Outside of caffeine, I have very few addictions. One of them is “Midnight Diner.”

“Midnight Diner” is a quirky, sometimes funny, sometimes bittersweet, Japanese series on Netflix. It’s about a small diner in Tokyo, open only in the wee hours of the morning, its enigmatic owner/cook, and the eclectic patrons that come and go. Each is seeking a dish that means something to them.

One episode (spoiler alert, in case you’re planning to watch it) deals with the regulars realizing a fellow who frequently comes in and orders potato salad is secretly Japan’s most famous porn actor, Erect Oki. This revelation garners him the respect, awe, and envy of the other male patrons, though Mr. Oki would rather be left to his potato salad.

The jokes are there ... but as things develop, we learn he has the potato salad because it reminds him of his mother’s potato salad — and that he’s been cut off from his family for more than 20 years because of his career path. The potato salad is all he has left.

While preparing for a shoot, he learns his mother has Alzheimer’s disease, and immediately returns home. As they sit talking on the patio of a care center, she tells him about her son, who lives in Tokyo, and loves her potato salad. The show doesn’t make it clear if she ever remembers who he is.

In the darkening hallways of her mind, she asks his sister for help in making potato salad for her visitor. It’s too salty, though whether this is from the ingredients or his tears is also never stated.

The episode is a poignant reminder of how Alzheimer’s disease is a worldwide human problem. Not American. Not western. Not restricted by race, or ethnicity, or continent. It effects us all as a species, as families, and as individuals. No matter what our jobs or backgrounds are.

For those of us on this side of the desk, it’s a reminder that effective treatments for Alzheimer’s disease are still not available. Yes, we have all kinds of new toys, but from a practical viewpoint it’s hard to say that we’ve made any major advances. I’m sure my drug reps will disagree with me, and I’m not saying any of the treatments of the last 28 years are worthless, but even now we’re still far from a cure, or even something that stops progression.

That’s not from lack of trying, either.

For all the jokes about his job, Mr. Oki is no different from any other children trying to hold onto their parents as the disease slowly takes them away.

I hope we have real answers, soon.
 

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

Outside of caffeine, I have very few addictions. One of them is “Midnight Diner.”

“Midnight Diner” is a quirky, sometimes funny, sometimes bittersweet, Japanese series on Netflix. It’s about a small diner in Tokyo, open only in the wee hours of the morning, its enigmatic owner/cook, and the eclectic patrons that come and go. Each is seeking a dish that means something to them.

One episode (spoiler alert, in case you’re planning to watch it) deals with the regulars realizing a fellow who frequently comes in and orders potato salad is secretly Japan’s most famous porn actor, Erect Oki. This revelation garners him the respect, awe, and envy of the other male patrons, though Mr. Oki would rather be left to his potato salad.

The jokes are there ... but as things develop, we learn he has the potato salad because it reminds him of his mother’s potato salad — and that he’s been cut off from his family for more than 20 years because of his career path. The potato salad is all he has left.

While preparing for a shoot, he learns his mother has Alzheimer’s disease, and immediately returns home. As they sit talking on the patio of a care center, she tells him about her son, who lives in Tokyo, and loves her potato salad. The show doesn’t make it clear if she ever remembers who he is.

In the darkening hallways of her mind, she asks his sister for help in making potato salad for her visitor. It’s too salty, though whether this is from the ingredients or his tears is also never stated.

The episode is a poignant reminder of how Alzheimer’s disease is a worldwide human problem. Not American. Not western. Not restricted by race, or ethnicity, or continent. It effects us all as a species, as families, and as individuals. No matter what our jobs or backgrounds are.

For those of us on this side of the desk, it’s a reminder that effective treatments for Alzheimer’s disease are still not available. Yes, we have all kinds of new toys, but from a practical viewpoint it’s hard to say that we’ve made any major advances. I’m sure my drug reps will disagree with me, and I’m not saying any of the treatments of the last 28 years are worthless, but even now we’re still far from a cure, or even something that stops progression.

That’s not from lack of trying, either.

For all the jokes about his job, Mr. Oki is no different from any other children trying to hold onto their parents as the disease slowly takes them away.

I hope we have real answers, soon.
 

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

Outside of caffeine, I have very few addictions. One of them is “Midnight Diner.”

“Midnight Diner” is a quirky, sometimes funny, sometimes bittersweet, Japanese series on Netflix. It’s about a small diner in Tokyo, open only in the wee hours of the morning, its enigmatic owner/cook, and the eclectic patrons that come and go. Each is seeking a dish that means something to them.

One episode (spoiler alert, in case you’re planning to watch it) deals with the regulars realizing a fellow who frequently comes in and orders potato salad is secretly Japan’s most famous porn actor, Erect Oki. This revelation garners him the respect, awe, and envy of the other male patrons, though Mr. Oki would rather be left to his potato salad.

The jokes are there ... but as things develop, we learn he has the potato salad because it reminds him of his mother’s potato salad — and that he’s been cut off from his family for more than 20 years because of his career path. The potato salad is all he has left.

While preparing for a shoot, he learns his mother has Alzheimer’s disease, and immediately returns home. As they sit talking on the patio of a care center, she tells him about her son, who lives in Tokyo, and loves her potato salad. The show doesn’t make it clear if she ever remembers who he is.

In the darkening hallways of her mind, she asks his sister for help in making potato salad for her visitor. It’s too salty, though whether this is from the ingredients or his tears is also never stated.

The episode is a poignant reminder of how Alzheimer’s disease is a worldwide human problem. Not American. Not western. Not restricted by race, or ethnicity, or continent. It effects us all as a species, as families, and as individuals. No matter what our jobs or backgrounds are.

For those of us on this side of the desk, it’s a reminder that effective treatments for Alzheimer’s disease are still not available. Yes, we have all kinds of new toys, but from a practical viewpoint it’s hard to say that we’ve made any major advances. I’m sure my drug reps will disagree with me, and I’m not saying any of the treatments of the last 28 years are worthless, but even now we’re still far from a cure, or even something that stops progression.

That’s not from lack of trying, either.

For all the jokes about his job, Mr. Oki is no different from any other children trying to hold onto their parents as the disease slowly takes them away.

I hope we have real answers, soon.
 

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

Scenario I. Let’s say you wake with a collection of symptoms. None of them is concerning, but the combination seems a bit unusual, or at least confusing. You would like to speak to your PCP, whom you have known for a long time, and ask for either reassurance or advice on whether you should make an appointment. However, your experience with the front office’s organization tells you that the quick 4-minute conversation you’re looking for is not going to happen easily.

You have that robotic phone message memorized. It begins suggesting that you think you have an emergency to call 911. Then it reminds you that if have a question about COVID to press “2,” which will take you to a recorded message and eventually link you to a triage nurse if the recording doesn’t answer your questions. If you need a prescription refill you should press “3.” If you are a doctor’s office and wish speak to the doctor press “4.” If you know you need an appointment press “5.” And finally if you have a question press “6” and leave a message and a nurse will get back to you before the end of the day.

The good news is that your PCP’s office is good to its word and will return your call the same day, but the bad news is that it is likely to be well into the afternoon. And, while you don’t consider your symptoms life-threatening, you don’t want getting an answer to be an exercise in schedule disruption.

You were a doctor before you retired and you still have an “office.” It’s really more of a combination den and studio. So, technically you are a doctor’s office wanting to speak to the doctor. And, you know that pressing “4” will get you the answer you are looking for in a matter of minutes.



Scenario II. Your spouse, or your aunt, or the elderly widow next door asks you to accompany her at an upcoming doctor’s visit because she had been having trouble understanding the physician’s plan regarding further diagnosis and possible treatment. She believes having you along as kind of an interpreter/advocate would be a big help. Do you agree and do you make any stipulations?



Scenario III. Your PCP has referred you to a specialist. You are filling out the previsit form(s). Do you list your occupation as “retired physician” or just “retired”? Or just leave it blank?


Whether you deserve it or not, graduating from medical school has conferred on you a specialness in the eyes of many people. It is assumed you are smarter than the average bear and in taking the Hippocratic oath you have joined an elite club. And, with that membership comes some special undefined privileges.

But with that specialness there are are some downsides. For example, in some states being a physician once allowed you to have a license plate with “MD” in the number sequence. Sometimes that helped you avoid the occasional parking ticket. That is until folks realized the “MD” made you a target for car thieves and drug seekers who mistakenly believe we all carry drugs in our glove compartments.

So what about that first scenario? Do you press “4” to jump yourself to the head of the queue and avoid the inconvenience of having to wait for a reasonably timely response from your PCP? After all, you are fellow physicians and you’ve known her for a decade or two. If you are retired is your time any more valuable than that of her other patients? If you are still in active practice you can argue that getting special attention will benefit your patients. But, if it’s a weekend and you are off it’s a bit harder to rationalize special treatment. Playing the doctor card in this situation is your own decision but you must be prepared to shoulder the perceptions by your PCP and her staff as well as your own sense of fairness.

The other two scenarios are much different. In neither are you risking the impression that you are asking for a favor. But, they each have their downsides. In the second scenario you are doing someone a favor to act as an interpreter. How could this have downside? Unfortunately, what happens too often in situations like this is that when the patient’s physician learns that you are a fellow physician, the rest of the visit becomes a dialogue in doctor-speak between the two physicians with the patient sitting by as an observer. In the end this discussion may benefit the patient by creating a treatment plan that the patient can understand either because they overheard it or more likely because you eventually explained it to them.

On the other the hand, this doctor-to-doctor chat has done nothing to build a doctor-patient relationship that had obviously been lacking something. In situations like this it is probably better to keep the doctor card up your sleeve to be played at the end of the visit or maybe not at all. Before agreeing to be an interpreter/advocate, ask the patient to avoid mentioning that you are a physician. Instead, ask that she introduce you as a friend or relative that she has asked to come along to serve as a memory bank. During the visit it may be helpful to occasionally interject and suggest that the patient ask a question that hasn’t been adequately addressed. While some physicians may be upset when they belatedly find you have not revealed up front that you are a physician, I find this a harmless omission that has the benefit of improving patient care.

