The American College of Cardiology has released an Expert Consensus Decision Pathway (ECDP) on the management of heart failure with preserved ejection fraction (HFpEF).

The 44-page document highlights the “critical need” to accurately diagnose HFpEF to permit timely implementation of evidence- and guideline-based therapies to improve patient outcomes.

Although the incidence of overall HF in the United States appears to be stable or declining, the incidence of HFpEF continues to rise in tandem with increasing age and burdens of obesity, sedentary lifestyle, and cardiometabolic disorders.

HFpEF now accounts for more than one half of HF cases but remains “underrecognized” in everyday clinical practice, said the writing group, led by Michelle Kittleson, MD, PhD, professor of medicine, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles.

HFpEF is a complex condition, often with multiple overlapping comorbidities, including hypertension, diabetes, obesity, and sleep apnea; optimal management requires a multidisciplinary approach, the writing group said.

The ECDP on HFpEF lays out a structure for diagnosis, clinical decision-making, management of comorbidities, implementation of the latest guideline-directed medical therapy (pharmacologic and nonpharmacologic), and equitable delivery of care.

The document was published online in the Journal of the American College of Cardiology.

It aligns with and builds on recommendations from the 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure.

“HFpEF is one of the most pressing diagnostic and therapeutic challenges in clinical medicine today given its increasing prevalence, under diagnosis, poor prognosis, limited therapeutic options, and substantial burden on the health care system worldwide,” wrote the authors of a companion scientific statement on HFpEF.

Despite these challenges, the success of recent sodium-glucose cotransporter 2 inhibitor trials has shown that HFpEF is treatable, Barry Borlaug, MD, department of cardiovascular medicine, Mayo Clinic, Rochester, Minn., and coauthors pointed out.

They noted that “ongoing large-scale studies of HFpEF pathobiology, an increasing number of translational studies spanning the gap between the bedside and the bench, and numerous clinical trials of novel therapeutics in HFpEF offer a glimpse of hope toward a future of reduced prevalence, morbidity, and mortality associated with HFpEF, which would be a major advance for population health.”

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

The American College of Cardiology has released an Expert Consensus Decision Pathway (ECDP) on the management of heart failure with preserved ejection fraction (HFpEF).

The 44-page document highlights the “critical need” to accurately diagnose HFpEF to permit timely implementation of evidence- and guideline-based therapies to improve patient outcomes.

Although the incidence of overall HF in the United States appears to be stable or declining, the incidence of HFpEF continues to rise in tandem with increasing age and burdens of obesity, sedentary lifestyle, and cardiometabolic disorders.

HFpEF now accounts for more than one half of HF cases but remains “underrecognized” in everyday clinical practice, said the writing group, led by Michelle Kittleson, MD, PhD, professor of medicine, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles.

HFpEF is a complex condition, often with multiple overlapping comorbidities, including hypertension, diabetes, obesity, and sleep apnea; optimal management requires a multidisciplinary approach, the writing group said.

The ECDP on HFpEF lays out a structure for diagnosis, clinical decision-making, management of comorbidities, implementation of the latest guideline-directed medical therapy (pharmacologic and nonpharmacologic), and equitable delivery of care.

The document was published online in the Journal of the American College of Cardiology.

It aligns with and builds on recommendations from the 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure.

“HFpEF is one of the most pressing diagnostic and therapeutic challenges in clinical medicine today given its increasing prevalence, under diagnosis, poor prognosis, limited therapeutic options, and substantial burden on the health care system worldwide,” wrote the authors of a companion scientific statement on HFpEF.

Despite these challenges, the success of recent sodium-glucose cotransporter 2 inhibitor trials has shown that HFpEF is treatable, Barry Borlaug, MD, department of cardiovascular medicine, Mayo Clinic, Rochester, Minn., and coauthors pointed out.

They noted that “ongoing large-scale studies of HFpEF pathobiology, an increasing number of translational studies spanning the gap between the bedside and the bench, and numerous clinical trials of novel therapeutics in HFpEF offer a glimpse of hope toward a future of reduced prevalence, morbidity, and mortality associated with HFpEF, which would be a major advance for population health.”

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

The American College of Cardiology has released an Expert Consensus Decision Pathway (ECDP) on the management of heart failure with preserved ejection fraction (HFpEF).

The 44-page document highlights the “critical need” to accurately diagnose HFpEF to permit timely implementation of evidence- and guideline-based therapies to improve patient outcomes.

Although the incidence of overall HF in the United States appears to be stable or declining, the incidence of HFpEF continues to rise in tandem with increasing age and burdens of obesity, sedentary lifestyle, and cardiometabolic disorders.

HFpEF now accounts for more than one half of HF cases but remains “underrecognized” in everyday clinical practice, said the writing group, led by Michelle Kittleson, MD, PhD, professor of medicine, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles.

HFpEF is a complex condition, often with multiple overlapping comorbidities, including hypertension, diabetes, obesity, and sleep apnea; optimal management requires a multidisciplinary approach, the writing group said.

The ECDP on HFpEF lays out a structure for diagnosis, clinical decision-making, management of comorbidities, implementation of the latest guideline-directed medical therapy (pharmacologic and nonpharmacologic), and equitable delivery of care.

The document was published online in the Journal of the American College of Cardiology.

It aligns with and builds on recommendations from the 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure.

“HFpEF is one of the most pressing diagnostic and therapeutic challenges in clinical medicine today given its increasing prevalence, under diagnosis, poor prognosis, limited therapeutic options, and substantial burden on the health care system worldwide,” wrote the authors of a companion scientific statement on HFpEF.

Despite these challenges, the success of recent sodium-glucose cotransporter 2 inhibitor trials has shown that HFpEF is treatable, Barry Borlaug, MD, department of cardiovascular medicine, Mayo Clinic, Rochester, Minn., and coauthors pointed out.

They noted that “ongoing large-scale studies of HFpEF pathobiology, an increasing number of translational studies spanning the gap between the bedside and the bench, and numerous clinical trials of novel therapeutics in HFpEF offer a glimpse of hope toward a future of reduced prevalence, morbidity, and mortality associated with HFpEF, which would be a major advance for population health.”

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

Last week, unbeknownst to most people, Dayton, Ohio, hosted the world championships of Winter Drumline. It’s a combination of percussion instruments, dance, and music, with a storyline. Think of it as a very fast-paced half-time show, with only percussion, in 6 minutes or less.

My daughter fell in love with it her second year of high school, and has participated in it through college. Her specialty is the pit – marimba, vibraphone, xylophone. This gives our house a cruise ship atmosphere when she comes home to practice on weekends.

Over the years my wife and I have gone to many of her shows and competitions, streamed others online, and always been amazed by the variety of costumes, choreography, music numbers, and overall themes different teams come up with. We’ve seen shows based on 1930s detective fiction, ocean life, westerns, science fiction, toxic waste, emotions, relationships, flamenco, pirate ships, and many others.

And, as always, I marvel at the human brain.

Only 2-3 pounds but still an amazing thing. The capacity for imagination is endless, and one of the things that got us where we are today. The ability to see things that don’t exist yet, and work out the details on how to get there. The pyramids, Petra, the Great Wall, flight, the steam engine, landing on the moon, the ISS. And, of course, Winter Drumline.

It’s a uniquely (as far as we know) human capacity. To look at a rock and envision what it might be carved into. To look at Jupiter and think of a way to get a probe there. To sit in an empty gym and imagine the floor covered with dozens of percussion instruments and their players, imagining what each will be playing and doing at a given moment.

It’s really a remarkable capacity when you think about it. I’m sure it originally began as a way to figure out where you might find shelter or food, or simply to outwit the other tribe. But it’s become so much more than that. Someone envisioned every movie you see, book you read, and the computer I’m writing this on.

In his 1968 novelization of “2001: A Space Odyssey” Arthur C. Clarke described the thoughts of the unknown civilization that had left the Monolith behind for us as “in all the galaxy they had found nothing more precious than Mind.”

I’d agree with that. Even after 30 years of learning about the 2-3 pounds of semi-solid tissue we all carry upstairs, and doing my best to treat its malfunctions, I’ve never ceased to be amazed by it.

I hope I always will be.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Last week, unbeknownst to most people, Dayton, Ohio, hosted the world championships of Winter Drumline. It’s a combination of percussion instruments, dance, and music, with a storyline. Think of it as a very fast-paced half-time show, with only percussion, in 6 minutes or less.

My daughter fell in love with it her second year of high school, and has participated in it through college. Her specialty is the pit – marimba, vibraphone, xylophone. This gives our house a cruise ship atmosphere when she comes home to practice on weekends.

Over the years my wife and I have gone to many of her shows and competitions, streamed others online, and always been amazed by the variety of costumes, choreography, music numbers, and overall themes different teams come up with. We’ve seen shows based on 1930s detective fiction, ocean life, westerns, science fiction, toxic waste, emotions, relationships, flamenco, pirate ships, and many others.

And, as always, I marvel at the human brain.

Only 2-3 pounds but still an amazing thing. The capacity for imagination is endless, and one of the things that got us where we are today. The ability to see things that don’t exist yet, and work out the details on how to get there. The pyramids, Petra, the Great Wall, flight, the steam engine, landing on the moon, the ISS. And, of course, Winter Drumline.

It’s a uniquely (as far as we know) human capacity. To look at a rock and envision what it might be carved into. To look at Jupiter and think of a way to get a probe there. To sit in an empty gym and imagine the floor covered with dozens of percussion instruments and their players, imagining what each will be playing and doing at a given moment.

It’s really a remarkable capacity when you think about it. I’m sure it originally began as a way to figure out where you might find shelter or food, or simply to outwit the other tribe. But it’s become so much more than that. Someone envisioned every movie you see, book you read, and the computer I’m writing this on.

In his 1968 novelization of “2001: A Space Odyssey” Arthur C. Clarke described the thoughts of the unknown civilization that had left the Monolith behind for us as “in all the galaxy they had found nothing more precious than Mind.”

I’d agree with that. Even after 30 years of learning about the 2-3 pounds of semi-solid tissue we all carry upstairs, and doing my best to treat its malfunctions, I’ve never ceased to be amazed by it.

I hope I always will be.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Last week, unbeknownst to most people, Dayton, Ohio, hosted the world championships of Winter Drumline. It’s a combination of percussion instruments, dance, and music, with a storyline. Think of it as a very fast-paced half-time show, with only percussion, in 6 minutes or less.

My daughter fell in love with it her second year of high school, and has participated in it through college. Her specialty is the pit – marimba, vibraphone, xylophone. This gives our house a cruise ship atmosphere when she comes home to practice on weekends.

Over the years my wife and I have gone to many of her shows and competitions, streamed others online, and always been amazed by the variety of costumes, choreography, music numbers, and overall themes different teams come up with. We’ve seen shows based on 1930s detective fiction, ocean life, westerns, science fiction, toxic waste, emotions, relationships, flamenco, pirate ships, and many others.

And, as always, I marvel at the human brain.

Only 2-3 pounds but still an amazing thing. The capacity for imagination is endless, and one of the things that got us where we are today. The ability to see things that don’t exist yet, and work out the details on how to get there. The pyramids, Petra, the Great Wall, flight, the steam engine, landing on the moon, the ISS. And, of course, Winter Drumline.

It’s a uniquely (as far as we know) human capacity. To look at a rock and envision what it might be carved into. To look at Jupiter and think of a way to get a probe there. To sit in an empty gym and imagine the floor covered with dozens of percussion instruments and their players, imagining what each will be playing and doing at a given moment.

It’s really a remarkable capacity when you think about it. I’m sure it originally began as a way to figure out where you might find shelter or food, or simply to outwit the other tribe. But it’s become so much more than that. Someone envisioned every movie you see, book you read, and the computer I’m writing this on.

In his 1968 novelization of “2001: A Space Odyssey” Arthur C. Clarke described the thoughts of the unknown civilization that had left the Monolith behind for us as “in all the galaxy they had found nothing more precious than Mind.”

I’d agree with that. Even after 30 years of learning about the 2-3 pounds of semi-solid tissue we all carry upstairs, and doing my best to treat its malfunctions, I’ve never ceased to be amazed by it.

I hope I always will be.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

How old were you when you had your first job? No, not that one when the neighbors paid you to feed their goldfish while they were on vacation. I mean the one when you first saw the dreaded letters “FICA” on your pay stub and realized that “making $9.00 an hour” didn’t mean that you would be taking home $360 at the end of a 40-hour week.

Were you still in middle school or just entering high school? Was it during the summer before you entered college? Was it a positive experience? If not financially, did that job at least provide some life lessons that you have found valuable?

Among my peers in a middle class dominated small town, having a “good” summer job was somewhat of a status symbol. Few of us worked during the school year. Having family connections meant that you might be lucky enough to be hired “doing construction” and making big bucks. Most of our families didn’t “need” the money we earned. Our paychecks provided us with our first taste of what it meant do some “discretionary spending” and build a savings account. And ... it meant we weren’t hanging around the house getting into trouble. As I recall we and our parents saw working as a teenager as a win-win situation.

A recent survey done by investigators at the C.S. Mott Children’s Hospital at the University of Michigan polled parents about their thoughts about teenagers working (Parents see upsides and downsides to teen jobs, Mott Poll Report, April 17, 2023). In reviewing data from the hospital’s National Poll On Children’s Health, the researchers found that parents prioritized whether the job would fit their teens’ schedules (87%), the logistics of getting the teenager to the job (68%), and whether it would provide a learning experience (54%). Only a third listed pay rate as a consideration.

Parents reported half of their 18-year-olds had jobs, 42% aged 16-17 had jobs, and less than 10% of the 14- to 15-year-olds had jobs. Parents of teenagers with jobs felt that the work experience made a positive impact on money management (76%), self-esteem (70%), and time management (63%). On the other hand, a smaller percentage of parents reported a negative effect on sleep (16%), activities (11%), social life (11%), and grades (4%). Forty-four percent of parents of working teenagers reported that their children had experienced problems at work. These included issues of too many or too few hours, disagreements with coworkers or managers, and pay not meeting expectations.

It is interesting that although I can’t provide any data, my impression is that a much higher percentage of my peer group were working when we were younger than 18. Not surprisingly, the teenagers who are currently working distribute their income much as we had done 50 years ago.

How should we as primary care providers interpret the results of this poll? Of course they support my bias or I wouldn’t be sharing them with you. I have found that for most teenagers, a job can have a positive influence on their development and with a modest amount of parental oversight will have a minimal impact on their health and safety. As a result I have asked most teenagers at their health maintenance visits if they have any summer work plans. This survey also demonstrated that parents don’t need to be cautioned about the potential downsides. In fact, they might even benefit from the observation that the upsides of work are considerable.

The fact that nearly half of teenagers experienced workplace problems doesn’t impress me as a downside. It merely reflects reality and provides opportunities for learning and growth. With the unemployment rate at rock bottom, this is an excellent climate for teenagers to dip their toes into the working world. If they feel they are being mistreated on the job they should realize that they are in the driver’s seat. They won’t have to look very far to find a “hiring” sign in another window just down the street.
 

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.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

How old were you when you had your first job? No, not that one when the neighbors paid you to feed their goldfish while they were on vacation. I mean the one when you first saw the dreaded letters “FICA” on your pay stub and realized that “making $9.00 an hour” didn’t mean that you would be taking home $360 at the end of a 40-hour week.

