MDedge Endocrinology

Bicycling has always been part of who I am because it offered me the freedom to explore as a preteen. As an adult I have always been a bicycle commuter and a very visible part of the community as I pedal around town to do my errands. But, I didn’t always wear a helmet ... because well, I just didn’t. I saw the helmet as a nuisance with very little benefit to myself. Eventually, when bike races required helmets I bought one just for the competitions. Until one day about 30 years ago when the mother of a child I was seeing in the office said, “Dr. Wilkoff, you know as an influential member of this community, particularly its children, you should be wearing a helmet.” My wife had been badgering me for years but this woman’s courage to speak up embarrassed me into changing my ways.

For some, maybe many, people, wearing a mask during the COVID-19 pandemic is a nuisance and an assault on their independence just as I viewed a bicycle helmet. Initially there was some information being circulated that any mask less robust than a N-95 had very little if any effect, either as protection or as way to decrease spread. I certainly had my doubts about the value of mask other than as a statement of solidarity. However, we are now learning that masks can serve an important role along with social distancing in a comprehensive community effort to minimize contagion.

In light of this new information, why are there are still people who won’t wear a mask? It may be that they are receiving their news filtered through a lens that discredits science. But, it is more likely the result of the same mindset that permeates the anti-vaccine faction that the common good is less important than personal freedom to follow their beliefs.

Do we have any tools at our disposal to increase the number of folks wearing masks? Based on our experience with attempts to convince those who are anti-vaccine, education will be ineffective in shifting the focus from personal freedom to a commitment to the welfare of the community at large. Shaming might be effective, but it runs the risk of igniting conflicts and further widening the gaps in our society. Some establishments have been effective in simply saying “no mask, no entry,” but this runs the same risk of creating friction depending on the community and the situation.

The ship may have already sailed on our best opportunity to achieve community compliance when the leaders of our national government have chosen to ignore their obligation to set an example by refusing to wear masks. I fear that the wedge has already been set and the widening of the gap between those who see their responsibility to the community at large and those who do not will continue to grow.

I am fortunate to live in a town whose residents look out for each other and have relied on local leaders to set an example in the absence of leadership on a national level.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

Bicycling has always been part of who I am because it offered me the freedom to explore as a preteen. As an adult I have always been a bicycle commuter and a very visible part of the community as I pedal around town to do my errands. But, I didn’t always wear a helmet ... because well, I just didn’t. I saw the helmet as a nuisance with very little benefit to myself. Eventually, when bike races required helmets I bought one just for the competitions. Until one day about 30 years ago when the mother of a child I was seeing in the office said, “Dr. Wilkoff, you know as an influential member of this community, particularly its children, you should be wearing a helmet.” My wife had been badgering me for years but this woman’s courage to speak up embarrassed me into changing my ways.

For some, maybe many, people, wearing a mask during the COVID-19 pandemic is a nuisance and an assault on their independence just as I viewed a bicycle helmet. Initially there was some information being circulated that any mask less robust than a N-95 had very little if any effect, either as protection or as way to decrease spread. I certainly had my doubts about the value of mask other than as a statement of solidarity. However, we are now learning that masks can serve an important role along with social distancing in a comprehensive community effort to minimize contagion.

In light of this new information, why are there are still people who won’t wear a mask? It may be that they are receiving their news filtered through a lens that discredits science. But, it is more likely the result of the same mindset that permeates the anti-vaccine faction that the common good is less important than personal freedom to follow their beliefs.

Do we have any tools at our disposal to increase the number of folks wearing masks? Based on our experience with attempts to convince those who are anti-vaccine, education will be ineffective in shifting the focus from personal freedom to a commitment to the welfare of the community at large. Shaming might be effective, but it runs the risk of igniting conflicts and further widening the gaps in our society. Some establishments have been effective in simply saying “no mask, no entry,” but this runs the same risk of creating friction depending on the community and the situation.

The ship may have already sailed on our best opportunity to achieve community compliance when the leaders of our national government have chosen to ignore their obligation to set an example by refusing to wear masks. I fear that the wedge has already been set and the widening of the gap between those who see their responsibility to the community at large and those who do not will continue to grow.

I am fortunate to live in a town whose residents look out for each other and have relied on local leaders to set an example in the absence of leadership on a national level.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

Bicycling has always been part of who I am because it offered me the freedom to explore as a preteen. As an adult I have always been a bicycle commuter and a very visible part of the community as I pedal around town to do my errands. But, I didn’t always wear a helmet ... because well, I just didn’t. I saw the helmet as a nuisance with very little benefit to myself. Eventually, when bike races required helmets I bought one just for the competitions. Until one day about 30 years ago when the mother of a child I was seeing in the office said, “Dr. Wilkoff, you know as an influential member of this community, particularly its children, you should be wearing a helmet.” My wife had been badgering me for years but this woman’s courage to speak up embarrassed me into changing my ways.

For some, maybe many, people, wearing a mask during the COVID-19 pandemic is a nuisance and an assault on their independence just as I viewed a bicycle helmet. Initially there was some information being circulated that any mask less robust than a N-95 had very little if any effect, either as protection or as way to decrease spread. I certainly had my doubts about the value of mask other than as a statement of solidarity. However, we are now learning that masks can serve an important role along with social distancing in a comprehensive community effort to minimize contagion.

In light of this new information, why are there are still people who won’t wear a mask? It may be that they are receiving their news filtered through a lens that discredits science. But, it is more likely the result of the same mindset that permeates the anti-vaccine faction that the common good is less important than personal freedom to follow their beliefs.

Do we have any tools at our disposal to increase the number of folks wearing masks? Based on our experience with attempts to convince those who are anti-vaccine, education will be ineffective in shifting the focus from personal freedom to a commitment to the welfare of the community at large. Shaming might be effective, but it runs the risk of igniting conflicts and further widening the gaps in our society. Some establishments have been effective in simply saying “no mask, no entry,” but this runs the same risk of creating friction depending on the community and the situation.

The ship may have already sailed on our best opportunity to achieve community compliance when the leaders of our national government have chosen to ignore their obligation to set an example by refusing to wear masks. I fear that the wedge has already been set and the widening of the gap between those who see their responsibility to the community at large and those who do not will continue to grow.

I am fortunate to live in a town whose residents look out for each other and have relied on local leaders to set an example in the absence of leadership on a national level.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

A phase 1/2 trial of a vaccine against SARS-CoV-2 being developed by the University of Oxford has found that the vaccine is safe, causes few side effects, and induces strong immune responses.

The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.

Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.

In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.

The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.

However, there were no serious adverse events from the vaccine, the researchers said.
 

‘Still a long way to go’

Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.

“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.

“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”

The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.

A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.

ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.

On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
 

Expert reaction to the findings

The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.

“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”

Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.

“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”

He said it was also vital that people older than 55 were included in later trials.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.

“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”

This article first appeared on Medscape.com.

A phase 1/2 trial of a vaccine against SARS-CoV-2 being developed by the University of Oxford has found that the vaccine is safe, causes few side effects, and induces strong immune responses.

The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.

Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.

In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.

The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.

However, there were no serious adverse events from the vaccine, the researchers said.
 

‘Still a long way to go’

Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.

“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.

“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”

The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.

A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.

ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.

On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
 

Expert reaction to the findings

The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.

“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”

Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.

“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”

He said it was also vital that people older than 55 were included in later trials.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.

“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”

This article first appeared on Medscape.com.

A phase 1/2 trial of a vaccine against SARS-CoV-2 being developed by the University of Oxford has found that the vaccine is safe, causes few side effects, and induces strong immune responses.

The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.

Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.

In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.

The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.

However, there were no serious adverse events from the vaccine, the researchers said.
 

‘Still a long way to go’

Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.

“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.

“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”

The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.

A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.

ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.

On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
 

Expert reaction to the findings

The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.

“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”

Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.

“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”

He said it was also vital that people older than 55 were included in later trials.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.

“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”

This article first appeared on Medscape.com.

The American Society for Metabolic & Bariatric Surgery (ASMBS) has issued a statement declaring that obesity surgery is not elective and should be resumed as soon as it›s safe to do so during the COVID-19 pandemic.

The ASMBS statement, “Safer Through Surgery,” was published online in Surgery for Obesity and Related Diseases by the ASMBS executive committee.

It is a reaction to the fact that some U.S. states have placed metabolic and bariatric surgery in the same low-priority category as cosmetic surgery as examples of “elective” procedures that should be among the last to be restarted when pandemic restrictions are eased.

Rather, ASMBS argues, although obesity surgery must be postponed along with other nonemergency procedures when surges in the novel coronavirus make them unsafe, such operations should be resumed as soon as possible along with other medically necessary procedures.

“Metabolic and bariatric surgery is NOT elective. Metabolic and bariatric surgery is medically necessary and the best treatment for those with the life-threatening and life-limiting disease of severe obesity,” the statement says.

And obesity itself is a major risk factor for worse COVID-19 outcomes, ASMBS President Matt Hutter, MD, told Medscape Medical News, noting that individuals with obesity are “more likely to be in [intensive care units].”

“Mortality rates are higher, even in young patients. And [obesity] ... is associated with other comorbidities including diabetes and heart disease...We know the clock is ticking for some folks. For those with early diabetes, the sooner the [bariatric] surgery the more likely it is [for diabetes] to go into remission.”

Because the pandemic may be around for a while, “If we can make people [with obesity] safer ... because they’ve had surgery ... they may be better off,” should they get COVID-19 later, he pointed out.

Hutter noted that the ASMBS recorded a series of webinars, archived on the society’s website, with panels discussing in-depth issues to consider in prioritizing patients when restarting metabolic and bariatric surgery.

There are some differences of opinion, such as whether the sickest patients should be the first to have the surgeries upon reopening, or whether those individuals might be worse off if they contract COVID-19 in the perioperative setting.

“I don’t think there’s a right or wrong answer, but I think we have to figure out what’s right for the individual patient, considering their specific risks of having versus not having surgery, of waiting 1 month, 2 months, or 6 months. One thing we do know is that obesity is a significant disease.”
 

‘Before, during, and after COVID, obesity itself remains an epidemic’

Asked to comment on the ASMBS stance, Obesity Society president Lee M. Kaplan, MD, PhD, sent Medscape Medical News a statement.

“We do not fully understand which aspects of obesity pathophysiology ... are most responsible for the adverse COVID-19 outcomes, nor do we know the degree to which reduced access to care, social isolation, and other social and environmental determinants of health disproportionately affect COVID-19 patients with obesity,” he noted.

“At this early stage, we have not yet determined the impact of weight loss and various types of antiobesity therapies on these risks.”

Nonetheless, Kaplan said, “the extended COVID-19 pandemic underscores the importance of increasing, not diminishing, our commitment to understanding and treating obesity, using all available, evidence-based therapies, including lifestyle modification, antiobesity medications, bariatric surgery, and combinations thereof.”

As all health care delivery is being reorganized around the pandemic, Kaplan added: “Rethinking and changing our approach to obesity needs to be a central feature of this process.

“Before, during, and after COVID, obesity itself remains an epidemic. Its high global prevalence, increasing severity, and profound impact on all aspects of health and disease require that it be addressed more universally within the health care system, with the same commitment afforded to other chronic diseases.”

Obesity treatment isn’t generally considered an emergency, he noted, “because obesity is a chronic disease, whose adverse health effects often accumulate slowly and insidiously. Its generally slow progression allows for careful and coordinated care planning, and advanced scheduling of therapeutic interventions, including surgery. These characteristics, however, should not lead us to infer that treating obesity itself is optional.”

Hutter has reported receiving honoraria from Ethicon and Medtronic, and is a consultant for Vicarious Surgical and Sigilon Therapeutics. Kaplan has reported consulting for Boehringer Ingelheim, Fractyl, Gelesis, GI Dynamics, Johnson & Johnson, Novo Nordisk, Pfizer, Rhythm Pharmaceuticals, the National Institutes of Health, and the Department of State.

This article first appeared on Medscape.com.

The American Society for Metabolic & Bariatric Surgery (ASMBS) has issued a statement declaring that obesity surgery is not elective and should be resumed as soon as it›s safe to do so during the COVID-19 pandemic.

The ASMBS statement, “Safer Through Surgery,” was published online in Surgery for Obesity and Related Diseases by the ASMBS executive committee.

It is a reaction to the fact that some U.S. states have placed metabolic and bariatric surgery in the same low-priority category as cosmetic surgery as examples of “elective” procedures that should be among the last to be restarted when pandemic restrictions are eased.

Rather, ASMBS argues, although obesity surgery must be postponed along with other nonemergency procedures when surges in the novel coronavirus make them unsafe, such operations should be resumed as soon as possible along with other medically necessary procedures.

“Metabolic and bariatric surgery is NOT elective. Metabolic and bariatric surgery is medically necessary and the best treatment for those with the life-threatening and life-limiting disease of severe obesity,” the statement says.

And obesity itself is a major risk factor for worse COVID-19 outcomes, ASMBS President Matt Hutter, MD, told Medscape Medical News, noting that individuals with obesity are “more likely to be in [intensive care units].”

“Mortality rates are higher, even in young patients. And [obesity] ... is associated with other comorbidities including diabetes and heart disease...We know the clock is ticking for some folks. For those with early diabetes, the sooner the [bariatric] surgery the more likely it is [for diabetes] to go into remission.”

Because the pandemic may be around for a while, “If we can make people [with obesity] safer ... because they’ve had surgery ... they may be better off,” should they get COVID-19 later, he pointed out.

Hutter noted that the ASMBS recorded a series of webinars, archived on the society’s website, with panels discussing in-depth issues to consider in prioritizing patients when restarting metabolic and bariatric surgery.

There are some differences of opinion, such as whether the sickest patients should be the first to have the surgeries upon reopening, or whether those individuals might be worse off if they contract COVID-19 in the perioperative setting.