The final scenario — in which you are the patient — is likely to occur more often as you get older. When filling out a previsit form, I often simply put retired or leave it blank. But, how I answer the question often seems to be irrelevant because I have learned that physicians and their staff read those boilerplate forms so cursorily that even when I report my status as “retired physician” everyone seems surprised if and when it later comes to light.

My rationale in keeping the doctor card close to my vest in these situations is that I want to be addressed without any assumptions regarding my medical knowledge, which in my situation is well over half a century old and spotty at best. I don’t want my physicians to say “I’m sure you understand.” Because I often don’t. I would like them to learn about who I am just as I hope they would other patients. I won’t be offended if they “talk down” to me. If this specialist is as good as I’ve heard she is, I want to hear her full performance, not one edited for fellow and former physicians.

There have been numerous times when patients have made me feel special because of what I have done in my role as a physician. But, that is a kind specialness that must be earned. It doesn’t arrive gold edged with a list of special privileges. If it comes with any extras, they are risks that must be avoided.

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 [email protected].

Scenario I. Let’s say you wake with a collection of symptoms. None of them is concerning, but the combination seems a bit unusual, or at least confusing. You would like to speak to your PCP, whom you have known for a long time, and ask for either reassurance or advice on whether you should make an appointment. However, your experience with the front office’s organization tells you that the quick 4-minute conversation you’re looking for is not going to happen easily.

You have that robotic phone message memorized. It begins suggesting that you think you have an emergency to call 911. Then it reminds you that if have a question about COVID to press “2,” which will take you to a recorded message and eventually link you to a triage nurse if the recording doesn’t answer your questions. If you need a prescription refill you should press “3.” If you are a doctor’s office and wish speak to the doctor press “4.” If you know you need an appointment press “5.” And finally if you have a question press “6” and leave a message and a nurse will get back to you before the end of the day.

The good news is that your PCP’s office is good to its word and will return your call the same day, but the bad news is that it is likely to be well into the afternoon. And, while you don’t consider your symptoms life-threatening, you don’t want getting an answer to be an exercise in schedule disruption.

You were a doctor before you retired and you still have an “office.” It’s really more of a combination den and studio. So, technically you are a doctor’s office wanting to speak to the doctor. And, you know that pressing “4” will get you the answer you are looking for in a matter of minutes.



Scenario II. Your spouse, or your aunt, or the elderly widow next door asks you to accompany her at an upcoming doctor’s visit because she had been having trouble understanding the physician’s plan regarding further diagnosis and possible treatment. She believes having you along as kind of an interpreter/advocate would be a big help. Do you agree and do you make any stipulations?



Scenario III. Your PCP has referred you to a specialist. You are filling out the previsit form(s). Do you list your occupation as “retired physician” or just “retired”? Or just leave it blank?


Whether you deserve it or not, graduating from medical school has conferred on you a specialness in the eyes of many people. It is assumed you are smarter than the average bear and in taking the Hippocratic oath you have joined an elite club. And, with that membership comes some special undefined privileges.

But with that specialness there are are some downsides. For example, in some states being a physician once allowed you to have a license plate with “MD” in the number sequence. Sometimes that helped you avoid the occasional parking ticket. That is until folks realized the “MD” made you a target for car thieves and drug seekers who mistakenly believe we all carry drugs in our glove compartments.

So what about that first scenario? Do you press “4” to jump yourself to the head of the queue and avoid the inconvenience of having to wait for a reasonably timely response from your PCP? After all, you are fellow physicians and you’ve known her for a decade or two. If you are retired is your time any more valuable than that of her other patients? If you are still in active practice you can argue that getting special attention will benefit your patients. But, if it’s a weekend and you are off it’s a bit harder to rationalize special treatment. Playing the doctor card in this situation is your own decision but you must be prepared to shoulder the perceptions by your PCP and her staff as well as your own sense of fairness.

The other two scenarios are much different. In neither are you risking the impression that you are asking for a favor. But, they each have their downsides. In the second scenario you are doing someone a favor to act as an interpreter. How could this have downside? Unfortunately, what happens too often in situations like this is that when the patient’s physician learns that you are a fellow physician, the rest of the visit becomes a dialogue in doctor-speak between the two physicians with the patient sitting by as an observer. In the end this discussion may benefit the patient by creating a treatment plan that the patient can understand either because they overheard it or more likely because you eventually explained it to them.

On the other the hand, this doctor-to-doctor chat has done nothing to build a doctor-patient relationship that had obviously been lacking something. In situations like this it is probably better to keep the doctor card up your sleeve to be played at the end of the visit or maybe not at all. Before agreeing to be an interpreter/advocate, ask the patient to avoid mentioning that you are a physician. Instead, ask that she introduce you as a friend or relative that she has asked to come along to serve as a memory bank. During the visit it may be helpful to occasionally interject and suggest that the patient ask a question that hasn’t been adequately addressed. While some physicians may be upset when they belatedly find you have not revealed up front that you are a physician, I find this a harmless omission that has the benefit of improving patient care.

The final scenario — in which you are the patient — is likely to occur more often as you get older. When filling out a previsit form, I often simply put retired or leave it blank. But, how I answer the question often seems to be irrelevant because I have learned that physicians and their staff read those boilerplate forms so cursorily that even when I report my status as “retired physician” everyone seems surprised if and when it later comes to light.

My rationale in keeping the doctor card close to my vest in these situations is that I want to be addressed without any assumptions regarding my medical knowledge, which in my situation is well over half a century old and spotty at best. I don’t want my physicians to say “I’m sure you understand.” Because I often don’t. I would like them to learn about who I am just as I hope they would other patients. I won’t be offended if they “talk down” to me. If this specialist is as good as I’ve heard she is, I want to hear her full performance, not one edited for fellow and former physicians.

There have been numerous times when patients have made me feel special because of what I have done in my role as a physician. But, that is a kind specialness that must be earned. It doesn’t arrive gold edged with a list of special privileges. If it comes with any extras, they are risks that must be avoided.

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 [email protected].

Scenario I. Let’s say you wake with a collection of symptoms. None of them is concerning, but the combination seems a bit unusual, or at least confusing. You would like to speak to your PCP, whom you have known for a long time, and ask for either reassurance or advice on whether you should make an appointment. However, your experience with the front office’s organization tells you that the quick 4-minute conversation you’re looking for is not going to happen easily.

You have that robotic phone message memorized. It begins suggesting that you think you have an emergency to call 911. Then it reminds you that if have a question about COVID to press “2,” which will take you to a recorded message and eventually link you to a triage nurse if the recording doesn’t answer your questions. If you need a prescription refill you should press “3.” If you are a doctor’s office and wish speak to the doctor press “4.” If you know you need an appointment press “5.” And finally if you have a question press “6” and leave a message and a nurse will get back to you before the end of the day.

The good news is that your PCP’s office is good to its word and will return your call the same day, but the bad news is that it is likely to be well into the afternoon. And, while you don’t consider your symptoms life-threatening, you don’t want getting an answer to be an exercise in schedule disruption.

You were a doctor before you retired and you still have an “office.” It’s really more of a combination den and studio. So, technically you are a doctor’s office wanting to speak to the doctor. And, you know that pressing “4” will get you the answer you are looking for in a matter of minutes.



Scenario II. Your spouse, or your aunt, or the elderly widow next door asks you to accompany her at an upcoming doctor’s visit because she had been having trouble understanding the physician’s plan regarding further diagnosis and possible treatment. She believes having you along as kind of an interpreter/advocate would be a big help. Do you agree and do you make any stipulations?



Scenario III. Your PCP has referred you to a specialist. You are filling out the previsit form(s). Do you list your occupation as “retired physician” or just “retired”? Or just leave it blank?


Whether you deserve it or not, graduating from medical school has conferred on you a specialness in the eyes of many people. It is assumed you are smarter than the average bear and in taking the Hippocratic oath you have joined an elite club. And, with that membership comes some special undefined privileges.

But with that specialness there are are some downsides. For example, in some states being a physician once allowed you to have a license plate with “MD” in the number sequence. Sometimes that helped you avoid the occasional parking ticket. That is until folks realized the “MD” made you a target for car thieves and drug seekers who mistakenly believe we all carry drugs in our glove compartments.

So what about that first scenario? Do you press “4” to jump yourself to the head of the queue and avoid the inconvenience of having to wait for a reasonably timely response from your PCP? After all, you are fellow physicians and you’ve known her for a decade or two. If you are retired is your time any more valuable than that of her other patients? If you are still in active practice you can argue that getting special attention will benefit your patients. But, if it’s a weekend and you are off it’s a bit harder to rationalize special treatment. Playing the doctor card in this situation is your own decision but you must be prepared to shoulder the perceptions by your PCP and her staff as well as your own sense of fairness.

The other two scenarios are much different. In neither are you risking the impression that you are asking for a favor. But, they each have their downsides. In the second scenario you are doing someone a favor to act as an interpreter. How could this have downside? Unfortunately, what happens too often in situations like this is that when the patient’s physician learns that you are a fellow physician, the rest of the visit becomes a dialogue in doctor-speak between the two physicians with the patient sitting by as an observer. In the end this discussion may benefit the patient by creating a treatment plan that the patient can understand either because they overheard it or more likely because you eventually explained it to them.

On the other the hand, this doctor-to-doctor chat has done nothing to build a doctor-patient relationship that had obviously been lacking something. In situations like this it is probably better to keep the doctor card up your sleeve to be played at the end of the visit or maybe not at all. Before agreeing to be an interpreter/advocate, ask the patient to avoid mentioning that you are a physician. Instead, ask that she introduce you as a friend or relative that she has asked to come along to serve as a memory bank. During the visit it may be helpful to occasionally interject and suggest that the patient ask a question that hasn’t been adequately addressed. While some physicians may be upset when they belatedly find you have not revealed up front that you are a physician, I find this a harmless omission that has the benefit of improving patient care.

The final scenario — in which you are the patient — is likely to occur more often as you get older. When filling out a previsit form, I often simply put retired or leave it blank. But, how I answer the question often seems to be irrelevant because I have learned that physicians and their staff read those boilerplate forms so cursorily that even when I report my status as “retired physician” everyone seems surprised if and when it later comes to light.