Were you still in middle school or just entering high school? Was it during the summer before you entered college? Was it a positive experience? If not financially, did that job at least provide some life lessons that you have found valuable?

Among my peers in a middle class dominated small town, having a “good” summer job was somewhat of a status symbol. Few of us worked during the school year. Having family connections meant that you might be lucky enough to be hired “doing construction” and making big bucks. Most of our families didn’t “need” the money we earned. Our paychecks provided us with our first taste of what it meant do some “discretionary spending” and build a savings account. And ... it meant we weren’t hanging around the house getting into trouble. As I recall we and our parents saw working as a teenager as a win-win situation.

A recent survey done by investigators at the C.S. Mott Children’s Hospital at the University of Michigan polled parents about their thoughts about teenagers working (Parents see upsides and downsides to teen jobs, Mott Poll Report, April 17, 2023). In reviewing data from the hospital’s National Poll On Children’s Health, the researchers found that parents prioritized whether the job would fit their teens’ schedules (87%), the logistics of getting the teenager to the job (68%), and whether it would provide a learning experience (54%). Only a third listed pay rate as a consideration.

Parents reported half of their 18-year-olds had jobs, 42% aged 16-17 had jobs, and less than 10% of the 14- to 15-year-olds had jobs. Parents of teenagers with jobs felt that the work experience made a positive impact on money management (76%), self-esteem (70%), and time management (63%). On the other hand, a smaller percentage of parents reported a negative effect on sleep (16%), activities (11%), social life (11%), and grades (4%). Forty-four percent of parents of working teenagers reported that their children had experienced problems at work. These included issues of too many or too few hours, disagreements with coworkers or managers, and pay not meeting expectations.

It is interesting that although I can’t provide any data, my impression is that a much higher percentage of my peer group were working when we were younger than 18. Not surprisingly, the teenagers who are currently working distribute their income much as we had done 50 years ago.

How should we as primary care providers interpret the results of this poll? Of course they support my bias or I wouldn’t be sharing them with you. I have found that for most teenagers, a job can have a positive influence on their development and with a modest amount of parental oversight will have a minimal impact on their health and safety. As a result I have asked most teenagers at their health maintenance visits if they have any summer work plans. This survey also demonstrated that parents don’t need to be cautioned about the potential downsides. In fact, they might even benefit from the observation that the upsides of work are considerable.

The fact that nearly half of teenagers experienced workplace problems doesn’t impress me as a downside. It merely reflects reality and provides opportunities for learning and growth. With the unemployment rate at rock bottom, this is an excellent climate for teenagers to dip their toes into the working world. If they feel they are being mistreated on the job they should realize that they are in the driver’s seat. They won’t have to look very far to find a “hiring” sign in another window just down the street.
 

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.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

How old were you when you had your first job? No, not that one when the neighbors paid you to feed their goldfish while they were on vacation. I mean the one when you first saw the dreaded letters “FICA” on your pay stub and realized that “making $9.00 an hour” didn’t mean that you would be taking home $360 at the end of a 40-hour week.

Were you still in middle school or just entering high school? Was it during the summer before you entered college? Was it a positive experience? If not financially, did that job at least provide some life lessons that you have found valuable?

Among my peers in a middle class dominated small town, having a “good” summer job was somewhat of a status symbol. Few of us worked during the school year. Having family connections meant that you might be lucky enough to be hired “doing construction” and making big bucks. Most of our families didn’t “need” the money we earned. Our paychecks provided us with our first taste of what it meant do some “discretionary spending” and build a savings account. And ... it meant we weren’t hanging around the house getting into trouble. As I recall we and our parents saw working as a teenager as a win-win situation.

A recent survey done by investigators at the C.S. Mott Children’s Hospital at the University of Michigan polled parents about their thoughts about teenagers working (Parents see upsides and downsides to teen jobs, Mott Poll Report, April 17, 2023). In reviewing data from the hospital’s National Poll On Children’s Health, the researchers found that parents prioritized whether the job would fit their teens’ schedules (87%), the logistics of getting the teenager to the job (68%), and whether it would provide a learning experience (54%). Only a third listed pay rate as a consideration.

Parents reported half of their 18-year-olds had jobs, 42% aged 16-17 had jobs, and less than 10% of the 14- to 15-year-olds had jobs. Parents of teenagers with jobs felt that the work experience made a positive impact on money management (76%), self-esteem (70%), and time management (63%). On the other hand, a smaller percentage of parents reported a negative effect on sleep (16%), activities (11%), social life (11%), and grades (4%). Forty-four percent of parents of working teenagers reported that their children had experienced problems at work. These included issues of too many or too few hours, disagreements with coworkers or managers, and pay not meeting expectations.

It is interesting that although I can’t provide any data, my impression is that a much higher percentage of my peer group were working when we were younger than 18. Not surprisingly, the teenagers who are currently working distribute their income much as we had done 50 years ago.

How should we as primary care providers interpret the results of this poll? Of course they support my bias or I wouldn’t be sharing them with you. I have found that for most teenagers, a job can have a positive influence on their development and with a modest amount of parental oversight will have a minimal impact on their health and safety. As a result I have asked most teenagers at their health maintenance visits if they have any summer work plans. This survey also demonstrated that parents don’t need to be cautioned about the potential downsides. In fact, they might even benefit from the observation that the upsides of work are considerable.

The fact that nearly half of teenagers experienced workplace problems doesn’t impress me as a downside. It merely reflects reality and provides opportunities for learning and growth. With the unemployment rate at rock bottom, this is an excellent climate for teenagers to dip their toes into the working world. If they feel they are being mistreated on the job they should realize that they are in the driver’s seat. They won’t have to look very far to find a “hiring” sign in another window just down the street.
 

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.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

This discussion was recorded on April 6, 2023. This transcript has been edited for clarity.

Robert D. Glatter, MD: Welcome. I’m Dr. Robert Glatter, medical adviser for Medscape Emergency Medicine. Joining us today is Dr. Lewis Nelson, professor and chair of emergency medicine at Rutgers New Jersey Medical School and a certified medical toxicologist.

Today, we will be discussing an important and disturbing Gen Z trend circulating on social media, known as blackout rage gallon, or BORG.

Welcome, Lewis.

Lewis S. Nelson, MD: Thanks for having me.

Dr. Glatter: Thanks so much for joining us. This trend that’s been circulating on social media is really disturbing. It has elements that focus on binge drinking: Talking about taking a jug; emptying half of it out; and putting one fifth of vodka and some electrolytes, caffeine, or other things too is just incredibly disturbing. Teens and parents are looking at this. I’ll let you jump into the discussion.

Dr. Nelson: You’re totally right, it is disturbing. Binge drinking is a huge problem in this country in general. It’s a particular problem with young people – teenagers and young adults. I don’t think people appreciate the dangers associated with binge drinking, such as the amount of alcohol they consume and some of the unintended consequences of doing that.

To frame things quickly, we think there are probably around six people a day in the United States who die of alcohol poisoning. Alcohol poisoning basically is binge drinking to such an extent that you die of the alcohol itself. You’re not dying of a car crash or doing something that injures you. You’re dying of the alcohol. You’re drinking so much that your breathing slows, it stops, you have heart rhythm disturbances, and so on. It totals about 2,200 people a year in the United States.

Dr. Glatter: That’s alarming. For this trend, their argument is that half of the gallon is water. Therefore, I’m fine. I can drink it over 8-12 hours and it’s not an issue. How would you respond to that?

Dr. Nelson: Well, alcohol is alcohol. It’s all about how much you take in over what time period. I guess, in concept, it could be safer if you do it right. That’s not the way it’s been, so to speak, marketed on the various social media platforms. It’s meant to be a way to protect yourself from having your drink spiked or eating or ingesting contaminants from other people’s mouths when you share glasses or dip cups into communal pots like jungle juice or something.

Clearly, if you’re going to drink a large amount of alcohol over a short or long period of time, you do run the risk of having significant consequences, including bad decision-making if you’re just a little drunk all the way down to that of the complications you described about alcohol poisoning.

Dr. Glatter: There has been a comment made that this could be a form of harm reduction. The point of harm reduction is that we run trials, we validate it, and we test it. This, certainly in my mind, is no form of true harm reduction. I think you would agree.

Dr. Nelson: Many things that are marketed as harm reduction aren’t. There could be some aspects of this that could be considered harm reduction. You may believe – and there’s no reason not to – that protecting your drink is a good idea. If you’re at a bar and you leave your glass open and somebody put something in it, you can be drugged. Drug-facilitated sexual assault, for example, is a big issue. That means you have to leave your glass unattended. If you tend to your glass, it’s probably fine. One of the ways of harm reduction they mention is that by having a cap and having this bottle with you at all times, that can’t happen.

Now, in fairness, by far the drug most commonly associated with sexual assault is alcohol. It’s not gamma-hydroxybutyrate or ketamine. It’s not the other things that people are concerned about. Those happen, but those are small problems in the big picture. It’s drinking too much.

A form of harm reduction that you can comment on perhaps is that you make this drink concoction yourself, so you know what is in there. You can take that bottle, pour out half the water, and fill up the other half with water and nobody’s going to know. More likely, the way they say you should do it is you take your gallon jug, you pour it out, and you fill it up with one fifth of vodka.

One fifth of vodka is the same amount of volume as a bottle of wine. At 750 mL, that’s a huge amount of alcohol. If you measure the number of shots in that bottle, it’s about 17 shots. Even if you drink that over 6 hours, that’s still several shots an hour. That’s a large amount of alcohol. You might do two or three shots once and then not drink for a few hours. To sit and drink two or three shots an hour for 6 hours, that’s just an exceptional amount of alcohol.

They flavorize it and add caffeine, which only adds to the risk. It doesn’t make it in any way safer. With the volume, 1 gal of water or equivalent over a short period of time in and of itself could be a problem. There’s a large amount of mismessaging here. Whether something’s harm reduction, it could flip around to be easily construed or understood as being harmful.

Not to mention, the idea that when you make something safer, one of the unintended consequences of harm reduction is what we call risk compensation. This is best probably described as what’s called the Peltzman effect. The way that we think about airbags and seatbelts is that they’re going to reduce car crash deaths; and they do, but people drive faster and more recklessly because they know they’re safe.

This is a well-described problem in epidemiology: You expect a certain amount of harm reduction through some implemented process, but you don’t meet that because people take increased risks.

Dr. Glatter: Right. The idea of not developing a hangover is common among many teens and 20-somethings, thinking that because there’s hydration there, because half of it is water, it’s just not going to happen. There’s your “harm reduction,” but your judgment’s impaired. It’s day drinking at its best, all day long. Then someone has the idea to get behind the wheel. These are the disastrous consequences that we all fear.

Dr. Nelson: There is a great example, perhaps of an unintended consequence of harm reduction. By putting caffeine in it, depending on how much caffeine you put in, some of these mixtures can have up to 1,000 mg of caffeine. Remember, a cup of coffee is about 1-200 mg, so you’re talking about several cups of coffee. The idea is that you will not be able to sense, as you normally do, how drunk you are. You’re not going to be a sleepy drunk, you’re going to be an awake drunk.

The idea that you’re going to have to drive so you’re going to drink a strong cup of black coffee before you go driving, you’re not going to drive any better. I can assure you that. You’re going to be more awake, perhaps, and not fall asleep at the wheel, but you’re still going to have psychomotor impairment. Your judgment is going to be impaired. There’s nothing good that comes with adding caffeine except that you’re going to be awake.

From a hangover perspective, there are many things that we’ve guessed at or suggested as either prevention or cures for hangovers. I don’t doubt that you’re going to have some volume depletion if you drink a large amount of alcohol. Alcohol’s a diuretic, so you’re going to lose more volume than you bring in.

Hydrating is probably always a good idea, but there is hydrating and then there’s overhydrating. We don’t need volumes like that. If you drink a cup or two of water, you’re probably fine. You don’t need to drink half a gallon of water. That can lead to problems like delusional hyponatremia, and so forth. There’s not any clear benefit to doing it.

If you want to prevent a hangover, one of the ways you might do it is by using vodka. There are nice data that show that clear alcohols typically, particularly vodka, don’t have many of the congeners that make the specific forms of alcohol what they are. Bourbon smells and tastes like bourbon because of these little molecules, these alkalis and ketones and amino acids and things that make it taste and smell the way it does. That’s true for all the other alcohols.

Vodka has the least amount of that. Even wine and beer have those in them, but vodka is basically alcohol mixed with water. It’s probably the least hangover-prone of all the alcohols; but still, if you drink a lot of vodka, you’re going to have a hangover. It’s just a dose-response curve to how much alcohol you drink, to how drunk you get, and to how much of a hangover you’re going to have.

Dr. Glatter: The hangover is really what it’s about because people want to be functional the next day. There are many companies out there that market hangover remedies, but people are using this as the hangover remedy in a way that’s socially accepted. That’s a good point you make.

The question is how do we get the message out to parents and teens? What’s the best way you feel to really sound the alarm here?

Dr. Nelson: These are challenging issues. We face this all the time with all the sorts of social media in particular. Most parents are not as savvy on social media as their kids are. You have to know what your children are doing. You should know what they’re listening to and watching. You do have to pay attention to the media directed at parents that will inform you a little bit about what your kids are doing. You have to talk with your kids and make sure they understand what it is that they’re doing.

We do this with our kids for some things. Hopefully, we talk about drinking, smoking, sex, and other things with our children (like driving if they get to that stage) and make sure they understand what the risks are and how to mitigate those risks. Being an attentive parent is part of it.

Sometimes you need outside messengers to do it. We’d like to believe that these social media companies are able to police themselves – at least they pay lip service to the fact they do. They have warnings that they’ll take things down that aren’t socially appropriate. Whether they do or not, I don’t know, because you keep seeing things about BORG on these media sites. If they are doing it, they’re not doing it efficiently or quickly enough.

Dr. Glatter: There has to be some censorship. These are young persons who are impressionable, who have developing brains, who are looking at this, thinking that if it’s out there on social media, such as TikTok or Instagram, then it’s okay to do so. That message has to be driven home.

Dr. Nelson: That’s a great point, and it’s tough. We know there’s been debate over the liability of social media or what they post, and whether or not they should be held liable like a more conventional media company or not. That’s politics and philosophy, and we’re probably not going to solve it here.

All these things wind up going viral and there’s probably got to be some filter on things that go viral. Maybe they need to have a bit more attentiveness to that when those things start happening. Now, clearly not every one of these is viral. When you think about some of the challenges we’ve seen in the past, such as the Tide Pod challenge and cinnamon challenge, some of these things could be quickly figured out to be dangerous.

I remember that the ice bucket challenge for amyotrophic lateral sclerosis was pretty benign. You pour a bucket of water over your head, and people aren’t really getting hurt. That’s fun and good, and let people go out and do that. That could pass through the filter. When you start to see people drinking excessive amounts of alcohol, it doesn’t take an emergency physician to know that’s not a good thing. Any parent should know that if my kid drinks half a bottle or a bottle of vodka over a short period of time, that just can’t be okay.

Dr. Glatter: It’s a public health issue. That’s what we need to elevate it to because ultimately that’s what it impacts: welfare and safety.

Speaking of buckets, there’s a new bucket challenge, wherein unsuspecting people have a bucket put on their head, can’t breathe, and then pass out. There’s been a number of these reported and actually filmed on social media. Here’s another example of dangerous types of behavior that essentially are a form of assault. Unsuspecting people suffer injuries from young children and teens trying to play pranks.

