco,” and 61.6% think that “a smoker can prevent developing cancer caused by smoking if they know to quit on time.”
Overweight and obesity
Although diet and excess weight represent the third and fourth biggest avoidable cancer risk factors, after smoking and alcohol, only 30% of survey respondents knew of this link.
“Among the causes of cancer known and cited by respondents without prompting, excessive weight and obesity were mentioned only 100 times out of 12,558 responses,” highlighted the authors of the report. The explanation put forward by the authors is that discourse about diet has been more focused on diet as a protective health factor, especially in preventing cardiovascular diseases. “The link between cancer and diet is less prominent in the public space,” they noted.
Breastfeeding and cancer
About 63% of survey respondents, which for the first time included both women and men, believe that breastfeeding does not affect mothers’ risk of breast cancer, but this is a misconception. And almost 1 in 3 respondents said that breastfeeding provides health benefits for the mother.
Artificial UV rays
Exposure to UV rays, whether of natural or artificial origin, is a major risk factor for skin cancer. However, 1 in 5 people (20.9%) think that a session in a tanning bed is less harmful than sun exposure.
Daily stress
Regarding psychological factors linked to cancer, the authors noted that risk factors not supported by scientific evidence were, ironically, cited more often by respondents than proven risk factors. There is a real knowledge gap between scientific data and the beliefs of the French people. For example, “working at night” is largely not seen as a risk factor, but data show that it presents a clear risk. However, “not being able to express one’s feelings,” “having been weakened by traumatic experiences,” and “being exposed to the stress of modern life” are seen as risk factors of cancer, without any scientific evidence.
Cigarettes and e-cigarettes
About 53% of respondents agreed that “e-cigarettes are just as harmful or more harmful than traditional cigarettes.” Nicotine and the flavors in e-cigarettes are largely perceived as “very” or “extremely” harmful to the health of a person. However, the authors note that “no published study on nicotine substitutes has shown harmful effects on the health of a person, let alone determined it a risk factor for cancer. The nicotine doses in e-cigarettes are similar to traditional nicotine substitutes, and no cytotoxic effect of nicotine in its inhaled form has been found.” There seems to be confusion between dependence and risk of cancer.
Alcohol consumption
Eight of 10 respondents believe that “some people can drink a lot of alcohol all their life without ever getting cancer,” which goes against the scientific literature. The authors of the report state that the negative effects of alcohol on health seem poorly understood. Although alcohol is the second biggest cause of cancer, only a third of survey respondents cited it without having been prompted as one of the main causes of cancer. And 23.5% even think that “in terms of decreasing your risk of cancer, it’s better to drink a little wine than to drink no wine at all.”
This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.
FRANCE – Conducted every 5 years since 2005, the Cancer Survey documents the knowledge, perceptions, and way of life of the French people in relation to cancer. The researchers analyzed responses to telephone interviews of a representative sample of almost 5,000 individuals aged 15-85 years.
This study shows how thinking has changed over time and how difficult it is to alter preconceived notions.
Is cancer hereditary?
The report shows that 67.7% of respondents believe that cancer is a hereditary disease. Respondents were asked to explain their answer. “Data show that medical practices for cancer treatment substantiate this belief [that cancer is hereditary],” wrote the authors of the report.
“Indeed, health care professionals almost systematically ask questions about family history of breast cancer and, when a family member has been diagnosed with cancer, medical monitoring of other family members is often sought out, thus reinforcing the belief that cancer is hereditary,” they said.
Furthermore, there seems to be confusion regarding the role of genes in the development of cancer. A person can inherit cancer-predisposing genes, not cancer itself. The authors highlighted their concern that this confusion may “lead people to think that prevention measures are unnecessary because cancer is inherited.”
Misconceptions about smoking
About 41% of smokers think that the length of time one has been smoking is the biggest determining factor for developing cancer; 58.1% think the number of cigarettes smoked per day has a bigger impact.
Experts at InCA and SPF put the debate to rest, stating that prolonged exposure to carcinogenic substances is far more toxic. As for the danger threshold concerning the number of cigarettes smoked per day, respondents believed this to be 9.2 cigarettes per day, on average. They believed that the danger threshold for the number of years as an active smoker is 13.4, on average.
“The [survey] respondents clearly understand that smoking carries a risk, but many smokers think that light smoking or smoking for a short period of time doesn’t carry any risks.” Yet it is understood that even occasional tobacco consumption increases mortality.
This was not the only misconception regarding smoking and its relationship with cancer. About 34% of survey respondents agreed with the following statement: “Smoking doesn’t cause cancer unless you’re a heavy smoker and have smoked for a long time.” Furthermore, 43.3% agreed with the statement, “Pollution is more likely to cause cancer than smoking,” 54.6% think that “exercising cleans your lungs of tobacco,” and 61.6% think that “a smoker can prevent developing cancer caused by smoking if they know to quit on time.”
Overweight and obesity
Although diet and excess weight represent the third and fourth biggest avoidable cancer risk factors, after smoking and alcohol, only 30% of survey respondents knew of this link.
“Among the causes of cancer known and cited by respondents without prompting, excessive weight and obesity were mentioned only 100 times out of 12,558 responses,” highlighted the authors of the report. The explanation put forward by the authors is that discourse about diet has been more focused on diet as a protective health factor, especially in preventing cardiovascular diseases. “The link between cancer and diet is less prominent in the public space,” they noted.
Breastfeeding and cancer
About 63% of survey respondents, which for the first time included both women and men, believe that breastfeeding does not affect mothers’ risk of breast cancer, but this is a misconception. And almost 1 in 3 respondents said that breastfeeding provides health benefits for the mother.
Artificial UV rays
Exposure to UV rays, whether of natural or artificial origin, is a major risk factor for skin cancer. However, 1 in 5 people (20.9%) think that a session in a tanning bed is less harmful than sun exposure.
Daily stress
Regarding psychological factors linked to cancer, the authors noted that risk factors not supported by scientific evidence were, ironically, cited more often by respondents than proven risk factors. There is a real knowledge gap between scientific data and the beliefs of the French people. For example, “working at night” is largely not seen as a risk factor, but data show that it presents a clear risk. However, “not being able to express one’s feelings,” “having been weakened by traumatic experiences,” and “being exposed to the stress of modern life” are seen as risk factors of cancer, without any scientific evidence.
Cigarettes and e-cigarettes
About 53% of respondents agreed that “e-cigarettes are just as harmful or more harmful than traditional cigarettes.” Nicotine and the flavors in e-cigarettes are largely perceived as “very” or “extremely” harmful to the health of a person. However, the authors note that “no published study on nicotine substitutes has shown harmful effects on the health of a person, let alone determined it a risk factor for cancer. The nicotine doses in e-cigarettes are similar to traditional nicotine substitutes, and no cytotoxic effect of nicotine in its inhaled form has been found.” There seems to be confusion between dependence and risk of cancer.
Alcohol consumption
Eight of 10 respondents believe that “some people can drink a lot of alcohol all their life without ever getting cancer,” which goes against the scientific literature. The authors of the report state that the negative effects of alcohol on health seem poorly understood. Although alcohol is the second biggest cause of cancer, only a third of survey respondents cited it without having been prompted as one of the main causes of cancer. And 23.5% even think that “in terms of decreasing your risk of cancer, it’s better to drink a little wine than to drink no wine at all.”
This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.
FRANCE – Conducted every 5 years since 2005, the Cancer Survey documents the knowledge, perceptions, and way of life of the French people in relation to cancer. The researchers analyzed responses to telephone interviews of a representative sample of almost 5,000 individuals aged 15-85 years.
This study shows how thinking has changed over time and how difficult it is to alter preconceived notions.
Is cancer hereditary?
The report shows that 67.7% of respondents believe that cancer is a hereditary disease. Respondents were asked to explain their answer. “Data show that medical practices for cancer treatment substantiate this belief [that cancer is hereditary],” wrote the authors of the report.
“Indeed, health care professionals almost systematically ask questions about family history of breast cancer and, when a family member has been diagnosed with cancer, medical monitoring of other family members is often sought out, thus reinforcing the belief that cancer is hereditary,” they said.
Furthermore, there seems to be confusion regarding the role of genes in the development of cancer. A person can inherit cancer-predisposing genes, not cancer itself. The authors highlighted their concern that this confusion may “lead people to think that prevention measures are unnecessary because cancer is inherited.”
Misconceptions about smoking
About 41% of smokers think that the length of time one has been smoking is the biggest determining factor for developing cancer; 58.1% think the number of cigarettes smoked per day has a bigger impact.
Experts at InCA and SPF put the debate to rest, stating that prolonged exposure to carcinogenic substances is far more toxic. As for the danger threshold concerning the number of cigarettes smoked per day, respondents believed this to be 9.2 cigarettes per day, on average. They believed that the danger threshold for the number of years as an active smoker is 13.4, on average.
“The [survey] respondents clearly understand that smoking carries a risk, but many smokers think that light smoking or smoking for a short period of time doesn’t carry any risks.” Yet it is understood that even occasional tobacco consumption increases mortality.
This was not the only misconception regarding smoking and its relationship with cancer. About 34% of survey respondents agreed with the following statement: “Smoking doesn’t cause cancer unless you’re a heavy smoker and have smoked for a long time.” Furthermore, 43.3% agreed with the statement, “Pollution is more likely to cause cancer than smoking,” 54.6% think that “exercising cleans your lungs of tobacco,” and 61.6% think that “a smoker can prevent developing cancer caused by smoking if they know to quit on time.”
Overweight and obesity
Although diet and excess weight represent the third and fourth biggest avoidable cancer risk factors, after smoking and alcohol, only 30% of survey respondents knew of this link.