My rationale in keeping the doctor card close to my vest in these situations is that I want to be addressed without any assumptions regarding my medical knowledge, which in my situation is well over half a century old and spotty at best. I don’t want my physicians to say “I’m sure you understand.” Because I often don’t. I would like them to learn about who I am just as I hope they would other patients. I won’t be offended if they “talk down” to me. If this specialist is as good as I’ve heard she is, I want to hear her full performance, not one edited for fellow and former physicians.

There have been numerous times when patients have made me feel special because of what I have done in my role as a physician. But, that is a kind specialness that must be earned. It doesn’t arrive gold edged with a list of special privileges. If it comes with any extras, they are risks that must be avoided.

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 [email protected].

The Food and Drug Administration (FDA) has approved the targeted interleukin-13 inhibitor lebrikizumab (Ebglyss) for the treatment of adults and children age 12 years and older who have moderate to severe atopic dermatitis (AD) that is not well controlled, despite treatment with topical prescription therapies.

The recommended initial starting dose of lebrikizumab consists of 500 mg (two 250 mg injections) at baseline and week 2, followed by 250 mg every 2 weeks until week 16 or later when adequate clinical response is achieved. Then, maintenance dosing is recommended with one monthly injection (250 mg every 4 weeks). Children aged 12-17 years must weigh at least 88 pounds (40 kg) to be eligible for lebrikizumab treatment.

According to a press release from Lilly, which has been developing lebrikizumab, approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1000 adults and children aged 12 and older with moderate to severe AD. The primary endpoint for these studies was evaluated at 16 weeks and measured clear or almost clear skin (IGA score of 0 or 1).

According to Lilly, 38% of people in ADvocate 1 and 2 who took lebrikizumab achieved clear or almost-clear skin at 16 weeks, compared with 12% of those in the placebo arm, and 10% experienced these results as early as 4 weeks. Of those treated with lebrikizumab who experienced clear or almost-clear skin at week 16, 77% maintained those results at 1 year on the once-monthly dose. In addition, on average, 43% of those on lebrikizumab experienced relief of itch at 16 weeks, compared with 12% of those on placebo, according to the press release. 

The most common side effects of lebrikizumab observed in the clinical trials include eye and eyelid inflammation, such as redness, swelling, and itching; injection-site reactions; and herpes zoster (shingles).

Lebrikizumab was approved in Japan in January 2024, and by the European Commission in 2023.

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

The Food and Drug Administration (FDA) has approved the targeted interleukin-13 inhibitor lebrikizumab (Ebglyss) for the treatment of adults and children age 12 years and older who have moderate to severe atopic dermatitis (AD) that is not well controlled, despite treatment with topical prescription therapies.

The recommended initial starting dose of lebrikizumab consists of 500 mg (two 250 mg injections) at baseline and week 2, followed by 250 mg every 2 weeks until week 16 or later when adequate clinical response is achieved. Then, maintenance dosing is recommended with one monthly injection (250 mg every 4 weeks). Children aged 12-17 years must weigh at least 88 pounds (40 kg) to be eligible for lebrikizumab treatment.

According to a press release from Lilly, which has been developing lebrikizumab, approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1000 adults and children aged 12 and older with moderate to severe AD. The primary endpoint for these studies was evaluated at 16 weeks and measured clear or almost clear skin (IGA score of 0 or 1).

According to Lilly, 38% of people in ADvocate 1 and 2 who took lebrikizumab achieved clear or almost-clear skin at 16 weeks, compared with 12% of those in the placebo arm, and 10% experienced these results as early as 4 weeks. Of those treated with lebrikizumab who experienced clear or almost-clear skin at week 16, 77% maintained those results at 1 year on the once-monthly dose. In addition, on average, 43% of those on lebrikizumab experienced relief of itch at 16 weeks, compared with 12% of those on placebo, according to the press release. 

The most common side effects of lebrikizumab observed in the clinical trials include eye and eyelid inflammation, such as redness, swelling, and itching; injection-site reactions; and herpes zoster (shingles).

Lebrikizumab was approved in Japan in January 2024, and by the European Commission in 2023.

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

The Food and Drug Administration (FDA) has approved the targeted interleukin-13 inhibitor lebrikizumab (Ebglyss) for the treatment of adults and children age 12 years and older who have moderate to severe atopic dermatitis (AD) that is not well controlled, despite treatment with topical prescription therapies.

The recommended initial starting dose of lebrikizumab consists of 500 mg (two 250 mg injections) at baseline and week 2, followed by 250 mg every 2 weeks until week 16 or later when adequate clinical response is achieved. Then, maintenance dosing is recommended with one monthly injection (250 mg every 4 weeks). Children aged 12-17 years must weigh at least 88 pounds (40 kg) to be eligible for lebrikizumab treatment.

According to a press release from Lilly, which has been developing lebrikizumab, approval was based on results from the ADvocate 1, ADvocate 2, and ADhere studies, which included over 1000 adults and children aged 12 and older with moderate to severe AD. The primary endpoint for these studies was evaluated at 16 weeks and measured clear or almost clear skin (IGA score of 0 or 1).

According to Lilly, 38% of people in ADvocate 1 and 2 who took lebrikizumab achieved clear or almost-clear skin at 16 weeks, compared with 12% of those in the placebo arm, and 10% experienced these results as early as 4 weeks. Of those treated with lebrikizumab who experienced clear or almost-clear skin at week 16, 77% maintained those results at 1 year on the once-monthly dose. In addition, on average, 43% of those on lebrikizumab experienced relief of itch at 16 weeks, compared with 12% of those on placebo, according to the press release. 

The most common side effects of lebrikizumab observed in the clinical trials include eye and eyelid inflammation, such as redness, swelling, and itching; injection-site reactions; and herpes zoster (shingles).

Lebrikizumab was approved in Japan in January 2024, and by the European Commission in 2023.

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

BY XOCHITL LONGSTAFF, BS; ANGELINA LABIB, MD; AND DAWN EICHENFIELD, MD, PHD

Diagnosis: Subungual bony exostosis

X-ray showed findings were consistent with subungual bony exostosis

Rady Children’s Hospital San Diego

The patient was referred to orthopedics for further evaluation and ultimately underwent excisional surgery. At her most recent follow-up visit with orthopedic surgery, her new nail was observed to be growing well.

Rady Children’s Hospital San Diego

Subungual exostosis, also known as Dupuytren’s exostosis, is a benign osteocartilaginous tumor that classically presents as a bony growth at the dorsal aspect of the distal phalanx of the great toe, near the nail bed. The pathogenesis remains unclear, but suggested etiologies include prior trauma, infection, and hereditary abnormalities.¹

Clinically, lesions can be painful and may be associated with skin ulceration. The location at the dorsal distal great toe is a key distinguishing feature. Physical exam reveals a firm, fixed nodule with a hyperkeratotic smooth surface.²

MiLo Studios

Radiographic evaluation, particularly with a lateral view, is often diagnostic. The classic radiographic finding in subungual exostosis is an osseous structure connected to the distal phalanx, with a hazy periphery representing a fibrocartilage cap.

Treatment involves complete marginal excision. The complications from surgical excision are minimal, with the most common being recurrence.³ However, the recurrence rate is also generally low, around 4%.¹

courtesy University of Miami

Ms. Longstaff is currently completing a research year as a Pediatric Clinical Research Fellow at University of California San Diego (UCSD) Rady Children’s Hospital prior to finishing her final year at the David Geffen School of Medicine at the University of California, Los Angeles. Dr. Labib is the Post-Doctoral Pediatric Clinical Research Fellow at UCSD Rady Children’s Hospital. Dr. Eichenfield is a dermatologist at Rady Children’s Hospital–San Diego and assistant clinical professor at UCSD.

University of California, San Diego

References

1. Alabdullrahman LW et al. Osteochondroma. In: StatPearls [Internet]. 2024 Feb 26. https://www.ncbi.nlm.nih.gov/books/NBK544296/#.

2. DaCambra MP et al. Clin Orthop Relat Res. 2014 Apr;472(4):1251-9. doi: 10.1007/s11999-013-3345-4.

3. Womack ME et al. J Am Acad Orthop Surg Glob Res Rev. 2022 Mar 22;6(3):e21.00239. doi: 10.5435/JAAOSGlobal-D-21-00239.

BY XOCHITL LONGSTAFF, BS; ANGELINA LABIB, MD; AND DAWN EICHENFIELD, MD, PHD

Diagnosis: Subungual bony exostosis

X-ray showed findings were consistent with subungual bony exostosis

Rady Children’s Hospital San Diego

The patient was referred to orthopedics for further evaluation and ultimately underwent excisional surgery. At her most recent follow-up visit with orthopedic surgery, her new nail was observed to be growing well.

Rady Children’s Hospital San Diego

Subungual exostosis, also known as Dupuytren’s exostosis, is a benign osteocartilaginous tumor that classically presents as a bony growth at the dorsal aspect of the distal phalanx of the great toe, near the nail bed. The pathogenesis remains unclear, but suggested etiologies include prior trauma, infection, and hereditary abnormalities.¹

Clinically, lesions can be painful and may be associated with skin ulceration. The location at the dorsal distal great toe is a key distinguishing feature. Physical exam reveals a firm, fixed nodule with a hyperkeratotic smooth surface.²

MiLo Studios

Radiographic evaluation, particularly with a lateral view, is often diagnostic. The classic radiographic finding in subungual exostosis is an osseous structure connected to the distal phalanx, with a hazy periphery representing a fibrocartilage cap.

Treatment involves complete marginal excision. The complications from surgical excision are minimal, with the most common being recurrence.³ However, the recurrence rate is also generally low, around 4%.¹

courtesy University of Miami

Ms. Longstaff is currently completing a research year as a Pediatric Clinical Research Fellow at University of California San Diego (UCSD) Rady Children’s Hospital prior to finishing her final year at the David Geffen School of Medicine at the University of California, Los Angeles. Dr. Labib is the Post-Doctoral Pediatric Clinical Research Fellow at UCSD Rady Children’s Hospital. Dr. Eichenfield is a dermatologist at Rady Children’s Hospital–San Diego and assistant clinical professor at UCSD.

University of California, San Diego

References

1. Alabdullrahman LW et al. Osteochondroma. In: StatPearls [Internet]. 2024 Feb 26. https://www.ncbi.nlm.nih.gov/books/NBK544296/#.