“I don’t think there’s a right or wrong answer, but I think we have to figure out what’s right for the individual patient, considering their specific risks of having versus not having surgery, of waiting 1 month, 2 months, or 6 months. One thing we do know is that obesity is a significant disease.”
 

‘Before, during, and after COVID, obesity itself remains an epidemic’

Asked to comment on the ASMBS stance, Obesity Society president Lee M. Kaplan, MD, PhD, sent Medscape Medical News a statement.

“We do not fully understand which aspects of obesity pathophysiology ... are most responsible for the adverse COVID-19 outcomes, nor do we know the degree to which reduced access to care, social isolation, and other social and environmental determinants of health disproportionately affect COVID-19 patients with obesity,” he noted.

“At this early stage, we have not yet determined the impact of weight loss and various types of antiobesity therapies on these risks.”

Nonetheless, Kaplan said, “the extended COVID-19 pandemic underscores the importance of increasing, not diminishing, our commitment to understanding and treating obesity, using all available, evidence-based therapies, including lifestyle modification, antiobesity medications, bariatric surgery, and combinations thereof.”

As all health care delivery is being reorganized around the pandemic, Kaplan added: “Rethinking and changing our approach to obesity needs to be a central feature of this process.

“Before, during, and after COVID, obesity itself remains an epidemic. Its high global prevalence, increasing severity, and profound impact on all aspects of health and disease require that it be addressed more universally within the health care system, with the same commitment afforded to other chronic diseases.”

Obesity treatment isn’t generally considered an emergency, he noted, “because obesity is a chronic disease, whose adverse health effects often accumulate slowly and insidiously. Its generally slow progression allows for careful and coordinated care planning, and advanced scheduling of therapeutic interventions, including surgery. These characteristics, however, should not lead us to infer that treating obesity itself is optional.”

Hutter has reported receiving honoraria from Ethicon and Medtronic, and is a consultant for Vicarious Surgical and Sigilon Therapeutics. Kaplan has reported consulting for Boehringer Ingelheim, Fractyl, Gelesis, GI Dynamics, Johnson & Johnson, Novo Nordisk, Pfizer, Rhythm Pharmaceuticals, the National Institutes of Health, and the Department of State.

This article first appeared on Medscape.com.

The American Society for Metabolic & Bariatric Surgery (ASMBS) has issued a statement declaring that obesity surgery is not elective and should be resumed as soon as it›s safe to do so during the COVID-19 pandemic.

The ASMBS statement, “Safer Through Surgery,” was published online in Surgery for Obesity and Related Diseases by the ASMBS executive committee.

It is a reaction to the fact that some U.S. states have placed metabolic and bariatric surgery in the same low-priority category as cosmetic surgery as examples of “elective” procedures that should be among the last to be restarted when pandemic restrictions are eased.

Rather, ASMBS argues, although obesity surgery must be postponed along with other nonemergency procedures when surges in the novel coronavirus make them unsafe, such operations should be resumed as soon as possible along with other medically necessary procedures.

“Metabolic and bariatric surgery is NOT elective. Metabolic and bariatric surgery is medically necessary and the best treatment for those with the life-threatening and life-limiting disease of severe obesity,” the statement says.

And obesity itself is a major risk factor for worse COVID-19 outcomes, ASMBS President Matt Hutter, MD, told Medscape Medical News, noting that individuals with obesity are “more likely to be in [intensive care units].”

“Mortality rates are higher, even in young patients. And [obesity] ... is associated with other comorbidities including diabetes and heart disease...We know the clock is ticking for some folks. For those with early diabetes, the sooner the [bariatric] surgery the more likely it is [for diabetes] to go into remission.”

Because the pandemic may be around for a while, “If we can make people [with obesity] safer ... because they’ve had surgery ... they may be better off,” should they get COVID-19 later, he pointed out.

Hutter noted that the ASMBS recorded a series of webinars, archived on the society’s website, with panels discussing in-depth issues to consider in prioritizing patients when restarting metabolic and bariatric surgery.

There are some differences of opinion, such as whether the sickest patients should be the first to have the surgeries upon reopening, or whether those individuals might be worse off if they contract COVID-19 in the perioperative setting.

“I don’t think there’s a right or wrong answer, but I think we have to figure out what’s right for the individual patient, considering their specific risks of having versus not having surgery, of waiting 1 month, 2 months, or 6 months. One thing we do know is that obesity is a significant disease.”
 

‘Before, during, and after COVID, obesity itself remains an epidemic’

Asked to comment on the ASMBS stance, Obesity Society president Lee M. Kaplan, MD, PhD, sent Medscape Medical News a statement.

“We do not fully understand which aspects of obesity pathophysiology ... are most responsible for the adverse COVID-19 outcomes, nor do we know the degree to which reduced access to care, social isolation, and other social and environmental determinants of health disproportionately affect COVID-19 patients with obesity,” he noted.

“At this early stage, we have not yet determined the impact of weight loss and various types of antiobesity therapies on these risks.”

Nonetheless, Kaplan said, “the extended COVID-19 pandemic underscores the importance of increasing, not diminishing, our commitment to understanding and treating obesity, using all available, evidence-based therapies, including lifestyle modification, antiobesity medications, bariatric surgery, and combinations thereof.”

As all health care delivery is being reorganized around the pandemic, Kaplan added: “Rethinking and changing our approach to obesity needs to be a central feature of this process.

“Before, during, and after COVID, obesity itself remains an epidemic. Its high global prevalence, increasing severity, and profound impact on all aspects of health and disease require that it be addressed more universally within the health care system, with the same commitment afforded to other chronic diseases.”

Obesity treatment isn’t generally considered an emergency, he noted, “because obesity is a chronic disease, whose adverse health effects often accumulate slowly and insidiously. Its generally slow progression allows for careful and coordinated care planning, and advanced scheduling of therapeutic interventions, including surgery. These characteristics, however, should not lead us to infer that treating obesity itself is optional.”

Hutter has reported receiving honoraria from Ethicon and Medtronic, and is a consultant for Vicarious Surgical and Sigilon Therapeutics. Kaplan has reported consulting for Boehringer Ingelheim, Fractyl, Gelesis, GI Dynamics, Johnson & Johnson, Novo Nordisk, Pfizer, Rhythm Pharmaceuticals, the National Institutes of Health, and the Department of State.

This article first appeared on Medscape.com.

Every person who received Moderna’s COVID-19 vaccine, mRNA-1273, developed an immune response to the virus that causes it, the company says in a news release.

Researchers also reported some side effects in the 45 people in the phase I study, but no significant safety issues, the news release says.

The vaccine is among hundreds being tested worldwide in an effort to halt the pandemic that has killed nearly 600,000 worldwide.

A researcher testing the vaccine called the results encouraging but cautioned more study is needed. “Importantly, the vaccine resulted in a robust immune response,” Evan Anderson, MD, principal investigator for the trial at Emory University, says in a news release. Emory and Kaiser Permanente Washington Health Research Institute were the two sites for the study.

The company is already testing the vaccine in a larger group of people, known as a phase II trial. It plans to begin phase III trials in late July. Phase III trials involve testing the vaccine on an even larger group and are the final step before FDA approval.

The study results are published in The New England Journal of Medicine. The study was led by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Moderna’s vaccine uses messenger RNA, also called mRNA. It carries the instruction for making the spike protein, a key protein on the surface of the virus that allows it to enter cells when a person is infected. After it’s injected, it goes to the immune cells and instructs them to make copies of the spike protein, acting as if the cells have been infected with the actual coronavirus. This allows other immune cells to develop immunity.

In the study, participants were divided into three groups of 15 people each. All groups received two vaccinations 28 days apart. Each group received a different strength of the vaccine – either 25, 100, or 250 micrograms.

Every person in the study developed antibodies that can block the infection. Most commonly reported side effects after the second vaccination in the 100-microgram group were fatigue, chills, headache, and muscle pains, ranging from mild to moderately severe.

The phase II study has 300 heathy adults ages 18-55, along with another 300 ages 55 and older

Moderna says it hopes to include about 30,000 participants at the 100-microgram dose level in the U.S. for the phase III trial. The estimated start date is July 27.

This article first appeared on WebMD.com.

Every person who received Moderna’s COVID-19 vaccine, mRNA-1273, developed an immune response to the virus that causes it, the company says in a news release.

Researchers also reported some side effects in the 45 people in the phase I study, but no significant safety issues, the news release says.

The vaccine is among hundreds being tested worldwide in an effort to halt the pandemic that has killed nearly 600,000 worldwide.

A researcher testing the vaccine called the results encouraging but cautioned more study is needed. “Importantly, the vaccine resulted in a robust immune response,” Evan Anderson, MD, principal investigator for the trial at Emory University, says in a news release. Emory and Kaiser Permanente Washington Health Research Institute were the two sites for the study.

The company is already testing the vaccine in a larger group of people, known as a phase II trial. It plans to begin phase III trials in late July. Phase III trials involve testing the vaccine on an even larger group and are the final step before FDA approval.

The study results are published in The New England Journal of Medicine. The study was led by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Moderna’s vaccine uses messenger RNA, also called mRNA. It carries the instruction for making the spike protein, a key protein on the surface of the virus that allows it to enter cells when a person is infected. After it’s injected, it goes to the immune cells and instructs them to make copies of the spike protein, acting as if the cells have been infected with the actual coronavirus. This allows other immune cells to develop immunity.

In the study, participants were divided into three groups of 15 people each. All groups received two vaccinations 28 days apart. Each group received a different strength of the vaccine – either 25, 100, or 250 micrograms.

Every person in the study developed antibodies that can block the infection. Most commonly reported side effects after the second vaccination in the 100-microgram group were fatigue, chills, headache, and muscle pains, ranging from mild to moderately severe.

The phase II study has 300 heathy adults ages 18-55, along with another 300 ages 55 and older

Moderna says it hopes to include about 30,000 participants at the 100-microgram dose level in the U.S. for the phase III trial. The estimated start date is July 27.

This article first appeared on WebMD.com.

Every person who received Moderna’s COVID-19 vaccine, mRNA-1273, developed an immune response to the virus that causes it, the company says in a news release.

Researchers also reported some side effects in the 45 people in the phase I study, but no significant safety issues, the news release says.

The vaccine is among hundreds being tested worldwide in an effort to halt the pandemic that has killed nearly 600,000 worldwide.

A researcher testing the vaccine called the results encouraging but cautioned more study is needed. “Importantly, the vaccine resulted in a robust immune response,” Evan Anderson, MD, principal investigator for the trial at Emory University, says in a news release. Emory and Kaiser Permanente Washington Health Research Institute were the two sites for the study.

The company is already testing the vaccine in a larger group of people, known as a phase II trial. It plans to begin phase III trials in late July. Phase III trials involve testing the vaccine on an even larger group and are the final step before FDA approval.

The study results are published in The New England Journal of Medicine. The study was led by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Moderna’s vaccine uses messenger RNA, also called mRNA. It carries the instruction for making the spike protein, a key protein on the surface of the virus that allows it to enter cells when a person is infected. After it’s injected, it goes to the immune cells and instructs them to make copies of the spike protein, acting as if the cells have been infected with the actual coronavirus. This allows other immune cells to develop immunity.

In the study, participants were divided into three groups of 15 people each. All groups received two vaccinations 28 days apart. Each group received a different strength of the vaccine – either 25, 100, or 250 micrograms.

Every person in the study developed antibodies that can block the infection. Most commonly reported side effects after the second vaccination in the 100-microgram group were fatigue, chills, headache, and muscle pains, ranging from mild to moderately severe.

The phase II study has 300 heathy adults ages 18-55, along with another 300 ages 55 and older

Moderna says it hopes to include about 30,000 participants at the 100-microgram dose level in the U.S. for the phase III trial. The estimated start date is July 27.

This article first appeared on WebMD.com.

People with a body mass index of 30 kg/m² or above are at significantly increased risk for severe COVID-19, while a BMI of 35 and higher dramatically increases the risk for death, new research suggests.

The data, from nearly 500 patients hospitalized with COVID-19 in March and April 2020, were published in the European Journal of Endocrinology by Matteo Rottoli, MD, of the Alma Mater Studiorum, University of Bologna (Italy), and colleagues.

The data support the recent change by the Centers for Disease Control and Prevention to lower the cutoff for categorizing a person at increased risk from COVID-19 from a BMI of 40 down to 30. However, in the United Kingdom, the National Health Service still lists only a BMI of 40 or above as placing a person at “moderate risk (clinically vulnerable).”

“This finding calls for prevention and treatment strategies to reduce the risk of infection and hospitalization in patients with relevant degrees of obesity, supporting a revision of the BMI cutoff of 40 kg/m², which was proposed as an independent risk factor for an adverse outcome of COVID-19 in the ... guidelines for social distancing in the United Kingdom: It may be appropriate to include patients with BMI >30 among those at higher risk for COVID-19 severe progression,” the authors wrote.

The study included 482 adults admitted with confirmed COVID-19 to a single Italian hospital between March 1 and April 20, 2020. Of those, 41.9% had a BMI of less than 25 (normal weight), 36.5% had a BMI of 25-29.9 (overweight), and 21.6% had BMI of at least 30 (obese). Of the obese group, 20 (4.1%) had BMIs of at least 35, while 18 patients (3.7%) had BMIs of less than 20 (underweight).

Among those with obesity, 51.9% experienced respiratory failure, 36.4% were admitted to the ICU, 25% required mechanical ventilation, and 29.8% died within 30 days of symptom onset.