“Among the causes of cancer known and cited by respondents without prompting, excessive weight and obesity were mentioned only 100 times out of 12,558 responses,” highlighted the authors of the report. The explanation put forward by the authors is that discourse about diet has been more focused on diet as a protective health factor, especially in preventing cardiovascular diseases. “The link between cancer and diet is less prominent in the public space,” they noted.
Breastfeeding and cancer
About 63% of survey respondents, which for the first time included both women and men, believe that breastfeeding does not affect mothers’ risk of breast cancer, but this is a misconception. And almost 1 in 3 respondents said that breastfeeding provides health benefits for the mother.
Artificial UV rays
Exposure to UV rays, whether of natural or artificial origin, is a major risk factor for skin cancer. However, 1 in 5 people (20.9%) think that a session in a tanning bed is less harmful than sun exposure.
Daily stress
Regarding psychological factors linked to cancer, the authors noted that risk factors not supported by scientific evidence were, ironically, cited more often by respondents than proven risk factors. There is a real knowledge gap between scientific data and the beliefs of the French people. For example, “working at night” is largely not seen as a risk factor, but data show that it presents a clear risk. However, “not being able to express one’s feelings,” “having been weakened by traumatic experiences,” and “being exposed to the stress of modern life” are seen as risk factors of cancer, without any scientific evidence.
Cigarettes and e-cigarettes
About 53% of respondents agreed that “e-cigarettes are just as harmful or more harmful than traditional cigarettes.” Nicotine and the flavors in e-cigarettes are largely perceived as “very” or “extremely” harmful to the health of a person. However, the authors note that “no published study on nicotine substitutes has shown harmful effects on the health of a person, let alone determined it a risk factor for cancer. The nicotine doses in e-cigarettes are similar to traditional nicotine substitutes, and no cytotoxic effect of nicotine in its inhaled form has been found.” There seems to be confusion between dependence and risk of cancer.
Alcohol consumption
Eight of 10 respondents believe that “some people can drink a lot of alcohol all their life without ever getting cancer,” which goes against the scientific literature. The authors of the report state that the negative effects of alcohol on health seem poorly understood. Although alcohol is the second biggest cause of cancer, only a third of survey respondents cited it without having been prompted as one of the main causes of cancer. And 23.5% even think that “in terms of decreasing your risk of cancer, it’s better to drink a little wine than to drink no wine at all.”
This article was translated from the Medscape French edition. A version of this article appeared on Medscape.com.
Physician pleads guilty to 52 counts in opioid scheme
Jeffrey B. Sutton, DO, a neuromuscular medicine specialist, pled guilty on January 30 in federal court to 31 counts of illegally prescribing opioids and other controlled substances, 1 count of illegally distributing controlled substances, and 20 counts of health care fraud.
Prosecutors said Dr. Sutton admitted that he ignored warnings from prescription drug management organizations, insurers, and state authorities that he was prescribing excessively high dosages of opioids.
Dr. Sutton also admitted to ignoring patient requests to lower dosages and that he also ignored signs that patients were selling prescribed medications or otherwise engaging in illicit activity, including violations of a “pain management agreement” that he required them to sign.
The fraud counts pertained to Dr. Sutton billing Medicare, Medicaid, and other insurers for medically unnecessary visits that he required of patients so that he could prescribe inappropriate or unnecessary opioids.
In the charging document shared with this news organization, prosecutors said Dr. Sutton had sex with at least three patients, including during office visits and outside of the office. Occasionally, the physician would give opioids or other controlled substances – often benzodiazepines – to these patients, without a prescription or valid medical need.
Dr. Sutton escalated the dosage for one of those patients, even as the subjective pain score did not improve and when the patient’s urine tests showed the presence of THC and buprenorphine, but not any of the prescribed medications.
Another patient came to Dr. Sutton in 2007 with a warning that she had a history of “narcotic-seeking” behavior and diagnoses of depression, anxiety, paranoid schizophrenia, and obsessive-compulsive disorder.
The patient was hospitalized in 2018 for complications from benzodiazepine use (prescribed by Dr. Sutton). She weighed 80 pounds at the time. Dr. Sutton continued to prescribe benzodiazepines and extreme doses of opioids – in excess of 2,000 morphine equivalent dose – “despite recognizing and documenting repeated instances of noncompliance with treatment for psychiatric conditions, and despite the known contraindications of long-term opioid use for patients with these mental illnesses,” according to the charging document.
Dr. Sutton continued to prescribe opioids despite two hospitalizations for overdoses, more than 20 failed urine drug screens that showed presence of illicit drugs such as cocaine, and documented excessive use of alprazolam (Xanax) and methadone.
The physician surrendered his Drug Enforcement Administration Certificate of Registration of Controlled Substances Privileges in February 2022 “as an indication of your good faith in desiring to remedy any incorrect or unlawful practices on your part,” according to a letter to Dr. Sutton from the State Medical Board of Ohio. In that September 2022 letter, the Board notified Dr. Sutton of its intention to possibly suspend or revoke his license.
Dr. Sutton did not request a hearing, and the Board permanently revoked his medical license on January 16.
The court will sentence Dr. Sutton on May 23, according to a report by WFMJ.
A version of this article originally appeared on Medscape.com.
Jeffrey B. Sutton, DO, a neuromuscular medicine specialist, pled guilty on January 30 in federal court to 31 counts of illegally prescribing opioids and other controlled substances, 1 count of illegally distributing controlled substances, and 20 counts of health care fraud.
Prosecutors said Dr. Sutton admitted that he ignored warnings from prescription drug management organizations, insurers, and state authorities that he was prescribing excessively high dosages of opioids.
Dr. Sutton also admitted to ignoring patient requests to lower dosages and that he also ignored signs that patients were selling prescribed medications or otherwise engaging in illicit activity, including violations of a “pain management agreement” that he required them to sign.
The fraud counts pertained to Dr. Sutton billing Medicare, Medicaid, and other insurers for medically unnecessary visits that he required of patients so that he could prescribe inappropriate or unnecessary opioids.
In the charging document shared with this news organization, prosecutors said Dr. Sutton had sex with at least three patients, including during office visits and outside of the office. Occasionally, the physician would give opioids or other controlled substances – often benzodiazepines – to these patients, without a prescription or valid medical need.
Dr. Sutton escalated the dosage for one of those patients, even as the subjective pain score did not improve and when the patient’s urine tests showed the presence of THC and buprenorphine, but not any of the prescribed medications.
Another patient came to Dr. Sutton in 2007 with a warning that she had a history of “narcotic-seeking” behavior and diagnoses of depression, anxiety, paranoid schizophrenia, and obsessive-compulsive disorder.
The patient was hospitalized in 2018 for complications from benzodiazepine use (prescribed by Dr. Sutton). She weighed 80 pounds at the time. Dr. Sutton continued to prescribe benzodiazepines and extreme doses of opioids – in excess of 2,000 morphine equivalent dose – “despite recognizing and documenting repeated instances of noncompliance with treatment for psychiatric conditions, and despite the known contraindications of long-term opioid use for patients with these mental illnesses,” according to the charging document.
Dr. Sutton continued to prescribe opioids despite two hospitalizations for overdoses, more than 20 failed urine drug screens that showed presence of illicit drugs such as cocaine, and documented excessive use of alprazolam (Xanax) and methadone.
The physician surrendered his Drug Enforcement Administration Certificate of Registration of Controlled Substances Privileges in February 2022 “as an indication of your good faith in desiring to remedy any incorrect or unlawful practices on your part,” according to a letter to Dr. Sutton from the State Medical Board of Ohio. In that September 2022 letter, the Board notified Dr. Sutton of its intention to possibly suspend or revoke his license.
Dr. Sutton did not request a hearing, and the Board permanently revoked his medical license on January 16.
The court will sentence Dr. Sutton on May 23, according to a report by WFMJ.
A version of this article originally appeared on Medscape.com.
Jeffrey B. Sutton, DO, a neuromuscular medicine specialist, pled guilty on January 30 in federal court to 31 counts of illegally prescribing opioids and other controlled substances, 1 count of illegally distributing controlled substances, and 20 counts of health care fraud.
Prosecutors said Dr. Sutton admitted that he ignored warnings from prescription drug management organizations, insurers, and state authorities that he was prescribing excessively high dosages of opioids.
Dr. Sutton also admitted to ignoring patient requests to lower dosages and that he also ignored signs that patients were selling prescribed medications or otherwise engaging in illicit activity, including violations of a “pain management agreement” that he required them to sign.
The fraud counts pertained to Dr. Sutton billing Medicare, Medicaid, and other insurers for medically unnecessary visits that he required of patients so that he could prescribe inappropriate or unnecessary opioids.
In the charging document shared with this news organization, prosecutors said Dr. Sutton had sex with at least three patients, including during office visits and outside of the office. Occasionally, the physician would give opioids or other controlled substances – often benzodiazepines – to these patients, without a prescription or valid medical need.
Dr. Sutton escalated the dosage for one of those patients, even as the subjective pain score did not improve and when the patient’s urine tests showed the presence of THC and buprenorphine, but not any of the prescribed medications.
Another patient came to Dr. Sutton in 2007 with a warning that she had a history of “narcotic-seeking” behavior and diagnoses of depression, anxiety, paranoid schizophrenia, and obsessive-compulsive disorder.
The patient was hospitalized in 2018 for complications from benzodiazepine use (prescribed by Dr. Sutton). She weighed 80 pounds at the time. Dr. Sutton continued to prescribe benzodiazepines and extreme doses of opioids – in excess of 2,000 morphine equivalent dose – “despite recognizing and documenting repeated instances of noncompliance with treatment for psychiatric conditions, and despite the known contraindications of long-term opioid use for patients with these mental illnesses,” according to the charging document.
Dr. Sutton continued to prescribe opioids despite two hospitalizations for overdoses, more than 20 failed urine drug screens that showed presence of illicit drugs such as cocaine, and documented excessive use of alprazolam (Xanax) and methadone.