2. DaCambra MP et al. Clin Orthop Relat Res. 2014 Apr;472(4):1251-9. doi: 10.1007/s11999-013-3345-4.

3. Womack ME et al. J Am Acad Orthop Surg Glob Res Rev. 2022 Mar 22;6(3):e21.00239. doi: 10.5435/JAAOSGlobal-D-21-00239.

BY XOCHITL LONGSTAFF, BS; ANGELINA LABIB, MD; AND DAWN EICHENFIELD, MD, PHD

Diagnosis: Subungual bony exostosis

X-ray showed findings were consistent with subungual bony exostosis

Rady Children’s Hospital San Diego

The patient was referred to orthopedics for further evaluation and ultimately underwent excisional surgery. At her most recent follow-up visit with orthopedic surgery, her new nail was observed to be growing well.

Rady Children’s Hospital San Diego

Subungual exostosis, also known as Dupuytren’s exostosis, is a benign osteocartilaginous tumor that classically presents as a bony growth at the dorsal aspect of the distal phalanx of the great toe, near the nail bed. The pathogenesis remains unclear, but suggested etiologies include prior trauma, infection, and hereditary abnormalities.¹

Clinically, lesions can be painful and may be associated with skin ulceration. The location at the dorsal distal great toe is a key distinguishing feature. Physical exam reveals a firm, fixed nodule with a hyperkeratotic smooth surface.²

MiLo Studios

Radiographic evaluation, particularly with a lateral view, is often diagnostic. The classic radiographic finding in subungual exostosis is an osseous structure connected to the distal phalanx, with a hazy periphery representing a fibrocartilage cap.

Treatment involves complete marginal excision. The complications from surgical excision are minimal, with the most common being recurrence.³ However, the recurrence rate is also generally low, around 4%.¹

courtesy University of Miami

Ms. Longstaff is currently completing a research year as a Pediatric Clinical Research Fellow at University of California San Diego (UCSD) Rady Children’s Hospital prior to finishing her final year at the David Geffen School of Medicine at the University of California, Los Angeles. Dr. Labib is the Post-Doctoral Pediatric Clinical Research Fellow at UCSD Rady Children’s Hospital. Dr. Eichenfield is a dermatologist at Rady Children’s Hospital–San Diego and assistant clinical professor at UCSD.

University of California, San Diego

References

1. Alabdullrahman LW et al. Osteochondroma. In: StatPearls [Internet]. 2024 Feb 26. https://www.ncbi.nlm.nih.gov/books/NBK544296/#.

2. DaCambra MP et al. Clin Orthop Relat Res. 2014 Apr;472(4):1251-9. doi: 10.1007/s11999-013-3345-4.

3. Womack ME et al. J Am Acad Orthop Surg Glob Res Rev. 2022 Mar 22;6(3):e21.00239. doi: 10.5435/JAAOSGlobal-D-21-00239.

Compared with endoscopy, the Baveno VI criteria present a noninvasive and cost-effective method to detect high-risk varices in patients with Child-Pugh A cirrhosis, according to new research.

Although upper gastrointestinal endoscopy continues to be the gold standard for detecting varices, the Baveno VI criteria combine liver stiffness and platelet count values to rule out high-risk varices, which can save on endoscopy costs.

“The Baveno VI criteria can reduce the need for endoscopies in patients with cirrhosis, but it is important to ascertain if they are also cost-effective,” said senior author Emmanuel Tsochatzis, MD, professor of hepatology at the University College London Institute for Liver and Digestive Health and Royal Free Hospital in London.

Andrew McConnell/EASL

“Our findings confirm that the application of these criteria is highly cost-effective, and given the fact that they are also safe, should be considered for widespread implementation,” he said.

The study was published online in Clinical Gastroenterology and Hepatology.
 

Baveno VI Criteria Analysis

On the basis of the Baveno VI Consensus, endoscopy screening can be avoided in patients with compensated advanced chronic liver disease and Child-Pugh A cirrhosis who have a platelet count > 150,000/mm³ and a liver stiffness measurement < 20 kPa. 

In addition, expanded Baveno VI criteria have suggested optimized cut-off values to avoid even more endoscopies — at a platelet value of > 110,000/mm³ and a liver stiffness < 25 kPa.

Previous research indicates that the expanded criteria could avoid double the number of endoscopies, the authors wrote, with a risk of missing high-risk varices in 1.6% of patients with the criteria and 0.6% of overall study participants. Both criteria have been validated in large groups of patients with compensated cirrhosis of different etiologies, but the cost-effectiveness hasn’t been analyzed.

Dr. Tsochatzis and colleagues created an analytical decision model to estimate the costs and benefits of using the Baveno VI criteria as compared with endoscopy as the standard of care among a hypothetical cohort of 1000 patients with Child-Pugh A cirrhosis. The research team looked at costs and clinical outcomes based on the United Kingdom National Health Service perspective at 1 year from diagnosis and then estimated the expected costs and outcomes at 5 years and 20 years, including factors such as liver disease progression and variceal bleeding.

As part of the model, the Baveno VI criteria were implemented at annual screenings with targeted endoscopy for patients who met the criteria, as compared with endoscopy as a biannual screening using esophagogastroduodenoscopy for everyone.

In general, the Baveno VI criteria were cost-effective compared with endoscopy in all analyses, including all time points, as well as deterministic and probabilistic sensitivity analyses. The cost of using the criteria was £67 per patient, as compared with £411 per patient for esophagogastroduodenoscopy.

For the 1000 patients, the criteria produced 0.16 additional quality-adjusted life years (QALYs) per patient at an incremental cost of £326, or about $443, over 5 years. This resulted in an incremental cost-effectiveness ratio (ICER) of £2081, or $2830, per additional QALY gained.

In addition, the incremental net monetary benefit of the Baveno VI criteria was £2808, or $3819, over 5 years per patient.

The results were also consistent and cost-effective in Canada and Spain using relevant cost inputs from those countries. In Canada, the ICER per QALY estimates were €3535, or $3712, over 5 years and €4610, or $4841, over 20 years. In Spain, the ICER per QALY estimates were €1966, or $2064, over 5 years and €2225, or $2336, over 20 years.
 

Baveno VI Considerations

Despite the small risk of false negatives, the Baveno VI criteria could avoid unnecessary endoscopies and provide significant cost savings, the study authors wrote.

“It should be mentioned, however, that sparing endoscopies could result in missing the incidental detection of esophageal and gastric cancers, particularly in patients with higher risk, such as those who misuse alcohol,” Dr. Tsochatzis said.

Future studies could investigate ways to broaden the applicability of the Baveno VI criteria to other patient subgroups, identify optimal cut-off points, and incorporate patients with systemic therapies.

“Baveno VI criteria can be safely used to avoid endoscopy in a substantial proportion of patients with compensated cirrhosis,” said Wayne Bai, MBChB, a gastroenterologist at Waikato Hospital and the University of Auckland in New Zealand.

Dr. Bai, who wasn’t involved with this study, has researched the Baveno VI criteria and participated in Baveno VII criteria meetings. In an analysis of more than two dozen studies, he and colleagues found that the Baveno VI criteria had a pooled 99% negative predictive value for ruling out high-risk varices and weren’t affected by the cause of cirrhosis. However, expanding the criteria had suboptimal performance in some cases.

Waikato Hospital

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

Compared with endoscopy, the Baveno VI criteria present a noninvasive and cost-effective method to detect high-risk varices in patients with Child-Pugh A cirrhosis, according to new research.

Although upper gastrointestinal endoscopy continues to be the gold standard for detecting varices, the Baveno VI criteria combine liver stiffness and platelet count values to rule out high-risk varices, which can save on endoscopy costs.

“The Baveno VI criteria can reduce the need for endoscopies in patients with cirrhosis, but it is important to ascertain if they are also cost-effective,” said senior author Emmanuel Tsochatzis, MD, professor of hepatology at the University College London Institute for Liver and Digestive Health and Royal Free Hospital in London.

Andrew McConnell/EASL

“Our findings confirm that the application of these criteria is highly cost-effective, and given the fact that they are also safe, should be considered for widespread implementation,” he said.

The study was published online in Clinical Gastroenterology and Hepatology.
 

Baveno VI Criteria Analysis

On the basis of the Baveno VI Consensus, endoscopy screening can be avoided in patients with compensated advanced chronic liver disease and Child-Pugh A cirrhosis who have a platelet count > 150,000/mm³ and a liver stiffness measurement < 20 kPa. 

In addition, expanded Baveno VI criteria have suggested optimized cut-off values to avoid even more endoscopies — at a platelet value of > 110,000/mm³ and a liver stiffness < 25 kPa.

Previous research indicates that the expanded criteria could avoid double the number of endoscopies, the authors wrote, with a risk of missing high-risk varices in 1.6% of patients with the criteria and 0.6% of overall study participants. Both criteria have been validated in large groups of patients with compensated cirrhosis of different etiologies, but the cost-effectiveness hasn’t been analyzed.

Dr. Tsochatzis and colleagues created an analytical decision model to estimate the costs and benefits of using the Baveno VI criteria as compared with endoscopy as the standard of care among a hypothetical cohort of 1000 patients with Child-Pugh A cirrhosis. The research team looked at costs and clinical outcomes based on the United Kingdom National Health Service perspective at 1 year from diagnosis and then estimated the expected costs and outcomes at 5 years and 20 years, including factors such as liver disease progression and variceal bleeding.

As part of the model, the Baveno VI criteria were implemented at annual screenings with targeted endoscopy for patients who met the criteria, as compared with endoscopy as a biannual screening using esophagogastroduodenoscopy for everyone.

In general, the Baveno VI criteria were cost-effective compared with endoscopy in all analyses, including all time points, as well as deterministic and probabilistic sensitivity analyses. The cost of using the criteria was £67 per patient, as compared with £411 per patient for esophagogastroduodenoscopy.

For the 1000 patients, the criteria produced 0.16 additional quality-adjusted life years (QALYs) per patient at an incremental cost of £326, or about $443, over 5 years. This resulted in an incremental cost-effectiveness ratio (ICER) of £2081, or $2830, per additional QALY gained.

In addition, the incremental net monetary benefit of the Baveno VI criteria was £2808, or $3819, over 5 years per patient.