Patients with BMIs of at least 30 had significantly increased risks for respiratory failure (odds ratio, 2.48; P = .001), ICU admission (OR, 5.28; P < .001), and death (2.35, P = .017), compared with those with lower BMIs. Within the group classified as obese, the risks of respiratory failure and ICU admission were higher, with BMIs of 30-34.9 (OR, 2.32; P = .004 and OR, 4.96; P < .001, respectively) and for BMIs of at least 35 (OR, 3.24; P = .019 and OR, 6.58; P < .001, respectively).

The risk of death was significantly higher among patients with a BMI of at least 35 (OR, 12.1; P < .001).

Every 1-unit increase in BMI was significantly associated with all outcomes, but there was no significant difference in any outcome between the 25-29.9 BMI category and normal weight. In all models, the BMI cutoff for increased risk was 30.

The authors reported no disclosures.

SOURCE: Rottoli M et al. Eur J Endocrinol. 2020 Jul 1. doi: 10.1530/EJE-20-054.

People with a body mass index of 30 kg/m² or above are at significantly increased risk for severe COVID-19, while a BMI of 35 and higher dramatically increases the risk for death, new research suggests.

The data, from nearly 500 patients hospitalized with COVID-19 in March and April 2020, were published in the European Journal of Endocrinology by Matteo Rottoli, MD, of the Alma Mater Studiorum, University of Bologna (Italy), and colleagues.

The data support the recent change by the Centers for Disease Control and Prevention to lower the cutoff for categorizing a person at increased risk from COVID-19 from a BMI of 40 down to 30. However, in the United Kingdom, the National Health Service still lists only a BMI of 40 or above as placing a person at “moderate risk (clinically vulnerable).”

“This finding calls for prevention and treatment strategies to reduce the risk of infection and hospitalization in patients with relevant degrees of obesity, supporting a revision of the BMI cutoff of 40 kg/m², which was proposed as an independent risk factor for an adverse outcome of COVID-19 in the ... guidelines for social distancing in the United Kingdom: It may be appropriate to include patients with BMI >30 among those at higher risk for COVID-19 severe progression,” the authors wrote.

The study included 482 adults admitted with confirmed COVID-19 to a single Italian hospital between March 1 and April 20, 2020. Of those, 41.9% had a BMI of less than 25 (normal weight), 36.5% had a BMI of 25-29.9 (overweight), and 21.6% had BMI of at least 30 (obese). Of the obese group, 20 (4.1%) had BMIs of at least 35, while 18 patients (3.7%) had BMIs of less than 20 (underweight).

Among those with obesity, 51.9% experienced respiratory failure, 36.4% were admitted to the ICU, 25% required mechanical ventilation, and 29.8% died within 30 days of symptom onset.

Patients with BMIs of at least 30 had significantly increased risks for respiratory failure (odds ratio, 2.48; P = .001), ICU admission (OR, 5.28; P < .001), and death (2.35, P = .017), compared with those with lower BMIs. Within the group classified as obese, the risks of respiratory failure and ICU admission were higher, with BMIs of 30-34.9 (OR, 2.32; P = .004 and OR, 4.96; P < .001, respectively) and for BMIs of at least 35 (OR, 3.24; P = .019 and OR, 6.58; P < .001, respectively).

The risk of death was significantly higher among patients with a BMI of at least 35 (OR, 12.1; P < .001).

Every 1-unit increase in BMI was significantly associated with all outcomes, but there was no significant difference in any outcome between the 25-29.9 BMI category and normal weight. In all models, the BMI cutoff for increased risk was 30.

The authors reported no disclosures.

SOURCE: Rottoli M et al. Eur J Endocrinol. 2020 Jul 1. doi: 10.1530/EJE-20-054.

People with a body mass index of 30 kg/m² or above are at significantly increased risk for severe COVID-19, while a BMI of 35 and higher dramatically increases the risk for death, new research suggests.

The data, from nearly 500 patients hospitalized with COVID-19 in March and April 2020, were published in the European Journal of Endocrinology by Matteo Rottoli, MD, of the Alma Mater Studiorum, University of Bologna (Italy), and colleagues.

The data support the recent change by the Centers for Disease Control and Prevention to lower the cutoff for categorizing a person at increased risk from COVID-19 from a BMI of 40 down to 30. However, in the United Kingdom, the National Health Service still lists only a BMI of 40 or above as placing a person at “moderate risk (clinically vulnerable).”

“This finding calls for prevention and treatment strategies to reduce the risk of infection and hospitalization in patients with relevant degrees of obesity, supporting a revision of the BMI cutoff of 40 kg/m², which was proposed as an independent risk factor for an adverse outcome of COVID-19 in the ... guidelines for social distancing in the United Kingdom: It may be appropriate to include patients with BMI >30 among those at higher risk for COVID-19 severe progression,” the authors wrote.

The study included 482 adults admitted with confirmed COVID-19 to a single Italian hospital between March 1 and April 20, 2020. Of those, 41.9% had a BMI of less than 25 (normal weight), 36.5% had a BMI of 25-29.9 (overweight), and 21.6% had BMI of at least 30 (obese). Of the obese group, 20 (4.1%) had BMIs of at least 35, while 18 patients (3.7%) had BMIs of less than 20 (underweight).

Among those with obesity, 51.9% experienced respiratory failure, 36.4% were admitted to the ICU, 25% required mechanical ventilation, and 29.8% died within 30 days of symptom onset.

Patients with BMIs of at least 30 had significantly increased risks for respiratory failure (odds ratio, 2.48; P = .001), ICU admission (OR, 5.28; P < .001), and death (2.35, P = .017), compared with those with lower BMIs. Within the group classified as obese, the risks of respiratory failure and ICU admission were higher, with BMIs of 30-34.9 (OR, 2.32; P = .004 and OR, 4.96; P < .001, respectively) and for BMIs of at least 35 (OR, 3.24; P = .019 and OR, 6.58; P < .001, respectively).

The risk of death was significantly higher among patients with a BMI of at least 35 (OR, 12.1; P < .001).

Every 1-unit increase in BMI was significantly associated with all outcomes, but there was no significant difference in any outcome between the 25-29.9 BMI category and normal weight. In all models, the BMI cutoff for increased risk was 30.

The authors reported no disclosures.

SOURCE: Rottoli M et al. Eur J Endocrinol. 2020 Jul 1. doi: 10.1530/EJE-20-054.

We live in historic times. A worldwide pandemic is surging in the United States, with millions infected and the world’s highest death rate. Many of our hospitals are overwhelmed. Schools have been closed for months. Businesses are struggling, and unemployment is at record levels. The murder of George Floyd unleashed an outpouring of grief and rage over police brutality and structural racism.

Thinkstock

The value of knowing about these risk factors would seem self-evident; it would inform a patient’s health care from screening for cancer or heart disease, referral for mild depressive symptoms, and counseling about alcohol consumption. But this research did not lead to the establishment of routine screening for childhood adversity in primary care practices. There are multiple reasons for this, including growing pressure on physician time and discomfort with starting conversations about potentially traumatic material. But perhaps the greatest obstacle has been uncertainty about what to offer patients who screened in. What is the treatment for a high ACE score?

Even without treatments, we have learned much about childhood adversity since Dr. Anda and Dr. Felitti published their landmark study. Other more chronic adverse childhood experiences also contribute to adult health risk, such as poverty, homelessness, discrimination, community violence, parental chronic illness, or disability or placement in foster care. Having a high ACE score does not only affect health in adulthood. Children with an ACE score of 4 are 2 times as likely to have asthma^2,3 and allergies³, 2 times as likely to be obese⁴, 3 times as likely to have headaches³ and dental problems^5,6, 4 times as likely to have depression^7,8, 5 times as likely to have ADHD^8,9, 7 times as likely to have high rates of school absenteeism³ and aggression¹⁰, and over 30 times as likely to have learning or behavioral problems at school⁴. There is a growing body of knowledge about how chronic, severe stress in childhood affects can lead to pathological alterations in neuroendocrine and immune function. But this has not led to any concrete treatments that may be preventive or reparative.

Movement toward expanding screening nonetheless has accelerated. In California, Nadine Burke-Harris, MD, a pediatrician who studied ACEs and children’s health was named the state’s first Surgeon General in 2019 and spearheaded an effort to make screening for ACEs easier. Starting in 2020, MediCal will pay for annual screenings, and the state is offering training and resources on how to screen and what to do with the information to help patients and families.

The coronavirus pandemic has only highlighted the risks of childhood adversity. The burden of infection and mortality has been borne disproportionately by people of color and those with multiple chronic medical conditions (obesity, cardiovascular disease, diabetes, etc.). While viruses do not discriminate, they are more likely to infect those with higher risk of exposure and to kill those who are physiologically vulnerable.

And the pandemic increases the risk for adversity for today’s children and families. When children cannot attend school, financially vulnerable parents may have to choose between supervising them or feeding them. Families who suddenly are all in a small apartment together without school or other outside supports may be at higher risk for domestic violence and child abuse. Unemployment and financial uncertainty will increase the rates of substance abuse and depression amongst parents. And the serious illness or death of a parent will be a more common event for children in the year ahead. One of these risk factors may increase the likelihood of others.

Beyond the obvious need for substantial policy changes focused on housing, education, and health care, there are immediate and concrete strategies that can build resilience in children and their families. And resilience can build on itself, as children face subsequent challenges with the support of caring connected adults.

The critical first step is asking. Then listen calmly and supportively, normalizing for parents and children how common these experiences are. Explain how they affect health and well-being. Explain that adversity and its consequences are not their fault. Then educate them about what is in their control: the skills they can practice to buffer against the consequences of adversity and build resilience. They sound simple, but still require effort and work. And the pandemic has created some difficulty (social distancing) and opportunity (more family time, fewer school demands).
 

Sleep

Help parents establish and protect consistent, restful sleep for their children. They can set a consistent bedtime and a calm routine, with screens all off at least 30 minutes before sleep and reading before sleep. Restful sleep is physiologically and psychologically protective to everyone in a family.

Movement

Beyond directly improving physical health, establishing habits of exercise – especially outside – every day can effectively manage ongoing stress, build skills of self-regulation, and help with sleep.

Find out what parents and their children like to do together (walking the dog, shooting hoops, even dancing) and help them devise ways to create family routines around exercise.
 

Nutrition

Food should be a source of pleasure, but stress can make food into a source of comfort or escape. Help parents to create realistic ways to consistently offer healthy family meals and discourage unhealthy habits.

Even small changes like water instead of soda can help, and there are nutritional and emotional benefits to eating a healthy breakfast or dinner together as a family.
 

Connections

Nourishing social connections are protective. Help parents think about protecting time to spend with their children for talking, playing games, or even singing.

They should support their children’s connections to other caring adults, through community organizations (church, community centers, or sports), and they should know who their children’s reliable friends are. Parents will benefit from these supports for themselves, which in turn will benefit the full family.
 

Self-awareness

Activities that cultivate mindfulness are protective. Parents can simply ask how their children are feeling, physically or emotionally, and be able to bear it when it is uncomfortable. Work towards nonjudgmental awareness of how they are feeling. Learning what is relaxing or recharging for them (exercise, music, a hot bath, a good book, time with a friend) will protect against defaulting into maladaptive coping such as escape, numbing, or avoidance.

Of course, if you learn about symptoms that suggest PTSD, depression, or addiction, you should help your patient connect with effective treatment. The difficulty of referring to a mental health provider does not mean you should not try and bring as many people onto the team and into the orbit of the child and family at risk. It may be easier to access some therapy given the new availability of telemedicine visits across many more systems of care. Although the heaviest burdens of adversity are not being borne equally, the fact that adversity is currently a shared experience makes this a moment of promise.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Dr. Swick and Dr. Jellinek had no relevant financial disclosures. Email them at pdnews@mdedge.com.

References
1. Am J Prev Med. 1998 May;14(4):245-58.
2. Ann Allergy Asthma Immunol. 2015;114: 379-84.
3. BMC Public Health. 2018. doi: 10.1186/s12889-018-5699-8.
4. Child Abuse Negl. 2011 Jun;35(6):408-13.
5. Community Dent Oral Epidemiol. 2015;43:193-9.
6. Community Dent Oral Epidemiol. 2018 Oct;46(5): 442-8.
7. Pediatrics 2016 Apr. doi: 10.1542/peds.2015-4016.
8. Matern Child Health J. 2016 Apr. doi: 10.1007/s10995-015-1915-7.
9. Acad Pediatr. 2017 May-Jun. doi: 10.1016/j.acap.2016.08.013.
10. Pediatrics. 2010 Apr. doi: 10.1542/peds.2009-0597.
 

This article was updated 7/27/2020.

We live in historic times. A worldwide pandemic is surging in the United States, with millions infected and the world’s highest death rate. Many of our hospitals are overwhelmed. Schools have been closed for months. Businesses are struggling, and unemployment is at record levels. The murder of George Floyd unleashed an outpouring of grief and rage over police brutality and structural racism.

Thinkstock

The value of knowing about these risk factors would seem self-evident; it would inform a patient’s health care from screening for cancer or heart disease, referral for mild depressive symptoms, and counseling about alcohol consumption. But this research did not lead to the establishment of routine screening for childhood adversity in primary care practices. There are multiple reasons for this, including growing pressure on physician time and discomfort with starting conversations about potentially traumatic material. But perhaps the greatest obstacle has been uncertainty about what to offer patients who screened in. What is the treatment for a high ACE score?