The physician surrendered his Drug Enforcement Administration Certificate of Registration of Controlled Substances Privileges in February 2022 “as an indication of your good faith in desiring to remedy any incorrect or unlawful practices on your part,” according to a letter to Dr. Sutton from the State Medical Board of Ohio. In that September 2022 letter, the Board notified Dr. Sutton of its intention to possibly suspend or revoke his license.
Dr. Sutton did not request a hearing, and the Board permanently revoked his medical license on January 16.
The court will sentence Dr. Sutton on May 23, according to a report by WFMJ.
A version of this article originally appeared on Medscape.com.
Recruiting gastroenterology and hepatology fellows virtually - Should we continue after the pandemic?
Recruiting medical trainees is a major yearly step for all teaching hospitals in health care. The concept of interviewing residents and fellows virtually is not completely new and has been used in the past.1 With the coronavirus disease-19 (COVID-19) epidemic, the Association of American Medical Colleges (AAMC) recommended in May 2020 that all interviews be conducted virtually to ensure safety and prevent spread of the disease.2,3 Over the past few years, and with the gradual loosening of some restrictions, some programs have adopted a hybrid interview model for their recruitment plan, while others continue to use the virtual model exclusively.
, from the standpoint of the program director (Dr. Clark) and the associate program director (Dr. Dakhoul) of the fellowship program at the University of Florida in Gainesville. We have conducted our fellowship interviews for the academic year 2022-2023 completely virtually over multiple half-day sessions and fully matched all four positions. At the time of the interviews, we extended a general invitation to all candidates for an in-person visit for the purpose of touring the facilities and our community. Out of the 37 applicants interviewed, 2 made an in-person visit later.
After we concluded the interview season, we conducted a brief, anonymous survey to assess the overall experience of the interviewees with their virtual interviews. (See end of this article.) The survey contained a combination of single-choice questions and open-ended questions. The response rate was 35%. Most responders (92.3%) thought that they had a great understanding of the program from the information provided to them, and 84.6% were quite satisfied with their virtual interview experience. Regarding the likelihood of accepting the interview if it were offered in person, only one person answered that he/she would not have accepted the invitation. A total of 31% of participants might have changed the ranking of the program if they’d had an in-person interview instead.
When asked to choose between an invitation for an in-person vs. a virtual interview, the majority (77%) chose the virtual option. The stated pros of being interviewed virtually included convenience (not having to find coverage, etc.), time and cost savings, and a less stressful experience. Cons were focused mostly on not being able to see the hospital or the geographical area in person, as well as limited exposure to the facility and work environment for subjective assessment of “fitting” into the program. Additional comments included mostly positive feedback about the whole experience specific to the program. Finally, 77% of respondents recommended that the program should continue to conduct its interviews virtually.
It seems that the general feedback from our survey was positive. Certainly, limitations exist, including but not limited to the response rate, the geographic locations of the invited candidates, the design of the interview day, and familiarity with the fellowship program and the surrounding area. Several studies have been published on the topic with variable results across centers and among specialties, but most of them reported an encouraging overall experience.4-9
While the virtual recruitment experience seems to be most appealing to candidates, fellowships program directors and faculty who are part of the selection committee do not seem to be completely satisfied with the process and/or the outcome. Although virtual recruitment was shown to reduce financial costs and use of institutional resources,6 the major drawbacks were a lack of perception of the communication skills of the candidates as well as an inability to properly assess the interpersonal interactions with fellows and other applicants, both major keys to ranking decisions.10
Furthermore, the number of candidates who applied to our program has been steadily on the rise since the virtual platform was introduced. This has been the case nationwide and in other specialties as well.11 Applicants invited for an interview rarely decline or cancel the invitation due to the convenience of the virtual setting.6 These factors can affect the choice of candidates and subsequently the results of the match, especially for smaller programs. These observations create a new dilemma of whether fellowship programs need to consider increasing the number of their interviewees to ascertain a full match. Although the number of gastroenterology fellowship positions is steadily increasing with new program openings every year, it might not match the speed of the up-trending number of applicants. This certainly creates concern for fairness and equity in the selection process in this very competitive subspecialty.
As most gastroenterology programs continue to recruit their fellows virtually, it is important to keep in mind a few key elements to enhance the virtual experience. These include: a) familiarity of the interviewers and interviewees with video conference software to avoid technical problems, b) inclusion of up-to-date information about the program on the institutional website as well as videos or live-stream tours to show the physical aspect of the training sites (mainly the endoscopy areas) as alternatives to in-person tours,12 and c) timing of the interview, taking into consideration the different time zones of the invited applicants. Despite optimizing the virtual experience, some interviewees might still choose to visit in person. While this decision is solely voluntary and remains optional (at least in our program), it does allow program directors to indirectly evaluate candidates with a strong interest in the program.
In conclusion, there is no clear-cut answer to whether conducting interviews virtually is the best way to continue to recruit gastroenterology and hepatology fellows beyond the pandemic. While our perspective might be somewhat biased by the positive experience we had in the past few years recruiting our fellows virtually, this should be an individualized decision for every program. It is highly dependent on the location and size of each fellowship program, faculty engagement in the interview process, and the historical matching rates of the program. On a positive note, the individualized approach by each fellowship program should highlight the best features of the program and have a positive impact on recruitment at the local level. We have to bear in mind that a nonstandardized approach to fellow recruitment may have disadvantages to both programs and applicants with fewer resources to successfully compete and may introduce another element of uncertainty to an already stressful process for applicants and programs alike. As we continue to understand the implications of using the virtual platform and to reflect on the previous match results through the performance and satisfaction of the fellows recruited virtually, this option does not seem to have completely replaced in-person meetings. Further follow-up to evaluate the impact of virtual interviews should be done by surveying program directors nationally on the impact of match results before and after implementation of virtual interviews.
Survey
A. Do you think you had a good understanding of the UF GI Fellowship program from the information provided to you during your virtual interview?
1. I was provided with all the information I needed to know, and I had a great understanding of the program
2. I was provided with some information, and I had a fair understanding of the program
3. I was not provided with enough information, and I don’t think I understand the program well
B. How likely were you to accept this interview if this had been an in-person interview?
1. I would have still accepted the invitation regardless
2. I would have thought about possibly not accepting the invitation
3. I wouldn’t have accepted the invitation
C. Do you think an in-person interview would have changed your program ranking?
1. Yes
2. Maybe, I am not sure
3. No
D. If you had a choice between conducting this interview virtually vs. in-person, which one would you have chosen?
1. Virtual
2. In-person
E. Overall, how satisfied were you with your virtual GI Fellowship interview experience at UF?
1. Quite satisfied
2. Somewhat satisfied
3. Not at all satisfied
F. If you chose “somewhat satisfied” or “not at all satisfied” in the previous question, please tell us why, and what are the things that we could have done better:G. Do you think the UF GI Fellowship program should continue to conduct its interviews virtually (regardless of COVID)?
1. Yes
2. No
H. Please list some of the pros and cons of being interviewed virtually, in your opinion:
I. Additional comments:
Dr. Dakhoul, Ms. Rhoden, and Dr. Clark are with the division of gastroenterology and hepatology, University of Florida, Gainesville. They have no disclosures or conflicts.
References
1. Shah SK et al. Randomized evaluation of a web based interview process for urology resident selection. J Urol. Apr 2012;187(4):1380-4.
2. AAMC Interview Guidance for the 2022-2023 Residency Cycle. May 16, 2022.
3. Bernstein SA et al. Graduate medical education virtual interviews and recruitment in the era of COVID-19. J Grad Med Educ. Oct 2020;12(5):557-60.
4. Gupta S et al. Is the changing landscape of fellowship recruitment during COVID-19 here to stay? J Pediatr Surg. Oct 2022;57(10):445-50.
5. Vining CC et al. Virtual surgical fellowship recruitment during COVID-19 and its implications for resident/fellow recruitment in the future. Ann Surg Oncol. 2020 Dec;27(Suppl 3):911-15.
6. Simmons RP et al. Virtual Recruitment: Experiences and Perspectives of Internal Medicine Program Directors. Am J Med. Feb 2022;135(2):258-63.e251.
7. Daram SR et al. Interview from anywhere: Feasibility and utility of web-based videoconference interviews in the gastroenterology fellowship selection process. Am J Gastroenterol. Feb 2014;109(2):155-9.
8. Ponterio JM et al. The virtual interview format for fellowship recruitment in obstetrics and gynecology: A nationwide survey of program directors. Med Educ Online. Dec 2022;27(1):2054304.
9. DiGiusto M et al. Impact of the COVID-19 pandemic on the 2020 pediatric anesthesiology fellowship application cycle: A survey of program directors. Paediatr Anaesth. Mar 2022;32(3):471-8.
10. Hamade N et al. Virtual Gastroenterology Fellowship Recruitment During COVID-19 and Its Implications for the Future. Dig Dis Sci. Jun 2022;67(6):2019-28.
11. AAMC: ERAS Statistics. Historical Specialty Specific Data.
12. Advani R et al. An Overview of the GI Fellowship Interview: Part II-Tips for Selection Committees and Interviewers. Dig Dis Sci. May 2022;67(5):1712-17.
Recruiting medical trainees is a major yearly step for all teaching hospitals in health care. The concept of interviewing residents and fellows virtually is not completely new and has been used in the past.1 With the coronavirus disease-19 (COVID-19) epidemic, the Association of American Medical Colleges (AAMC) recommended in May 2020 that all interviews be conducted virtually to ensure safety and prevent spread of the disease.2,3 Over the past few years, and with the gradual loosening of some restrictions, some programs have adopted a hybrid interview model for their recruitment plan, while others continue to use the virtual model exclusively.