The results were also consistent and cost-effective in Canada and Spain using relevant cost inputs from those countries. In Canada, the ICER per QALY estimates were €3535, or $3712, over 5 years and €4610, or $4841, over 20 years. In Spain, the ICER per QALY estimates were €1966, or $2064, over 5 years and €2225, or $2336, over 20 years.
 

Baveno VI Considerations

Despite the small risk of false negatives, the Baveno VI criteria could avoid unnecessary endoscopies and provide significant cost savings, the study authors wrote.

“It should be mentioned, however, that sparing endoscopies could result in missing the incidental detection of esophageal and gastric cancers, particularly in patients with higher risk, such as those who misuse alcohol,” Dr. Tsochatzis said.

Future studies could investigate ways to broaden the applicability of the Baveno VI criteria to other patient subgroups, identify optimal cut-off points, and incorporate patients with systemic therapies.

“Baveno VI criteria can be safely used to avoid endoscopy in a substantial proportion of patients with compensated cirrhosis,” said Wayne Bai, MBChB, a gastroenterologist at Waikato Hospital and the University of Auckland in New Zealand.

Dr. Bai, who wasn’t involved with this study, has researched the Baveno VI criteria and participated in Baveno VII criteria meetings. In an analysis of more than two dozen studies, he and colleagues found that the Baveno VI criteria had a pooled 99% negative predictive value for ruling out high-risk varices and weren’t affected by the cause of cirrhosis. However, expanding the criteria had suboptimal performance in some cases.

Waikato Hospital

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

Compared with endoscopy, the Baveno VI criteria present a noninvasive and cost-effective method to detect high-risk varices in patients with Child-Pugh A cirrhosis, according to new research.

Although upper gastrointestinal endoscopy continues to be the gold standard for detecting varices, the Baveno VI criteria combine liver stiffness and platelet count values to rule out high-risk varices, which can save on endoscopy costs.

“The Baveno VI criteria can reduce the need for endoscopies in patients with cirrhosis, but it is important to ascertain if they are also cost-effective,” said senior author Emmanuel Tsochatzis, MD, professor of hepatology at the University College London Institute for Liver and Digestive Health and Royal Free Hospital in London.

Andrew McConnell/EASL

“Our findings confirm that the application of these criteria is highly cost-effective, and given the fact that they are also safe, should be considered for widespread implementation,” he said.

The study was published online in Clinical Gastroenterology and Hepatology.
 

Baveno VI Criteria Analysis

On the basis of the Baveno VI Consensus, endoscopy screening can be avoided in patients with compensated advanced chronic liver disease and Child-Pugh A cirrhosis who have a platelet count > 150,000/mm³ and a liver stiffness measurement < 20 kPa. 

In addition, expanded Baveno VI criteria have suggested optimized cut-off values to avoid even more endoscopies — at a platelet value of > 110,000/mm³ and a liver stiffness < 25 kPa.

Previous research indicates that the expanded criteria could avoid double the number of endoscopies, the authors wrote, with a risk of missing high-risk varices in 1.6% of patients with the criteria and 0.6% of overall study participants. Both criteria have been validated in large groups of patients with compensated cirrhosis of different etiologies, but the cost-effectiveness hasn’t been analyzed.

Dr. Tsochatzis and colleagues created an analytical decision model to estimate the costs and benefits of using the Baveno VI criteria as compared with endoscopy as the standard of care among a hypothetical cohort of 1000 patients with Child-Pugh A cirrhosis. The research team looked at costs and clinical outcomes based on the United Kingdom National Health Service perspective at 1 year from diagnosis and then estimated the expected costs and outcomes at 5 years and 20 years, including factors such as liver disease progression and variceal bleeding.

As part of the model, the Baveno VI criteria were implemented at annual screenings with targeted endoscopy for patients who met the criteria, as compared with endoscopy as a biannual screening using esophagogastroduodenoscopy for everyone.

In general, the Baveno VI criteria were cost-effective compared with endoscopy in all analyses, including all time points, as well as deterministic and probabilistic sensitivity analyses. The cost of using the criteria was £67 per patient, as compared with £411 per patient for esophagogastroduodenoscopy.

For the 1000 patients, the criteria produced 0.16 additional quality-adjusted life years (QALYs) per patient at an incremental cost of £326, or about $443, over 5 years. This resulted in an incremental cost-effectiveness ratio (ICER) of £2081, or $2830, per additional QALY gained.

In addition, the incremental net monetary benefit of the Baveno VI criteria was £2808, or $3819, over 5 years per patient.

The results were also consistent and cost-effective in Canada and Spain using relevant cost inputs from those countries. In Canada, the ICER per QALY estimates were €3535, or $3712, over 5 years and €4610, or $4841, over 20 years. In Spain, the ICER per QALY estimates were €1966, or $2064, over 5 years and €2225, or $2336, over 20 years.
 

Baveno VI Considerations

Despite the small risk of false negatives, the Baveno VI criteria could avoid unnecessary endoscopies and provide significant cost savings, the study authors wrote.

“It should be mentioned, however, that sparing endoscopies could result in missing the incidental detection of esophageal and gastric cancers, particularly in patients with higher risk, such as those who misuse alcohol,” Dr. Tsochatzis said.

Future studies could investigate ways to broaden the applicability of the Baveno VI criteria to other patient subgroups, identify optimal cut-off points, and incorporate patients with systemic therapies.

“Baveno VI criteria can be safely used to avoid endoscopy in a substantial proportion of patients with compensated cirrhosis,” said Wayne Bai, MBChB, a gastroenterologist at Waikato Hospital and the University of Auckland in New Zealand.

Dr. Bai, who wasn’t involved with this study, has researched the Baveno VI criteria and participated in Baveno VII criteria meetings. In an analysis of more than two dozen studies, he and colleagues found that the Baveno VI criteria had a pooled 99% negative predictive value for ruling out high-risk varices and weren’t affected by the cause of cirrhosis. However, expanding the criteria had suboptimal performance in some cases.

Waikato Hospital

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

TOPLINE:

In 2022, nearly 22% of people who died of drug overdose had a non–substance-related mental health disorder (MHD), new data from the Centers for Disease Control and Prevention (CDC) show. Investigators say the findings point to the need for incorporating mental health care in overdose prevention efforts.

METHODOLOGY:

• The study analyzed data from the CDC’s State Unintentional Drug Overdose Reporting System for 2022, covering 43 states and the District of Columbia.
• A total of 63,424 unintentional and undetermined intent drug overdose deaths during 2022 were included; 92.3% had medical examiner or coroner reports.
• MHDs were identified using source documents such as medical records and categorized according to the DSM-5 criteria.
• Potential intervention opportunities within 1 month of death, such as release from institutional settings or emergency department visits, were also analyzed.

TAKEAWAY:

• In 2022, 21.9% of drug overdose deaths involved people with non–substance-related MHDs, most commonly depression (12.9%), anxiety (9.4%), and bipolar disorder (5.9%).
• Opioids were involved in 82.2% of overdose deaths, with fentanyl or its analogs present in 75.2% of cases.
• Decedents with MHDs had higher usage rates of antidepressants (9.7% vs 3.3%), benzodiazepines (15.3% vs 8.5%), and prescription opioids (16% vs 11.6%) compared with those without MHDs.
• About 24.5% of decedents with MHDs had at least one potential intervention opportunity within 1 month of death, compared with 14.6% of those without MHDs, most commonly release from an institutional setting, treatment for substance use disorder, emergency department or urgent care visit, and nonfatal overdose.

IN PRACTICE:

“This finding suggests the need to screen for SUDs [ substance use disorders] and other MHDs, which is consistent with US Preventive Services Task Force recommendations for adults in primary care settings, and the need to link and integrate treatments to prevent overdose and improve mental health,” the authors wrote.

SOURCE:

The study was led by Amanda T. Dinwiddie, MPH, Division of Overdose Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia. It was published online on August 29, 2024, in Morbidity and Mortality Weekly Report.

LIMITATIONS:

The findings might not be applicable to the entire US population. MHDs could have been undiagnosed or underreported, possibly leading to underestimation. Additionally, variations in the completeness of source documents could have affected the accuracy of identifying MHDs. Data on current or recent mental health treatment were also unavailable. Lastly, substance use disorders may have been recorded as MHDs when not specified.

DISCLOSURES:

The study funding source was not reported. The authors did not disclose any conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

In 2022, nearly 22% of people who died of drug overdose had a non–substance-related mental health disorder (MHD), new data from the Centers for Disease Control and Prevention (CDC) show. Investigators say the findings point to the need for incorporating mental health care in overdose prevention efforts.

METHODOLOGY:

• The study analyzed data from the CDC’s State Unintentional Drug Overdose Reporting System for 2022, covering 43 states and the District of Columbia.
• A total of 63,424 unintentional and undetermined intent drug overdose deaths during 2022 were included; 92.3% had medical examiner or coroner reports.
• MHDs were identified using source documents such as medical records and categorized according to the DSM-5 criteria.
• Potential intervention opportunities within 1 month of death, such as release from institutional settings or emergency department visits, were also analyzed.

TAKEAWAY:

• In 2022, 21.9% of drug overdose deaths involved people with non–substance-related MHDs, most commonly depression (12.9%), anxiety (9.4%), and bipolar disorder (5.9%).
• Opioids were involved in 82.2% of overdose deaths, with fentanyl or its analogs present in 75.2% of cases.
• Decedents with MHDs had higher usage rates of antidepressants (9.7% vs 3.3%), benzodiazepines (15.3% vs 8.5%), and prescription opioids (16% vs 11.6%) compared with those without MHDs.
• About 24.5% of decedents with MHDs had at least one potential intervention opportunity within 1 month of death, compared with 14.6% of those without MHDs, most commonly release from an institutional setting, treatment for substance use disorder, emergency department or urgent care visit, and nonfatal overdose.

IN PRACTICE:

“This finding suggests the need to screen for SUDs [ substance use disorders] and other MHDs, which is consistent with US Preventive Services Task Force recommendations for adults in primary care settings, and the need to link and integrate treatments to prevent overdose and improve mental health,” the authors wrote.

SOURCE:

The study was led by Amanda T. Dinwiddie, MPH, Division of Overdose Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia. It was published online on August 29, 2024, in Morbidity and Mortality Weekly Report.