Even without treatments, we have learned much about childhood adversity since Dr. Anda and Dr. Felitti published their landmark study. Other more chronic adverse childhood experiences also contribute to adult health risk, such as poverty, homelessness, discrimination, community violence, parental chronic illness, or disability or placement in foster care. Having a high ACE score does not only affect health in adulthood. Children with an ACE score of 4 are 2 times as likely to have asthma^2,3 and allergies³, 2 times as likely to be obese⁴, 3 times as likely to have headaches³ and dental problems^5,6, 4 times as likely to have depression^7,8, 5 times as likely to have ADHD^8,9, 7 times as likely to have high rates of school absenteeism³ and aggression¹⁰, and over 30 times as likely to have learning or behavioral problems at school⁴. There is a growing body of knowledge about how chronic, severe stress in childhood affects can lead to pathological alterations in neuroendocrine and immune function. But this has not led to any concrete treatments that may be preventive or reparative.

Movement toward expanding screening nonetheless has accelerated. In California, Nadine Burke-Harris, MD, a pediatrician who studied ACEs and children’s health was named the state’s first Surgeon General in 2019 and spearheaded an effort to make screening for ACEs easier. Starting in 2020, MediCal will pay for annual screenings, and the state is offering training and resources on how to screen and what to do with the information to help patients and families.

The coronavirus pandemic has only highlighted the risks of childhood adversity. The burden of infection and mortality has been borne disproportionately by people of color and those with multiple chronic medical conditions (obesity, cardiovascular disease, diabetes, etc.). While viruses do not discriminate, they are more likely to infect those with higher risk of exposure and to kill those who are physiologically vulnerable.

And the pandemic increases the risk for adversity for today’s children and families. When children cannot attend school, financially vulnerable parents may have to choose between supervising them or feeding them. Families who suddenly are all in a small apartment together without school or other outside supports may be at higher risk for domestic violence and child abuse. Unemployment and financial uncertainty will increase the rates of substance abuse and depression amongst parents. And the serious illness or death of a parent will be a more common event for children in the year ahead. One of these risk factors may increase the likelihood of others.

Beyond the obvious need for substantial policy changes focused on housing, education, and health care, there are immediate and concrete strategies that can build resilience in children and their families. And resilience can build on itself, as children face subsequent challenges with the support of caring connected adults.

The critical first step is asking. Then listen calmly and supportively, normalizing for parents and children how common these experiences are. Explain how they affect health and well-being. Explain that adversity and its consequences are not their fault. Then educate them about what is in their control: the skills they can practice to buffer against the consequences of adversity and build resilience. They sound simple, but still require effort and work. And the pandemic has created some difficulty (social distancing) and opportunity (more family time, fewer school demands).
 

Sleep

Help parents establish and protect consistent, restful sleep for their children. They can set a consistent bedtime and a calm routine, with screens all off at least 30 minutes before sleep and reading before sleep. Restful sleep is physiologically and psychologically protective to everyone in a family.

Movement

Beyond directly improving physical health, establishing habits of exercise – especially outside – every day can effectively manage ongoing stress, build skills of self-regulation, and help with sleep.

Find out what parents and their children like to do together (walking the dog, shooting hoops, even dancing) and help them devise ways to create family routines around exercise.
 

Nutrition

Food should be a source of pleasure, but stress can make food into a source of comfort or escape. Help parents to create realistic ways to consistently offer healthy family meals and discourage unhealthy habits.

Even small changes like water instead of soda can help, and there are nutritional and emotional benefits to eating a healthy breakfast or dinner together as a family.
 

Connections

Nourishing social connections are protective. Help parents think about protecting time to spend with their children for talking, playing games, or even singing.

They should support their children’s connections to other caring adults, through community organizations (church, community centers, or sports), and they should know who their children’s reliable friends are. Parents will benefit from these supports for themselves, which in turn will benefit the full family.
 

Self-awareness

Activities that cultivate mindfulness are protective. Parents can simply ask how their children are feeling, physically or emotionally, and be able to bear it when it is uncomfortable. Work towards nonjudgmental awareness of how they are feeling. Learning what is relaxing or recharging for them (exercise, music, a hot bath, a good book, time with a friend) will protect against defaulting into maladaptive coping such as escape, numbing, or avoidance.

Of course, if you learn about symptoms that suggest PTSD, depression, or addiction, you should help your patient connect with effective treatment. The difficulty of referring to a mental health provider does not mean you should not try and bring as many people onto the team and into the orbit of the child and family at risk. It may be easier to access some therapy given the new availability of telemedicine visits across many more systems of care. Although the heaviest burdens of adversity are not being borne equally, the fact that adversity is currently a shared experience makes this a moment of promise.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Dr. Swick and Dr. Jellinek had no relevant financial disclosures. Email them at pdnews@mdedge.com.

References
1. Am J Prev Med. 1998 May;14(4):245-58.
2. Ann Allergy Asthma Immunol. 2015;114: 379-84.
3. BMC Public Health. 2018. doi: 10.1186/s12889-018-5699-8.
4. Child Abuse Negl. 2011 Jun;35(6):408-13.
5. Community Dent Oral Epidemiol. 2015;43:193-9.
6. Community Dent Oral Epidemiol. 2018 Oct;46(5): 442-8.
7. Pediatrics 2016 Apr. doi: 10.1542/peds.2015-4016.
8. Matern Child Health J. 2016 Apr. doi: 10.1007/s10995-015-1915-7.
9. Acad Pediatr. 2017 May-Jun. doi: 10.1016/j.acap.2016.08.013.
10. Pediatrics. 2010 Apr. doi: 10.1542/peds.2009-0597.
 

This article was updated 7/27/2020.

We live in historic times. A worldwide pandemic is surging in the United States, with millions infected and the world’s highest death rate. Many of our hospitals are overwhelmed. Schools have been closed for months. Businesses are struggling, and unemployment is at record levels. The murder of George Floyd unleashed an outpouring of grief and rage over police brutality and structural racism.

Thinkstock

The value of knowing about these risk factors would seem self-evident; it would inform a patient’s health care from screening for cancer or heart disease, referral for mild depressive symptoms, and counseling about alcohol consumption. But this research did not lead to the establishment of routine screening for childhood adversity in primary care practices. There are multiple reasons for this, including growing pressure on physician time and discomfort with starting conversations about potentially traumatic material. But perhaps the greatest obstacle has been uncertainty about what to offer patients who screened in. What is the treatment for a high ACE score?

Even without treatments, we have learned much about childhood adversity since Dr. Anda and Dr. Felitti published their landmark study. Other more chronic adverse childhood experiences also contribute to adult health risk, such as poverty, homelessness, discrimination, community violence, parental chronic illness, or disability or placement in foster care. Having a high ACE score does not only affect health in adulthood. Children with an ACE score of 4 are 2 times as likely to have asthma^2,3 and allergies³, 2 times as likely to be obese⁴, 3 times as likely to have headaches³ and dental problems^5,6, 4 times as likely to have depression^7,8, 5 times as likely to have ADHD^8,9, 7 times as likely to have high rates of school absenteeism³ and aggression¹⁰, and over 30 times as likely to have learning or behavioral problems at school⁴. There is a growing body of knowledge about how chronic, severe stress in childhood affects can lead to pathological alterations in neuroendocrine and immune function. But this has not led to any concrete treatments that may be preventive or reparative.

Movement toward expanding screening nonetheless has accelerated. In California, Nadine Burke-Harris, MD, a pediatrician who studied ACEs and children’s health was named the state’s first Surgeon General in 2019 and spearheaded an effort to make screening for ACEs easier. Starting in 2020, MediCal will pay for annual screenings, and the state is offering training and resources on how to screen and what to do with the information to help patients and families.

The coronavirus pandemic has only highlighted the risks of childhood adversity. The burden of infection and mortality has been borne disproportionately by people of color and those with multiple chronic medical conditions (obesity, cardiovascular disease, diabetes, etc.). While viruses do not discriminate, they are more likely to infect those with higher risk of exposure and to kill those who are physiologically vulnerable.

And the pandemic increases the risk for adversity for today’s children and families. When children cannot attend school, financially vulnerable parents may have to choose between supervising them or feeding them. Families who suddenly are all in a small apartment together without school or other outside supports may be at higher risk for domestic violence and child abuse. Unemployment and financial uncertainty will increase the rates of substance abuse and depression amongst parents. And the serious illness or death of a parent will be a more common event for children in the year ahead. One of these risk factors may increase the likelihood of others.

Beyond the obvious need for substantial policy changes focused on housing, education, and health care, there are immediate and concrete strategies that can build resilience in children and their families. And resilience can build on itself, as children face subsequent challenges with the support of caring connected adults.

The critical first step is asking. Then listen calmly and supportively, normalizing for parents and children how common these experiences are. Explain how they affect health and well-being. Explain that adversity and its consequences are not their fault. Then educate them about what is in their control: the skills they can practice to buffer against the consequences of adversity and build resilience. They sound simple, but still require effort and work. And the pandemic has created some difficulty (social distancing) and opportunity (more family time, fewer school demands).
 

Sleep

Help parents establish and protect consistent, restful sleep for their children. They can set a consistent bedtime and a calm routine, with screens all off at least 30 minutes before sleep and reading before sleep. Restful sleep is physiologically and psychologically protective to everyone in a family.

Movement

Beyond directly improving physical health, establishing habits of exercise – especially outside – every day can effectively manage ongoing stress, build skills of self-regulation, and help with sleep.

Find out what parents and their children like to do together (walking the dog, shooting hoops, even dancing) and help them devise ways to create family routines around exercise.
 

Nutrition

Food should be a source of pleasure, but stress can make food into a source of comfort or escape. Help parents to create realistic ways to consistently offer healthy family meals and discourage unhealthy habits.

Even small changes like water instead of soda can help, and there are nutritional and emotional benefits to eating a healthy breakfast or dinner together as a family.
 

Connections

Nourishing social connections are protective. Help parents think about protecting time to spend with their children for talking, playing games, or even singing.

They should support their children’s connections to other caring adults, through community organizations (church, community centers, or sports), and they should know who their children’s reliable friends are. Parents will benefit from these supports for themselves, which in turn will benefit the full family.
 

Self-awareness

Activities that cultivate mindfulness are protective. Parents can simply ask how their children are feeling, physically or emotionally, and be able to bear it when it is uncomfortable. Work towards nonjudgmental awareness of how they are feeling. Learning what is relaxing or recharging for them (exercise, music, a hot bath, a good book, time with a friend) will protect against defaulting into maladaptive coping such as escape, numbing, or avoidance.

Of course, if you learn about symptoms that suggest PTSD, depression, or addiction, you should help your patient connect with effective treatment. The difficulty of referring to a mental health provider does not mean you should not try and bring as many people onto the team and into the orbit of the child and family at risk. It may be easier to access some therapy given the new availability of telemedicine visits across many more systems of care. Although the heaviest burdens of adversity are not being borne equally, the fact that adversity is currently a shared experience makes this a moment of promise.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Dr. Swick and Dr. Jellinek had no relevant financial disclosures. Email them at pdnews@mdedge.com.

References
1. Am J Prev Med. 1998 May;14(4):245-58.
2. Ann Allergy Asthma Immunol. 2015;114: 379-84.
3. BMC Public Health. 2018. doi: 10.1186/s12889-018-5699-8.
4. Child Abuse Negl. 2011 Jun;35(6):408-13.
5. Community Dent Oral Epidemiol. 2015;43:193-9.
6. Community Dent Oral Epidemiol. 2018 Oct;46(5): 442-8.
7. Pediatrics 2016 Apr. doi: 10.1542/peds.2015-4016.
8. Matern Child Health J. 2016 Apr. doi: 10.1007/s10995-015-1915-7.
9. Acad Pediatr. 2017 May-Jun. doi: 10.1016/j.acap.2016.08.013.
10. Pediatrics. 2010 Apr. doi: 10.1542/peds.2009-0597.
 

This article was updated 7/27/2020.

The use of compounded bioidentical hormone therapies should be limited to patients who are not able to use a hormone therapy product approved by the Food and Drug Administration for reasons of allergy or dosage, according to a new report from the National Academies of Sciences, Engineering, and Medicine.

yacobchuk/Getty Images

In recent years, compounded bioidentical hormone therapies (cBHTs) have been “marketed as a personalized and natural approach to enhanced wellness using tailored preparations that address a myriad of symptoms, including those associated with menopause and aging,” wrote Donald R. Mattison, MD, of the University of Ottawa, and chair of the committee charged with producing the report, and colleagues.

Although both cBHTs and bioidentical hormone therapies (BHTs) contain hormones that are structurally and chemically identical to those in the human body, cBHTs have not undergone the safety, efficacy, and quality control tests of approved FDA products, according to the report.

In addition, cBHTs have no standardization when it comes to medication doses, and the products often are available in topicals such as creams or ointments, as well as pills or pellets. The lack of standards in dosing or form can contribute to the risk of overdose, the report emphasized.

Various cBTH products continue to be marketed to the public for age-related hormone symptoms including hot flashes associated with menopause and decreased muscle mass associated with decreased testosterone. However, cBHTs are not approved by the FDA in part because the individually mixed products are not tested to verify the amount of hormone that may be absorbed.

In response to the increased use of cBHTs, the National Academies convened a Committee on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy and commissioned a report.

The two typical reasons to prescribe cBHT are either to provide a medication in an alternate dose not available in approved products or to omit components of a medication to which a patient is allergic, according to the report.

The report includes an algorithm to help guide clinicians in prescribing FDA-approved products, including off-label use of approved products, before cBHT products. “There is a dearth of high-quality evidence ... available to establish whether cBHT preparations are safe or efficacious for their prescribed uses,” the report states.

Of note, the committee also found no guidelines to recommend the use of cBHT products as a substitute for off-label use of FDA-approved BHT products for patients with female sexual dysfunction or gender dysphoria, two conditions for which no FDA-approved BHT products exist.

“The North American Menopause Society applauds the efforts of the National Academies of Sciences, Engineering, and Medicine (NASEM) and endorses their recommendations on compounded bioidentical hormone therapy,” Stephanie S. Faubion, MD, medical director of The North American Menopause Society, wrote in a statement. “As a society, we remain committed to improving the care of midlife women through the promotion of evidence-based research, education, and clinical care.”