, from the standpoint of the program director (Dr. Clark) and the associate program director (Dr. Dakhoul) of the fellowship program at the University of Florida in Gainesville. We have conducted our fellowship interviews for the academic year 2022-2023 completely virtually over multiple half-day sessions and fully matched all four positions. At the time of the interviews, we extended a general invitation to all candidates for an in-person visit for the purpose of touring the facilities and our community. Out of the 37 applicants interviewed, 2 made an in-person visit later.
After we concluded the interview season, we conducted a brief, anonymous survey to assess the overall experience of the interviewees with their virtual interviews. (See end of this article.) The survey contained a combination of single-choice questions and open-ended questions. The response rate was 35%. Most responders (92.3%) thought that they had a great understanding of the program from the information provided to them, and 84.6% were quite satisfied with their virtual interview experience. Regarding the likelihood of accepting the interview if it were offered in person, only one person answered that he/she would not have accepted the invitation. A total of 31% of participants might have changed the ranking of the program if they’d had an in-person interview instead.
When asked to choose between an invitation for an in-person vs. a virtual interview, the majority (77%) chose the virtual option. The stated pros of being interviewed virtually included convenience (not having to find coverage, etc.), time and cost savings, and a less stressful experience. Cons were focused mostly on not being able to see the hospital or the geographical area in person, as well as limited exposure to the facility and work environment for subjective assessment of “fitting” into the program. Additional comments included mostly positive feedback about the whole experience specific to the program. Finally, 77% of respondents recommended that the program should continue to conduct its interviews virtually.
It seems that the general feedback from our survey was positive. Certainly, limitations exist, including but not limited to the response rate, the geographic locations of the invited candidates, the design of the interview day, and familiarity with the fellowship program and the surrounding area. Several studies have been published on the topic with variable results across centers and among specialties, but most of them reported an encouraging overall experience.4-9
While the virtual recruitment experience seems to be most appealing to candidates, fellowships program directors and faculty who are part of the selection committee do not seem to be completely satisfied with the process and/or the outcome. Although virtual recruitment was shown to reduce financial costs and use of institutional resources,6 the major drawbacks were a lack of perception of the communication skills of the candidates as well as an inability to properly assess the interpersonal interactions with fellows and other applicants, both major keys to ranking decisions.10
Furthermore, the number of candidates who applied to our program has been steadily on the rise since the virtual platform was introduced. This has been the case nationwide and in other specialties as well.11 Applicants invited for an interview rarely decline or cancel the invitation due to the convenience of the virtual setting.6 These factors can affect the choice of candidates and subsequently the results of the match, especially for smaller programs. These observations create a new dilemma of whether fellowship programs need to consider increasing the number of their interviewees to ascertain a full match. Although the number of gastroenterology fellowship positions is steadily increasing with new program openings every year, it might not match the speed of the up-trending number of applicants. This certainly creates concern for fairness and equity in the selection process in this very competitive subspecialty.
As most gastroenterology programs continue to recruit their fellows virtually, it is important to keep in mind a few key elements to enhance the virtual experience. These include: a) familiarity of the interviewers and interviewees with video conference software to avoid technical problems, b) inclusion of up-to-date information about the program on the institutional website as well as videos or live-stream tours to show the physical aspect of the training sites (mainly the endoscopy areas) as alternatives to in-person tours,12 and c) timing of the interview, taking into consideration the different time zones of the invited applicants. Despite optimizing the virtual experience, some interviewees might still choose to visit in person. While this decision is solely voluntary and remains optional (at least in our program), it does allow program directors to indirectly evaluate candidates with a strong interest in the program.
In conclusion, there is no clear-cut answer to whether conducting interviews virtually is the best way to continue to recruit gastroenterology and hepatology fellows beyond the pandemic. While our perspective might be somewhat biased by the positive experience we had in the past few years recruiting our fellows virtually, this should be an individualized decision for every program. It is highly dependent on the location and size of each fellowship program, faculty engagement in the interview process, and the historical matching rates of the program. On a positive note, the individualized approach by each fellowship program should highlight the best features of the program and have a positive impact on recruitment at the local level. We have to bear in mind that a nonstandardized approach to fellow recruitment may have disadvantages to both programs and applicants with fewer resources to successfully compete and may introduce another element of uncertainty to an already stressful process for applicants and programs alike. As we continue to understand the implications of using the virtual platform and to reflect on the previous match results through the performance and satisfaction of the fellows recruited virtually, this option does not seem to have completely replaced in-person meetings. Further follow-up to evaluate the impact of virtual interviews should be done by surveying program directors nationally on the impact of match results before and after implementation of virtual interviews.
Survey
A. Do you think you had a good understanding of the UF GI Fellowship program from the information provided to you during your virtual interview?
1. I was provided with all the information I needed to know, and I had a great understanding of the program
2. I was provided with some information, and I had a fair understanding of the program
3. I was not provided with enough information, and I don’t think I understand the program well
B. How likely were you to accept this interview if this had been an in-person interview?
1. I would have still accepted the invitation regardless
2. I would have thought about possibly not accepting the invitation
3. I wouldn’t have accepted the invitation
C. Do you think an in-person interview would have changed your program ranking?
1. Yes
2. Maybe, I am not sure
3. No
D. If you had a choice between conducting this interview virtually vs. in-person, which one would you have chosen?
1. Virtual
2. In-person
E. Overall, how satisfied were you with your virtual GI Fellowship interview experience at UF?
1. Quite satisfied
2. Somewhat satisfied
3. Not at all satisfied
F. If you chose “somewhat satisfied” or “not at all satisfied” in the previous question, please tell us why, and what are the things that we could have done better:G. Do you think the UF GI Fellowship program should continue to conduct its interviews virtually (regardless of COVID)?
1. Yes
2. No
H. Please list some of the pros and cons of being interviewed virtually, in your opinion:
I. Additional comments:
Dr. Dakhoul, Ms. Rhoden, and Dr. Clark are with the division of gastroenterology and hepatology, University of Florida, Gainesville. They have no disclosures or conflicts.
References
1. Shah SK et al. Randomized evaluation of a web based interview process for urology resident selection. J Urol. Apr 2012;187(4):1380-4.
2. AAMC Interview Guidance for the 2022-2023 Residency Cycle. May 16, 2022.
3. Bernstein SA et al. Graduate medical education virtual interviews and recruitment in the era of COVID-19. J Grad Med Educ. Oct 2020;12(5):557-60.
4. Gupta S et al. Is the changing landscape of fellowship recruitment during COVID-19 here to stay? J Pediatr Surg. Oct 2022;57(10):445-50.
5. Vining CC et al. Virtual surgical fellowship recruitment during COVID-19 and its implications for resident/fellow recruitment in the future. Ann Surg Oncol. 2020 Dec;27(Suppl 3):911-15.
6. Simmons RP et al. Virtual Recruitment: Experiences and Perspectives of Internal Medicine Program Directors. Am J Med. Feb 2022;135(2):258-63.e251.
7. Daram SR et al. Interview from anywhere: Feasibility and utility of web-based videoconference interviews in the gastroenterology fellowship selection process. Am J Gastroenterol. Feb 2014;109(2):155-9.
8. Ponterio JM et al. The virtual interview format for fellowship recruitment in obstetrics and gynecology: A nationwide survey of program directors. Med Educ Online. Dec 2022;27(1):2054304.
9. DiGiusto M et al. Impact of the COVID-19 pandemic on the 2020 pediatric anesthesiology fellowship application cycle: A survey of program directors. Paediatr Anaesth. Mar 2022;32(3):471-8.
10. Hamade N et al. Virtual Gastroenterology Fellowship Recruitment During COVID-19 and Its Implications for the Future. Dig Dis Sci. Jun 2022;67(6):2019-28.
11. AAMC: ERAS Statistics. Historical Specialty Specific Data.
12. Advani R et al. An Overview of the GI Fellowship Interview: Part II-Tips for Selection Committees and Interviewers. Dig Dis Sci. May 2022;67(5):1712-17.
Recruiting medical trainees is a major yearly step for all teaching hospitals in health care. The concept of interviewing residents and fellows virtually is not completely new and has been used in the past.1 With the coronavirus disease-19 (COVID-19) epidemic, the Association of American Medical Colleges (AAMC) recommended in May 2020 that all interviews be conducted virtually to ensure safety and prevent spread of the disease.2,3 Over the past few years, and with the gradual loosening of some restrictions, some programs have adopted a hybrid interview model for their recruitment plan, while others continue to use the virtual model exclusively.
, from the standpoint of the program director (Dr. Clark) and the associate program director (Dr. Dakhoul) of the fellowship program at the University of Florida in Gainesville. We have conducted our fellowship interviews for the academic year 2022-2023 completely virtually over multiple half-day sessions and fully matched all four positions. At the time of the interviews, we extended a general invitation to all candidates for an in-person visit for the purpose of touring the facilities and our community. Out of the 37 applicants interviewed, 2 made an in-person visit later.
After we concluded the interview season, we conducted a brief, anonymous survey to assess the overall experience of the interviewees with their virtual interviews. (See end of this article.) The survey contained a combination of single-choice questions and open-ended questions. The response rate was 35%. Most responders (92.3%) thought that they had a great understanding of the program from the information provided to them, and 84.6% were quite satisfied with their virtual interview experience. Regarding the likelihood of accepting the interview if it were offered in person, only one person answered that he/she would not have accepted the invitation. A total of 31% of participants might have changed the ranking of the program if they’d had an in-person interview instead.
When asked to choose between an invitation for an in-person vs. a virtual interview, the majority (77%) chose the virtual option. The stated pros of being interviewed virtually included convenience (not having to find coverage, etc.), time and cost savings, and a less stressful experience. Cons were focused mostly on not being able to see the hospital or the geographical area in person, as well as limited exposure to the facility and work environment for subjective assessment of “fitting” into the program. Additional comments included mostly positive feedback about the whole experience specific to the program. Finally, 77% of respondents recommended that the program should continue to conduct its interviews virtually.