Again, had there not been this medium, we wouldn’t necessarily see the extent of the injuries. I guess going forward, the next step would be to send a message to colleges that there should be some form of warning if this trend is seen, at least from a public health standpoint.

Dr. Nelson: Education is a necessary thing to do, but it’s almost never the real solution to a problem. We can educate people as best we can that they need to do things right. At some point, we’re going to need to regulate it or manage it somehow.

Whether it’s through a carrot or a stick approach, or whether you want to give people kudos for doing the right thing or punish them for doing something wrong, that’s a tough decision to make and one that is going to be made by a parent or guardian, a school official, or law enforcement. Somehow, we have to figure out how to make this happen.

There’s not going to be a single size that fits all for this. At some level, we have to do something to educate and regulate. The balance between those two things is going to be political and philosophical in nature.

Dr. Glatter: Right, and the element of peer pressure and conformity in this is really part of the element. If we try to remove that aspect of it, then often these trends would go away. That aspect of conformity and peer pressure is instrumental in fueling these trends. Maybe we can make a full gallon of water be the trend without any alcohol in there.

Dr. Nelson: We say water is only water, but as a medical toxicologist, I can tell you that one of the foundations in medical toxicology is that everything is toxic. It’s just the dose that determines the toxicity. Oxygen is toxic, water is toxic. Everything’s toxic if you take enough of it.

We know that whether it’s psychogenic or intentional, polydipsia by drinking excessive amounts of water, especially without electrolytes, is one of the reasons they say you should add electrolytes. That’s all relative as well, because depending on the electrolyte and how much you put in and things like that, that could also become dangerous. Drinking excessive amounts of water like they’re suggesting, which sounds like a good thing to prevent hangover and so on, can in and of itself be a problem too.

Dr. Glatter: Right, and we know that there’s no magic bullet for a hangover. Obviously, abstinence is the only thing that truly works.

Dr. Nelson: Or moderation.

Dr. Glatter: Until research proves further.

Thank you so much. You’ve made some really important points. Thank you for talking about the BORG phenomenon, how it relates to society in general, and what we can do to try to change people’s perception of alcohol and the bigger picture of binge drinking. I really appreciate it.

Dr. Nelson: Thanks, Rob, for having me. It’s an important topic and hopefully we can get a handle on this. I appreciate your time.

Dr. Glatter is an attending physician at Lenox Hill Hospital in New York City and assistant professor of emergency medicine at Hofstra University, Hempstead, N.Y. Dr. Nelson is professor and chair of the department of emergency medicine and chief of the division of medical toxicology at Rutgers New Jersey Medical School, Newark. He is a member of the board of directors of the American Board of Emergency Medicine, the Accreditation Council for Continuing Medical Education, and Association of Academic Chairs in Emergency Medicine and is past-president of the American College of Medical Toxicology. Dr. Glatter and Dr. Nelson disclosed no relevant financial relationships.

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

This discussion was recorded on April 6, 2023. This transcript has been edited for clarity.

Robert D. Glatter, MD: Welcome. I’m Dr. Robert Glatter, medical adviser for Medscape Emergency Medicine. Joining us today is Dr. Lewis Nelson, professor and chair of emergency medicine at Rutgers New Jersey Medical School and a certified medical toxicologist.

Today, we will be discussing an important and disturbing Gen Z trend circulating on social media, known as blackout rage gallon, or BORG.

Welcome, Lewis.

Lewis S. Nelson, MD: Thanks for having me.

Dr. Glatter: Thanks so much for joining us. This trend that’s been circulating on social media is really disturbing. It has elements that focus on binge drinking: Talking about taking a jug; emptying half of it out; and putting one fifth of vodka and some electrolytes, caffeine, or other things too is just incredibly disturbing. Teens and parents are looking at this. I’ll let you jump into the discussion.

Dr. Nelson: You’re totally right, it is disturbing. Binge drinking is a huge problem in this country in general. It’s a particular problem with young people – teenagers and young adults. I don’t think people appreciate the dangers associated with binge drinking, such as the amount of alcohol they consume and some of the unintended consequences of doing that.

To frame things quickly, we think there are probably around six people a day in the United States who die of alcohol poisoning. Alcohol poisoning basically is binge drinking to such an extent that you die of the alcohol itself. You’re not dying of a car crash or doing something that injures you. You’re dying of the alcohol. You’re drinking so much that your breathing slows, it stops, you have heart rhythm disturbances, and so on. It totals about 2,200 people a year in the United States.

Dr. Glatter: That’s alarming. For this trend, their argument is that half of the gallon is water. Therefore, I’m fine. I can drink it over 8-12 hours and it’s not an issue. How would you respond to that?

Dr. Nelson: Well, alcohol is alcohol. It’s all about how much you take in over what time period. I guess, in concept, it could be safer if you do it right. That’s not the way it’s been, so to speak, marketed on the various social media platforms. It’s meant to be a way to protect yourself from having your drink spiked or eating or ingesting contaminants from other people’s mouths when you share glasses or dip cups into communal pots like jungle juice or something.

Clearly, if you’re going to drink a large amount of alcohol over a short or long period of time, you do run the risk of having significant consequences, including bad decision-making if you’re just a little drunk all the way down to that of the complications you described about alcohol poisoning.

Dr. Glatter: There has been a comment made that this could be a form of harm reduction. The point of harm reduction is that we run trials, we validate it, and we test it. This, certainly in my mind, is no form of true harm reduction. I think you would agree.

Dr. Nelson: Many things that are marketed as harm reduction aren’t. There could be some aspects of this that could be considered harm reduction. You may believe – and there’s no reason not to – that protecting your drink is a good idea. If you’re at a bar and you leave your glass open and somebody put something in it, you can be drugged. Drug-facilitated sexual assault, for example, is a big issue. That means you have to leave your glass unattended. If you tend to your glass, it’s probably fine. One of the ways of harm reduction they mention is that by having a cap and having this bottle with you at all times, that can’t happen.

Now, in fairness, by far the drug most commonly associated with sexual assault is alcohol. It’s not gamma-hydroxybutyrate or ketamine. It’s not the other things that people are concerned about. Those happen, but those are small problems in the big picture. It’s drinking too much.

A form of harm reduction that you can comment on perhaps is that you make this drink concoction yourself, so you know what is in there. You can take that bottle, pour out half the water, and fill up the other half with water and nobody’s going to know. More likely, the way they say you should do it is you take your gallon jug, you pour it out, and you fill it up with one fifth of vodka.

One fifth of vodka is the same amount of volume as a bottle of wine. At 750 mL, that’s a huge amount of alcohol. If you measure the number of shots in that bottle, it’s about 17 shots. Even if you drink that over 6 hours, that’s still several shots an hour. That’s a large amount of alcohol. You might do two or three shots once and then not drink for a few hours. To sit and drink two or three shots an hour for 6 hours, that’s just an exceptional amount of alcohol.

They flavorize it and add caffeine, which only adds to the risk. It doesn’t make it in any way safer. With the volume, 1 gal of water or equivalent over a short period of time in and of itself could be a problem. There’s a large amount of mismessaging here. Whether something’s harm reduction, it could flip around to be easily construed or understood as being harmful.

Not to mention, the idea that when you make something safer, one of the unintended consequences of harm reduction is what we call risk compensation. This is best probably described as what’s called the Peltzman effect. The way that we think about airbags and seatbelts is that they’re going to reduce car crash deaths; and they do, but people drive faster and more recklessly because they know they’re safe.

This is a well-described problem in epidemiology: You expect a certain amount of harm reduction through some implemented process, but you don’t meet that because people take increased risks.

Dr. Glatter: Right. The idea of not developing a hangover is common among many teens and 20-somethings, thinking that because there’s hydration there, because half of it is water, it’s just not going to happen. There’s your “harm reduction,” but your judgment’s impaired. It’s day drinking at its best, all day long. Then someone has the idea to get behind the wheel. These are the disastrous consequences that we all fear.

Dr. Nelson: There is a great example, perhaps of an unintended consequence of harm reduction. By putting caffeine in it, depending on how much caffeine you put in, some of these mixtures can have up to 1,000 mg of caffeine. Remember, a cup of coffee is about 1-200 mg, so you’re talking about several cups of coffee. The idea is that you will not be able to sense, as you normally do, how drunk you are. You’re not going to be a sleepy drunk, you’re going to be an awake drunk.

The idea that you’re going to have to drive so you’re going to drink a strong cup of black coffee before you go driving, you’re not going to drive any better. I can assure you that. You’re going to be more awake, perhaps, and not fall asleep at the wheel, but you’re still going to have psychomotor impairment. Your judgment is going to be impaired. There’s nothing good that comes with adding caffeine except that you’re going to be awake.

From a hangover perspective, there are many things that we’ve guessed at or suggested as either prevention or cures for hangovers. I don’t doubt that you’re going to have some volume depletion if you drink a large amount of alcohol. Alcohol’s a diuretic, so you’re going to lose more volume than you bring in.

Hydrating is probably always a good idea, but there is hydrating and then there’s overhydrating. We don’t need volumes like that. If you drink a cup or two of water, you’re probably fine. You don’t need to drink half a gallon of water. That can lead to problems like delusional hyponatremia, and so forth. There’s not any clear benefit to doing it.

If you want to prevent a hangover, one of the ways you might do it is by using vodka. There are nice data that show that clear alcohols typically, particularly vodka, don’t have many of the congeners that make the specific forms of alcohol what they are. Bourbon smells and tastes like bourbon because of these little molecules, these alkalis and ketones and amino acids and things that make it taste and smell the way it does. That’s true for all the other alcohols.

Vodka has the least amount of that. Even wine and beer have those in them, but vodka is basically alcohol mixed with water. It’s probably the least hangover-prone of all the alcohols; but still, if you drink a lot of vodka, you’re going to have a hangover. It’s just a dose-response curve to how much alcohol you drink, to how drunk you get, and to how much of a hangover you’re going to have.

Dr. Glatter: The hangover is really what it’s about because people want to be functional the next day. There are many companies out there that market hangover remedies, but people are using this as the hangover remedy in a way that’s socially accepted. That’s a good point you make.

The question is how do we get the message out to parents and teens? What’s the best way you feel to really sound the alarm here?

Dr. Nelson: These are challenging issues. We face this all the time with all the sorts of social media in particular. Most parents are not as savvy on social media as their kids are. You have to know what your children are doing. You should know what they’re listening to and watching. You do have to pay attention to the media directed at parents that will inform you a little bit about what your kids are doing. You have to talk with your kids and make sure they understand what it is that they’re doing.

We do this with our kids for some things. Hopefully, we talk about drinking, smoking, sex, and other things with our children (like driving if they get to that stage) and make sure they understand what the risks are and how to mitigate those risks. Being an attentive parent is part of it.

Sometimes you need outside messengers to do it. We’d like to believe that these social media companies are able to police themselves – at least they pay lip service to the fact they do. They have warnings that they’ll take things down that aren’t socially appropriate. Whether they do or not, I don’t know, because you keep seeing things about BORG on these media sites. If they are doing it, they’re not doing it efficiently or quickly enough.

Dr. Glatter: There has to be some censorship. These are young persons who are impressionable, who have developing brains, who are looking at this, thinking that if it’s out there on social media, such as TikTok or Instagram, then it’s okay to do so. That message has to be driven home.

Dr. Nelson: That’s a great point, and it’s tough. We know there’s been debate over the liability of social media or what they post, and whether or not they should be held liable like a more conventional media company or not. That’s politics and philosophy, and we’re probably not going to solve it here.

All these things wind up going viral and there’s probably got to be some filter on things that go viral. Maybe they need to have a bit more attentiveness to that when those things start happening. Now, clearly not every one of these is viral. When you think about some of the challenges we’ve seen in the past, such as the Tide Pod challenge and cinnamon challenge, some of these things could be quickly figured out to be dangerous.

I remember that the ice bucket challenge for amyotrophic lateral sclerosis was pretty benign. You pour a bucket of water over your head, and people aren’t really getting hurt. That’s fun and good, and let people go out and do that. That could pass through the filter. When you start to see people drinking excessive amounts of alcohol, it doesn’t take an emergency physician to know that’s not a good thing. Any parent should know that if my kid drinks half a bottle or a bottle of vodka over a short period of time, that just can’t be okay.

Dr. Glatter: It’s a public health issue. That’s what we need to elevate it to because ultimately that’s what it impacts: welfare and safety.

Speaking of buckets, there’s a new bucket challenge, wherein unsuspecting people have a bucket put on their head, can’t breathe, and then pass out. There’s been a number of these reported and actually filmed on social media. Here’s another example of dangerous types of behavior that essentially are a form of assault. Unsuspecting people suffer injuries from young children and teens trying to play pranks.

Again, had there not been this medium, we wouldn’t necessarily see the extent of the injuries. I guess going forward, the next step would be to send a message to colleges that there should be some form of warning if this trend is seen, at least from a public health standpoint.

Dr. Nelson: Education is a necessary thing to do, but it’s almost never the real solution to a problem. We can educate people as best we can that they need to do things right. At some point, we’re going to need to regulate it or manage it somehow.

Whether it’s through a carrot or a stick approach, or whether you want to give people kudos for doing the right thing or punish them for doing something wrong, that’s a tough decision to make and one that is going to be made by a parent or guardian, a school official, or law enforcement. Somehow, we have to figure out how to make this happen.

There’s not going to be a single size that fits all for this. At some level, we have to do something to educate and regulate. The balance between those two things is going to be political and philosophical in nature.

Dr. Glatter: Right, and the element of peer pressure and conformity in this is really part of the element. If we try to remove that aspect of it, then often these trends would go away. That aspect of conformity and peer pressure is instrumental in fueling these trends. Maybe we can make a full gallon of water be the trend without any alcohol in there.

Dr. Nelson: We say water is only water, but as a medical toxicologist, I can tell you that one of the foundations in medical toxicology is that everything is toxic. It’s just the dose that determines the toxicity. Oxygen is toxic, water is toxic. Everything’s toxic if you take enough of it.

We know that whether it’s psychogenic or intentional, polydipsia by drinking excessive amounts of water, especially without electrolytes, is one of the reasons they say you should add electrolytes. That’s all relative as well, because depending on the electrolyte and how much you put in and things like that, that could also become dangerous. Drinking excessive amounts of water like they’re suggesting, which sounds like a good thing to prevent hangover and so on, can in and of itself be a problem too.

Dr. Glatter: Right, and we know that there’s no magic bullet for a hangover. Obviously, abstinence is the only thing that truly works.

Dr. Nelson: Or moderation.

Dr. Glatter: Until research proves further.

Thank you so much. You’ve made some really important points. Thank you for talking about the BORG phenomenon, how it relates to society in general, and what we can do to try to change people’s perception of alcohol and the bigger picture of binge drinking. I really appreciate it.

Dr. Nelson: Thanks, Rob, for having me. It’s an important topic and hopefully we can get a handle on this. I appreciate your time.

Dr. Glatter is an attending physician at Lenox Hill Hospital in New York City and assistant professor of emergency medicine at Hofstra University, Hempstead, N.Y. Dr. Nelson is professor and chair of the department of emergency medicine and chief of the division of medical toxicology at Rutgers New Jersey Medical School, Newark. He is a member of the board of directors of the American Board of Emergency Medicine, the Accreditation Council for Continuing Medical Education, and Association of Academic Chairs in Emergency Medicine and is past-president of the American College of Medical Toxicology. Dr. Glatter and Dr. Nelson disclosed no relevant financial relationships.