A report on the use of cBHTs was important at this time because of the widespread and largely unregulated use of these products with little data to support their safety and efficacy, Dr. Faubion said in an interview.

“There are no indications for use of custom compounded hormone therapy aside from an allergy to a component in the FDA-approved products or lack of availability of the needed dose, which would be exceedingly rare given the variety of forms and doses available with FDA-approved products,” she said.

Main concerns regarding the use of cBHTs are the lack of safety and efficacy data, Dr. Faubion emphasized. “Women believe these products are safer than FDA-approved products because they do not receive a package insert outlining potential risks as they do with FDA-approved products.” A lack of data and safety monitoring of cBHTs means that adverse effects are not monitored and reported, she said. Also, safety concerns persist regarding some forms of cBHTs such as pellets, which were specifically highlighted in the report.

Dr. Faubion said that she “absolutely” agrees with the report’s limited circumstances in which the used of cBHTs would be appropriate. “There are very few reasons why women would need to use compounded hormones instead of the FDA-approved versions, which are regulated for quality, efficacy and safety, readily available in the local pharmacy, and often covered by insurance.”

In terms of the future, “we need more education for women as consumers and for medical providers on this topic,” Dr. Faubion noted. Also, “clearly, there is a dearth of research on the true efficacy and safety of these compounded hormone therapy products.”

The statement from the National Academies crystallizes what experts have been saying for decades, according to Lubna Pal, MBBS, director of the menopause program at Yale University, New Haven, Conn.

The formal recommendations to limit the use of cBHTs “are not novel, but certainly needed,” and the statement “offers guidance regardless of your specialty,” Dr. Pal said in an interview.

There is often a disconnect between consumers’ understanding of compounding and the reality of safety concerns, she said. “We are in a tabloid era,” and education is key to guiding patients toward the FDA-approved treatments with safety data and demonstrated effectiveness, she said. “Safety should be the driving factor.” In compounded products, “there is no consistency that what you get today is the same as what you get tomorrow,” and the lack of standardization of cBHTs increases the risk for adverse events, she emphasized.

For patients with special needs such as allergies or other specialized dosing requirements, as noted in the National Academies statement, clinicians should discuss the options with patients and monitor them regularly to head off potential adverse events such as the development of uterine cancer, said Dr. Pal, who is a member of the Ob.Gyn. News editorial advisory board.

The research involved in creating the report was supported by the Food and Drug Administration.

Dr. Faubion had no financial conflicts to disclose. Dr. Pal had no relevant financial disclosures.

obnews@mdedge.com

SOURCE: Mattison DR et al.; National Academies of Sciences, Engineering, and Medicine. The clinical utility of compounded bioidentical hormone therapy: A review of safety, effectiveness, and use. (Washington, DC: The National Academies Press. 2020.)

The use of compounded bioidentical hormone therapies should be limited to patients who are not able to use a hormone therapy product approved by the Food and Drug Administration for reasons of allergy or dosage, according to a new report from the National Academies of Sciences, Engineering, and Medicine.

yacobchuk/Getty Images

In recent years, compounded bioidentical hormone therapies (cBHTs) have been “marketed as a personalized and natural approach to enhanced wellness using tailored preparations that address a myriad of symptoms, including those associated with menopause and aging,” wrote Donald R. Mattison, MD, of the University of Ottawa, and chair of the committee charged with producing the report, and colleagues.

Although both cBHTs and bioidentical hormone therapies (BHTs) contain hormones that are structurally and chemically identical to those in the human body, cBHTs have not undergone the safety, efficacy, and quality control tests of approved FDA products, according to the report.

In addition, cBHTs have no standardization when it comes to medication doses, and the products often are available in topicals such as creams or ointments, as well as pills or pellets. The lack of standards in dosing or form can contribute to the risk of overdose, the report emphasized.

Various cBTH products continue to be marketed to the public for age-related hormone symptoms including hot flashes associated with menopause and decreased muscle mass associated with decreased testosterone. However, cBHTs are not approved by the FDA in part because the individually mixed products are not tested to verify the amount of hormone that may be absorbed.

In response to the increased use of cBHTs, the National Academies convened a Committee on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy and commissioned a report.

The two typical reasons to prescribe cBHT are either to provide a medication in an alternate dose not available in approved products or to omit components of a medication to which a patient is allergic, according to the report.

The report includes an algorithm to help guide clinicians in prescribing FDA-approved products, including off-label use of approved products, before cBHT products. “There is a dearth of high-quality evidence ... available to establish whether cBHT preparations are safe or efficacious for their prescribed uses,” the report states.

Of note, the committee also found no guidelines to recommend the use of cBHT products as a substitute for off-label use of FDA-approved BHT products for patients with female sexual dysfunction or gender dysphoria, two conditions for which no FDA-approved BHT products exist.

“The North American Menopause Society applauds the efforts of the National Academies of Sciences, Engineering, and Medicine (NASEM) and endorses their recommendations on compounded bioidentical hormone therapy,” Stephanie S. Faubion, MD, medical director of The North American Menopause Society, wrote in a statement. “As a society, we remain committed to improving the care of midlife women through the promotion of evidence-based research, education, and clinical care.”

A report on the use of cBHTs was important at this time because of the widespread and largely unregulated use of these products with little data to support their safety and efficacy, Dr. Faubion said in an interview.

“There are no indications for use of custom compounded hormone therapy aside from an allergy to a component in the FDA-approved products or lack of availability of the needed dose, which would be exceedingly rare given the variety of forms and doses available with FDA-approved products,” she said.

Main concerns regarding the use of cBHTs are the lack of safety and efficacy data, Dr. Faubion emphasized. “Women believe these products are safer than FDA-approved products because they do not receive a package insert outlining potential risks as they do with FDA-approved products.” A lack of data and safety monitoring of cBHTs means that adverse effects are not monitored and reported, she said. Also, safety concerns persist regarding some forms of cBHTs such as pellets, which were specifically highlighted in the report.

Dr. Faubion said that she “absolutely” agrees with the report’s limited circumstances in which the used of cBHTs would be appropriate. “There are very few reasons why women would need to use compounded hormones instead of the FDA-approved versions, which are regulated for quality, efficacy and safety, readily available in the local pharmacy, and often covered by insurance.”

In terms of the future, “we need more education for women as consumers and for medical providers on this topic,” Dr. Faubion noted. Also, “clearly, there is a dearth of research on the true efficacy and safety of these compounded hormone therapy products.”

The statement from the National Academies crystallizes what experts have been saying for decades, according to Lubna Pal, MBBS, director of the menopause program at Yale University, New Haven, Conn.

The formal recommendations to limit the use of cBHTs “are not novel, but certainly needed,” and the statement “offers guidance regardless of your specialty,” Dr. Pal said in an interview.

There is often a disconnect between consumers’ understanding of compounding and the reality of safety concerns, she said. “We are in a tabloid era,” and education is key to guiding patients toward the FDA-approved treatments with safety data and demonstrated effectiveness, she said. “Safety should be the driving factor.” In compounded products, “there is no consistency that what you get today is the same as what you get tomorrow,” and the lack of standardization of cBHTs increases the risk for adverse events, she emphasized.

For patients with special needs such as allergies or other specialized dosing requirements, as noted in the National Academies statement, clinicians should discuss the options with patients and monitor them regularly to head off potential adverse events such as the development of uterine cancer, said Dr. Pal, who is a member of the Ob.Gyn. News editorial advisory board.

The research involved in creating the report was supported by the Food and Drug Administration.

Dr. Faubion had no financial conflicts to disclose. Dr. Pal had no relevant financial disclosures.

obnews@mdedge.com

SOURCE: Mattison DR et al.; National Academies of Sciences, Engineering, and Medicine. The clinical utility of compounded bioidentical hormone therapy: A review of safety, effectiveness, and use. (Washington, DC: The National Academies Press. 2020.)

The use of compounded bioidentical hormone therapies should be limited to patients who are not able to use a hormone therapy product approved by the Food and Drug Administration for reasons of allergy or dosage, according to a new report from the National Academies of Sciences, Engineering, and Medicine.

yacobchuk/Getty Images

In recent years, compounded bioidentical hormone therapies (cBHTs) have been “marketed as a personalized and natural approach to enhanced wellness using tailored preparations that address a myriad of symptoms, including those associated with menopause and aging,” wrote Donald R. Mattison, MD, of the University of Ottawa, and chair of the committee charged with producing the report, and colleagues.

Although both cBHTs and bioidentical hormone therapies (BHTs) contain hormones that are structurally and chemically identical to those in the human body, cBHTs have not undergone the safety, efficacy, and quality control tests of approved FDA products, according to the report.

In addition, cBHTs have no standardization when it comes to medication doses, and the products often are available in topicals such as creams or ointments, as well as pills or pellets. The lack of standards in dosing or form can contribute to the risk of overdose, the report emphasized.

Various cBTH products continue to be marketed to the public for age-related hormone symptoms including hot flashes associated with menopause and decreased muscle mass associated with decreased testosterone. However, cBHTs are not approved by the FDA in part because the individually mixed products are not tested to verify the amount of hormone that may be absorbed.

In response to the increased use of cBHTs, the National Academies convened a Committee on the Clinical Utility of Treating Patients with Compounded Bioidentical Hormone Replacement Therapy and commissioned a report.

The two typical reasons to prescribe cBHT are either to provide a medication in an alternate dose not available in approved products or to omit components of a medication to which a patient is allergic, according to the report.

The report includes an algorithm to help guide clinicians in prescribing FDA-approved products, including off-label use of approved products, before cBHT products. “There is a dearth of high-quality evidence ... available to establish whether cBHT preparations are safe or efficacious for their prescribed uses,” the report states.

Of note, the committee also found no guidelines to recommend the use of cBHT products as a substitute for off-label use of FDA-approved BHT products for patients with female sexual dysfunction or gender dysphoria, two conditions for which no FDA-approved BHT products exist.

“The North American Menopause Society applauds the efforts of the National Academies of Sciences, Engineering, and Medicine (NASEM) and endorses their recommendations on compounded bioidentical hormone therapy,” Stephanie S. Faubion, MD, medical director of The North American Menopause Society, wrote in a statement. “As a society, we remain committed to improving the care of midlife women through the promotion of evidence-based research, education, and clinical care.”

A report on the use of cBHTs was important at this time because of the widespread and largely unregulated use of these products with little data to support their safety and efficacy, Dr. Faubion said in an interview.

“There are no indications for use of custom compounded hormone therapy aside from an allergy to a component in the FDA-approved products or lack of availability of the needed dose, which would be exceedingly rare given the variety of forms and doses available with FDA-approved products,” she said.

Main concerns regarding the use of cBHTs are the lack of safety and efficacy data, Dr. Faubion emphasized. “Women believe these products are safer than FDA-approved products because they do not receive a package insert outlining potential risks as they do with FDA-approved products.” A lack of data and safety monitoring of cBHTs means that adverse effects are not monitored and reported, she said. Also, safety concerns persist regarding some forms of cBHTs such as pellets, which were specifically highlighted in the report.

Dr. Faubion said that she “absolutely” agrees with the report’s limited circumstances in which the used of cBHTs would be appropriate. “There are very few reasons why women would need to use compounded hormones instead of the FDA-approved versions, which are regulated for quality, efficacy and safety, readily available in the local pharmacy, and often covered by insurance.”

In terms of the future, “we need more education for women as consumers and for medical providers on this topic,” Dr. Faubion noted. Also, “clearly, there is a dearth of research on the true efficacy and safety of these compounded hormone therapy products.”

The statement from the National Academies crystallizes what experts have been saying for decades, according to Lubna Pal, MBBS, director of the menopause program at Yale University, New Haven, Conn.

The formal recommendations to limit the use of cBHTs “are not novel, but certainly needed,” and the statement “offers guidance regardless of your specialty,” Dr. Pal said in an interview.

There is often a disconnect between consumers’ understanding of compounding and the reality of safety concerns, she said. “We are in a tabloid era,” and education is key to guiding patients toward the FDA-approved treatments with safety data and demonstrated effectiveness, she said. “Safety should be the driving factor.” In compounded products, “there is no consistency that what you get today is the same as what you get tomorrow,” and the lack of standardization of cBHTs increases the risk for adverse events, she emphasized.

For patients with special needs such as allergies or other specialized dosing requirements, as noted in the National Academies statement, clinicians should discuss the options with patients and monitor them regularly to head off potential adverse events such as the development of uterine cancer, said Dr. Pal, who is a member of the Ob.Gyn. News editorial advisory board.

The research involved in creating the report was supported by the Food and Drug Administration.

Dr. Faubion had no financial conflicts to disclose. Dr. Pal had no relevant financial disclosures.

obnews@mdedge.com

SOURCE: Mattison DR et al.; National Academies of Sciences, Engineering, and Medicine. The clinical utility of compounded bioidentical hormone therapy: A review of safety, effectiveness, and use. (Washington, DC: The National Academies Press. 2020.)

Given an opportunity to see physicians’ notes about their visits, patients mostly understand and agree with them, a survey shows.

Overall, 93% of respondents said the notes accurately described the visit; only 6% reported that something important was missing, write Suzanne G. Leveille, RN, PhD, of the University of Massachusetts, Boston, and colleagues in the Journal of General Internal Medicine.

“I think it’s wonderful news,” commented Howard Levy, MD, PhD, who spearheaded the implementation of open notes at Johns Hopkins University, Baltimore. “I’m thrilled with this report.”

Currently, 50 million Americans have access to their notes, the researchers report. Starting Nov. 2, 2020, the 21st Century Cures Act will require all US physicians to provide this access.