It seems that the general feedback from our survey was positive. Certainly, limitations exist, including but not limited to the response rate, the geographic locations of the invited candidates, the design of the interview day, and familiarity with the fellowship program and the surrounding area. Several studies have been published on the topic with variable results across centers and among specialties, but most of them reported an encouraging overall experience.4-9
While the virtual recruitment experience seems to be most appealing to candidates, fellowships program directors and faculty who are part of the selection committee do not seem to be completely satisfied with the process and/or the outcome. Although virtual recruitment was shown to reduce financial costs and use of institutional resources,6 the major drawbacks were a lack of perception of the communication skills of the candidates as well as an inability to properly assess the interpersonal interactions with fellows and other applicants, both major keys to ranking decisions.10
Furthermore, the number of candidates who applied to our program has been steadily on the rise since the virtual platform was introduced. This has been the case nationwide and in other specialties as well.11 Applicants invited for an interview rarely decline or cancel the invitation due to the convenience of the virtual setting.6 These factors can affect the choice of candidates and subsequently the results of the match, especially for smaller programs. These observations create a new dilemma of whether fellowship programs need to consider increasing the number of their interviewees to ascertain a full match. Although the number of gastroenterology fellowship positions is steadily increasing with new program openings every year, it might not match the speed of the up-trending number of applicants. This certainly creates concern for fairness and equity in the selection process in this very competitive subspecialty.
As most gastroenterology programs continue to recruit their fellows virtually, it is important to keep in mind a few key elements to enhance the virtual experience. These include: a) familiarity of the interviewers and interviewees with video conference software to avoid technical problems, b) inclusion of up-to-date information about the program on the institutional website as well as videos or live-stream tours to show the physical aspect of the training sites (mainly the endoscopy areas) as alternatives to in-person tours,12 and c) timing of the interview, taking into consideration the different time zones of the invited applicants. Despite optimizing the virtual experience, some interviewees might still choose to visit in person. While this decision is solely voluntary and remains optional (at least in our program), it does allow program directors to indirectly evaluate candidates with a strong interest in the program.
In conclusion, there is no clear-cut answer to whether conducting interviews virtually is the best way to continue to recruit gastroenterology and hepatology fellows beyond the pandemic. While our perspective might be somewhat biased by the positive experience we had in the past few years recruiting our fellows virtually, this should be an individualized decision for every program. It is highly dependent on the location and size of each fellowship program, faculty engagement in the interview process, and the historical matching rates of the program. On a positive note, the individualized approach by each fellowship program should highlight the best features of the program and have a positive impact on recruitment at the local level. We have to bear in mind that a nonstandardized approach to fellow recruitment may have disadvantages to both programs and applicants with fewer resources to successfully compete and may introduce another element of uncertainty to an already stressful process for applicants and programs alike. As we continue to understand the implications of using the virtual platform and to reflect on the previous match results through the performance and satisfaction of the fellows recruited virtually, this option does not seem to have completely replaced in-person meetings. Further follow-up to evaluate the impact of virtual interviews should be done by surveying program directors nationally on the impact of match results before and after implementation of virtual interviews.
Survey
A. Do you think you had a good understanding of the UF GI Fellowship program from the information provided to you during your virtual interview?
1. I was provided with all the information I needed to know, and I had a great understanding of the program
2. I was provided with some information, and I had a fair understanding of the program
3. I was not provided with enough information, and I don’t think I understand the program well
B. How likely were you to accept this interview if this had been an in-person interview?
1. I would have still accepted the invitation regardless
2. I would have thought about possibly not accepting the invitation
3. I wouldn’t have accepted the invitation
C. Do you think an in-person interview would have changed your program ranking?
1. Yes
2. Maybe, I am not sure
3. No
D. If you had a choice between conducting this interview virtually vs. in-person, which one would you have chosen?
1. Virtual
2. In-person
E. Overall, how satisfied were you with your virtual GI Fellowship interview experience at UF?
1. Quite satisfied
2. Somewhat satisfied
3. Not at all satisfied
F. If you chose “somewhat satisfied” or “not at all satisfied” in the previous question, please tell us why, and what are the things that we could have done better:G. Do you think the UF GI Fellowship program should continue to conduct its interviews virtually (regardless of COVID)?
1. Yes
2. No
H. Please list some of the pros and cons of being interviewed virtually, in your opinion:
I. Additional comments:
Dr. Dakhoul, Ms. Rhoden, and Dr. Clark are with the division of gastroenterology and hepatology, University of Florida, Gainesville. They have no disclosures or conflicts.
References
1. Shah SK et al. Randomized evaluation of a web based interview process for urology resident selection. J Urol. Apr 2012;187(4):1380-4.
2. AAMC Interview Guidance for the 2022-2023 Residency Cycle. May 16, 2022.
3. Bernstein SA et al. Graduate medical education virtual interviews and recruitment in the era of COVID-19. J Grad Med Educ. Oct 2020;12(5):557-60.
4. Gupta S et al. Is the changing landscape of fellowship recruitment during COVID-19 here to stay? J Pediatr Surg. Oct 2022;57(10):445-50.
5. Vining CC et al. Virtual surgical fellowship recruitment during COVID-19 and its implications for resident/fellow recruitment in the future. Ann Surg Oncol. 2020 Dec;27(Suppl 3):911-15.
6. Simmons RP et al. Virtual Recruitment: Experiences and Perspectives of Internal Medicine Program Directors. Am J Med. Feb 2022;135(2):258-63.e251.
7. Daram SR et al. Interview from anywhere: Feasibility and utility of web-based videoconference interviews in the gastroenterology fellowship selection process. Am J Gastroenterol. Feb 2014;109(2):155-9.
8. Ponterio JM et al. The virtual interview format for fellowship recruitment in obstetrics and gynecology: A nationwide survey of program directors. Med Educ Online. Dec 2022;27(1):2054304.
9. DiGiusto M et al. Impact of the COVID-19 pandemic on the 2020 pediatric anesthesiology fellowship application cycle: A survey of program directors. Paediatr Anaesth. Mar 2022;32(3):471-8.
10. Hamade N et al. Virtual Gastroenterology Fellowship Recruitment During COVID-19 and Its Implications for the Future. Dig Dis Sci. Jun 2022;67(6):2019-28.
11. AAMC: ERAS Statistics. Historical Specialty Specific Data.
12. Advani R et al. An Overview of the GI Fellowship Interview: Part II-Tips for Selection Committees and Interviewers. Dig Dis Sci. May 2022;67(5):1712-17.
Hemophilia A gene therapy under FDA review
Hemophilia A (a deficiency of clotting Factor X) is the most common form of the disease, accounting for about 85% of patients.
The other type is hemophilia B (deficiency of clotting Factor VIII), and a gene therapy for this form of the disease has recently been launched – etranacogene dezaparvovec (Hemgenix), at the enormous price tag of $3.5 million.
Both products are comprised of a one-off intravenous IV infusion that delivers a functional gene via an adeno-associated virus that instructs the body to make the missing clotting factor. The hope is that this one-off infusion will act as a ‘cure’ and that the individual will be freed from life-long prophylaxis and/or treatment.
The new clinical data on valoctocogene roxaparvovec, published online in the New England Journal of Medicine, show that the beneficial effects from the gene are largely durable at 2 years, but they are anticipated to fade with time.
Two years after the one-time infusion, there remained “a significant reduction in the annualized bleeding rates” among 132 men who, at baseline, had severe hemophilia A requiring ongoing factor VIII prophylaxis, said the investigators, led by hematologist Johnny Mahlangu, MBBCh, MMed, of the University of the Witwatersrand, Johannesburg, South Africa.
However, the team predicted that median factor VIII activity would decrease below 10% of normal by year 3 or 5 depending on measurement technique, which would still translate to mild disease with an annualized bleeding rate of less than 1 episode per year.
“Although valoctocogene roxaparvovec may not eliminate bleeding, it potentially provides more consistent protection than factor VIII prophylaxis with less treatment burden,” the team said.
New questions
Data from the study “will directly inform therapeutic decision-making” in Europe, where valoctocogene roxaparvovec is already conditionally approved, and the United States, where it is awaiting approval by the FDA, says Lindsey George, MD, a hematologist and gene therapy specialist at Children’s Hospital of Philadelphia, in an accompanying editorial.
The study speaks to an ongoing concern about the durability of gene therapy for hemophilia but also raises new questions, she said.
For instance, while some patients had normal Factor VIII production and activity at 2 years, activity had dropped substantially in others, including in six men who resumed prophylaxis. “The cause of the decrease in factor VIII expression is an unanswered question,” and despite an anticipated U.S. price tag of around $2.5 million per treatment, “it is not possible [at the moment] to predict where an individual patient may fall within this range,” she writes.
Also, some subjects had elevations in liver aminotransferase levels that lasted for several months, including 2 years after infusion in 29% of subjects. Elevations in liver aminotransferase levels were treated with immune suppression for a median of 33 weeks.
“This is a unique finding with an undefined cause and long-term safety implications,” Dr. George said.
Getting to the bottom of such issues will be necessary for hemophilia gene therapy to fulfill its promise as “a one-time, lifelong, disease-ameliorating” fix for the condition, she asserted.
Study details
The new report followed up on the initial trial in 134 men who were treated with a single infusion of 6 × 1013 vector genomes per kilogram of body weight.
Among the 132 subjects available for 2-year evaluation, median factor VIII activity was in the range of mild hemophilia (6%-49% of normal) with an 84.5% reduction in bleeding events from baseline.
More than 80% of participants had no bleeding events requiring treatment, and there was a 98% reduction from baseline in mean use of exogenous factor VIII.
Overall, at year 2, 4.5% of subjects had factor VIII activity consistent with severe hemophilia A; 9.1% had activity consistent with moderate disease; 59.8% had activity consistent with mild disease; and 26.5% had activity in the normal range above 40 IU/dL. The investigators estimated that the typical half-life of the transgene-derived factor VIII production system is 123 weeks.