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

This discussion was recorded on April 6, 2023. This transcript has been edited for clarity.

Robert D. Glatter, MD: Welcome. I’m Dr. Robert Glatter, medical adviser for Medscape Emergency Medicine. Joining us today is Dr. Lewis Nelson, professor and chair of emergency medicine at Rutgers New Jersey Medical School and a certified medical toxicologist.

Today, we will be discussing an important and disturbing Gen Z trend circulating on social media, known as blackout rage gallon, or BORG.

Welcome, Lewis.

Lewis S. Nelson, MD: Thanks for having me.

Dr. Glatter: Thanks so much for joining us. This trend that’s been circulating on social media is really disturbing. It has elements that focus on binge drinking: Talking about taking a jug; emptying half of it out; and putting one fifth of vodka and some electrolytes, caffeine, or other things too is just incredibly disturbing. Teens and parents are looking at this. I’ll let you jump into the discussion.

Dr. Nelson: You’re totally right, it is disturbing. Binge drinking is a huge problem in this country in general. It’s a particular problem with young people – teenagers and young adults. I don’t think people appreciate the dangers associated with binge drinking, such as the amount of alcohol they consume and some of the unintended consequences of doing that.

To frame things quickly, we think there are probably around six people a day in the United States who die of alcohol poisoning. Alcohol poisoning basically is binge drinking to such an extent that you die of the alcohol itself. You’re not dying of a car crash or doing something that injures you. You’re dying of the alcohol. You’re drinking so much that your breathing slows, it stops, you have heart rhythm disturbances, and so on. It totals about 2,200 people a year in the United States.

Dr. Glatter: That’s alarming. For this trend, their argument is that half of the gallon is water. Therefore, I’m fine. I can drink it over 8-12 hours and it’s not an issue. How would you respond to that?

Dr. Nelson: Well, alcohol is alcohol. It’s all about how much you take in over what time period. I guess, in concept, it could be safer if you do it right. That’s not the way it’s been, so to speak, marketed on the various social media platforms. It’s meant to be a way to protect yourself from having your drink spiked or eating or ingesting contaminants from other people’s mouths when you share glasses or dip cups into communal pots like jungle juice or something.

Clearly, if you’re going to drink a large amount of alcohol over a short or long period of time, you do run the risk of having significant consequences, including bad decision-making if you’re just a little drunk all the way down to that of the complications you described about alcohol poisoning.

Dr. Glatter: There has been a comment made that this could be a form of harm reduction. The point of harm reduction is that we run trials, we validate it, and we test it. This, certainly in my mind, is no form of true harm reduction. I think you would agree.

Dr. Nelson: Many things that are marketed as harm reduction aren’t. There could be some aspects of this that could be considered harm reduction. You may believe – and there’s no reason not to – that protecting your drink is a good idea. If you’re at a bar and you leave your glass open and somebody put something in it, you can be drugged. Drug-facilitated sexual assault, for example, is a big issue. That means you have to leave your glass unattended. If you tend to your glass, it’s probably fine. One of the ways of harm reduction they mention is that by having a cap and having this bottle with you at all times, that can’t happen.

Now, in fairness, by far the drug most commonly associated with sexual assault is alcohol. It’s not gamma-hydroxybutyrate or ketamine. It’s not the other things that people are concerned about. Those happen, but those are small problems in the big picture. It’s drinking too much.

A form of harm reduction that you can comment on perhaps is that you make this drink concoction yourself, so you know what is in there. You can take that bottle, pour out half the water, and fill up the other half with water and nobody’s going to know. More likely, the way they say you should do it is you take your gallon jug, you pour it out, and you fill it up with one fifth of vodka.

One fifth of vodka is the same amount of volume as a bottle of wine. At 750 mL, that’s a huge amount of alcohol. If you measure the number of shots in that bottle, it’s about 17 shots. Even if you drink that over 6 hours, that’s still several shots an hour. That’s a large amount of alcohol. You might do two or three shots once and then not drink for a few hours. To sit and drink two or three shots an hour for 6 hours, that’s just an exceptional amount of alcohol.

They flavorize it and add caffeine, which only adds to the risk. It doesn’t make it in any way safer. With the volume, 1 gal of water or equivalent over a short period of time in and of itself could be a problem. There’s a large amount of mismessaging here. Whether something’s harm reduction, it could flip around to be easily construed or understood as being harmful.

Not to mention, the idea that when you make something safer, one of the unintended consequences of harm reduction is what we call risk compensation. This is best probably described as what’s called the Peltzman effect. The way that we think about airbags and seatbelts is that they’re going to reduce car crash deaths; and they do, but people drive faster and more recklessly because they know they’re safe.

This is a well-described problem in epidemiology: You expect a certain amount of harm reduction through some implemented process, but you don’t meet that because people take increased risks.

Dr. Glatter: Right. The idea of not developing a hangover is common among many teens and 20-somethings, thinking that because there’s hydration there, because half of it is water, it’s just not going to happen. There’s your “harm reduction,” but your judgment’s impaired. It’s day drinking at its best, all day long. Then someone has the idea to get behind the wheel. These are the disastrous consequences that we all fear.

Dr. Nelson: There is a great example, perhaps of an unintended consequence of harm reduction. By putting caffeine in it, depending on how much caffeine you put in, some of these mixtures can have up to 1,000 mg of caffeine. Remember, a cup of coffee is about 1-200 mg, so you’re talking about several cups of coffee. The idea is that you will not be able to sense, as you normally do, how drunk you are. You’re not going to be a sleepy drunk, you’re going to be an awake drunk.

The idea that you’re going to have to drive so you’re going to drink a strong cup of black coffee before you go driving, you’re not going to drive any better. I can assure you that. You’re going to be more awake, perhaps, and not fall asleep at the wheel, but you’re still going to have psychomotor impairment. Your judgment is going to be impaired. There’s nothing good that comes with adding caffeine except that you’re going to be awake.

From a hangover perspective, there are many things that we’ve guessed at or suggested as either prevention or cures for hangovers. I don’t doubt that you’re going to have some volume depletion if you drink a large amount of alcohol. Alcohol’s a diuretic, so you’re going to lose more volume than you bring in.

Hydrating is probably always a good idea, but there is hydrating and then there’s overhydrating. We don’t need volumes like that. If you drink a cup or two of water, you’re probably fine. You don’t need to drink half a gallon of water. That can lead to problems like delusional hyponatremia, and so forth. There’s not any clear benefit to doing it.

If you want to prevent a hangover, one of the ways you might do it is by using vodka. There are nice data that show that clear alcohols typically, particularly vodka, don’t have many of the congeners that make the specific forms of alcohol what they are. Bourbon smells and tastes like bourbon because of these little molecules, these alkalis and ketones and amino acids and things that make it taste and smell the way it does. That’s true for all the other alcohols.

Vodka has the least amount of that. Even wine and beer have those in them, but vodka is basically alcohol mixed with water. It’s probably the least hangover-prone of all the alcohols; but still, if you drink a lot of vodka, you’re going to have a hangover. It’s just a dose-response curve to how much alcohol you drink, to how drunk you get, and to how much of a hangover you’re going to have.

Dr. Glatter: The hangover is really what it’s about because people want to be functional the next day. There are many companies out there that market hangover remedies, but people are using this as the hangover remedy in a way that’s socially accepted. That’s a good point you make.

The question is how do we get the message out to parents and teens? What’s the best way you feel to really sound the alarm here?

Dr. Nelson: These are challenging issues. We face this all the time with all the sorts of social media in particular. Most parents are not as savvy on social media as their kids are. You have to know what your children are doing. You should know what they’re listening to and watching. You do have to pay attention to the media directed at parents that will inform you a little bit about what your kids are doing. You have to talk with your kids and make sure they understand what it is that they’re doing.

We do this with our kids for some things. Hopefully, we talk about drinking, smoking, sex, and other things with our children (like driving if they get to that stage) and make sure they understand what the risks are and how to mitigate those risks. Being an attentive parent is part of it.

Sometimes you need outside messengers to do it. We’d like to believe that these social media companies are able to police themselves – at least they pay lip service to the fact they do. They have warnings that they’ll take things down that aren’t socially appropriate. Whether they do or not, I don’t know, because you keep seeing things about BORG on these media sites. If they are doing it, they’re not doing it efficiently or quickly enough.

Dr. Glatter: There has to be some censorship. These are young persons who are impressionable, who have developing brains, who are looking at this, thinking that if it’s out there on social media, such as TikTok or Instagram, then it’s okay to do so. That message has to be driven home.

Dr. Nelson: That’s a great point, and it’s tough. We know there’s been debate over the liability of social media or what they post, and whether or not they should be held liable like a more conventional media company or not. That’s politics and philosophy, and we’re probably not going to solve it here.

All these things wind up going viral and there’s probably got to be some filter on things that go viral. Maybe they need to have a bit more attentiveness to that when those things start happening. Now, clearly not every one of these is viral. When you think about some of the challenges we’ve seen in the past, such as the Tide Pod challenge and cinnamon challenge, some of these things could be quickly figured out to be dangerous.

I remember that the ice bucket challenge for amyotrophic lateral sclerosis was pretty benign. You pour a bucket of water over your head, and people aren’t really getting hurt. That’s fun and good, and let people go out and do that. That could pass through the filter. When you start to see people drinking excessive amounts of alcohol, it doesn’t take an emergency physician to know that’s not a good thing. Any parent should know that if my kid drinks half a bottle or a bottle of vodka over a short period of time, that just can’t be okay.

Dr. Glatter: It’s a public health issue. That’s what we need to elevate it to because ultimately that’s what it impacts: welfare and safety.

Speaking of buckets, there’s a new bucket challenge, wherein unsuspecting people have a bucket put on their head, can’t breathe, and then pass out. There’s been a number of these reported and actually filmed on social media. Here’s another example of dangerous types of behavior that essentially are a form of assault. Unsuspecting people suffer injuries from young children and teens trying to play pranks.

Again, had there not been this medium, we wouldn’t necessarily see the extent of the injuries. I guess going forward, the next step would be to send a message to colleges that there should be some form of warning if this trend is seen, at least from a public health standpoint.

Dr. Nelson: Education is a necessary thing to do, but it’s almost never the real solution to a problem. We can educate people as best we can that they need to do things right. At some point, we’re going to need to regulate it or manage it somehow.

Whether it’s through a carrot or a stick approach, or whether you want to give people kudos for doing the right thing or punish them for doing something wrong, that’s a tough decision to make and one that is going to be made by a parent or guardian, a school official, or law enforcement. Somehow, we have to figure out how to make this happen.

There’s not going to be a single size that fits all for this. At some level, we have to do something to educate and regulate. The balance between those two things is going to be political and philosophical in nature.

Dr. Glatter: Right, and the element of peer pressure and conformity in this is really part of the element. If we try to remove that aspect of it, then often these trends would go away. That aspect of conformity and peer pressure is instrumental in fueling these trends. Maybe we can make a full gallon of water be the trend without any alcohol in there.

Dr. Nelson: We say water is only water, but as a medical toxicologist, I can tell you that one of the foundations in medical toxicology is that everything is toxic. It’s just the dose that determines the toxicity. Oxygen is toxic, water is toxic. Everything’s toxic if you take enough of it.

We know that whether it’s psychogenic or intentional, polydipsia by drinking excessive amounts of water, especially without electrolytes, is one of the reasons they say you should add electrolytes. That’s all relative as well, because depending on the electrolyte and how much you put in and things like that, that could also become dangerous. Drinking excessive amounts of water like they’re suggesting, which sounds like a good thing to prevent hangover and so on, can in and of itself be a problem too.

Dr. Glatter: Right, and we know that there’s no magic bullet for a hangover. Obviously, abstinence is the only thing that truly works.

Dr. Nelson: Or moderation.

Dr. Glatter: Until research proves further.

Thank you so much. You’ve made some really important points. Thank you for talking about the BORG phenomenon, how it relates to society in general, and what we can do to try to change people’s perception of alcohol and the bigger picture of binge drinking. I really appreciate it.

Dr. Nelson: Thanks, Rob, for having me. It’s an important topic and hopefully we can get a handle on this. I appreciate your time.

Dr. Glatter is an attending physician at Lenox Hill Hospital in New York City and assistant professor of emergency medicine at Hofstra University, Hempstead, N.Y. Dr. Nelson is professor and chair of the department of emergency medicine and chief of the division of medical toxicology at Rutgers New Jersey Medical School, Newark. He is a member of the board of directors of the American Board of Emergency Medicine, the Accreditation Council for Continuing Medical Education, and Association of Academic Chairs in Emergency Medicine and is past-president of the American College of Medical Toxicology. Dr. Glatter and Dr. Nelson disclosed no relevant financial relationships.

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

Regular meditation reduced depression by roughly 44% in adults with coronary artery disease who were involved in a cardiovascular rehabilitation program.

An increasing body of research supports the impact of psychological risk factors including stress, personality type, anger, and hostility on conditions such as depression and anxiety, but also social isolation and low socioeconomic status, Ana Luisa Vitorino Monteiro, MD, of the University of Lisbon said in a presentation at the annual congress of the European Association of Preventive Cardiology. In addition, “stress, anxiety, and depression deteriorate the cardiovascular (CV) system through psycho-neuro-immunoendocrinology system and behavioral pathways.”

Meditation as a tool for stress management has been gaining popularity, but its use as part of a CV rehabilitation program as a complementary therapy has not been well studied, she added.

Dr. Monteiro and colleagues recruited 80 adults with CAD who were undergoing CV rehabilitation to join a meditation program. Of these, 48 accepted (60%) and 40% declined. Those who accepted were part of an exercise-based CV rehabilitation program that met three times a week for at least 6 months. The mean age of the participants was 65 years, and 80% were male.

Participants were randomized to an intervention group with a weekly 90-minute session that included breathing and meditation for 1 month in addition to usual care, or to usual care in the rehabilitation program. Over the next 3 months, the intervention patients were encouraged to practice daily meditation for 20 minutes alone or using video support material, with a weekly follow-up phone call. Assessments of stress, anxiety, and depression took place at baseline and after 4 months using the Perceived Stress Scale, Beck Anxiety Inventory, Beck Depression Inventory, and HeartQoL questionnaire.

At 4 months, individuals in the meditation group had reduced depression levels significantly, by 44%, compared with controls (P < .001). Anxiety and stress decreased significantly, by 30% (P = .04) and 31% (P = .05), respectively. After 4 months, individuals in the control group were offered the opportunity to follow the meditation protocol.

In addition, “the emotional dimension of quality of life increased by 60% in the intervention group,” Dr. Monteiro noted. However, physical QoL did not change between groups.

The study was limited by the small sample size, and more research is needed in larger and more diverse populations, Dr. Monteiro said. However, the results support the value of meditation as an adjunct component of care for CAD patients in a long-term rehabilitation program.
 

Motivation makes a difference

The current study is important as an exploration of “a straightforward, simple, low-risk approach that could be an adjunct to benefit patients with serious cardiovascular disease,” Brian Olshansky, MD, a cardiologist at the University of Iowa, Iowa City, said in an interview.

“We have moved into a time of polypharmacy and multiple interventions for patients with underlying cardiovascular disease which, in many cases, have proven benefit but also potential adverse effects,” he said. “Engaging patients to participate in their health care, when there is serious underlying cardiovascular disease, has potential beneficial impact in many ways. Meditation is a low-risk, low-cost, potentially beneficial adjunct to standard medical therapy that may enhance psychological outcomes as shown here in this small study.”