The regulation follows a movement to involve patients more actively in their care. Previous research has shown that access to visit notes improves patients’ feelings of control, helps them adhere to their medication regimens, and enables them to better understand their care plans.

Although physicians often feel that giving patients access to notes will lead to unnecessary conversations that will waste their time, previous studies have not borne that out. “Most clinical providers don’t notice a thing,” Levy told Medscape Medical News. “There was no change in the volume of work.”

Leveille and colleagues wanted to know how patients viewed the clarity, accuracy, and completeness of the notes they were reading and whether they had suggestions for improvements.

They surveyed all 136,815 adult outpatients affiliated with Beth Israel Deaconess Medical Center in Boston, Massachusetts; the University of Washington Medicine, in Seattle; and the Geisinger Health System, based in Danville, Pennsylvania. These systems all offer patients access to physicians’ notes.

The researchers asked the patients to recall one note written by a doctor, nurse practitioner, physician assistant, or mental health professional.

They received responses from 21,664 patients who had read at least one note. Of these, two thirds were women, three quarters were aged 45 years or older, and 85% were White.

Seventy-two percent had completed college. Although 85% reported being in good or excellent health, more of the respondents than nonrespondents had chronic health problems.

Ninety-seven percent of those with college educations understood their notes, compared with 92% of those who had not completed college, a finding that conflicted with the researchers’ expectations. “Good gracious, that’s wonderful,” Levy said. “In medicine we almost never get a 92% success rate in anything we do.”

Of the patients in fair or poor health, 88.6% said the note was accurate, compared with 94.4% of those in better health. Those in worse health were also more likely to say something important was missing.

When patients didn’t understand something, 35% searched the Internet, 27% asked a clinician, 7% asked a friend or family member, and 27% didn’t get help. (The researchers did not account for the other 4%.)

Of those patients whose note was written by a physician, 95% reported that the note accurately described the visit, compared with 92% of those whose note was written by a nurse practitioner and 90% of those whose note was written by a physician assistant.

Of patients reporting on a primary care note, 97% understood the note, compared with 94% of those reporting on a note from a visit to a specialist.

Ninety-three percent of those who understood their note were likely to recommend their clinician, compared with 77% of those who didn’t completely understand their note.

Asked how the notes could be improved, 3,812 people responded with comments of at least five words. These responses were included in the analysis.

Most commonly, patients wanted new information to be prominently featured at the top of the note, with clear instructions about next steps, referrals, and explanations of test results.

Often, they complained of old information or templates that felt impersonal. They stumbled over medical jargon and suggested links to glossaries. They bristled at such terms as “obese” and “patient denies.” Some wanted a way to comment on the notes.

Regarding the portals in which the notes were found, some patients said the notes were sometimes hard to find. Some said the notes were not posted quickly enough after the visits.

Levy said physicians should learn to write notes more succinctly, and he expects new regulations from the Centers for Medicare & Medicaid Services to encourage that. Previous regulations may have given physicians the impression that longer notes would allow them to bill at higher rates, he said. “The change in billing requirements will make it easier for healthcare providers to feel comfortable that they don’t have to restate information that had already been stated,” he said.

On the other hand, physicians should continue to use medical terminology, he said. “At times we use jargon, because it conveys rich, dense information in a few words,” he said. “That’s something that we should not have to give up.” Patients can research terms they don’t understand, he said.

Family physician Doug Iliff, MD, thinks it’s about time that his colleagues share their notes. He’s been doing it since he opened his solo practice in Topeka, Kansas, in 1984.

He still does it the way he always did, with carbonless copy paper. After each visit, he simply tears off the copy and hands it to the patient.

“It makes them know we’re on the same page,” he told Medscape Medical News. “It gives them confidence that I’m telling them what I really think.”

He has one comment on the work of Leveille and her colleagues. “Why are they studying this? Isn’t it obvious that it’s a good thing?”

The study was funded by the Robert Wood Johnson Foundation, the Gordon and Betty Moore Foundation, the Peterson Center on Healthcare, and the Cambia Health Foundation. The study authors, Iliff, and Levy have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Given an opportunity to see physicians’ notes about their visits, patients mostly understand and agree with them, a survey shows.

Overall, 93% of respondents said the notes accurately described the visit; only 6% reported that something important was missing, write Suzanne G. Leveille, RN, PhD, of the University of Massachusetts, Boston, and colleagues in the Journal of General Internal Medicine.

“I think it’s wonderful news,” commented Howard Levy, MD, PhD, who spearheaded the implementation of open notes at Johns Hopkins University, Baltimore. “I’m thrilled with this report.”

Currently, 50 million Americans have access to their notes, the researchers report. Starting Nov. 2, 2020, the 21st Century Cures Act will require all US physicians to provide this access.

The regulation follows a movement to involve patients more actively in their care. Previous research has shown that access to visit notes improves patients’ feelings of control, helps them adhere to their medication regimens, and enables them to better understand their care plans.

Although physicians often feel that giving patients access to notes will lead to unnecessary conversations that will waste their time, previous studies have not borne that out. “Most clinical providers don’t notice a thing,” Levy told Medscape Medical News. “There was no change in the volume of work.”

Leveille and colleagues wanted to know how patients viewed the clarity, accuracy, and completeness of the notes they were reading and whether they had suggestions for improvements.

They surveyed all 136,815 adult outpatients affiliated with Beth Israel Deaconess Medical Center in Boston, Massachusetts; the University of Washington Medicine, in Seattle; and the Geisinger Health System, based in Danville, Pennsylvania. These systems all offer patients access to physicians’ notes.

The researchers asked the patients to recall one note written by a doctor, nurse practitioner, physician assistant, or mental health professional.

They received responses from 21,664 patients who had read at least one note. Of these, two thirds were women, three quarters were aged 45 years or older, and 85% were White.

Seventy-two percent had completed college. Although 85% reported being in good or excellent health, more of the respondents than nonrespondents had chronic health problems.

Ninety-seven percent of those with college educations understood their notes, compared with 92% of those who had not completed college, a finding that conflicted with the researchers’ expectations. “Good gracious, that’s wonderful,” Levy said. “In medicine we almost never get a 92% success rate in anything we do.”

Of the patients in fair or poor health, 88.6% said the note was accurate, compared with 94.4% of those in better health. Those in worse health were also more likely to say something important was missing.

When patients didn’t understand something, 35% searched the Internet, 27% asked a clinician, 7% asked a friend or family member, and 27% didn’t get help. (The researchers did not account for the other 4%.)

Of those patients whose note was written by a physician, 95% reported that the note accurately described the visit, compared with 92% of those whose note was written by a nurse practitioner and 90% of those whose note was written by a physician assistant.

Of patients reporting on a primary care note, 97% understood the note, compared with 94% of those reporting on a note from a visit to a specialist.

Ninety-three percent of those who understood their note were likely to recommend their clinician, compared with 77% of those who didn’t completely understand their note.

Asked how the notes could be improved, 3,812 people responded with comments of at least five words. These responses were included in the analysis.

Most commonly, patients wanted new information to be prominently featured at the top of the note, with clear instructions about next steps, referrals, and explanations of test results.

Often, they complained of old information or templates that felt impersonal. They stumbled over medical jargon and suggested links to glossaries. They bristled at such terms as “obese” and “patient denies.” Some wanted a way to comment on the notes.

Regarding the portals in which the notes were found, some patients said the notes were sometimes hard to find. Some said the notes were not posted quickly enough after the visits.

Levy said physicians should learn to write notes more succinctly, and he expects new regulations from the Centers for Medicare & Medicaid Services to encourage that. Previous regulations may have given physicians the impression that longer notes would allow them to bill at higher rates, he said. “The change in billing requirements will make it easier for healthcare providers to feel comfortable that they don’t have to restate information that had already been stated,” he said.

On the other hand, physicians should continue to use medical terminology, he said. “At times we use jargon, because it conveys rich, dense information in a few words,” he said. “That’s something that we should not have to give up.” Patients can research terms they don’t understand, he said.

Family physician Doug Iliff, MD, thinks it’s about time that his colleagues share their notes. He’s been doing it since he opened his solo practice in Topeka, Kansas, in 1984.

He still does it the way he always did, with carbonless copy paper. After each visit, he simply tears off the copy and hands it to the patient.

“It makes them know we’re on the same page,” he told Medscape Medical News. “It gives them confidence that I’m telling them what I really think.”

He has one comment on the work of Leveille and her colleagues. “Why are they studying this? Isn’t it obvious that it’s a good thing?”

The study was funded by the Robert Wood Johnson Foundation, the Gordon and Betty Moore Foundation, the Peterson Center on Healthcare, and the Cambia Health Foundation. The study authors, Iliff, and Levy have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Given an opportunity to see physicians’ notes about their visits, patients mostly understand and agree with them, a survey shows.

Overall, 93% of respondents said the notes accurately described the visit; only 6% reported that something important was missing, write Suzanne G. Leveille, RN, PhD, of the University of Massachusetts, Boston, and colleagues in the Journal of General Internal Medicine.

“I think it’s wonderful news,” commented Howard Levy, MD, PhD, who spearheaded the implementation of open notes at Johns Hopkins University, Baltimore. “I’m thrilled with this report.”

Currently, 50 million Americans have access to their notes, the researchers report. Starting Nov. 2, 2020, the 21st Century Cures Act will require all US physicians to provide this access.

The regulation follows a movement to involve patients more actively in their care. Previous research has shown that access to visit notes improves patients’ feelings of control, helps them adhere to their medication regimens, and enables them to better understand their care plans.

Although physicians often feel that giving patients access to notes will lead to unnecessary conversations that will waste their time, previous studies have not borne that out. “Most clinical providers don’t notice a thing,” Levy told Medscape Medical News. “There was no change in the volume of work.”

Leveille and colleagues wanted to know how patients viewed the clarity, accuracy, and completeness of the notes they were reading and whether they had suggestions for improvements.

They surveyed all 136,815 adult outpatients affiliated with Beth Israel Deaconess Medical Center in Boston, Massachusetts; the University of Washington Medicine, in Seattle; and the Geisinger Health System, based in Danville, Pennsylvania. These systems all offer patients access to physicians’ notes.

The researchers asked the patients to recall one note written by a doctor, nurse practitioner, physician assistant, or mental health professional.

They received responses from 21,664 patients who had read at least one note. Of these, two thirds were women, three quarters were aged 45 years or older, and 85% were White.

Seventy-two percent had completed college. Although 85% reported being in good or excellent health, more of the respondents than nonrespondents had chronic health problems.

Ninety-seven percent of those with college educations understood their notes, compared with 92% of those who had not completed college, a finding that conflicted with the researchers’ expectations. “Good gracious, that’s wonderful,” Levy said. “In medicine we almost never get a 92% success rate in anything we do.”

Of the patients in fair or poor health, 88.6% said the note was accurate, compared with 94.4% of those in better health. Those in worse health were also more likely to say something important was missing.

When patients didn’t understand something, 35% searched the Internet, 27% asked a clinician, 7% asked a friend or family member, and 27% didn’t get help. (The researchers did not account for the other 4%.)

Of those patients whose note was written by a physician, 95% reported that the note accurately described the visit, compared with 92% of those whose note was written by a nurse practitioner and 90% of those whose note was written by a physician assistant.

Of patients reporting on a primary care note, 97% understood the note, compared with 94% of those reporting on a note from a visit to a specialist.

Ninety-three percent of those who understood their note were likely to recommend their clinician, compared with 77% of those who didn’t completely understand their note.

Asked how the notes could be improved, 3,812 people responded with comments of at least five words. These responses were included in the analysis.

Most commonly, patients wanted new information to be prominently featured at the top of the note, with clear instructions about next steps, referrals, and explanations of test results.

Often, they complained of old information or templates that felt impersonal. They stumbled over medical jargon and suggested links to glossaries. They bristled at such terms as “obese” and “patient denies.” Some wanted a way to comment on the notes.

Regarding the portals in which the notes were found, some patients said the notes were sometimes hard to find. Some said the notes were not posted quickly enough after the visits.

Levy said physicians should learn to write notes more succinctly, and he expects new regulations from the Centers for Medicare & Medicaid Services to encourage that. Previous regulations may have given physicians the impression that longer notes would allow them to bill at higher rates, he said. “The change in billing requirements will make it easier for healthcare providers to feel comfortable that they don’t have to restate information that had already been stated,” he said.

On the other hand, physicians should continue to use medical terminology, he said. “At times we use jargon, because it conveys rich, dense information in a few words,” he said. “That’s something that we should not have to give up.” Patients can research terms they don’t understand, he said.

Family physician Doug Iliff, MD, thinks it’s about time that his colleagues share their notes. He’s been doing it since he opened his solo practice in Topeka, Kansas, in 1984.

He still does it the way he always did, with carbonless copy paper. After each visit, he simply tears off the copy and hands it to the patient.

“It makes them know we’re on the same page,” he told Medscape Medical News. “It gives them confidence that I’m telling them what I really think.”

He has one comment on the work of Leveille and her colleagues. “Why are they studying this? Isn’t it obvious that it’s a good thing?”

The study was funded by the Robert Wood Johnson Foundation, the Gordon and Betty Moore Foundation, the Peterson Center on Healthcare, and the Cambia Health Foundation. The study authors, Iliff, and Levy have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Empagliflozin showed favorable effects on diuretic use and congestion symptoms in patients with heart failure with reduced ejection fraction (HFrEF), but the oral sodium glucose cotransporter 2 (SGLT2) inhibitor did not improve the primary endpoint of improved exercise capacity in the EMPERIAL-Reduced trial, investigators reported at the European Society of Cardiology Heart Failure Discoveries virtual meeting.