Among the six men who resumed prophylaxis, most had fewer bleeding events than when they were on prophylaxis before the infusion, investigators noted.
All the subjects developed antibodies to the virus delivery vector, precluding retreatment.
The work was funded by valoctocogene roxaparvovec maker BioMarin Pharmaceuticals. Several investigators are employees. Others reported ties to BioMarin and other companies; Dr. Mahlangu, for instance, reported research grants from BioMarin, Roche, Novo Nordisk, Pfizer, and others. Dr. George reported a research grant from Asklepios Biopharmaceutical and having a patent licensed to the company. The full list of author disclosures can be found with the original article.
A version of this article first appeared on Medscape.com.
Hemophilia A (a deficiency of clotting Factor X) is the most common form of the disease, accounting for about 85% of patients.
The other type is hemophilia B (deficiency of clotting Factor VIII), and a gene therapy for this form of the disease has recently been launched – etranacogene dezaparvovec (Hemgenix), at the enormous price tag of $3.5 million.
Both products are comprised of a one-off intravenous IV infusion that delivers a functional gene via an adeno-associated virus that instructs the body to make the missing clotting factor. The hope is that this one-off infusion will act as a ‘cure’ and that the individual will be freed from life-long prophylaxis and/or treatment.
The new clinical data on valoctocogene roxaparvovec, published online in the New England Journal of Medicine, show that the beneficial effects from the gene are largely durable at 2 years, but they are anticipated to fade with time.
Two years after the one-time infusion, there remained “a significant reduction in the annualized bleeding rates” among 132 men who, at baseline, had severe hemophilia A requiring ongoing factor VIII prophylaxis, said the investigators, led by hematologist Johnny Mahlangu, MBBCh, MMed, of the University of the Witwatersrand, Johannesburg, South Africa.
However, the team predicted that median factor VIII activity would decrease below 10% of normal by year 3 or 5 depending on measurement technique, which would still translate to mild disease with an annualized bleeding rate of less than 1 episode per year.
“Although valoctocogene roxaparvovec may not eliminate bleeding, it potentially provides more consistent protection than factor VIII prophylaxis with less treatment burden,” the team said.
New questions
Data from the study “will directly inform therapeutic decision-making” in Europe, where valoctocogene roxaparvovec is already conditionally approved, and the United States, where it is awaiting approval by the FDA, says Lindsey George, MD, a hematologist and gene therapy specialist at Children’s Hospital of Philadelphia, in an accompanying editorial.
The study speaks to an ongoing concern about the durability of gene therapy for hemophilia but also raises new questions, she said.
For instance, while some patients had normal Factor VIII production and activity at 2 years, activity had dropped substantially in others, including in six men who resumed prophylaxis. “The cause of the decrease in factor VIII expression is an unanswered question,” and despite an anticipated U.S. price tag of around $2.5 million per treatment, “it is not possible [at the moment] to predict where an individual patient may fall within this range,” she writes.
Also, some subjects had elevations in liver aminotransferase levels that lasted for several months, including 2 years after infusion in 29% of subjects. Elevations in liver aminotransferase levels were treated with immune suppression for a median of 33 weeks.
“This is a unique finding with an undefined cause and long-term safety implications,” Dr. George said.
Getting to the bottom of such issues will be necessary for hemophilia gene therapy to fulfill its promise as “a one-time, lifelong, disease-ameliorating” fix for the condition, she asserted.
Study details
The new report followed up on the initial trial in 134 men who were treated with a single infusion of 6 × 1013 vector genomes per kilogram of body weight.
Among the 132 subjects available for 2-year evaluation, median factor VIII activity was in the range of mild hemophilia (6%-49% of normal) with an 84.5% reduction in bleeding events from baseline.
More than 80% of participants had no bleeding events requiring treatment, and there was a 98% reduction from baseline in mean use of exogenous factor VIII.
Overall, at year 2, 4.5% of subjects had factor VIII activity consistent with severe hemophilia A; 9.1% had activity consistent with moderate disease; 59.8% had activity consistent with mild disease; and 26.5% had activity in the normal range above 40 IU/dL. The investigators estimated that the typical half-life of the transgene-derived factor VIII production system is 123 weeks.
Among the six men who resumed prophylaxis, most had fewer bleeding events than when they were on prophylaxis before the infusion, investigators noted.
All the subjects developed antibodies to the virus delivery vector, precluding retreatment.
The work was funded by valoctocogene roxaparvovec maker BioMarin Pharmaceuticals. Several investigators are employees. Others reported ties to BioMarin and other companies; Dr. Mahlangu, for instance, reported research grants from BioMarin, Roche, Novo Nordisk, Pfizer, and others. Dr. George reported a research grant from Asklepios Biopharmaceutical and having a patent licensed to the company. The full list of author disclosures can be found with the original article.
A version of this article first appeared on Medscape.com.
Hemophilia A (a deficiency of clotting Factor X) is the most common form of the disease, accounting for about 85% of patients.
The other type is hemophilia B (deficiency of clotting Factor VIII), and a gene therapy for this form of the disease has recently been launched – etranacogene dezaparvovec (Hemgenix), at the enormous price tag of $3.5 million.
Both products are comprised of a one-off intravenous IV infusion that delivers a functional gene via an adeno-associated virus that instructs the body to make the missing clotting factor. The hope is that this one-off infusion will act as a ‘cure’ and that the individual will be freed from life-long prophylaxis and/or treatment.
The new clinical data on valoctocogene roxaparvovec, published online in the New England Journal of Medicine, show that the beneficial effects from the gene are largely durable at 2 years, but they are anticipated to fade with time.
Two years after the one-time infusion, there remained “a significant reduction in the annualized bleeding rates” among 132 men who, at baseline, had severe hemophilia A requiring ongoing factor VIII prophylaxis, said the investigators, led by hematologist Johnny Mahlangu, MBBCh, MMed, of the University of the Witwatersrand, Johannesburg, South Africa.
However, the team predicted that median factor VIII activity would decrease below 10% of normal by year 3 or 5 depending on measurement technique, which would still translate to mild disease with an annualized bleeding rate of less than 1 episode per year.
“Although valoctocogene roxaparvovec may not eliminate bleeding, it potentially provides more consistent protection than factor VIII prophylaxis with less treatment burden,” the team said.
New questions
Data from the study “will directly inform therapeutic decision-making” in Europe, where valoctocogene roxaparvovec is already conditionally approved, and the United States, where it is awaiting approval by the FDA, says Lindsey George, MD, a hematologist and gene therapy specialist at Children’s Hospital of Philadelphia, in an accompanying editorial.
The study speaks to an ongoing concern about the durability of gene therapy for hemophilia but also raises new questions, she said.
For instance, while some patients had normal Factor VIII production and activity at 2 years, activity had dropped substantially in others, including in six men who resumed prophylaxis. “The cause of the decrease in factor VIII expression is an unanswered question,” and despite an anticipated U.S. price tag of around $2.5 million per treatment, “it is not possible [at the moment] to predict where an individual patient may fall within this range,” she writes.
Also, some subjects had elevations in liver aminotransferase levels that lasted for several months, including 2 years after infusion in 29% of subjects. Elevations in liver aminotransferase levels were treated with immune suppression for a median of 33 weeks.
“This is a unique finding with an undefined cause and long-term safety implications,” Dr. George said.
Getting to the bottom of such issues will be necessary for hemophilia gene therapy to fulfill its promise as “a one-time, lifelong, disease-ameliorating” fix for the condition, she asserted.
Study details
The new report followed up on the initial trial in 134 men who were treated with a single infusion of 6 × 1013 vector genomes per kilogram of body weight.
Among the 132 subjects available for 2-year evaluation, median factor VIII activity was in the range of mild hemophilia (6%-49% of normal) with an 84.5% reduction in bleeding events from baseline.
More than 80% of participants had no bleeding events requiring treatment, and there was a 98% reduction from baseline in mean use of exogenous factor VIII.
Overall, at year 2, 4.5% of subjects had factor VIII activity consistent with severe hemophilia A; 9.1% had activity consistent with moderate disease; 59.8% had activity consistent with mild disease; and 26.5% had activity in the normal range above 40 IU/dL. The investigators estimated that the typical half-life of the transgene-derived factor VIII production system is 123 weeks.
Among the six men who resumed prophylaxis, most had fewer bleeding events than when they were on prophylaxis before the infusion, investigators noted.
All the subjects developed antibodies to the virus delivery vector, precluding retreatment.
The work was funded by valoctocogene roxaparvovec maker BioMarin Pharmaceuticals. Several investigators are employees. Others reported ties to BioMarin and other companies; Dr. Mahlangu, for instance, reported research grants from BioMarin, Roche, Novo Nordisk, Pfizer, and others. Dr. George reported a research grant from Asklepios Biopharmaceutical and having a patent licensed to the company. The full list of author disclosures can be found with the original article.
A version of this article first appeared on Medscape.com.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Efanesoctocog alfa treatment: ‘Victory’ over hemophilia A
One injection of efanesoctocog alfa, a factor VIII therapy, resolved almost all bleeding episodes (97%) in the overall patient population, and weekly prophylaxis provided mean factor VIII activity in the normal or near-normal range (> 40 IU/dL) for most of the week.
Efanesoctocog alfa is currently under priority review by the U.S. Food and Drug Administration, and the target action date for the approval decision was set for Tuesday, February 28.
“Currently, [patients] often need to make trade-offs between bleed protection and dosing frequency,” study researcher Angela Weyand, MD, of Michigan Medicine, said in a press release. The current phase 3 XTEND-1 results assessing efanesoctocog alfa demonstrate that “we have the opportunity to provide near normal factor activity levels for an extended period of time (the majority of a week) with a single dose, which is a first for hemophilia A.”