LIMITATIONS:

The findings might not be applicable to the entire US population. MHDs could have been undiagnosed or underreported, possibly leading to underestimation. Additionally, variations in the completeness of source documents could have affected the accuracy of identifying MHDs. Data on current or recent mental health treatment were also unavailable. Lastly, substance use disorders may have been recorded as MHDs when not specified.

DISCLOSURES:

The study funding source was not reported. The authors did not disclose any conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

In 2022, nearly 22% of people who died of drug overdose had a non–substance-related mental health disorder (MHD), new data from the Centers for Disease Control and Prevention (CDC) show. Investigators say the findings point to the need for incorporating mental health care in overdose prevention efforts.

METHODOLOGY:

• The study analyzed data from the CDC’s State Unintentional Drug Overdose Reporting System for 2022, covering 43 states and the District of Columbia.
• A total of 63,424 unintentional and undetermined intent drug overdose deaths during 2022 were included; 92.3% had medical examiner or coroner reports.
• MHDs were identified using source documents such as medical records and categorized according to the DSM-5 criteria.
• Potential intervention opportunities within 1 month of death, such as release from institutional settings or emergency department visits, were also analyzed.

TAKEAWAY:

• In 2022, 21.9% of drug overdose deaths involved people with non–substance-related MHDs, most commonly depression (12.9%), anxiety (9.4%), and bipolar disorder (5.9%).
• Opioids were involved in 82.2% of overdose deaths, with fentanyl or its analogs present in 75.2% of cases.
• Decedents with MHDs had higher usage rates of antidepressants (9.7% vs 3.3%), benzodiazepines (15.3% vs 8.5%), and prescription opioids (16% vs 11.6%) compared with those without MHDs.
• About 24.5% of decedents with MHDs had at least one potential intervention opportunity within 1 month of death, compared with 14.6% of those without MHDs, most commonly release from an institutional setting, treatment for substance use disorder, emergency department or urgent care visit, and nonfatal overdose.

IN PRACTICE:

“This finding suggests the need to screen for SUDs [ substance use disorders] and other MHDs, which is consistent with US Preventive Services Task Force recommendations for adults in primary care settings, and the need to link and integrate treatments to prevent overdose and improve mental health,” the authors wrote.

SOURCE:

The study was led by Amanda T. Dinwiddie, MPH, Division of Overdose Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia. It was published online on August 29, 2024, in Morbidity and Mortality Weekly Report.

LIMITATIONS:

The findings might not be applicable to the entire US population. MHDs could have been undiagnosed or underreported, possibly leading to underestimation. Additionally, variations in the completeness of source documents could have affected the accuracy of identifying MHDs. Data on current or recent mental health treatment were also unavailable. Lastly, substance use disorders may have been recorded as MHDs when not specified.

DISCLOSURES:

The study funding source was not reported. The authors did not disclose any conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

The 2025 Crohn’s & Colitis Congress^®, a partnership of the Crohn’s & Colitis Foundation and AGA, is now accepting original inflammatory bowel disease (IBD)-research abstract submissions through Oct. 16. Abstracts are free to submit and may be selected for in-person lectures or poster presentations. Accepted abstracts will also be co-published in AGA’s Gastroenterology (https://www.gastrojournal.org/) and the Crohn’s & Colitis Foundation’s Inflammatory Bowel Diseases (https://academic.oup.com/ibdjournal).

Be sure to review the abstract submission guidelines and submit by 9 p.m. EDT, Wednesday, Oct. 16.

Presenting authors will receive notification of acceptance on Monday, Dec. 9.

The Crohn’s & Colitis Congress will take place Feb. 6-8, 2025, in San Francisco, California. It brings together the community of multidisciplinary experts and colleagues to revolutionize prevention, care and outcomes for IBD patients.

Learn alongside your colleagues and discover how to provide the absolute best care to those suffering with Crohn’s disease and ulcerative colitis.

The 2025 Crohn’s & Colitis Congress^®, a partnership of the Crohn’s & Colitis Foundation and AGA, is now accepting original inflammatory bowel disease (IBD)-research abstract submissions through Oct. 16. Abstracts are free to submit and may be selected for in-person lectures or poster presentations. Accepted abstracts will also be co-published in AGA’s Gastroenterology (https://www.gastrojournal.org/) and the Crohn’s & Colitis Foundation’s Inflammatory Bowel Diseases (https://academic.oup.com/ibdjournal).

Be sure to review the abstract submission guidelines and submit by 9 p.m. EDT, Wednesday, Oct. 16.

Presenting authors will receive notification of acceptance on Monday, Dec. 9.

The Crohn’s & Colitis Congress will take place Feb. 6-8, 2025, in San Francisco, California. It brings together the community of multidisciplinary experts and colleagues to revolutionize prevention, care and outcomes for IBD patients.

Learn alongside your colleagues and discover how to provide the absolute best care to those suffering with Crohn’s disease and ulcerative colitis.

The 2025 Crohn’s & Colitis Congress^®, a partnership of the Crohn’s & Colitis Foundation and AGA, is now accepting original inflammatory bowel disease (IBD)-research abstract submissions through Oct. 16. Abstracts are free to submit and may be selected for in-person lectures or poster presentations. Accepted abstracts will also be co-published in AGA’s Gastroenterology (https://www.gastrojournal.org/) and the Crohn’s & Colitis Foundation’s Inflammatory Bowel Diseases (https://academic.oup.com/ibdjournal).

Be sure to review the abstract submission guidelines and submit by 9 p.m. EDT, Wednesday, Oct. 16.

Presenting authors will receive notification of acceptance on Monday, Dec. 9.

The Crohn’s & Colitis Congress will take place Feb. 6-8, 2025, in San Francisco, California. It brings together the community of multidisciplinary experts and colleagues to revolutionize prevention, care and outcomes for IBD patients.

Learn alongside your colleagues and discover how to provide the absolute best care to those suffering with Crohn’s disease and ulcerative colitis.

MADRID — Amycretin, a dual-pathway, oral weight loss drug, led to up to 13% body weight loss in participants with overweight or obesity according to phase 1, first-in-human study data presented at the European Association for the Study of Diabetes (EASD) 2024 annual meeting.

Body weight loss was “remarkable for an orally delivered biologic,” said Agnes Gasiorek, PhD, senior clinical pharmacology specialist at Novo Nordisk, Måløv, Denmark, who presented the results. And “there was no plateauing of weight loss in the treatment period.”

The mean change in percentage body weight was –10.4% with amycretin 50 mg, –13.1% with amycretin 2 × 50 mg, and –1.2% with placebo after 12 weeks of treatment.

With respect to the primary endpoint, stepwise dose escalation demonstrated that all tested dose levels up to and including 2 × 50 mg over a 12-week escalation period were safe and tolerable, Dr. Gasiorek reported.

The adverse events were in line with what was expected from targeting these receptors, and no new safety signals appeared during the study, she added.
 

Dual Pathways

Amycretin is a novel protein-based unimolecular amylin combined with a glucagon-like peptide 1 receptor agonist (GLP-1 RA) and is the first oral formulation of this combination under development.

The two components are both known to reduce appetite and energy intake and increase satiety, said Dr. Gasiorek, but amylin is considered to potentially increase leptin sensitivity and GLP-1 RAs are known to increase insulin secretion and biosynthesis. Together, the two components improve insulin sensitivity, decrease glucagon secretion, and lead to acute delay in gastric emptying.

The single-center, placebo-controlled, double-blind phase 1 study enrolled men and women aged 18-55 years (mean, 38-42 years across groups) with a body mass index of 25.0-39.9, without diabetes, and considered otherwise healthy. 

Participants were randomly assigned to receive to receive oral amycretin (n = 95) or placebo (n = 29) once a day for up to 12 weeks. Study arms comprised single-ascending dosing (increasing from 1 mg/d to 25 mg), and multiple-ascending dosing. The latter consisted of multiple ascending doses (from 3 to 12 mg) over 10 days and multiple ascending doses (stepwise dose escalation, from 3 mg up to a final dose of 2 × 50 mg) over 12 weeks. 

In her presentation at the EASD meeting, Dr. Gasiorek focused on results of the 12-week multiple ascending dose schedule with amycretin 50 mg (n = 16), amycretin 2 × 50 mg (n = 16), and placebo (n = 12). 

The primary endpoint of the study was the number of treatment-emergent adverse events, while the area under the amycretin plasma concentration time curve and the maximum plasma concentration of amycretin were secondary endpoints. 

The researchers also added percentage change in body weight after 12 weeks of treatment as an exploratory endpoint. 
 

Safety Findings of Multiple Dosing

A total of 242 treatment-emergent adverse events were reported in the combined active and placebo groups and were of mild to moderate severity. 

Treatment-emergent adverse events were found in 75% of the amycretin 50 mg group, 93.8% of the amycretin 2 × 50 mg group, and 33.3% of placebo recipients.

“Most adverse events reported were mild to moderate in severity and related to gastrointestinal discomfort (nausea and vomiting) and occurred in a dose-proportional manner,” reported Dr. Gasiorek.

Gastrointestinal events were experienced by 50%, 87.5%, and 16.7% of participants receiving amycretin 50 mg, amycretin 2 × 50 mg, and placebo, respectively (112 in total). 

Decreased appetite was also found in 56.3%, 81.3%, and 16.7% of the amycretin 50 mg, amycretin 2 × 50 mg, and placebo groups, respectively.

Two serious adverse events occurred, one of which was acute cholecystitis and the other diabetic ketoacidosis; “however, the [latter] participant was found to have autoantibodies for beta cells before treatment and was later diagnosed with type 1 diabetes,” Dr. Gasiorek said.
 

Body Weight Reduction 

Participants on 50 mg amycretin lost an average of 10.4% of their body weight (estimated treatment difference vs placebo, –9.2; 95% CI, –12.0 to –6.5), whereas those on 2 × 50 mg amycretin lost 13.1% of their body weight (estimated treatment difference vs placebo, –11.8; 95% CI, –14.6 to –9.0). Placebo group participants lost 1.2% of their body weight over the 12 weeks. 

Although no plateauing of weight loss was seen, said Dr. Gasiorek, it is important to consider the relatively short treatment duration and the limited time on the final dose, which could potentially introduce bias.