In the matching EMPERIAL-Preserved trial, conducted in patients with heart failure with preserved ejection fraction (HFpEF), empagliflozin (Jardiance) produced modest improvements in diuretic use, as well as a reduction in unscheduled outpatient visits, compared with placebo-treated controls, although these trends failed to achieve statistical significance. And as in the EMPERIAL-Reduced trial, the SGLT2 inhibitor didn’t move the needle at all on the primary endpoint of improved exercise capacity as measured by 6-minute hall walk distance.

EMPERIAL-Reduced and -Preserved were identically designed, concurrent, phase 3, double-blind, 12-week randomized trials of empagliflozin versus placebo in 312 patients with HFrEF and 315 with HFpEF, defined in EMPERIAL-preserved as a left ventricular ejection fraction above 40%. The majority of participants had type 2 diabetes.

From a baseline median 6-minute walk distance of about 300 meters, the 6-minute walk distance at week 12 was actually 4.0 meters worse in the empagliflozin-treated HFrEF patients than it was in controls and a mere 4.0 meters better than with placebo in empagliflozin-treated patients with HFpEF, reported William T. Abraham, MD, professor of medicine, director of the division of cardiovascular medicine, and associate dean at Ohio State University, Columbus.

He indicated that the audience shouldn’t make too much of the failure to achieve the primary endpoint in the two trials in light of the studies’ major limitations: namely, their relatively small size for purposes of evaluating clinical outcomes and the relatively short 12-week duration.

“In many ways, I would say it’s remarkable that we can observe a positive signal, a favorable signal, in outcomes around congestion. In the case of HFrEF it’s statistically significant, and in HFpEF it’s a trend towards improvement. Of course, there are larger trials ongoing that may confirm these observations. Hopefully the EMPERIAL trials predict a good outcome for those ongoing trials,” Dr. Abraham said.

Piotr Ponikowski, MD, presented the study results for the secondary outcomes of congestion symptoms, diuretic use, and utilization of health care resources. In EMPERIAL-Reduced, intensification of diuretic therapy – often a prelude to acute decompensation and a trip to the hospital – occurred at a rate of 4.5% with empagliflozin and 16.1% with placebo, for a highly significant 73% relative risk reduction. Intensification of loop diuretics occurred in 2.6% of the empagliflozin group and 14.2% of controls, for a 82% risk reduction.

“That’s a pretty significant effect,” observed Dr. Ponikowski, professor of cardiology and head of the department of heart diseases at the Medical University of Wroclaw (Poland).

Moreover, a congestion symptoms score comprising a summary of orthopnea, jugular veinous distention, and edema improved by 47% after 12 weeks on empagliflozin, a statistically significant and clinically meaningful improvement that grew in magnitude over time and at 12 weeks was twice as large, compared with the reduction in placebo group, he added.

There was a trend for fewer unscheduled outpatient visits in the empagliflozin arm of EMPERIAL-Reduced with a rate of 10.4%, compared with 25.8% in controls; however, this 26% reduction in relative risk did not achieve statistical significance.

Intensification of loop diuretics occurred in 9% of EMPERIAL-Preserved participants on empagliflozin and 13.5% on placebo, but this 34% reduction in risk didn’t reach significance.

Adverse events in the EMPERIAL trials were similar across the active treatment and placebo arms. The benign safety profile was similar to what was seen in the earlier major clinical trials of empagliflozin for treatment of type 2 diabetes.

Session chair Stephane Heymans, MD, PhD, of the University of Maastricht (the Netherlands) noted that a substantial minority of patients in EMPERIAL-Reduced were on the combined neprilysin inhibitor sacubitril and the angiotensin receptor blocker valsartan (Entresto), whereas far fewer were in EMPERIAL-Preserved. He wondered if this greater use of background sacubitril/valsartan could explain empagliflozin’s greater efficacy in EMPERIAL-Reduced.

Highly unlikely, according to the investigators.

“It looks like, as is the case with most of our heart failure therapies, that we do see incremental value here. If you met the criteria for these trials, it appears you derived benefit from empagliflozin regardless of whether you were on an angiotensin receptor neprilysin inhibitor or not. I think that speaks to the incremental benefit of SGLT2 inhibitors on top of current guideline-directed medical therapy,” Dr. Abraham said.

Dr. Ponikowski observed that the same point was underscored in the DAPA-HF trial of the SGLT2 inhibitor dapagliflozin (Farxiga) in patients with heart failure (DAPA-HF: N Engl J Med. 2019 Nov 21;381[21]:1995-2008).

“You’ll see that the mortality and morbidity and quality-of-life benefit is in those treated with dapagliflozin with or without angiotensin receptor neprilysin inhibition; so, regardless of background therapy. And the effect is especially clear in patients on both therapies,” the cardiologist said.

The EMPERIAL trials were sponsored by Boehringer Ingelheim. Dr. Abraham and Dr. Ponikowksi reported receiving consultant fees from the company for serving on the trials’ executive committee.

bjancin@mdedge.com

Empagliflozin showed favorable effects on diuretic use and congestion symptoms in patients with heart failure with reduced ejection fraction (HFrEF), but the oral sodium glucose cotransporter 2 (SGLT2) inhibitor did not improve the primary endpoint of improved exercise capacity in the EMPERIAL-Reduced trial, investigators reported at the European Society of Cardiology Heart Failure Discoveries virtual meeting.

In the matching EMPERIAL-Preserved trial, conducted in patients with heart failure with preserved ejection fraction (HFpEF), empagliflozin (Jardiance) produced modest improvements in diuretic use, as well as a reduction in unscheduled outpatient visits, compared with placebo-treated controls, although these trends failed to achieve statistical significance. And as in the EMPERIAL-Reduced trial, the SGLT2 inhibitor didn’t move the needle at all on the primary endpoint of improved exercise capacity as measured by 6-minute hall walk distance.

EMPERIAL-Reduced and -Preserved were identically designed, concurrent, phase 3, double-blind, 12-week randomized trials of empagliflozin versus placebo in 312 patients with HFrEF and 315 with HFpEF, defined in EMPERIAL-preserved as a left ventricular ejection fraction above 40%. The majority of participants had type 2 diabetes.

From a baseline median 6-minute walk distance of about 300 meters, the 6-minute walk distance at week 12 was actually 4.0 meters worse in the empagliflozin-treated HFrEF patients than it was in controls and a mere 4.0 meters better than with placebo in empagliflozin-treated patients with HFpEF, reported William T. Abraham, MD, professor of medicine, director of the division of cardiovascular medicine, and associate dean at Ohio State University, Columbus.

He indicated that the audience shouldn’t make too much of the failure to achieve the primary endpoint in the two trials in light of the studies’ major limitations: namely, their relatively small size for purposes of evaluating clinical outcomes and the relatively short 12-week duration.

“In many ways, I would say it’s remarkable that we can observe a positive signal, a favorable signal, in outcomes around congestion. In the case of HFrEF it’s statistically significant, and in HFpEF it’s a trend towards improvement. Of course, there are larger trials ongoing that may confirm these observations. Hopefully the EMPERIAL trials predict a good outcome for those ongoing trials,” Dr. Abraham said.

Piotr Ponikowski, MD, presented the study results for the secondary outcomes of congestion symptoms, diuretic use, and utilization of health care resources. In EMPERIAL-Reduced, intensification of diuretic therapy – often a prelude to acute decompensation and a trip to the hospital – occurred at a rate of 4.5% with empagliflozin and 16.1% with placebo, for a highly significant 73% relative risk reduction. Intensification of loop diuretics occurred in 2.6% of the empagliflozin group and 14.2% of controls, for a 82% risk reduction.

“That’s a pretty significant effect,” observed Dr. Ponikowski, professor of cardiology and head of the department of heart diseases at the Medical University of Wroclaw (Poland).

Moreover, a congestion symptoms score comprising a summary of orthopnea, jugular veinous distention, and edema improved by 47% after 12 weeks on empagliflozin, a statistically significant and clinically meaningful improvement that grew in magnitude over time and at 12 weeks was twice as large, compared with the reduction in placebo group, he added.

There was a trend for fewer unscheduled outpatient visits in the empagliflozin arm of EMPERIAL-Reduced with a rate of 10.4%, compared with 25.8% in controls; however, this 26% reduction in relative risk did not achieve statistical significance.

Intensification of loop diuretics occurred in 9% of EMPERIAL-Preserved participants on empagliflozin and 13.5% on placebo, but this 34% reduction in risk didn’t reach significance.

Adverse events in the EMPERIAL trials were similar across the active treatment and placebo arms. The benign safety profile was similar to what was seen in the earlier major clinical trials of empagliflozin for treatment of type 2 diabetes.

Session chair Stephane Heymans, MD, PhD, of the University of Maastricht (the Netherlands) noted that a substantial minority of patients in EMPERIAL-Reduced were on the combined neprilysin inhibitor sacubitril and the angiotensin receptor blocker valsartan (Entresto), whereas far fewer were in EMPERIAL-Preserved. He wondered if this greater use of background sacubitril/valsartan could explain empagliflozin’s greater efficacy in EMPERIAL-Reduced.

Highly unlikely, according to the investigators.

“It looks like, as is the case with most of our heart failure therapies, that we do see incremental value here. If you met the criteria for these trials, it appears you derived benefit from empagliflozin regardless of whether you were on an angiotensin receptor neprilysin inhibitor or not. I think that speaks to the incremental benefit of SGLT2 inhibitors on top of current guideline-directed medical therapy,” Dr. Abraham said.

Dr. Ponikowski observed that the same point was underscored in the DAPA-HF trial of the SGLT2 inhibitor dapagliflozin (Farxiga) in patients with heart failure (DAPA-HF: N Engl J Med. 2019 Nov 21;381[21]:1995-2008).

“You’ll see that the mortality and morbidity and quality-of-life benefit is in those treated with dapagliflozin with or without angiotensin receptor neprilysin inhibition; so, regardless of background therapy. And the effect is especially clear in patients on both therapies,” the cardiologist said.

The EMPERIAL trials were sponsored by Boehringer Ingelheim. Dr. Abraham and Dr. Ponikowksi reported receiving consultant fees from the company for serving on the trials’ executive committee.

bjancin@mdedge.com

Empagliflozin showed favorable effects on diuretic use and congestion symptoms in patients with heart failure with reduced ejection fraction (HFrEF), but the oral sodium glucose cotransporter 2 (SGLT2) inhibitor did not improve the primary endpoint of improved exercise capacity in the EMPERIAL-Reduced trial, investigators reported at the European Society of Cardiology Heart Failure Discoveries virtual meeting.

In the matching EMPERIAL-Preserved trial, conducted in patients with heart failure with preserved ejection fraction (HFpEF), empagliflozin (Jardiance) produced modest improvements in diuretic use, as well as a reduction in unscheduled outpatient visits, compared with placebo-treated controls, although these trends failed to achieve statistical significance. And as in the EMPERIAL-Reduced trial, the SGLT2 inhibitor didn’t move the needle at all on the primary endpoint of improved exercise capacity as measured by 6-minute hall walk distance.

EMPERIAL-Reduced and -Preserved were identically designed, concurrent, phase 3, double-blind, 12-week randomized trials of empagliflozin versus placebo in 312 patients with HFrEF and 315 with HFpEF, defined in EMPERIAL-preserved as a left ventricular ejection fraction above 40%. The majority of participants had type 2 diabetes.

From a baseline median 6-minute walk distance of about 300 meters, the 6-minute walk distance at week 12 was actually 4.0 meters worse in the empagliflozin-treated HFrEF patients than it was in controls and a mere 4.0 meters better than with placebo in empagliflozin-treated patients with HFpEF, reported William T. Abraham, MD, professor of medicine, director of the division of cardiovascular medicine, and associate dean at Ohio State University, Columbus.

He indicated that the audience shouldn’t make too much of the failure to achieve the primary endpoint in the two trials in light of the studies’ major limitations: namely, their relatively small size for purposes of evaluating clinical outcomes and the relatively short 12-week duration.

“In many ways, I would say it’s remarkable that we can observe a positive signal, a favorable signal, in outcomes around congestion. In the case of HFrEF it’s statistically significant, and in HFpEF it’s a trend towards improvement. Of course, there are larger trials ongoing that may confirm these observations. Hopefully the EMPERIAL trials predict a good outcome for those ongoing trials,” Dr. Abraham said.

Piotr Ponikowski, MD, presented the study results for the secondary outcomes of congestion symptoms, diuretic use, and utilization of health care resources. In EMPERIAL-Reduced, intensification of diuretic therapy – often a prelude to acute decompensation and a trip to the hospital – occurred at a rate of 4.5% with empagliflozin and 16.1% with placebo, for a highly significant 73% relative risk reduction. Intensification of loop diuretics occurred in 2.6% of the empagliflozin group and 14.2% of controls, for a 82% risk reduction.

“That’s a pretty significant effect,” observed Dr. Ponikowski, professor of cardiology and head of the department of heart diseases at the Medical University of Wroclaw (Poland).

Moreover, a congestion symptoms score comprising a summary of orthopnea, jugular veinous distention, and edema improved by 47% after 12 weeks on empagliflozin, a statistically significant and clinically meaningful improvement that grew in magnitude over time and at 12 weeks was twice as large, compared with the reduction in placebo group, he added.

There was a trend for fewer unscheduled outpatient visits in the empagliflozin arm of EMPERIAL-Reduced with a rate of 10.4%, compared with 25.8% in controls; however, this 26% reduction in relative risk did not achieve statistical significance.

Intensification of loop diuretics occurred in 9% of EMPERIAL-Preserved participants on empagliflozin and 13.5% on placebo, but this 34% reduction in risk didn’t reach significance.

Adverse events in the EMPERIAL trials were similar across the active treatment and placebo arms. The benign safety profile was similar to what was seen in the earlier major clinical trials of empagliflozin for treatment of type 2 diabetes.