According to the researchers, efanesoctocog alfa is also the first investigational treatment for hemophilia A to surpass the von Willebrand factor half-life ceiling, which imposes a half-life limitation on current factor VIII therapies.
The study, which was funded by drugmakers Sanofi and Sobi, was published online in the New England Journal of Medicine.
Hemophilia A is a rare genetic disorder caused by a lack of blood clotting factor VIII. Normalizing factor VIII levels can help protect patients from spontaneous and traumatic bleeding but maintaining factor VIII levels in the normal (50-150 IU/dL) or close-to-normal range (> 40 to < 50 IU/dL) with currently available factor VIII therapies requires frequent administration, the study authors explained.
In the phase 3, open-label trial, the authors evaluated the efficacy, safety, and pharmacokinetics of efanesoctocog alfa for routine prophylaxis, treatment of bleeding episodes, and perioperative management in previously treated patients with severe hemophilia A.
Patients were 12 years of age or older with endogenous factor VIII activity of less than 1 IU/dL or a genotype known to produce severe hemophilia A. Patients were required to have had at least 150 previous exposure days to recombinant or plasma-derived factor VIII concentrates or cryoprecipitate.
Overall, 133 patients received once-weekly prophylaxis doses of 50 IU per kg of intravenous efanesoctocog alfa for 52 weeks (group A), and 26 patients received on-demand efanesoctocog alfa treatment for 26 weeks, followed by once-weekly prophylaxis with the medication for 26 weeks at the same 50 IU per kg dosage (group B). The primary endpoint was the mean annualized bleeding rate in group A.
Among those in group A, the annualized bleeding rate was 0 (interquartile range, 0-1.04) and the estimated mean annualized bleeding rate was 0.71. Overall, 65% of these patients (86 of 133) had no bleeding episodes and 93% had 0-2 bleeding episodes.
As for spontaneous bleeding, no episodes were reported in 80% of patients in group A (107 of 133) and 85% of patients (22 of 26) during the prophylaxis period in group B.
A total of 362 bleeding events occurred during the study, with most (268 of 362, or 74%) occurring in group B during the on-demand treatment period.
Among those in group A, switching from the prestudy standard of care to efanesoctocog alfa prophylaxis reduced the mean annualized bleeding rate from 2.96 to 0.69, a decrease of 77%. In group B, the mean annualized bleeding rate also decreased when patients switched from on-demand efanesoctocog alfa to prophylaxis (21.42 vs. 0.69).
Scores of physical health, joint health, and pain intensity were significantly improved within the 52 weeks. In patients with target joints at baseline, 100% of the target joints were resolved after at least 12 months of continuous prophylaxis.
In other words, not only did the treatment stop bleeding, but efanesoctocog alfa also improved the overall quality of life for patients, said lead author Annette von Drygalski MD, PharmD, of the University of California, San Diego.
“[Efanesoctocog] alfa’s half-life and clotting factor activity levels truly translated into a number of other patient outcomes,” Dr. von Drygalski told this news organization. “All these reductions in parameters, pain improvement, improvement in joint health, reduction in pain, and of course reduction of infusions really resulted in improved quality of life for most patients, and so that’s remarkable.”
In addition, no patients developed inhibitors to factor VIII and there were no reports of serious allergic reactions, anaphylaxis, or vascular thrombotic events.
Of the 159 patients who received at least one dose of efanesoctocog alfa, 123 (77%) had at least one adverse event that developed or worsened during the treatment period. The most common adverse events were headache, arthralgia, fall, and back pain.
In an accompanying editorial, Cindy Leissinger, MD, called efanesoctocog alfa a “victory” for patients with hemophilia A.
“In a crowded field of transformative therapies for hemophilia, efanesoctocog alfa stands out as a winner – a major therapeutic advance that achieves highly protective factor VIII levels with a once-weekly infusion,” writes Dr. Leissinger, director of the Louisiana Center for Bleeding and Clotting Disorders at Tulane University, New Orleans.
The study was supported by Sanofi and Sobi. Both Dr. von Drygalski and Dr. Leissinger disclosed serving as consultants for Sanofi, among other disclosures. Other authors provided a range of disclosures, including serving as consultants for Sanofi and Sobi.
A version of this article first appeared on Medscape.com.
One injection of efanesoctocog alfa, a factor VIII therapy, resolved almost all bleeding episodes (97%) in the overall patient population, and weekly prophylaxis provided mean factor VIII activity in the normal or near-normal range (> 40 IU/dL) for most of the week.
Efanesoctocog alfa is currently under priority review by the U.S. Food and Drug Administration, and the target action date for the approval decision was set for Tuesday, February 28.
“Currently, [patients] often need to make trade-offs between bleed protection and dosing frequency,” study researcher Angela Weyand, MD, of Michigan Medicine, said in a press release. The current phase 3 XTEND-1 results assessing efanesoctocog alfa demonstrate that “we have the opportunity to provide near normal factor activity levels for an extended period of time (the majority of a week) with a single dose, which is a first for hemophilia A.”
According to the researchers, efanesoctocog alfa is also the first investigational treatment for hemophilia A to surpass the von Willebrand factor half-life ceiling, which imposes a half-life limitation on current factor VIII therapies.
The study, which was funded by drugmakers Sanofi and Sobi, was published online in the New England Journal of Medicine.
Hemophilia A is a rare genetic disorder caused by a lack of blood clotting factor VIII. Normalizing factor VIII levels can help protect patients from spontaneous and traumatic bleeding but maintaining factor VIII levels in the normal (50-150 IU/dL) or close-to-normal range (> 40 to < 50 IU/dL) with currently available factor VIII therapies requires frequent administration, the study authors explained.
In the phase 3, open-label trial, the authors evaluated the efficacy, safety, and pharmacokinetics of efanesoctocog alfa for routine prophylaxis, treatment of bleeding episodes, and perioperative management in previously treated patients with severe hemophilia A.
Patients were 12 years of age or older with endogenous factor VIII activity of less than 1 IU/dL or a genotype known to produce severe hemophilia A. Patients were required to have had at least 150 previous exposure days to recombinant or plasma-derived factor VIII concentrates or cryoprecipitate.
Overall, 133 patients received once-weekly prophylaxis doses of 50 IU per kg of intravenous efanesoctocog alfa for 52 weeks (group A), and 26 patients received on-demand efanesoctocog alfa treatment for 26 weeks, followed by once-weekly prophylaxis with the medication for 26 weeks at the same 50 IU per kg dosage (group B). The primary endpoint was the mean annualized bleeding rate in group A.
Among those in group A, the annualized bleeding rate was 0 (interquartile range, 0-1.04) and the estimated mean annualized bleeding rate was 0.71. Overall, 65% of these patients (86 of 133) had no bleeding episodes and 93% had 0-2 bleeding episodes.
As for spontaneous bleeding, no episodes were reported in 80% of patients in group A (107 of 133) and 85% of patients (22 of 26) during the prophylaxis period in group B.
A total of 362 bleeding events occurred during the study, with most (268 of 362, or 74%) occurring in group B during the on-demand treatment period.
Among those in group A, switching from the prestudy standard of care to efanesoctocog alfa prophylaxis reduced the mean annualized bleeding rate from 2.96 to 0.69, a decrease of 77%. In group B, the mean annualized bleeding rate also decreased when patients switched from on-demand efanesoctocog alfa to prophylaxis (21.42 vs. 0.69).
Scores of physical health, joint health, and pain intensity were significantly improved within the 52 weeks. In patients with target joints at baseline, 100% of the target joints were resolved after at least 12 months of continuous prophylaxis.
In other words, not only did the treatment stop bleeding, but efanesoctocog alfa also improved the overall quality of life for patients, said lead author Annette von Drygalski MD, PharmD, of the University of California, San Diego.
“[Efanesoctocog] alfa’s half-life and clotting factor activity levels truly translated into a number of other patient outcomes,” Dr. von Drygalski told this news organization. “All these reductions in parameters, pain improvement, improvement in joint health, reduction in pain, and of course reduction of infusions really resulted in improved quality of life for most patients, and so that’s remarkable.”
In addition, no patients developed inhibitors to factor VIII and there were no reports of serious allergic reactions, anaphylaxis, or vascular thrombotic events.
Of the 159 patients who received at least one dose of efanesoctocog alfa, 123 (77%) had at least one adverse event that developed or worsened during the treatment period. The most common adverse events were headache, arthralgia, fall, and back pain.
In an accompanying editorial, Cindy Leissinger, MD, called efanesoctocog alfa a “victory” for patients with hemophilia A.
“In a crowded field of transformative therapies for hemophilia, efanesoctocog alfa stands out as a winner – a major therapeutic advance that achieves highly protective factor VIII levels with a once-weekly infusion,” writes Dr. Leissinger, director of the Louisiana Center for Bleeding and Clotting Disorders at Tulane University, New Orleans.
The study was supported by Sanofi and Sobi. Both Dr. von Drygalski and Dr. Leissinger disclosed serving as consultants for Sanofi, among other disclosures. Other authors provided a range of disclosures, including serving as consultants for Sanofi and Sobi.
A version of this article first appeared on Medscape.com.
One injection of efanesoctocog alfa, a factor VIII therapy, resolved almost all bleeding episodes (97%) in the overall patient population, and weekly prophylaxis provided mean factor VIII activity in the normal or near-normal range (> 40 IU/dL) for most of the week.
Efanesoctocog alfa is currently under priority review by the U.S. Food and Drug Administration, and the target action date for the approval decision was set for Tuesday, February 28.
“Currently, [patients] often need to make trade-offs between bleed protection and dosing frequency,” study researcher Angela Weyand, MD, of Michigan Medicine, said in a press release. The current phase 3 XTEND-1 results assessing efanesoctocog alfa demonstrate that “we have the opportunity to provide near normal factor activity levels for an extended period of time (the majority of a week) with a single dose, which is a first for hemophilia A.”