However, “patients often rely on high-cost, potentially high-risk therapeutic interventions, expecting complete control of their problems without their own collaborative intervention,” he noted.

Dr. Olshansky said he was not surprised by any of the findings, and would have been surprised if meditation had failed to show any benefit for the study population.

“I am very pleased to see these results and would encourage meditation practice to be part of cardiovascular rehabilitation for motivated individuals,” he said. “What did surprise me was the adherence to the meditation protocol for those who participated. This represents a highly motivated group and it may be difficult to expect the same results in less motivated individuals.”

The current study has several strengths, including the use of controls and high rates of adherence to the protocol, said Dr. Olshansky. Other strengths include the standardized approach and the reasonable quality of the outcome measures, which showed a substantial benefit.

However, “this is a small study of motivated individuals of whom 80% were male,” and generalizability to other populations is unclear, Dr. Olshansky said. In addition, the racial mix was not described, and the severity of the underlying coronary artery disease and the therapies provided to these individuals is not detailed. A sicker population may not fare as well.”

The reasons for the benefits of meditation remain uncertain, Dr. Olshansky said. “It could be, specifically, that the meditation itself has physiological effects that ultimately translate into psychosocial benefit. However, those who enrolled and were interested may have derived a placebo effect. In any case, benefit was achieved, but the crossover benefit to the control group is unclear.

“In other words, the statistical approach to benefit is uncertain as to when it was measured, but presumably before the control group was allowed to engage in a meditation practice,” and the follow-up was short term, said Dr. Olshansky.
 

Data support patient engagement

The message to clinicians and patients: “Patients should be engaged in their own health care when it comes to rehabilitation for cardiovascular disease,” said Dr. Olshansky. “Motivated individuals who are educated about a meditative practice performed in a standardized way will have improvement most likely in their quality of life, and when it comes to measurements of depression, stress and anxiety.”

Although the mechanisms behind the benefits remain unclear, “having a standardized credible prescription for which patients can become intimately engaged is beneficial,” he added.

The study received no outside funding. Neither Dr. Monteiro nor Dr. Olshansky had any financial conflicts to disclose.


 

Regular meditation reduced depression by roughly 44% in adults with coronary artery disease who were involved in a cardiovascular rehabilitation program.

An increasing body of research supports the impact of psychological risk factors including stress, personality type, anger, and hostility on conditions such as depression and anxiety, but also social isolation and low socioeconomic status, Ana Luisa Vitorino Monteiro, MD, of the University of Lisbon said in a presentation at the annual congress of the European Association of Preventive Cardiology. In addition, “stress, anxiety, and depression deteriorate the cardiovascular (CV) system through psycho-neuro-immunoendocrinology system and behavioral pathways.”

Meditation as a tool for stress management has been gaining popularity, but its use as part of a CV rehabilitation program as a complementary therapy has not been well studied, she added.

Dr. Monteiro and colleagues recruited 80 adults with CAD who were undergoing CV rehabilitation to join a meditation program. Of these, 48 accepted (60%) and 40% declined. Those who accepted were part of an exercise-based CV rehabilitation program that met three times a week for at least 6 months. The mean age of the participants was 65 years, and 80% were male.

Participants were randomized to an intervention group with a weekly 90-minute session that included breathing and meditation for 1 month in addition to usual care, or to usual care in the rehabilitation program. Over the next 3 months, the intervention patients were encouraged to practice daily meditation for 20 minutes alone or using video support material, with a weekly follow-up phone call. Assessments of stress, anxiety, and depression took place at baseline and after 4 months using the Perceived Stress Scale, Beck Anxiety Inventory, Beck Depression Inventory, and HeartQoL questionnaire.

At 4 months, individuals in the meditation group had reduced depression levels significantly, by 44%, compared with controls (P < .001). Anxiety and stress decreased significantly, by 30% (P = .04) and 31% (P = .05), respectively. After 4 months, individuals in the control group were offered the opportunity to follow the meditation protocol.

In addition, “the emotional dimension of quality of life increased by 60% in the intervention group,” Dr. Monteiro noted. However, physical QoL did not change between groups.

The study was limited by the small sample size, and more research is needed in larger and more diverse populations, Dr. Monteiro said. However, the results support the value of meditation as an adjunct component of care for CAD patients in a long-term rehabilitation program.
 

Motivation makes a difference

The current study is important as an exploration of “a straightforward, simple, low-risk approach that could be an adjunct to benefit patients with serious cardiovascular disease,” Brian Olshansky, MD, a cardiologist at the University of Iowa, Iowa City, said in an interview.

“We have moved into a time of polypharmacy and multiple interventions for patients with underlying cardiovascular disease which, in many cases, have proven benefit but also potential adverse effects,” he said. “Engaging patients to participate in their health care, when there is serious underlying cardiovascular disease, has potential beneficial impact in many ways. Meditation is a low-risk, low-cost, potentially beneficial adjunct to standard medical therapy that may enhance psychological outcomes as shown here in this small study.”

However, “patients often rely on high-cost, potentially high-risk therapeutic interventions, expecting complete control of their problems without their own collaborative intervention,” he noted.

Dr. Olshansky said he was not surprised by any of the findings, and would have been surprised if meditation had failed to show any benefit for the study population.

“I am very pleased to see these results and would encourage meditation practice to be part of cardiovascular rehabilitation for motivated individuals,” he said. “What did surprise me was the adherence to the meditation protocol for those who participated. This represents a highly motivated group and it may be difficult to expect the same results in less motivated individuals.”

The current study has several strengths, including the use of controls and high rates of adherence to the protocol, said Dr. Olshansky. Other strengths include the standardized approach and the reasonable quality of the outcome measures, which showed a substantial benefit.

However, “this is a small study of motivated individuals of whom 80% were male,” and generalizability to other populations is unclear, Dr. Olshansky said. In addition, the racial mix was not described, and the severity of the underlying coronary artery disease and the therapies provided to these individuals is not detailed. A sicker population may not fare as well.”

The reasons for the benefits of meditation remain uncertain, Dr. Olshansky said. “It could be, specifically, that the meditation itself has physiological effects that ultimately translate into psychosocial benefit. However, those who enrolled and were interested may have derived a placebo effect. In any case, benefit was achieved, but the crossover benefit to the control group is unclear.

“In other words, the statistical approach to benefit is uncertain as to when it was measured, but presumably before the control group was allowed to engage in a meditation practice,” and the follow-up was short term, said Dr. Olshansky.
 

Data support patient engagement

The message to clinicians and patients: “Patients should be engaged in their own health care when it comes to rehabilitation for cardiovascular disease,” said Dr. Olshansky. “Motivated individuals who are educated about a meditative practice performed in a standardized way will have improvement most likely in their quality of life, and when it comes to measurements of depression, stress and anxiety.”

Although the mechanisms behind the benefits remain unclear, “having a standardized credible prescription for which patients can become intimately engaged is beneficial,” he added.

The study received no outside funding. Neither Dr. Monteiro nor Dr. Olshansky had any financial conflicts to disclose.


 

Regular meditation reduced depression by roughly 44% in adults with coronary artery disease who were involved in a cardiovascular rehabilitation program.

An increasing body of research supports the impact of psychological risk factors including stress, personality type, anger, and hostility on conditions such as depression and anxiety, but also social isolation and low socioeconomic status, Ana Luisa Vitorino Monteiro, MD, of the University of Lisbon said in a presentation at the annual congress of the European Association of Preventive Cardiology. In addition, “stress, anxiety, and depression deteriorate the cardiovascular (CV) system through psycho-neuro-immunoendocrinology system and behavioral pathways.”

Meditation as a tool for stress management has been gaining popularity, but its use as part of a CV rehabilitation program as a complementary therapy has not been well studied, she added.

Dr. Monteiro and colleagues recruited 80 adults with CAD who were undergoing CV rehabilitation to join a meditation program. Of these, 48 accepted (60%) and 40% declined. Those who accepted were part of an exercise-based CV rehabilitation program that met three times a week for at least 6 months. The mean age of the participants was 65 years, and 80% were male.

Participants were randomized to an intervention group with a weekly 90-minute session that included breathing and meditation for 1 month in addition to usual care, or to usual care in the rehabilitation program. Over the next 3 months, the intervention patients were encouraged to practice daily meditation for 20 minutes alone or using video support material, with a weekly follow-up phone call. Assessments of stress, anxiety, and depression took place at baseline and after 4 months using the Perceived Stress Scale, Beck Anxiety Inventory, Beck Depression Inventory, and HeartQoL questionnaire.

At 4 months, individuals in the meditation group had reduced depression levels significantly, by 44%, compared with controls (P < .001). Anxiety and stress decreased significantly, by 30% (P = .04) and 31% (P = .05), respectively. After 4 months, individuals in the control group were offered the opportunity to follow the meditation protocol.

In addition, “the emotional dimension of quality of life increased by 60% in the intervention group,” Dr. Monteiro noted. However, physical QoL did not change between groups.

The study was limited by the small sample size, and more research is needed in larger and more diverse populations, Dr. Monteiro said. However, the results support the value of meditation as an adjunct component of care for CAD patients in a long-term rehabilitation program.
 

Motivation makes a difference

The current study is important as an exploration of “a straightforward, simple, low-risk approach that could be an adjunct to benefit patients with serious cardiovascular disease,” Brian Olshansky, MD, a cardiologist at the University of Iowa, Iowa City, said in an interview.

“We have moved into a time of polypharmacy and multiple interventions for patients with underlying cardiovascular disease which, in many cases, have proven benefit but also potential adverse effects,” he said. “Engaging patients to participate in their health care, when there is serious underlying cardiovascular disease, has potential beneficial impact in many ways. Meditation is a low-risk, low-cost, potentially beneficial adjunct to standard medical therapy that may enhance psychological outcomes as shown here in this small study.”

However, “patients often rely on high-cost, potentially high-risk therapeutic interventions, expecting complete control of their problems without their own collaborative intervention,” he noted.

Dr. Olshansky said he was not surprised by any of the findings, and would have been surprised if meditation had failed to show any benefit for the study population.

“I am very pleased to see these results and would encourage meditation practice to be part of cardiovascular rehabilitation for motivated individuals,” he said. “What did surprise me was the adherence to the meditation protocol for those who participated. This represents a highly motivated group and it may be difficult to expect the same results in less motivated individuals.”

The current study has several strengths, including the use of controls and high rates of adherence to the protocol, said Dr. Olshansky. Other strengths include the standardized approach and the reasonable quality of the outcome measures, which showed a substantial benefit.

However, “this is a small study of motivated individuals of whom 80% were male,” and generalizability to other populations is unclear, Dr. Olshansky said. In addition, the racial mix was not described, and the severity of the underlying coronary artery disease and the therapies provided to these individuals is not detailed. A sicker population may not fare as well.”

The reasons for the benefits of meditation remain uncertain, Dr. Olshansky said. “It could be, specifically, that the meditation itself has physiological effects that ultimately translate into psychosocial benefit. However, those who enrolled and were interested may have derived a placebo effect. In any case, benefit was achieved, but the crossover benefit to the control group is unclear.

“In other words, the statistical approach to benefit is uncertain as to when it was measured, but presumably before the control group was allowed to engage in a meditation practice,” and the follow-up was short term, said Dr. Olshansky.
 

Data support patient engagement

The message to clinicians and patients: “Patients should be engaged in their own health care when it comes to rehabilitation for cardiovascular disease,” said Dr. Olshansky. “Motivated individuals who are educated about a meditative practice performed in a standardized way will have improvement most likely in their quality of life, and when it comes to measurements of depression, stress and anxiety.”

Although the mechanisms behind the benefits remain unclear, “having a standardized credible prescription for which patients can become intimately engaged is beneficial,” he added.

The study received no outside funding. Neither Dr. Monteiro nor Dr. Olshansky had any financial conflicts to disclose.


 

Doctors’ groups are lining up to support new federal legislation to permanently tie Medicare physician payment updates to inflation.

Introduced by four physician U.S. House representatives, HR 2474 would link Medicare fee schedule updates to the Medicare Economic Index, a measure of inflation related to physicians’ practice costs and wages.

That’s a long-sought goal of the American Medical Association, which is leading 120 state medical societies and medical specialty groups in championing the bill.

The legislation is essential to enabling physician practices to better absorb payment distributions triggered by budget neutrality rules, performance adjustments, and periods of high inflation, the groups wrote in a joint letter sent to the bill’s sponsors. The sponsors say they hope the legislation will improve access to care, as low reimbursements cause some physicians to limit their number of Medicare patients.

Physicians groups for years have urged federal lawmakers to scrap short-term fixes staving off Medicare pay cuts in favor of permanent reforms. Unlike nearly all other Medicare clinicians including hospitals, physicians’ Medicare payment updates aren’t currently tied to inflation.

Adjusted for inflation, Medicare payments to physicians have declined 26% between 2001 and 2023, including a 2% payment reduction in 2023, according to the AMA. Small and rural physician practices have been disproportionately affected by these reductions, as have doctors treating low-income or uninsured patients, the AMA said.

Last month, an influential federal advisory panel recommended permanently tying Medicare physician pay increases to inflation. Clinicians’ cost of providing services, measured by the Medicare Economic Index, rose by 2.6% in 2021 and are estimated to have risen 4.7% in 2022, significantly more than in recent years, the Medicare Payment Advisory Commission said.

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

Doctors’ groups are lining up to support new federal legislation to permanently tie Medicare physician payment updates to inflation.

Introduced by four physician U.S. House representatives, HR 2474 would link Medicare fee schedule updates to the Medicare Economic Index, a measure of inflation related to physicians’ practice costs and wages.

That’s a long-sought goal of the American Medical Association, which is leading 120 state medical societies and medical specialty groups in championing the bill.

The legislation is essential to enabling physician practices to better absorb payment distributions triggered by budget neutrality rules, performance adjustments, and periods of high inflation, the groups wrote in a joint letter sent to the bill’s sponsors. The sponsors say they hope the legislation will improve access to care, as low reimbursements cause some physicians to limit their number of Medicare patients.

Physicians groups for years have urged federal lawmakers to scrap short-term fixes staving off Medicare pay cuts in favor of permanent reforms. Unlike nearly all other Medicare clinicians including hospitals, physicians’ Medicare payment updates aren’t currently tied to inflation.

Adjusted for inflation, Medicare payments to physicians have declined 26% between 2001 and 2023, including a 2% payment reduction in 2023, according to the AMA. Small and rural physician practices have been disproportionately affected by these reductions, as have doctors treating low-income or uninsured patients, the AMA said.

Last month, an influential federal advisory panel recommended permanently tying Medicare physician pay increases to inflation. Clinicians’ cost of providing services, measured by the Medicare Economic Index, rose by 2.6% in 2021 and are estimated to have risen 4.7% in 2022, significantly more than in recent years, the Medicare Payment Advisory Commission said.

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

Doctors’ groups are lining up to support new federal legislation to permanently tie Medicare physician payment updates to inflation.

Introduced by four physician U.S. House representatives, HR 2474 would link Medicare fee schedule updates to the Medicare Economic Index, a measure of inflation related to physicians’ practice costs and wages.

That’s a long-sought goal of the American Medical Association, which is leading 120 state medical societies and medical specialty groups in championing the bill.