Session chair Stephane Heymans, MD, PhD, of the University of Maastricht (the Netherlands) noted that a substantial minority of patients in EMPERIAL-Reduced were on the combined neprilysin inhibitor sacubitril and the angiotensin receptor blocker valsartan (Entresto), whereas far fewer were in EMPERIAL-Preserved. He wondered if this greater use of background sacubitril/valsartan could explain empagliflozin’s greater efficacy in EMPERIAL-Reduced.

Highly unlikely, according to the investigators.

“It looks like, as is the case with most of our heart failure therapies, that we do see incremental value here. If you met the criteria for these trials, it appears you derived benefit from empagliflozin regardless of whether you were on an angiotensin receptor neprilysin inhibitor or not. I think that speaks to the incremental benefit of SGLT2 inhibitors on top of current guideline-directed medical therapy,” Dr. Abraham said.

Dr. Ponikowski observed that the same point was underscored in the DAPA-HF trial of the SGLT2 inhibitor dapagliflozin (Farxiga) in patients with heart failure (DAPA-HF: N Engl J Med. 2019 Nov 21;381[21]:1995-2008).

“You’ll see that the mortality and morbidity and quality-of-life benefit is in those treated with dapagliflozin with or without angiotensin receptor neprilysin inhibition; so, regardless of background therapy. And the effect is especially clear in patients on both therapies,” the cardiologist said.

The EMPERIAL trials were sponsored by Boehringer Ingelheim. Dr. Abraham and Dr. Ponikowksi reported receiving consultant fees from the company for serving on the trials’ executive committee.

bjancin@mdedge.com

A former nursing assistant and Army veteran pleaded guilty to federal murder charges this week in connection with the 2017-2018 deaths of seven patients in a West Virginia veteran’s hospital, according to news reports.

Prosecutors said in court documents filed on July 13 that Reta Mays, 46, injected lethal doses of insulin into seven veterans at the Louis A. Johnson VA Medical Center (VAMC) in rural Clarksburg, W.Va.

Their blood glucose levels plummeted, and each died shortly after their injections, according to the Tennessean.

An eighth patient, a 92-year-old man whom Mays is accused of assaulting with an insulin injection, initially survived after staff were able to stabilize him but died 2 weeks later at a nursing home, NPR reports.

According to NPR, US Attorney Jarod Douglas told the court Tuesday that the medical investigator could not determine whether the insulin contributed to the man’s death but that it was Mays’ intention to kill him.

“No one watched while she injected them with lethal doses of insulin during an 11-month killing rampage,” the Washington Post reported.
 

No motive offered

The Post article said no motive has been established, but after a 2-year investigation into a pattern of suspicious deaths that took the hospital almost a year to detect, Mays, who had denied any wrongdoing in multiple interviews with investigators, told a federal judge she preyed on some of the country›s most vulnerable service members.

An attorney for Mays, Brian Kornbrath, contacted by Medscape Medical News, said: “The defense team decided that we would have no public comment at this time.”

According to court documents from the Northern District of West Virginia, Mays was charged with seven counts of second-degree murder and one count of assault with intent to commit murder in connection with the patient who died later.

Mays was hired at the VAMC in Clarksburg in June 2015. She worked from 7:30 PM to 8:00 AM in the medical surgical unit, court documents say.

According to the documents, “VAMC Clarksburg did not require a nursing assistant to have a certification or licensure for initial appointment or as a condition of continuing employment.”

The documents indicate that in June 2018, a hospitalist employed by VAMC Clarksburg reported concern about several deaths from unexplained hypoglycemic events in the same ward and noted that many of the affected patients did not have diabetes.

By that time, according to the Tennessean, “at least eight patients had died under suspicious circumstances. Several had been embalmed and buried, destroying potential evidence. One veteran had been cremated.”

An internal investigation began, followed by a criminal investigation, and in July 2018, Mays was removed from patient care.
 

Mays fired in 2019 because of lies on resume; claims suffers from PTSD

The Post reports that Mays was fired from the hospital in 2019, 7 months after she was banned from patient care, «after it was discovered she had lied about her qualifications on her resume.»

Court documents indicate that her duties included acting as a sitter for patients, checking vital signs, intake and output, and testing blood glucose levels, but she was not qualified to administer medications, including insulin.

Similarities in the deaths were evident, the Post reported. Citing sources familiar with the case, the report said, “elderly patients in private rooms were injected in their abdomen and limbs with insulin the hospital had not ordered.”

The Post reported that Mays sobbed by the end of the hearing on Tuesday.

The article notes that Mays has three sons and served in the Army National Guard from November 2000 to April 2001 and again from February 2003 to May 2004, when she was deployed to Iraq and Kuwait. She told the judge she was taking medication for posttraumatic stress disorder.

By pleading guilty, she waived her right to have the case presented to a grand jury. A sentencing hearing has not been scheduled, the Post reports.

NPR notes that prosecutors have requested that Mays serve seven consecutive life sentences and an additional 20 years in prison.
 

“Our hearts go out to those affected by these tragic deaths”

A spokesman for VAMC Clarksburg said in a statement to Medscape Medical News: “Our hearts go out to those affected by these tragic deaths. Clarksburg VA Medical Center discovered these allegations and reported them to VA›s independent inspector general more than 2 years ago. Clarksburg VA Medical Center also fired the individual at the center of the allegations.

“We’re glad the Department of Justice stepped in to push this investigation across the finish line and hopeful our court system will deliver the justice Clarksburg-area Veterans and families deserve.”

According to the Tennessean, Michael Missal, inspector general for the Department of Veteran Affairs, said the agency is investigating the hospital’s practices, “including medication management and communications among staffers.”

This article first appeared on Medscape.com.

A former nursing assistant and Army veteran pleaded guilty to federal murder charges this week in connection with the 2017-2018 deaths of seven patients in a West Virginia veteran’s hospital, according to news reports.

Prosecutors said in court documents filed on July 13 that Reta Mays, 46, injected lethal doses of insulin into seven veterans at the Louis A. Johnson VA Medical Center (VAMC) in rural Clarksburg, W.Va.

Their blood glucose levels plummeted, and each died shortly after their injections, according to the Tennessean.

An eighth patient, a 92-year-old man whom Mays is accused of assaulting with an insulin injection, initially survived after staff were able to stabilize him but died 2 weeks later at a nursing home, NPR reports.

According to NPR, US Attorney Jarod Douglas told the court Tuesday that the medical investigator could not determine whether the insulin contributed to the man’s death but that it was Mays’ intention to kill him.

“No one watched while she injected them with lethal doses of insulin during an 11-month killing rampage,” the Washington Post reported.
 

No motive offered

The Post article said no motive has been established, but after a 2-year investigation into a pattern of suspicious deaths that took the hospital almost a year to detect, Mays, who had denied any wrongdoing in multiple interviews with investigators, told a federal judge she preyed on some of the country›s most vulnerable service members.

An attorney for Mays, Brian Kornbrath, contacted by Medscape Medical News, said: “The defense team decided that we would have no public comment at this time.”

According to court documents from the Northern District of West Virginia, Mays was charged with seven counts of second-degree murder and one count of assault with intent to commit murder in connection with the patient who died later.

Mays was hired at the VAMC in Clarksburg in June 2015. She worked from 7:30 PM to 8:00 AM in the medical surgical unit, court documents say.

According to the documents, “VAMC Clarksburg did not require a nursing assistant to have a certification or licensure for initial appointment or as a condition of continuing employment.”

The documents indicate that in June 2018, a hospitalist employed by VAMC Clarksburg reported concern about several deaths from unexplained hypoglycemic events in the same ward and noted that many of the affected patients did not have diabetes.

By that time, according to the Tennessean, “at least eight patients had died under suspicious circumstances. Several had been embalmed and buried, destroying potential evidence. One veteran had been cremated.”

An internal investigation began, followed by a criminal investigation, and in July 2018, Mays was removed from patient care.
 

Mays fired in 2019 because of lies on resume; claims suffers from PTSD

The Post reports that Mays was fired from the hospital in 2019, 7 months after she was banned from patient care, «after it was discovered she had lied about her qualifications on her resume.»

Court documents indicate that her duties included acting as a sitter for patients, checking vital signs, intake and output, and testing blood glucose levels, but she was not qualified to administer medications, including insulin.

Similarities in the deaths were evident, the Post reported. Citing sources familiar with the case, the report said, “elderly patients in private rooms were injected in their abdomen and limbs with insulin the hospital had not ordered.”

The Post reported that Mays sobbed by the end of the hearing on Tuesday.

The article notes that Mays has three sons and served in the Army National Guard from November 2000 to April 2001 and again from February 2003 to May 2004, when she was deployed to Iraq and Kuwait. She told the judge she was taking medication for posttraumatic stress disorder.

By pleading guilty, she waived her right to have the case presented to a grand jury. A sentencing hearing has not been scheduled, the Post reports.

NPR notes that prosecutors have requested that Mays serve seven consecutive life sentences and an additional 20 years in prison.
 

“Our hearts go out to those affected by these tragic deaths”

A spokesman for VAMC Clarksburg said in a statement to Medscape Medical News: “Our hearts go out to those affected by these tragic deaths. Clarksburg VA Medical Center discovered these allegations and reported them to VA›s independent inspector general more than 2 years ago. Clarksburg VA Medical Center also fired the individual at the center of the allegations.

“We’re glad the Department of Justice stepped in to push this investigation across the finish line and hopeful our court system will deliver the justice Clarksburg-area Veterans and families deserve.”

According to the Tennessean, Michael Missal, inspector general for the Department of Veteran Affairs, said the agency is investigating the hospital’s practices, “including medication management and communications among staffers.”

This article first appeared on Medscape.com.

A former nursing assistant and Army veteran pleaded guilty to federal murder charges this week in connection with the 2017-2018 deaths of seven patients in a West Virginia veteran’s hospital, according to news reports.

Prosecutors said in court documents filed on July 13 that Reta Mays, 46, injected lethal doses of insulin into seven veterans at the Louis A. Johnson VA Medical Center (VAMC) in rural Clarksburg, W.Va.

Their blood glucose levels plummeted, and each died shortly after their injections, according to the Tennessean.

An eighth patient, a 92-year-old man whom Mays is accused of assaulting with an insulin injection, initially survived after staff were able to stabilize him but died 2 weeks later at a nursing home, NPR reports.

According to NPR, US Attorney Jarod Douglas told the court Tuesday that the medical investigator could not determine whether the insulin contributed to the man’s death but that it was Mays’ intention to kill him.

“No one watched while she injected them with lethal doses of insulin during an 11-month killing rampage,” the Washington Post reported.
 

No motive offered

The Post article said no motive has been established, but after a 2-year investigation into a pattern of suspicious deaths that took the hospital almost a year to detect, Mays, who had denied any wrongdoing in multiple interviews with investigators, told a federal judge she preyed on some of the country›s most vulnerable service members.

An attorney for Mays, Brian Kornbrath, contacted by Medscape Medical News, said: “The defense team decided that we would have no public comment at this time.”

According to court documents from the Northern District of West Virginia, Mays was charged with seven counts of second-degree murder and one count of assault with intent to commit murder in connection with the patient who died later.

Mays was hired at the VAMC in Clarksburg in June 2015. She worked from 7:30 PM to 8:00 AM in the medical surgical unit, court documents say.

According to the documents, “VAMC Clarksburg did not require a nursing assistant to have a certification or licensure for initial appointment or as a condition of continuing employment.”

The documents indicate that in June 2018, a hospitalist employed by VAMC Clarksburg reported concern about several deaths from unexplained hypoglycemic events in the same ward and noted that many of the affected patients did not have diabetes.

By that time, according to the Tennessean, “at least eight patients had died under suspicious circumstances. Several had been embalmed and buried, destroying potential evidence. One veteran had been cremated.”

An internal investigation began, followed by a criminal investigation, and in July 2018, Mays was removed from patient care.
 

Mays fired in 2019 because of lies on resume; claims suffers from PTSD

The Post reports that Mays was fired from the hospital in 2019, 7 months after she was banned from patient care, «after it was discovered she had lied about her qualifications on her resume.»

Court documents indicate that her duties included acting as a sitter for patients, checking vital signs, intake and output, and testing blood glucose levels, but she was not qualified to administer medications, including insulin.

Similarities in the deaths were evident, the Post reported. Citing sources familiar with the case, the report said, “elderly patients in private rooms were injected in their abdomen and limbs with insulin the hospital had not ordered.”

The Post reported that Mays sobbed by the end of the hearing on Tuesday.

The article notes that Mays has three sons and served in the Army National Guard from November 2000 to April 2001 and again from February 2003 to May 2004, when she was deployed to Iraq and Kuwait. She told the judge she was taking medication for posttraumatic stress disorder.

By pleading guilty, she waived her right to have the case presented to a grand jury. A sentencing hearing has not been scheduled, the Post reports.

NPR notes that prosecutors have requested that Mays serve seven consecutive life sentences and an additional 20 years in prison.
 

“Our hearts go out to those affected by these tragic deaths”

A spokesman for VAMC Clarksburg said in a statement to Medscape Medical News: “Our hearts go out to those affected by these tragic deaths. Clarksburg VA Medical Center discovered these allegations and reported them to VA›s independent inspector general more than 2 years ago. Clarksburg VA Medical Center also fired the individual at the center of the allegations.

“We’re glad the Department of Justice stepped in to push this investigation across the finish line and hopeful our court system will deliver the justice Clarksburg-area Veterans and families deserve.”

According to the Tennessean, Michael Missal, inspector general for the Department of Veteran Affairs, said the agency is investigating the hospital’s practices, “including medication management and communications among staffers.”

This article first appeared on Medscape.com.