To date, weight loss medications based on GLP-1 RA technology are injectables. A combination of the injectable amylin analogue cagrilintide and the GLP-1 RA semaglutide is also being explored as a subcutaneous treatment solution.

In a comment, Martin Holst Lange, MD, PhD, executive vice president of development at Novo Nordisk, said that “amycretin is the first treatment to harness the two distinct biological pathways stimulated by amylin and GLP-1 in a single molecule.”

The safety and tolerability profiles and the magnitude of weight loss support further development of amycretin in patients with overweight or obesity, said Dr. Lange, who noted that the company was awaiting data from the ongoing phase 1 trial with subcutaneous amycretin, expected in 2025.

Having heard the presentation, co-moderator Timo Müller, PhD, professor at Ludwig Maximilian University of Munich, Germany, gave a considered response. “The drug was relatively well tolerated, with the typical GLP-1–induced GI [gastrointestinal] adverse effects being the most frequently reported.”

But he pointed out that questions remain. “We still need to know whether, at the given dose, the drug outperforms best-in-class drugs like semaglutide or tirzepatide at the highest approved doses. Furthermore, it warrants clarification if and to what extent the activation of the amylin receptor contributes to the shown effect and if and to what extent the glycemic benefits result from activation of the glucagon receptor (amylin improved glycemia by decreasing the secretion of glucagon). In any way, the current data remain friendly and support phase 2 development.” 
 

Oral Meds Could Bring Down Cost

Commenting on the data, Nerys Astbury, PhD, associate professor of diet and obesity at Nuffield Department of Primary Health Care Sciences, University of Oxford, England, said, “It is important to note that whilst the participants in this trial did lose weight over the 12-week study — and this was statistically more weight than in the placebo group — this study was not designed or powered to detect differences in body weight over longer periods of time.” 

If the results are confirmed in future studies, amycretin might widen the treatment options and introduce competition, probably bringing down the costs in the longer-term, said Dr. Astbury, who welcomes the prospect. 

“It is possible that some people might find the oral medications more acceptable than the injectable GLP-1 agonists currently available,” she said. And the current options are expensive, “which raises challenges to a taxpayer-funded health system like the NHS [National Health Service].” 

“Furthermore, if the growing number of oral obesity medications prove safe, tolerable, and effective ... they are likely to significantly reduce the risks of developing many complications of obesity.”

Naveed Sattar, MD, professor of cardiometabolic medicine and honorary consultant, University of Glasgow, Scotland, agreed. “The more medicines coming forward to treat obesity, the better,” he said. In particular, oral medications would be more easily available, and cheaper, “for the many millions around the world struggling with obesity and its complications.”

Dr. Gasiorek declares she is an employee of and a shareholder in Novo Nordisk. Dr. Astbury declares no financial disclosures. Dr. Sattar declares having consulted for several companies that make diabetes medicines but also contributed to several lifestyle trials. For Novo Nordisk, he has consulted for the company on advisory boards, but not on any of their weight loss drug trial committees, and he is on the steering committee for the ZEUS trial, which is not a weight loss trial product but an anti-inflammatory. He does not have any shares for any product in health etc. He declares consulting fees and/or speaker honoraria from Abbott Laboratories, Afimmune, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi Pharmaceuticals, Janssen, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, and Sanofi, and grant support paid to his university from AstraZeneca, Boehringer Ingelheim, Novartis, and Roche Diagnostics. Dr. Müller received financial support or an honorarium from Novo Nordisk, Merck, Eli Lilly, Boehringer Ingelheim, and Mercodia; he further holds stocks at Novo Nordisk and Eli Lilly and is cofounder of Bluewater Biosciences.

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

MADRID — Amycretin, a dual-pathway, oral weight loss drug, led to up to 13% body weight loss in participants with overweight or obesity according to phase 1, first-in-human study data presented at the European Association for the Study of Diabetes (EASD) 2024 annual meeting.

Body weight loss was “remarkable for an orally delivered biologic,” said Agnes Gasiorek, PhD, senior clinical pharmacology specialist at Novo Nordisk, Måløv, Denmark, who presented the results. And “there was no plateauing of weight loss in the treatment period.”

The mean change in percentage body weight was –10.4% with amycretin 50 mg, –13.1% with amycretin 2 × 50 mg, and –1.2% with placebo after 12 weeks of treatment.

With respect to the primary endpoint, stepwise dose escalation demonstrated that all tested dose levels up to and including 2 × 50 mg over a 12-week escalation period were safe and tolerable, Dr. Gasiorek reported.

The adverse events were in line with what was expected from targeting these receptors, and no new safety signals appeared during the study, she added.
 

Dual Pathways

Amycretin is a novel protein-based unimolecular amylin combined with a glucagon-like peptide 1 receptor agonist (GLP-1 RA) and is the first oral formulation of this combination under development.

The two components are both known to reduce appetite and energy intake and increase satiety, said Dr. Gasiorek, but amylin is considered to potentially increase leptin sensitivity and GLP-1 RAs are known to increase insulin secretion and biosynthesis. Together, the two components improve insulin sensitivity, decrease glucagon secretion, and lead to acute delay in gastric emptying.

The single-center, placebo-controlled, double-blind phase 1 study enrolled men and women aged 18-55 years (mean, 38-42 years across groups) with a body mass index of 25.0-39.9, without diabetes, and considered otherwise healthy. 

Participants were randomly assigned to receive to receive oral amycretin (n = 95) or placebo (n = 29) once a day for up to 12 weeks. Study arms comprised single-ascending dosing (increasing from 1 mg/d to 25 mg), and multiple-ascending dosing. The latter consisted of multiple ascending doses (from 3 to 12 mg) over 10 days and multiple ascending doses (stepwise dose escalation, from 3 mg up to a final dose of 2 × 50 mg) over 12 weeks. 

In her presentation at the EASD meeting, Dr. Gasiorek focused on results of the 12-week multiple ascending dose schedule with amycretin 50 mg (n = 16), amycretin 2 × 50 mg (n = 16), and placebo (n = 12). 

The primary endpoint of the study was the number of treatment-emergent adverse events, while the area under the amycretin plasma concentration time curve and the maximum plasma concentration of amycretin were secondary endpoints. 

The researchers also added percentage change in body weight after 12 weeks of treatment as an exploratory endpoint. 
 

Safety Findings of Multiple Dosing

A total of 242 treatment-emergent adverse events were reported in the combined active and placebo groups and were of mild to moderate severity. 

Treatment-emergent adverse events were found in 75% of the amycretin 50 mg group, 93.8% of the amycretin 2 × 50 mg group, and 33.3% of placebo recipients.

“Most adverse events reported were mild to moderate in severity and related to gastrointestinal discomfort (nausea and vomiting) and occurred in a dose-proportional manner,” reported Dr. Gasiorek.

Gastrointestinal events were experienced by 50%, 87.5%, and 16.7% of participants receiving amycretin 50 mg, amycretin 2 × 50 mg, and placebo, respectively (112 in total). 

Decreased appetite was also found in 56.3%, 81.3%, and 16.7% of the amycretin 50 mg, amycretin 2 × 50 mg, and placebo groups, respectively.

Two serious adverse events occurred, one of which was acute cholecystitis and the other diabetic ketoacidosis; “however, the [latter] participant was found to have autoantibodies for beta cells before treatment and was later diagnosed with type 1 diabetes,” Dr. Gasiorek said.
 

Body Weight Reduction 

Participants on 50 mg amycretin lost an average of 10.4% of their body weight (estimated treatment difference vs placebo, –9.2; 95% CI, –12.0 to –6.5), whereas those on 2 × 50 mg amycretin lost 13.1% of their body weight (estimated treatment difference vs placebo, –11.8; 95% CI, –14.6 to –9.0). Placebo group participants lost 1.2% of their body weight over the 12 weeks. 

Although no plateauing of weight loss was seen, said Dr. Gasiorek, it is important to consider the relatively short treatment duration and the limited time on the final dose, which could potentially introduce bias.

To date, weight loss medications based on GLP-1 RA technology are injectables. A combination of the injectable amylin analogue cagrilintide and the GLP-1 RA semaglutide is also being explored as a subcutaneous treatment solution.

In a comment, Martin Holst Lange, MD, PhD, executive vice president of development at Novo Nordisk, said that “amycretin is the first treatment to harness the two distinct biological pathways stimulated by amylin and GLP-1 in a single molecule.”

The safety and tolerability profiles and the magnitude of weight loss support further development of amycretin in patients with overweight or obesity, said Dr. Lange, who noted that the company was awaiting data from the ongoing phase 1 trial with subcutaneous amycretin, expected in 2025.

Having heard the presentation, co-moderator Timo Müller, PhD, professor at Ludwig Maximilian University of Munich, Germany, gave a considered response. “The drug was relatively well tolerated, with the typical GLP-1–induced GI [gastrointestinal] adverse effects being the most frequently reported.”

But he pointed out that questions remain. “We still need to know whether, at the given dose, the drug outperforms best-in-class drugs like semaglutide or tirzepatide at the highest approved doses. Furthermore, it warrants clarification if and to what extent the activation of the amylin receptor contributes to the shown effect and if and to what extent the glycemic benefits result from activation of the glucagon receptor (amylin improved glycemia by decreasing the secretion of glucagon). In any way, the current data remain friendly and support phase 2 development.” 
 

Oral Meds Could Bring Down Cost

Commenting on the data, Nerys Astbury, PhD, associate professor of diet and obesity at Nuffield Department of Primary Health Care Sciences, University of Oxford, England, said, “It is important to note that whilst the participants in this trial did lose weight over the 12-week study — and this was statistically more weight than in the placebo group — this study was not designed or powered to detect differences in body weight over longer periods of time.” 

If the results are confirmed in future studies, amycretin might widen the treatment options and introduce competition, probably bringing down the costs in the longer-term, said Dr. Astbury, who welcomes the prospect. 

“It is possible that some people might find the oral medications more acceptable than the injectable GLP-1 agonists currently available,” she said. And the current options are expensive, “which raises challenges to a taxpayer-funded health system like the NHS [National Health Service].” 

“Furthermore, if the growing number of oral obesity medications prove safe, tolerable, and effective ... they are likely to significantly reduce the risks of developing many complications of obesity.”