The legislation is essential to enabling physician practices to better absorb payment distributions triggered by budget neutrality rules, performance adjustments, and periods of high inflation, the groups wrote in a joint letter sent to the bill’s sponsors. The sponsors say they hope the legislation will improve access to care, as low reimbursements cause some physicians to limit their number of Medicare patients.

Physicians groups for years have urged federal lawmakers to scrap short-term fixes staving off Medicare pay cuts in favor of permanent reforms. Unlike nearly all other Medicare clinicians including hospitals, physicians’ Medicare payment updates aren’t currently tied to inflation.

Adjusted for inflation, Medicare payments to physicians have declined 26% between 2001 and 2023, including a 2% payment reduction in 2023, according to the AMA. Small and rural physician practices have been disproportionately affected by these reductions, as have doctors treating low-income or uninsured patients, the AMA said.

Last month, an influential federal advisory panel recommended permanently tying Medicare physician pay increases to inflation. Clinicians’ cost of providing services, measured by the Medicare Economic Index, rose by 2.6% in 2021 and are estimated to have risen 4.7% in 2022, significantly more than in recent years, the Medicare Payment Advisory Commission said.

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

General and orthopedic surgeons and intensivists earn the highest net reimbursements from private U.S. insurers, a new report estimates.

On average in 2021, they were paid $5.8 million, $4.9 million, and $3.3 million, respectively, according to figures compiled by AMN Healthcare, a Dallas-based health staffing company.

None of 15 other physician specialties topped $3 million in net reimbursement on average, and three – dermatology, pediatrics, and family medicine – didn’t reach $1 million.

The report doesn’t include data about reimbursement from Medicare and Medicaid, and its numbers assume that 50% of insurance claims are denied. Denial rates differ from practice to practice.

Still, the findings offer a “benchmark tool” to help clinicians understand how they rank against their peers, Linda Murphy, president of AMN Healthcare’s Revenue Cycle Solutions division, said in an interview.

This is the first year that the company has calculated physician reimbursement levels by using claim and clearinghouse data, Ms. Murphy said. Previously, a division of the firm compiled data by surveying chief financial officers from hospitals.

The report’s estimate that insurers deny 50% of claims is “conservative,” Ms. Murphy said. Miscoding is a significant factor behind that number.

The estimated 2021 net private insurance reimbursements by specialty for direct services, assuming a 50% denial rate:

• Anesthesiology: $1,665,510
• Cardiology: $1,703,013
• Critical Care (intensivist): $3,338,656
• Dermatology: $729,107
• Family medicine: $697,094
• Gastroenterology: $2,765,110
• Internal medicine: $1,297,200
• Neurology: $1,390,181
• Obstetrician/gynecology: $1,880,888
• Otolaryngology: $2,095,277
• Pediatrics: $661,552
• Psychiatry: $1,348,730
• Pulmonology: $1,561,617
• Radiology: $1,015,750
• Rheumatology: $1,705,140
• General surgery: $5,834,508
• Orthopedic surgery: $4,904,757
• Urology: $2,943,381

Among 18 physician specialties overall, the report estimated that the average net reimbursement in 2021 was $1.9 million.

The report also estimated that the net reimbursement amounts at $875,140 for certified registered nurse anesthetists and $388,696 for nurse practitioners.

Surprisingly, Ms. Murphy said, there’s “a really large swing” among reimbursement levels for individual specialties. The quartile of cardiologists with the lowest level of reimbursement, for example, submitted $2.1 million in claims in 2021, netting about $1 million at a 50% denial rate versus the $7.3 million made by those in the highest quartile, netting about $3.6 million.

The gap seems to be due to regional variations, she said, adding that a rural cardiologist will have different billing practices than does one practicing in New York City.

The quartile of general surgeons with the highest reimbursement levels billed for $21.1 million on average in 2021, making about $10.5 million at a 50% denial rate. The lowest quartile billed for $5.5 million, making about $2.7 million at a 50% denial rate.

The report noted that primary care physicians – that is, family medicine, internal medicine, and pediatrics specialists – have much lower levels of reimbursement, compared with most other specialties. But the work of primary care physicians “may lead to considerable ‘downstream revenue’ through the hospital admissions, tests and treatment they order.”

A previous analysis by a division of AMN Healthcare found that primary care physicians, on average, generate $2,113,273 a year in net annual revenue for their affiliated hospitals, nearing the $2,446,429 in net annual hospital revenue generated by specialists.

AMN Healthcare is preparing another report that will examine Medicare reimbursements, Ms. Murphy said. According to the new report, payments by nonprivate insurers amount to about one-third of the total amount of reimbursement by commercial insurers.

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

General and orthopedic surgeons and intensivists earn the highest net reimbursements from private U.S. insurers, a new report estimates.

On average in 2021, they were paid $5.8 million, $4.9 million, and $3.3 million, respectively, according to figures compiled by AMN Healthcare, a Dallas-based health staffing company.

None of 15 other physician specialties topped $3 million in net reimbursement on average, and three – dermatology, pediatrics, and family medicine – didn’t reach $1 million.

The report doesn’t include data about reimbursement from Medicare and Medicaid, and its numbers assume that 50% of insurance claims are denied. Denial rates differ from practice to practice.

Still, the findings offer a “benchmark tool” to help clinicians understand how they rank against their peers, Linda Murphy, president of AMN Healthcare’s Revenue Cycle Solutions division, said in an interview.

This is the first year that the company has calculated physician reimbursement levels by using claim and clearinghouse data, Ms. Murphy said. Previously, a division of the firm compiled data by surveying chief financial officers from hospitals.

The report’s estimate that insurers deny 50% of claims is “conservative,” Ms. Murphy said. Miscoding is a significant factor behind that number.

The estimated 2021 net private insurance reimbursements by specialty for direct services, assuming a 50% denial rate:

• Anesthesiology: $1,665,510
• Cardiology: $1,703,013
• Critical Care (intensivist): $3,338,656
• Dermatology: $729,107
• Family medicine: $697,094
• Gastroenterology: $2,765,110
• Internal medicine: $1,297,200
• Neurology: $1,390,181
• Obstetrician/gynecology: $1,880,888
• Otolaryngology: $2,095,277
• Pediatrics: $661,552
• Psychiatry: $1,348,730
• Pulmonology: $1,561,617
• Radiology: $1,015,750
• Rheumatology: $1,705,140
• General surgery: $5,834,508
• Orthopedic surgery: $4,904,757
• Urology: $2,943,381

Among 18 physician specialties overall, the report estimated that the average net reimbursement in 2021 was $1.9 million.

The report also estimated that the net reimbursement amounts at $875,140 for certified registered nurse anesthetists and $388,696 for nurse practitioners.

Surprisingly, Ms. Murphy said, there’s “a really large swing” among reimbursement levels for individual specialties. The quartile of cardiologists with the lowest level of reimbursement, for example, submitted $2.1 million in claims in 2021, netting about $1 million at a 50% denial rate versus the $7.3 million made by those in the highest quartile, netting about $3.6 million.

The gap seems to be due to regional variations, she said, adding that a rural cardiologist will have different billing practices than does one practicing in New York City.

The quartile of general surgeons with the highest reimbursement levels billed for $21.1 million on average in 2021, making about $10.5 million at a 50% denial rate. The lowest quartile billed for $5.5 million, making about $2.7 million at a 50% denial rate.

The report noted that primary care physicians – that is, family medicine, internal medicine, and pediatrics specialists – have much lower levels of reimbursement, compared with most other specialties. But the work of primary care physicians “may lead to considerable ‘downstream revenue’ through the hospital admissions, tests and treatment they order.”

A previous analysis by a division of AMN Healthcare found that primary care physicians, on average, generate $2,113,273 a year in net annual revenue for their affiliated hospitals, nearing the $2,446,429 in net annual hospital revenue generated by specialists.

AMN Healthcare is preparing another report that will examine Medicare reimbursements, Ms. Murphy said. According to the new report, payments by nonprivate insurers amount to about one-third of the total amount of reimbursement by commercial insurers.

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

General and orthopedic surgeons and intensivists earn the highest net reimbursements from private U.S. insurers, a new report estimates.

On average in 2021, they were paid $5.8 million, $4.9 million, and $3.3 million, respectively, according to figures compiled by AMN Healthcare, a Dallas-based health staffing company.

None of 15 other physician specialties topped $3 million in net reimbursement on average, and three – dermatology, pediatrics, and family medicine – didn’t reach $1 million.

The report doesn’t include data about reimbursement from Medicare and Medicaid, and its numbers assume that 50% of insurance claims are denied. Denial rates differ from practice to practice.

Still, the findings offer a “benchmark tool” to help clinicians understand how they rank against their peers, Linda Murphy, president of AMN Healthcare’s Revenue Cycle Solutions division, said in an interview.

This is the first year that the company has calculated physician reimbursement levels by using claim and clearinghouse data, Ms. Murphy said. Previously, a division of the firm compiled data by surveying chief financial officers from hospitals.

The report’s estimate that insurers deny 50% of claims is “conservative,” Ms. Murphy said. Miscoding is a significant factor behind that number.

The estimated 2021 net private insurance reimbursements by specialty for direct services, assuming a 50% denial rate:

• Anesthesiology: $1,665,510
• Cardiology: $1,703,013
• Critical Care (intensivist): $3,338,656
• Dermatology: $729,107
• Family medicine: $697,094
• Gastroenterology: $2,765,110
• Internal medicine: $1,297,200
• Neurology: $1,390,181
• Obstetrician/gynecology: $1,880,888
• Otolaryngology: $2,095,277
• Pediatrics: $661,552
• Psychiatry: $1,348,730
• Pulmonology: $1,561,617
• Radiology: $1,015,750
• Rheumatology: $1,705,140
• General surgery: $5,834,508
• Orthopedic surgery: $4,904,757
• Urology: $2,943,381

Among 18 physician specialties overall, the report estimated that the average net reimbursement in 2021 was $1.9 million.

The report also estimated that the net reimbursement amounts at $875,140 for certified registered nurse anesthetists and $388,696 for nurse practitioners.

Surprisingly, Ms. Murphy said, there’s “a really large swing” among reimbursement levels for individual specialties. The quartile of cardiologists with the lowest level of reimbursement, for example, submitted $2.1 million in claims in 2021, netting about $1 million at a 50% denial rate versus the $7.3 million made by those in the highest quartile, netting about $3.6 million.

The gap seems to be due to regional variations, she said, adding that a rural cardiologist will have different billing practices than does one practicing in New York City.

The quartile of general surgeons with the highest reimbursement levels billed for $21.1 million on average in 2021, making about $10.5 million at a 50% denial rate. The lowest quartile billed for $5.5 million, making about $2.7 million at a 50% denial rate.

The report noted that primary care physicians – that is, family medicine, internal medicine, and pediatrics specialists – have much lower levels of reimbursement, compared with most other specialties. But the work of primary care physicians “may lead to considerable ‘downstream revenue’ through the hospital admissions, tests and treatment they order.”

A previous analysis by a division of AMN Healthcare found that primary care physicians, on average, generate $2,113,273 a year in net annual revenue for their affiliated hospitals, nearing the $2,446,429 in net annual hospital revenue generated by specialists.

AMN Healthcare is preparing another report that will examine Medicare reimbursements, Ms. Murphy said. According to the new report, payments by nonprivate insurers amount to about one-third of the total amount of reimbursement by commercial insurers.

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

A new federal research project aims to answer lingering questions about long COVID using mobile monitoring devices to help track the condition.

The federally funded RECOVER Initiative expects to give out 10,000 sensors to people with long COVID to collect data in real time.

Terry Rudd/MDedge News

The hope is that researchers will be able to provide doctors and patients with a wealth of information to address gaps in knowledge about long COVID.

The project takes advantage of the approach other researchers have used to track patients’ health data on heart rate, exercise, and more using mobile monitoring devices such as Fitbits, smartwatches, and other remote sensors. 

Researchers believe the initiative could be particularly useful for people with long COVID – whose symptoms come and go. They can use a wristband sensor to passively collect data in real time.

For a condition defined by its symptoms, that kind of data promises to be useful, experts said. 

But not everyone has room in their budget for a smartwatch or a fitness tracker. Until recently, most clinical trials were BYOD: Bring your own device. At a time when researchers are trying to make sure that clinical trials reflect the diversity of the population, that leaves a lot of people out.

So, researchers are starting to supply subjects with their own monitors. The RECOVER Initiative expects to give out 10,000 sensors to people who are eligible based on race/ethnicity, income, and other demographic factors (rural residents for example). After 2 months, all people in the RECOVER study over the age of 13 will be eligible for the sensors.

The federal program builds on earlier research at places like The Scripps Institute, a center of research into remote monitoring. The institute supplied 7,000 monitors to people in an arm of the All of Us study, a 5-year-old multisite cohort that aims to collect medical information from 1 million people. 

The devices went to people who have been historically underrepresented in biomedical research, said Scripps researchers, who plan to give out more this year. 

In March of 2023, Scripps researchers published a study on the tracking data that found a significant post-COVID-19 drop in physical activity. But the data are incomplete because many people can’t always afford these devices. Most of the people in the study were “White, young, and active,” they wrote.

Researchers at an All of Us site at Vanderbilt University, which also used a BYOD approach, realized that they produced biased results. They reported their findings at the Pacific Symposium on Biocomputing in January.

“[The] majority of participants who provided Fitbit data reported being White and employed for wages,” they said. “However, these data represent participants who had their own Fitbit devices and consented to share EHR [electronic health record] data.”

Their solution: The program has begun providing Fitbit devices to all study participants who do not own one or cannot afford one. 

Now, the web page for the All of Us study asks visitors to “Learn about the All of Us WEAR study. You could get a Fitbit at no cost! … As a part of the WEAR Study, you could receive a new Fitbit to wear at no cost to you. All of Us will be able to get the data the Fitbit collects. This data may help us understand how behavior impacts health.”

Jennifer Radin, PhD, an epidemiologist at Scripps Research Translational Institute, is heading up the DETECT study, which is a remote monitoring research project that has enrolled over 40,000 people who have their own sensors – be it a smartwatch or Fitbit. She was looking at remote monitoring for disease before COVID emerged.

Dr. Radin said she began researching remote sensing after working in public health and dealing with outdated data collection systems. 

“They typically rely on case reports that are recorded by pen and paper and faxed or mailed in,” she said. “Then, they have to be entered into a database. “

In addition to offering objective data on a subject’s physical response to the infection, she said, the data collection can be long-term and continuous. 

DETECT collects data on resting heart rate, which is unique to every person, and activity levels. Both measures are meaningful for those with long COVID. Her research found differences in sleep, heart rate, and activity between those with COVID and those without.

Joseph Kvedar, MD, is a Harvard Medical School researcher and the editor of  NPJ Digital Medicine. He’s been studying digital health systems and called clinical research a “beachhead” for the use of data from monitors. But he also said problems remain that need to be worked out. The quality of the devices and their Bluetooth connections are better. But different devices measure different things, and a counted step can vary from person to person, he said. And the problems of the early days of electronic health records have not been fully resolved.

“We haven’t gotten to this universal language to connect all these things and make them relevant,” he said. 

The All of Us researchers are working with the RECOVER project to address some of those issues. Usually not focused on a single condition, the All of Us researchers are testing a machine-learning approach for identifying long COVID. 
 

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

A new federal research project aims to answer lingering questions about long COVID using mobile monitoring devices to help track the condition.