According to the researchers, efanesoctocog alfa is also the first investigational treatment for hemophilia A to surpass the von Willebrand factor half-life ceiling, which imposes a half-life limitation on current factor VIII therapies.
The study, which was funded by drugmakers Sanofi and Sobi, was published online in the New England Journal of Medicine.
Hemophilia A is a rare genetic disorder caused by a lack of blood clotting factor VIII. Normalizing factor VIII levels can help protect patients from spontaneous and traumatic bleeding but maintaining factor VIII levels in the normal (50-150 IU/dL) or close-to-normal range (> 40 to < 50 IU/dL) with currently available factor VIII therapies requires frequent administration, the study authors explained.
In the phase 3, open-label trial, the authors evaluated the efficacy, safety, and pharmacokinetics of efanesoctocog alfa for routine prophylaxis, treatment of bleeding episodes, and perioperative management in previously treated patients with severe hemophilia A.
Patients were 12 years of age or older with endogenous factor VIII activity of less than 1 IU/dL or a genotype known to produce severe hemophilia A. Patients were required to have had at least 150 previous exposure days to recombinant or plasma-derived factor VIII concentrates or cryoprecipitate.
Overall, 133 patients received once-weekly prophylaxis doses of 50 IU per kg of intravenous efanesoctocog alfa for 52 weeks (group A), and 26 patients received on-demand efanesoctocog alfa treatment for 26 weeks, followed by once-weekly prophylaxis with the medication for 26 weeks at the same 50 IU per kg dosage (group B). The primary endpoint was the mean annualized bleeding rate in group A.
Among those in group A, the annualized bleeding rate was 0 (interquartile range, 0-1.04) and the estimated mean annualized bleeding rate was 0.71. Overall, 65% of these patients (86 of 133) had no bleeding episodes and 93% had 0-2 bleeding episodes.
As for spontaneous bleeding, no episodes were reported in 80% of patients in group A (107 of 133) and 85% of patients (22 of 26) during the prophylaxis period in group B.
A total of 362 bleeding events occurred during the study, with most (268 of 362, or 74%) occurring in group B during the on-demand treatment period.
Among those in group A, switching from the prestudy standard of care to efanesoctocog alfa prophylaxis reduced the mean annualized bleeding rate from 2.96 to 0.69, a decrease of 77%. In group B, the mean annualized bleeding rate also decreased when patients switched from on-demand efanesoctocog alfa to prophylaxis (21.42 vs. 0.69).
Scores of physical health, joint health, and pain intensity were significantly improved within the 52 weeks. In patients with target joints at baseline, 100% of the target joints were resolved after at least 12 months of continuous prophylaxis.
In other words, not only did the treatment stop bleeding, but efanesoctocog alfa also improved the overall quality of life for patients, said lead author Annette von Drygalski MD, PharmD, of the University of California, San Diego.
“[Efanesoctocog] alfa’s half-life and clotting factor activity levels truly translated into a number of other patient outcomes,” Dr. von Drygalski told this news organization. “All these reductions in parameters, pain improvement, improvement in joint health, reduction in pain, and of course reduction of infusions really resulted in improved quality of life for most patients, and so that’s remarkable.”
In addition, no patients developed inhibitors to factor VIII and there were no reports of serious allergic reactions, anaphylaxis, or vascular thrombotic events.
Of the 159 patients who received at least one dose of efanesoctocog alfa, 123 (77%) had at least one adverse event that developed or worsened during the treatment period. The most common adverse events were headache, arthralgia, fall, and back pain.
In an accompanying editorial, Cindy Leissinger, MD, called efanesoctocog alfa a “victory” for patients with hemophilia A.
“In a crowded field of transformative therapies for hemophilia, efanesoctocog alfa stands out as a winner – a major therapeutic advance that achieves highly protective factor VIII levels with a once-weekly infusion,” writes Dr. Leissinger, director of the Louisiana Center for Bleeding and Clotting Disorders at Tulane University, New Orleans.
The study was supported by Sanofi and Sobi. Both Dr. von Drygalski and Dr. Leissinger disclosed serving as consultants for Sanofi, among other disclosures. Other authors provided a range of disclosures, including serving as consultants for Sanofi and Sobi.
A version of this article first appeared on Medscape.com.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Europe approves first gene therapy for hemophilia B
The approval means that the product will now be available in all the countries of the European Union as well as the European Economic Area.
The gene therapy was approved in the United States in November 2022. It was launched with a price tag of $3.5 million, making it the most expensive treatment to date.
The treatment comprises a one-time infusion of a functional gene that acts as a blueprint for coagulation factor IX, a protein important for blood clotting, stated the manufacturer, CSL.
People living with hemophilia B currently require lifelong treatment of intravenous infusions of factor IX to maintain sufficient levels, which can have a significant impact on their quality of life and well-being, the company explained in its press release.
The approval was based on findings from the pivotal HOPE-B trial, a single-arm, open-label study of 54 men who relied on factor IX replacement therapy; first results from this trial were reported at the 2020 annual meeting of the American Society of Hematology.
The results showed that patients with hemophilia B treated with the gene therapy demonstrated stable and durable increases in mean factor IX activity (with a mean factor IX activity of 36.9%), which led to an adjusted annualized bleeding rate reduction of 64%.
After receiving the gene therapy, 96% of patients discontinued routine factor IX prophylaxis and mean factor IX consumption was reduced by 97% at 18 months post treatment compared with the lead-in period, the company noted.
“Data from the HOPE-B study demonstrate the potential of Hemgenix to remove the need for routine prophylaxis by providing durable factor IX activity, as well as improved bleeding outcomes and quality of life for people with hemophilia B,” said one of the trialists, Wolfgang Miesbach, MD, PHD, head of coagulation disorders at the Comprehensive Care Center, University Hospital of Frankfurt, Germany.
This European approval “marks an important step forward in the treatment of hemophilia B, which could be transformative for people who are debilitated by bleeds into their muscles, joints, and internal organs, alleviating the burden of lifelong intravenous infusions of factor IX products,” Dr. Miesbach said in the company press release.
A version of this article first appeared on Medscape.com.
The approval means that the product will now be available in all the countries of the European Union as well as the European Economic Area.
The gene therapy was approved in the United States in November 2022. It was launched with a price tag of $3.5 million, making it the most expensive treatment to date.
The treatment comprises a one-time infusion of a functional gene that acts as a blueprint for coagulation factor IX, a protein important for blood clotting, stated the manufacturer, CSL.
People living with hemophilia B currently require lifelong treatment of intravenous infusions of factor IX to maintain sufficient levels, which can have a significant impact on their quality of life and well-being, the company explained in its press release.
The approval was based on findings from the pivotal HOPE-B trial, a single-arm, open-label study of 54 men who relied on factor IX replacement therapy; first results from this trial were reported at the 2020 annual meeting of the American Society of Hematology.
The results showed that patients with hemophilia B treated with the gene therapy demonstrated stable and durable increases in mean factor IX activity (with a mean factor IX activity of 36.9%), which led to an adjusted annualized bleeding rate reduction of 64%.
After receiving the gene therapy, 96% of patients discontinued routine factor IX prophylaxis and mean factor IX consumption was reduced by 97% at 18 months post treatment compared with the lead-in period, the company noted.
“Data from the HOPE-B study demonstrate the potential of Hemgenix to remove the need for routine prophylaxis by providing durable factor IX activity, as well as improved bleeding outcomes and quality of life for people with hemophilia B,” said one of the trialists, Wolfgang Miesbach, MD, PHD, head of coagulation disorders at the Comprehensive Care Center, University Hospital of Frankfurt, Germany.
This European approval “marks an important step forward in the treatment of hemophilia B, which could be transformative for people who are debilitated by bleeds into their muscles, joints, and internal organs, alleviating the burden of lifelong intravenous infusions of factor IX products,” Dr. Miesbach said in the company press release.
A version of this article first appeared on Medscape.com.
The approval means that the product will now be available in all the countries of the European Union as well as the European Economic Area.
The gene therapy was approved in the United States in November 2022. It was launched with a price tag of $3.5 million, making it the most expensive treatment to date.
The treatment comprises a one-time infusion of a functional gene that acts as a blueprint for coagulation factor IX, a protein important for blood clotting, stated the manufacturer, CSL.
People living with hemophilia B currently require lifelong treatment of intravenous infusions of factor IX to maintain sufficient levels, which can have a significant impact on their quality of life and well-being, the company explained in its press release.
The approval was based on findings from the pivotal HOPE-B trial, a single-arm, open-label study of 54 men who relied on factor IX replacement therapy; first results from this trial were reported at the 2020 annual meeting of the American Society of Hematology.
The results showed that patients with hemophilia B treated with the gene therapy demonstrated stable and durable increases in mean factor IX activity (with a mean factor IX activity of 36.9%), which led to an adjusted annualized bleeding rate reduction of 64%.
After receiving the gene therapy, 96% of patients discontinued routine factor IX prophylaxis and mean factor IX consumption was reduced by 97% at 18 months post treatment compared with the lead-in period, the company noted.
“Data from the HOPE-B study demonstrate the potential of Hemgenix to remove the need for routine prophylaxis by providing durable factor IX activity, as well as improved bleeding outcomes and quality of life for people with hemophilia B,” said one of the trialists, Wolfgang Miesbach, MD, PHD, head of coagulation disorders at the Comprehensive Care Center, University Hospital of Frankfurt, Germany.
This European approval “marks an important step forward in the treatment of hemophilia B, which could be transformative for people who are debilitated by bleeds into their muscles, joints, and internal organs, alleviating the burden of lifelong intravenous infusions of factor IX products,” Dr. Miesbach said in the company press release.
A version of this article first appeared on Medscape.com.