The federally funded RECOVER Initiative expects to give out 10,000 sensors to people with long COVID to collect data in real time.

Terry Rudd/MDedge News

The hope is that researchers will be able to provide doctors and patients with a wealth of information to address gaps in knowledge about long COVID.

The project takes advantage of the approach other researchers have used to track patients’ health data on heart rate, exercise, and more using mobile monitoring devices such as Fitbits, smartwatches, and other remote sensors. 

Researchers believe the initiative could be particularly useful for people with long COVID – whose symptoms come and go. They can use a wristband sensor to passively collect data in real time.

For a condition defined by its symptoms, that kind of data promises to be useful, experts said. 

But not everyone has room in their budget for a smartwatch or a fitness tracker. Until recently, most clinical trials were BYOD: Bring your own device. At a time when researchers are trying to make sure that clinical trials reflect the diversity of the population, that leaves a lot of people out.

So, researchers are starting to supply subjects with their own monitors. The RECOVER Initiative expects to give out 10,000 sensors to people who are eligible based on race/ethnicity, income, and other demographic factors (rural residents for example). After 2 months, all people in the RECOVER study over the age of 13 will be eligible for the sensors.

The federal program builds on earlier research at places like The Scripps Institute, a center of research into remote monitoring. The institute supplied 7,000 monitors to people in an arm of the All of Us study, a 5-year-old multisite cohort that aims to collect medical information from 1 million people. 

The devices went to people who have been historically underrepresented in biomedical research, said Scripps researchers, who plan to give out more this year. 

In March of 2023, Scripps researchers published a study on the tracking data that found a significant post-COVID-19 drop in physical activity. But the data are incomplete because many people can’t always afford these devices. Most of the people in the study were “White, young, and active,” they wrote.

Researchers at an All of Us site at Vanderbilt University, which also used a BYOD approach, realized that they produced biased results. They reported their findings at the Pacific Symposium on Biocomputing in January.

“[The] majority of participants who provided Fitbit data reported being White and employed for wages,” they said. “However, these data represent participants who had their own Fitbit devices and consented to share EHR [electronic health record] data.”

Their solution: The program has begun providing Fitbit devices to all study participants who do not own one or cannot afford one. 

Now, the web page for the All of Us study asks visitors to “Learn about the All of Us WEAR study. You could get a Fitbit at no cost! … As a part of the WEAR Study, you could receive a new Fitbit to wear at no cost to you. All of Us will be able to get the data the Fitbit collects. This data may help us understand how behavior impacts health.”

Jennifer Radin, PhD, an epidemiologist at Scripps Research Translational Institute, is heading up the DETECT study, which is a remote monitoring research project that has enrolled over 40,000 people who have their own sensors – be it a smartwatch or Fitbit. She was looking at remote monitoring for disease before COVID emerged.

Dr. Radin said she began researching remote sensing after working in public health and dealing with outdated data collection systems. 

“They typically rely on case reports that are recorded by pen and paper and faxed or mailed in,” she said. “Then, they have to be entered into a database. “

In addition to offering objective data on a subject’s physical response to the infection, she said, the data collection can be long-term and continuous. 

DETECT collects data on resting heart rate, which is unique to every person, and activity levels. Both measures are meaningful for those with long COVID. Her research found differences in sleep, heart rate, and activity between those with COVID and those without.

Joseph Kvedar, MD, is a Harvard Medical School researcher and the editor of  NPJ Digital Medicine. He’s been studying digital health systems and called clinical research a “beachhead” for the use of data from monitors. But he also said problems remain that need to be worked out. The quality of the devices and their Bluetooth connections are better. But different devices measure different things, and a counted step can vary from person to person, he said. And the problems of the early days of electronic health records have not been fully resolved.

“We haven’t gotten to this universal language to connect all these things and make them relevant,” he said. 

The All of Us researchers are working with the RECOVER project to address some of those issues. Usually not focused on a single condition, the All of Us researchers are testing a machine-learning approach for identifying long COVID. 
 

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

A new federal research project aims to answer lingering questions about long COVID using mobile monitoring devices to help track the condition.

The federally funded RECOVER Initiative expects to give out 10,000 sensors to people with long COVID to collect data in real time.

Terry Rudd/MDedge News

The hope is that researchers will be able to provide doctors and patients with a wealth of information to address gaps in knowledge about long COVID.

The project takes advantage of the approach other researchers have used to track patients’ health data on heart rate, exercise, and more using mobile monitoring devices such as Fitbits, smartwatches, and other remote sensors. 

Researchers believe the initiative could be particularly useful for people with long COVID – whose symptoms come and go. They can use a wristband sensor to passively collect data in real time.

For a condition defined by its symptoms, that kind of data promises to be useful, experts said. 

But not everyone has room in their budget for a smartwatch or a fitness tracker. Until recently, most clinical trials were BYOD: Bring your own device. At a time when researchers are trying to make sure that clinical trials reflect the diversity of the population, that leaves a lot of people out.

So, researchers are starting to supply subjects with their own monitors. The RECOVER Initiative expects to give out 10,000 sensors to people who are eligible based on race/ethnicity, income, and other demographic factors (rural residents for example). After 2 months, all people in the RECOVER study over the age of 13 will be eligible for the sensors.

The federal program builds on earlier research at places like The Scripps Institute, a center of research into remote monitoring. The institute supplied 7,000 monitors to people in an arm of the All of Us study, a 5-year-old multisite cohort that aims to collect medical information from 1 million people. 

The devices went to people who have been historically underrepresented in biomedical research, said Scripps researchers, who plan to give out more this year. 

In March of 2023, Scripps researchers published a study on the tracking data that found a significant post-COVID-19 drop in physical activity. But the data are incomplete because many people can’t always afford these devices. Most of the people in the study were “White, young, and active,” they wrote.

Researchers at an All of Us site at Vanderbilt University, which also used a BYOD approach, realized that they produced biased results. They reported their findings at the Pacific Symposium on Biocomputing in January.

“[The] majority of participants who provided Fitbit data reported being White and employed for wages,” they said. “However, these data represent participants who had their own Fitbit devices and consented to share EHR [electronic health record] data.”

Their solution: The program has begun providing Fitbit devices to all study participants who do not own one or cannot afford one. 

Now, the web page for the All of Us study asks visitors to “Learn about the All of Us WEAR study. You could get a Fitbit at no cost! … As a part of the WEAR Study, you could receive a new Fitbit to wear at no cost to you. All of Us will be able to get the data the Fitbit collects. This data may help us understand how behavior impacts health.”

Jennifer Radin, PhD, an epidemiologist at Scripps Research Translational Institute, is heading up the DETECT study, which is a remote monitoring research project that has enrolled over 40,000 people who have their own sensors – be it a smartwatch or Fitbit. She was looking at remote monitoring for disease before COVID emerged.

Dr. Radin said she began researching remote sensing after working in public health and dealing with outdated data collection systems. 

“They typically rely on case reports that are recorded by pen and paper and faxed or mailed in,” she said. “Then, they have to be entered into a database. “

In addition to offering objective data on a subject’s physical response to the infection, she said, the data collection can be long-term and continuous. 

DETECT collects data on resting heart rate, which is unique to every person, and activity levels. Both measures are meaningful for those with long COVID. Her research found differences in sleep, heart rate, and activity between those with COVID and those without.

Joseph Kvedar, MD, is a Harvard Medical School researcher and the editor of  NPJ Digital Medicine. He’s been studying digital health systems and called clinical research a “beachhead” for the use of data from monitors. But he also said problems remain that need to be worked out. The quality of the devices and their Bluetooth connections are better. But different devices measure different things, and a counted step can vary from person to person, he said. And the problems of the early days of electronic health records have not been fully resolved.

“We haven’t gotten to this universal language to connect all these things and make them relevant,” he said. 

The All of Us researchers are working with the RECOVER project to address some of those issues. Usually not focused on a single condition, the All of Us researchers are testing a machine-learning approach for identifying long COVID. 
 

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

NEW YORK – The Food and Drug Administration’s 2016 approval of the Bruton’s tyrosine kinase inhibitor ibrutinib (IB) as a frontline therapy for chronic lymphocytic leukemia (CLL) dramatically improved overall survival rates for patients with this condition. Follow-up data from 8 years after the RESONATE-2 trial indicated that patients with CLL (65 years or older) who remain on IB therapy can expect to live as long as someone in the general population.

Physicians now face two challenges in frontline CLL treatment: finding safe and effective drugs with fewer side effects, allowing patients to maintain therapy; and offering young or genomically high-risk patients treatments that reduce the risk of relapse.

courtesy Dr. Allan

“My preferred approach to CLL treatment is the use of second generation Bruton’s tyrosine kinase inhibitors, due to their improved toxicity profiles. These drugs are a great frontline option for most, if not all CLL patients,” said John N. Allan, associate professor at Weill Cornell Medicine, New York, in his presentation on frontline CLL treatments at the Great Debates and Updates Hematologic Malignancies Conference. “This is true even of older patients or those with comorbidities because this class of drug allows us to keep patients on treatment with excellent long-term outcomes.”

Results from the Alpine trial (NCT03734016), which included patients with and without high genomic risk, confirmed the superiority of the second generation Bruton’s tyrosine kinase inhibitor zanubrutinib (ZB) versus ibrutinib in terms of overall response rate 86.2% versus 75.5%, progression free survival 2-years after treatment 79.5% versus 67.3%, and adverse events (AEs) leading to discontinuation 15.4% versus 22.2% respectively.

The SEQUOIA trial (NCT03336333) demonstrated the effectiveness of ZB versus bendamustine + rituximab combination (BR) therapy in treatment-naive CLL / small lymphocytic leukemia patients with normal and high genomic risk. Overall 24-month progression free survival (PFS) was 85% in the ZB cohort vs. 69% in the BR cohort. This trend held true among high-risk subgroups like patients with an unmutated IgVH gene or 11q22.3 gene deletion.

Therapies known as “doublets” and “triplets” (which include a Bruton’s tyrosine kinase inhibitor in addition to other drugs) are not FDA approved for frontline CLL treatment. Yet studies suggest that young patients who are better able to tolerate AEs or high-risk patients with a greater risk of relapse (even on monotherapy maintenance), may derive benefits from multidrug frontline treatment.

“With doublets and triplets, doctors add treatment intensity up front so that patients can have a fixed duration of therapy versus continuous indefinite therapy,” said Vu Nguyen MD, a hematologist at Oakland (Calif.) Medical Center. “This is encouraging because if you can have a fixed duration of treatment, patients can come off treatment agents and hopefully have a prolonged remission and normal lifespan without chronic therapy and side effects.”

The CAPTIVATE study confirmed this approach with 3 cycles of IB followed by 12 cycles of IB + venetoclax leading to a 24-month PFS rate of 94% in patients with high risk or relapse. “Furthermore, 95% of study participants patients less than 70 years old completed 12 months of combination treatment without major problems,” said Dr. Allan. He concluded his remarks by noting that “we need longer term data on the use of combination therapy for frontline CLL treatment to confirm if and when it should be used.”

Dr. Allan disclosed relationships with Adaptive Biotechnologies, ADC Therapeutics, AstraZeneca, BeiGene, Epizyme, Genentech, Janssen, Lilly, Pharmacyclics, and TG Therapeutics. Dr. Nguyen reported no disclosures.

NEW YORK – The Food and Drug Administration’s 2016 approval of the Bruton’s tyrosine kinase inhibitor ibrutinib (IB) as a frontline therapy for chronic lymphocytic leukemia (CLL) dramatically improved overall survival rates for patients with this condition. Follow-up data from 8 years after the RESONATE-2 trial indicated that patients with CLL (65 years or older) who remain on IB therapy can expect to live as long as someone in the general population.

Physicians now face two challenges in frontline CLL treatment: finding safe and effective drugs with fewer side effects, allowing patients to maintain therapy; and offering young or genomically high-risk patients treatments that reduce the risk of relapse.

courtesy Dr. Allan

“My preferred approach to CLL treatment is the use of second generation Bruton’s tyrosine kinase inhibitors, due to their improved toxicity profiles. These drugs are a great frontline option for most, if not all CLL patients,” said John N. Allan, associate professor at Weill Cornell Medicine, New York, in his presentation on frontline CLL treatments at the Great Debates and Updates Hematologic Malignancies Conference. “This is true even of older patients or those with comorbidities because this class of drug allows us to keep patients on treatment with excellent long-term outcomes.”

Results from the Alpine trial (NCT03734016), which included patients with and without high genomic risk, confirmed the superiority of the second generation Bruton’s tyrosine kinase inhibitor zanubrutinib (ZB) versus ibrutinib in terms of overall response rate 86.2% versus 75.5%, progression free survival 2-years after treatment 79.5% versus 67.3%, and adverse events (AEs) leading to discontinuation 15.4% versus 22.2% respectively.

The SEQUOIA trial (NCT03336333) demonstrated the effectiveness of ZB versus bendamustine + rituximab combination (BR) therapy in treatment-naive CLL / small lymphocytic leukemia patients with normal and high genomic risk. Overall 24-month progression free survival (PFS) was 85% in the ZB cohort vs. 69% in the BR cohort. This trend held true among high-risk subgroups like patients with an unmutated IgVH gene or 11q22.3 gene deletion.

Therapies known as “doublets” and “triplets” (which include a Bruton’s tyrosine kinase inhibitor in addition to other drugs) are not FDA approved for frontline CLL treatment. Yet studies suggest that young patients who are better able to tolerate AEs or high-risk patients with a greater risk of relapse (even on monotherapy maintenance), may derive benefits from multidrug frontline treatment.

“With doublets and triplets, doctors add treatment intensity up front so that patients can have a fixed duration of therapy versus continuous indefinite therapy,” said Vu Nguyen MD, a hematologist at Oakland (Calif.) Medical Center. “This is encouraging because if you can have a fixed duration of treatment, patients can come off treatment agents and hopefully have a prolonged remission and normal lifespan without chronic therapy and side effects.”

The CAPTIVATE study confirmed this approach with 3 cycles of IB followed by 12 cycles of IB + venetoclax leading to a 24-month PFS rate of 94% in patients with high risk or relapse. “Furthermore, 95% of study participants patients less than 70 years old completed 12 months of combination treatment without major problems,” said Dr. Allan. He concluded his remarks by noting that “we need longer term data on the use of combination therapy for frontline CLL treatment to confirm if and when it should be used.”

Dr. Allan disclosed relationships with Adaptive Biotechnologies, ADC Therapeutics, AstraZeneca, BeiGene, Epizyme, Genentech, Janssen, Lilly, Pharmacyclics, and TG Therapeutics. Dr. Nguyen reported no disclosures.

NEW YORK – The Food and Drug Administration’s 2016 approval of the Bruton’s tyrosine kinase inhibitor ibrutinib (IB) as a frontline therapy for chronic lymphocytic leukemia (CLL) dramatically improved overall survival rates for patients with this condition. Follow-up data from 8 years after the RESONATE-2 trial indicated that patients with CLL (65 years or older) who remain on IB therapy can expect to live as long as someone in the general population.

Physicians now face two challenges in frontline CLL treatment: finding safe and effective drugs with fewer side effects, allowing patients to maintain therapy; and offering young or genomically high-risk patients treatments that reduce the risk of relapse.

courtesy Dr. Allan

“My preferred approach to CLL treatment is the use of second generation Bruton’s tyrosine kinase inhibitors, due to their improved toxicity profiles. These drugs are a great frontline option for most, if not all CLL patients,” said John N. Allan, associate professor at Weill Cornell Medicine, New York, in his presentation on frontline CLL treatments at the Great Debates and Updates Hematologic Malignancies Conference. “This is true even of older patients or those with comorbidities because this class of drug allows us to keep patients on treatment with excellent long-term outcomes.”

Results from the Alpine trial (NCT03734016), which included patients with and without high genomic risk, confirmed the superiority of the second generation Bruton’s tyrosine kinase inhibitor zanubrutinib (ZB) versus ibrutinib in terms of overall response rate 86.2% versus 75.5%, progression free survival 2-years after treatment 79.5% versus 67.3%, and adverse events (AEs) leading to discontinuation 15.4% versus 22.2% respectively.

The SEQUOIA trial (NCT03336333) demonstrated the effectiveness of ZB versus bendamustine + rituximab combination (BR) therapy in treatment-naive CLL / small lymphocytic leukemia patients with normal and high genomic risk. Overall 24-month progression free survival (PFS) was 85% in the ZB cohort vs. 69% in the BR cohort. This trend held true among high-risk subgroups like patients with an unmutated IgVH gene or 11q22.3 gene deletion.

Therapies known as “doublets” and “triplets” (which include a Bruton’s tyrosine kinase inhibitor in addition to other drugs) are not FDA approved for frontline CLL treatment. Yet studies suggest that young patients who are better able to tolerate AEs or high-risk patients with a greater risk of relapse (even on monotherapy maintenance), may derive benefits from multidrug frontline treatment.

“With doublets and triplets, doctors add treatment intensity up front so that patients can have a fixed duration of therapy versus continuous indefinite therapy,” said Vu Nguyen MD, a hematologist at Oakland (Calif.) Medical Center. “This is encouraging because if you can have a fixed duration of treatment, patients can come off treatment agents and hopefully have a prolonged remission and normal lifespan without chronic therapy and side effects.”

The CAPTIVATE study confirmed this approach with 3 cycles of IB followed by 12 cycles of IB + venetoclax leading to a 24-month PFS rate of 94% in patients with high risk or relapse. “Furthermore, 95% of study participants patients less than 70 years old completed 12 months of combination treatment without major problems,” said Dr. Allan. He concluded his remarks by noting that “we need longer term data on the use of combination therapy for frontline CLL treatment to confirm if and when it should be used.”

Dr. Allan disclosed relationships with Adaptive Biotechnologies, ADC Therapeutics, AstraZeneca, BeiGene, Epizyme, Genentech, Janssen, Lilly, Pharmacyclics, and TG Therapeutics. Dr. Nguyen reported no disclosures.

A position paper by the National Psoriasis Foundation’s Telemedicine Task Force outlines key principles and practices for managing psoriatic disease via telemedicine.

The success of telemedicine in managing chronic inflammatory skin conditions including psoriasis during the COVID-19 pandemic “highlighted that teledermatology can be used beyond the context of a global health crisis to provide continuity of care and improve access to health care more broadly,” the task force wrote in a paper published online in JAAD International.

Jean-philippe WALLET/Getty Images

Co–senior author George Han, MD, PhD, said in an interview that the impetus for the guidelines came from NPF patient advocates, who realized that the organization needed something to take to payers and governmental agencies to advocate for better access to dermatologic care. He is associate professor of dermatology and director of teledermatology at the Hofstra/Northwell department of dermatology, Hyde Park, New York.

“We realized that, in many places around the country, people don’t have access to dermatology.” In upstate New York, said Dr. Han, his anecdotal research has revealed wait times of 6 months or more.

As a guiding principle, the authors pronounce teledermatology “a reasonable alternative for providing long-term management of patients with psoriasis.” Research shows that nearly all dermatologists used teledermatology during the pandemic, the authors noted, and that well-run programs improve Psoriasis Area and Severity Index (PASI) scores and other measures on par with in-person care. Telemedicine may be especially useful for initial visits, they added, particularly when distance, patient incapacity, and circumstances prevent face-to-face evaluation.

Additional position statements emphasize that teledermatology should support rather than supplant in-person visits, and that this balance may be particularly important in cases involving psoriatic arthritis (PsA). “Even though we can’t do a physical exam and palpate some of those joints in person,” said Dr. Han, “tools have been developed that, through a series of questions the patient can answer, can guide you towards whether there is a high index of suspicion for psoriatic arthritis.” Such patients require in-person evaluation with urgency, he said, because delays in PsA diagnosis and treatment can lead to irreversible joint damage and significant functional impairment.

Another motivation for producing the guidelines, said Dr. Han, was that, even when underserved patients get a dermatology appointment, some providers may not have all the latest tools or medicines available for treating psoriasis. In such cases, telemedicine may allow dermatologists specializing in psoriasis care to extend their reach in comanaging patients with primary care physicians and community dermatologists.

Before the appointment, guidelines suggest determining what form of teledermatology will best suit each patient. Authors recommended gauging patients’ savviness with computers and cameras, and counseling patients regarding available virtual evaluation tools – such as live video visits, store-and-forward photo strategies, and assessment-tool training videos.

A subsequent guideline underscores the importance of continuously improving technology to support expeditious image capture and workflows that emulate in-person practice. Dr. Han explained, “we wanted to make sure that on the back end there’s adequate support such that – if through teledermatology, we determine that the patient should get, say, a systemic treatment – the patient is able to get the appropriate lab tests, get the medicine, and know how to inject it.”

Regarding reimbursement, Dr. Han said that policies varied prepandemic, but many commercial insurers covered telemedicine at a rate 20% lower than the in-person rate. During the pandemic, he said, insurers shifted to provide the higher rate for telemedicine, consistent with policies adopted by the Centers for Medicare & Medicaid Services.

“There are differences in coverage and reimbursement from plan to plan,” Dr. Han added. “And even within the same plan, there are carve-outs so that some plans don’t allow certain services. The big picture is that for the most part these services are covered at a level comparable to an in-person visit at present.”

With the Department of Health & Human Services’ public health emergency declaration expiring in May, he said, physicians have worried that some of the allowances made by CMS – such as lifting requirements that Medicare patients in rural areas be seen at care sites – will expire. “It seems that some of those limitations have been addressed, and those allowances are going to be extended until Congress is able to pass something that gives us durable access to telemedicine care. We think that based on the current environment telemedicine is here to stay.”

The study was funded by the NPF. Dr. Han has been an investigator, adviser, speaker, or researcher for AbbVie, Amgen, Apogee Therapeutics, Arcutis, Athenex, Bausch Health, Beiersdorf, Boehringer Ingelheim, Bond Avillion, Bristol Myers Squibb, Celgene, CeraVe, Dermavant, DermTech, Eli Lilly, EPI Health, Janssen Pharmaceuticals, LEO Pharma, L’Oreal, MC2 Therapeutics, Novartis, Ortho Dermatologics, PellePharm, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, SUN Pharmaceuticals, and UCB.

A position paper by the National Psoriasis Foundation’s Telemedicine Task Force outlines key principles and practices for managing psoriatic disease via telemedicine.

The success of telemedicine in managing chronic inflammatory skin conditions including psoriasis during the COVID-19 pandemic “highlighted that teledermatology can be used beyond the context of a global health crisis to provide continuity of care and improve access to health care more broadly,” the task force wrote in a paper published online in JAAD International.

Jean-philippe WALLET/Getty Images

Co–senior author George Han, MD, PhD, said in an interview that the impetus for the guidelines came from NPF patient advocates, who realized that the organization needed something to take to payers and governmental agencies to advocate for better access to dermatologic care. He is associate professor of dermatology and director of teledermatology at the Hofstra/Northwell department of dermatology, Hyde Park, New York.

“We realized that, in many places around the country, people don’t have access to dermatology.” In upstate New York, said Dr. Han, his anecdotal research has revealed wait times of 6 months or more.

As a guiding principle, the authors pronounce teledermatology “a reasonable alternative for providing long-term management of patients with psoriasis.” Research shows that nearly all dermatologists used teledermatology during the pandemic, the authors noted, and that well-run programs improve Psoriasis Area and Severity Index (PASI) scores and other measures on par with in-person care. Telemedicine may be especially useful for initial visits, they added, particularly when distance, patient incapacity, and circumstances prevent face-to-face evaluation.

Additional position statements emphasize that teledermatology should support rather than supplant in-person visits, and that this balance may be particularly important in cases involving psoriatic arthritis (PsA). “Even though we can’t do a physical exam and palpate some of those joints in person,” said Dr. Han, “tools have been developed that, through a series of questions the patient can answer, can guide you towards whether there is a high index of suspicion for psoriatic arthritis.” Such patients require in-person evaluation with urgency, he said, because delays in PsA diagnosis and treatment can lead to irreversible joint damage and significant functional impairment.

Another motivation for producing the guidelines, said Dr. Han, was that, even when underserved patients get a dermatology appointment, some providers may not have all the latest tools or medicines available for treating psoriasis. In such cases, telemedicine may allow dermatologists specializing in psoriasis care to extend their reach in comanaging patients with primary care physicians and community dermatologists.

Before the appointment, guidelines suggest determining what form of teledermatology will best suit each patient. Authors recommended gauging patients’ savviness with computers and cameras, and counseling patients regarding available virtual evaluation tools – such as live video visits, store-and-forward photo strategies, and assessment-tool training videos.

A subsequent guideline underscores the importance of continuously improving technology to support expeditious image capture and workflows that emulate in-person practice. Dr. Han explained, “we wanted to make sure that on the back end there’s adequate support such that – if through teledermatology, we determine that the patient should get, say, a systemic treatment – the patient is able to get the appropriate lab tests, get the medicine, and know how to inject it.”

Regarding reimbursement, Dr. Han said that policies varied prepandemic, but many commercial insurers covered telemedicine at a rate 20% lower than the in-person rate. During the pandemic, he said, insurers shifted to provide the higher rate for telemedicine, consistent with policies adopted by the Centers for Medicare & Medicaid Services.

“There are differences in coverage and reimbursement from plan to plan,” Dr. Han added. “And even within the same plan, there are carve-outs so that some plans don’t allow certain services. The big picture is that for the most part these services are covered at a level comparable to an in-person visit at present.”

With the Department of Health & Human Services’ public health emergency declaration expiring in May, he said, physicians have worried that some of the allowances made by CMS – such as lifting requirements that Medicare patients in rural areas be seen at care sites – will expire. “It seems that some of those limitations have been addressed, and those allowances are going to be extended until Congress is able to pass something that gives us durable access to telemedicine care. We think that based on the current environment telemedicine is here to stay.”

The study was funded by the NPF. Dr. Han has been an investigator, adviser, speaker, or researcher for AbbVie, Amgen, Apogee Therapeutics, Arcutis, Athenex, Bausch Health, Beiersdorf, Boehringer Ingelheim, Bond Avillion, Bristol Myers Squibb, Celgene, CeraVe, Dermavant, DermTech, Eli Lilly, EPI Health, Janssen Pharmaceuticals, LEO Pharma, L’Oreal, MC2 Therapeutics, Novartis, Ortho Dermatologics, PellePharm, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, SUN Pharmaceuticals, and UCB.

A position paper by the National Psoriasis Foundation’s Telemedicine Task Force outlines key principles and practices for managing psoriatic disease via telemedicine.

The success of telemedicine in managing chronic inflammatory skin conditions including psoriasis during the COVID-19 pandemic “highlighted that teledermatology can be used beyond the context of a global health crisis to provide continuity of care and improve access to health care more broadly,” the task force wrote in a paper published online in JAAD International.

Jean-philippe WALLET/Getty Images

Co–senior author George Han, MD, PhD, said in an interview that the impetus for the guidelines came from NPF patient advocates, who realized that the organization needed something to take to payers and governmental agencies to advocate for better access to dermatologic care. He is associate professor of dermatology and director of teledermatology at the Hofstra/Northwell department of dermatology, Hyde Park, New York.

“We realized that, in many places around the country, people don’t have access to dermatology.” In upstate New York, said Dr. Han, his anecdotal research has revealed wait times of 6 months or more.

As a guiding principle, the authors pronounce teledermatology “a reasonable alternative for providing long-term management of patients with psoriasis.” Research shows that nearly all dermatologists used teledermatology during the pandemic, the authors noted, and that well-run programs improve Psoriasis Area and Severity Index (PASI) scores and other measures on par with in-person care. Telemedicine may be especially useful for initial visits, they added, particularly when distance, patient incapacity, and circumstances prevent face-to-face evaluation.

Additional position statements emphasize that teledermatology should support rather than supplant in-person visits, and that this balance may be particularly important in cases involving psoriatic arthritis (PsA). “Even though we can’t do a physical exam and palpate some of those joints in person,” said Dr. Han, “tools have been developed that, through a series of questions the patient can answer, can guide you towards whether there is a high index of suspicion for psoriatic arthritis.” Such patients require in-person evaluation with urgency, he said, because delays in PsA diagnosis and treatment can lead to irreversible joint damage and significant functional impairment.

Another motivation for producing the guidelines, said Dr. Han, was that, even when underserved patients get a dermatology appointment, some providers may not have all the latest tools or medicines available for treating psoriasis. In such cases, telemedicine may allow dermatologists specializing in psoriasis care to extend their reach in comanaging patients with primary care physicians and community dermatologists.

Before the appointment, guidelines suggest determining what form of teledermatology will best suit each patient. Authors recommended gauging patients’ savviness with computers and cameras, and counseling patients regarding available virtual evaluation tools – such as live video visits, store-and-forward photo strategies, and assessment-tool training videos.

A subsequent guideline underscores the importance of continuously improving technology to support expeditious image capture and workflows that emulate in-person practice. Dr. Han explained, “we wanted to make sure that on the back end there’s adequate support such that – if through teledermatology, we determine that the patient should get, say, a systemic treatment – the patient is able to get the appropriate lab tests, get the medicine, and know how to inject it.”

Regarding reimbursement, Dr. Han said that policies varied prepandemic, but many commercial insurers covered telemedicine at a rate 20% lower than the in-person rate. During the pandemic, he said, insurers shifted to provide the higher rate for telemedicine, consistent with policies adopted by the Centers for Medicare & Medicaid Services.

“There are differences in coverage and reimbursement from plan to plan,” Dr. Han added. “And even within the same plan, there are carve-outs so that some plans don’t allow certain services. The big picture is that for the most part these services are covered at a level comparable to an in-person visit at present.”

With the Department of Health & Human Services’ public health emergency declaration expiring in May, he said, physicians have worried that some of the allowances made by CMS – such as lifting requirements that Medicare patients in rural areas be seen at care sites – will expire. “It seems that some of those limitations have been addressed, and those allowances are going to be extended until Congress is able to pass something that gives us durable access to telemedicine care. We think that based on the current environment telemedicine is here to stay.”

The study was funded by the NPF. Dr. Han has been an investigator, adviser, speaker, or researcher for AbbVie, Amgen, Apogee Therapeutics, Arcutis, Athenex, Bausch Health, Beiersdorf, Boehringer Ingelheim, Bond Avillion, Bristol Myers Squibb, Celgene, CeraVe, Dermavant, DermTech, Eli Lilly, EPI Health, Janssen Pharmaceuticals, LEO Pharma, L’Oreal, MC2 Therapeutics, Novartis, Ortho Dermatologics, PellePharm, Pfizer, Regeneron Pharmaceuticals, Sanofi Genzyme, SUN Pharmaceuticals, and UCB.