Naveed Sattar, MD, professor of cardiometabolic medicine and honorary consultant, University of Glasgow, Scotland, agreed. “The more medicines coming forward to treat obesity, the better,” he said. In particular, oral medications would be more easily available, and cheaper, “for the many millions around the world struggling with obesity and its complications.”

Dr. Gasiorek declares she is an employee of and a shareholder in Novo Nordisk. Dr. Astbury declares no financial disclosures. Dr. Sattar declares having consulted for several companies that make diabetes medicines but also contributed to several lifestyle trials. For Novo Nordisk, he has consulted for the company on advisory boards, but not on any of their weight loss drug trial committees, and he is on the steering committee for the ZEUS trial, which is not a weight loss trial product but an anti-inflammatory. He does not have any shares for any product in health etc. He declares consulting fees and/or speaker honoraria from Abbott Laboratories, Afimmune, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi Pharmaceuticals, Janssen, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, and Sanofi, and grant support paid to his university from AstraZeneca, Boehringer Ingelheim, Novartis, and Roche Diagnostics. Dr. Müller received financial support or an honorarium from Novo Nordisk, Merck, Eli Lilly, Boehringer Ingelheim, and Mercodia; he further holds stocks at Novo Nordisk and Eli Lilly and is cofounder of Bluewater Biosciences.

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

MADRID — Amycretin, a dual-pathway, oral weight loss drug, led to up to 13% body weight loss in participants with overweight or obesity according to phase 1, first-in-human study data presented at the European Association for the Study of Diabetes (EASD) 2024 annual meeting.

Body weight loss was “remarkable for an orally delivered biologic,” said Agnes Gasiorek, PhD, senior clinical pharmacology specialist at Novo Nordisk, Måløv, Denmark, who presented the results. And “there was no plateauing of weight loss in the treatment period.”

The mean change in percentage body weight was –10.4% with amycretin 50 mg, –13.1% with amycretin 2 × 50 mg, and –1.2% with placebo after 12 weeks of treatment.

With respect to the primary endpoint, stepwise dose escalation demonstrated that all tested dose levels up to and including 2 × 50 mg over a 12-week escalation period were safe and tolerable, Dr. Gasiorek reported.

The adverse events were in line with what was expected from targeting these receptors, and no new safety signals appeared during the study, she added.
 

Dual Pathways

Amycretin is a novel protein-based unimolecular amylin combined with a glucagon-like peptide 1 receptor agonist (GLP-1 RA) and is the first oral formulation of this combination under development.

The two components are both known to reduce appetite and energy intake and increase satiety, said Dr. Gasiorek, but amylin is considered to potentially increase leptin sensitivity and GLP-1 RAs are known to increase insulin secretion and biosynthesis. Together, the two components improve insulin sensitivity, decrease glucagon secretion, and lead to acute delay in gastric emptying.

The single-center, placebo-controlled, double-blind phase 1 study enrolled men and women aged 18-55 years (mean, 38-42 years across groups) with a body mass index of 25.0-39.9, without diabetes, and considered otherwise healthy. 

Participants were randomly assigned to receive to receive oral amycretin (n = 95) or placebo (n = 29) once a day for up to 12 weeks. Study arms comprised single-ascending dosing (increasing from 1 mg/d to 25 mg), and multiple-ascending dosing. The latter consisted of multiple ascending doses (from 3 to 12 mg) over 10 days and multiple ascending doses (stepwise dose escalation, from 3 mg up to a final dose of 2 × 50 mg) over 12 weeks. 

In her presentation at the EASD meeting, Dr. Gasiorek focused on results of the 12-week multiple ascending dose schedule with amycretin 50 mg (n = 16), amycretin 2 × 50 mg (n = 16), and placebo (n = 12). 

The primary endpoint of the study was the number of treatment-emergent adverse events, while the area under the amycretin plasma concentration time curve and the maximum plasma concentration of amycretin were secondary endpoints. 

The researchers also added percentage change in body weight after 12 weeks of treatment as an exploratory endpoint. 
 

Safety Findings of Multiple Dosing

A total of 242 treatment-emergent adverse events were reported in the combined active and placebo groups and were of mild to moderate severity. 

Treatment-emergent adverse events were found in 75% of the amycretin 50 mg group, 93.8% of the amycretin 2 × 50 mg group, and 33.3% of placebo recipients.

“Most adverse events reported were mild to moderate in severity and related to gastrointestinal discomfort (nausea and vomiting) and occurred in a dose-proportional manner,” reported Dr. Gasiorek.

Gastrointestinal events were experienced by 50%, 87.5%, and 16.7% of participants receiving amycretin 50 mg, amycretin 2 × 50 mg, and placebo, respectively (112 in total). 

Decreased appetite was also found in 56.3%, 81.3%, and 16.7% of the amycretin 50 mg, amycretin 2 × 50 mg, and placebo groups, respectively.

Two serious adverse events occurred, one of which was acute cholecystitis and the other diabetic ketoacidosis; “however, the [latter] participant was found to have autoantibodies for beta cells before treatment and was later diagnosed with type 1 diabetes,” Dr. Gasiorek said.
 

Body Weight Reduction 

Participants on 50 mg amycretin lost an average of 10.4% of their body weight (estimated treatment difference vs placebo, –9.2; 95% CI, –12.0 to –6.5), whereas those on 2 × 50 mg amycretin lost 13.1% of their body weight (estimated treatment difference vs placebo, –11.8; 95% CI, –14.6 to –9.0). Placebo group participants lost 1.2% of their body weight over the 12 weeks. 

Although no plateauing of weight loss was seen, said Dr. Gasiorek, it is important to consider the relatively short treatment duration and the limited time on the final dose, which could potentially introduce bias.

To date, weight loss medications based on GLP-1 RA technology are injectables. A combination of the injectable amylin analogue cagrilintide and the GLP-1 RA semaglutide is also being explored as a subcutaneous treatment solution.

In a comment, Martin Holst Lange, MD, PhD, executive vice president of development at Novo Nordisk, said that “amycretin is the first treatment to harness the two distinct biological pathways stimulated by amylin and GLP-1 in a single molecule.”

The safety and tolerability profiles and the magnitude of weight loss support further development of amycretin in patients with overweight or obesity, said Dr. Lange, who noted that the company was awaiting data from the ongoing phase 1 trial with subcutaneous amycretin, expected in 2025.

Having heard the presentation, co-moderator Timo Müller, PhD, professor at Ludwig Maximilian University of Munich, Germany, gave a considered response. “The drug was relatively well tolerated, with the typical GLP-1–induced GI [gastrointestinal] adverse effects being the most frequently reported.”

But he pointed out that questions remain. “We still need to know whether, at the given dose, the drug outperforms best-in-class drugs like semaglutide or tirzepatide at the highest approved doses. Furthermore, it warrants clarification if and to what extent the activation of the amylin receptor contributes to the shown effect and if and to what extent the glycemic benefits result from activation of the glucagon receptor (amylin improved glycemia by decreasing the secretion of glucagon). In any way, the current data remain friendly and support phase 2 development.” 
 

Oral Meds Could Bring Down Cost

Commenting on the data, Nerys Astbury, PhD, associate professor of diet and obesity at Nuffield Department of Primary Health Care Sciences, University of Oxford, England, said, “It is important to note that whilst the participants in this trial did lose weight over the 12-week study — and this was statistically more weight than in the placebo group — this study was not designed or powered to detect differences in body weight over longer periods of time.” 

If the results are confirmed in future studies, amycretin might widen the treatment options and introduce competition, probably bringing down the costs in the longer-term, said Dr. Astbury, who welcomes the prospect. 

“It is possible that some people might find the oral medications more acceptable than the injectable GLP-1 agonists currently available,” she said. And the current options are expensive, “which raises challenges to a taxpayer-funded health system like the NHS [National Health Service].” 

“Furthermore, if the growing number of oral obesity medications prove safe, tolerable, and effective ... they are likely to significantly reduce the risks of developing many complications of obesity.”

Naveed Sattar, MD, professor of cardiometabolic medicine and honorary consultant, University of Glasgow, Scotland, agreed. “The more medicines coming forward to treat obesity, the better,” he said. In particular, oral medications would be more easily available, and cheaper, “for the many millions around the world struggling with obesity and its complications.”

Dr. Gasiorek declares she is an employee of and a shareholder in Novo Nordisk. Dr. Astbury declares no financial disclosures. Dr. Sattar declares having consulted for several companies that make diabetes medicines but also contributed to several lifestyle trials. For Novo Nordisk, he has consulted for the company on advisory boards, but not on any of their weight loss drug trial committees, and he is on the steering committee for the ZEUS trial, which is not a weight loss trial product but an anti-inflammatory. He does not have any shares for any product in health etc. He declares consulting fees and/or speaker honoraria from Abbott Laboratories, Afimmune, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi Pharmaceuticals, Janssen, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, and Sanofi, and grant support paid to his university from AstraZeneca, Boehringer Ingelheim, Novartis, and Roche Diagnostics. Dr. Müller received financial support or an honorarium from Novo Nordisk, Merck, Eli Lilly, Boehringer Ingelheim, and Mercodia; he further holds stocks at Novo Nordisk and Eli Lilly and is cofounder of Bluewater Biosciences.

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

As the deadline nears for a Montana healthcare system to pay what has been called a “jaw-dropping” settlement of nearly $11 million dollars to resolve an alleged violation of the False Claims Act, the legal troubles for the oncologist at the center of the case are ongoing and escalating.

On August 26, the US Attorney’s Office for the District of Montana and other agencies announced the settlement agreement with St. Peter’s Health, a nonprofit healthcare system in Helena, to resolve allegations that it submitted “false claims for payments to federal health care programs for services performed by an oncology doctor.”

More specifically, the government contended that St. Peter’s Health allegedly violated the False Claims Act by “knowingly submitting” upcoded and nonpayable claims from the oncologist to the Federal Health Care Program.

“This settlement would not have been possible without the cooperation of St. Peter’s Health, who voluntarily disclosed the misconduct and cooperated with federal investigators to identify the problem and amount of false billing,” said US Attorney Jesse Laslovich in a press release announcing the settlement.

On the same day, the US Attorney’s Office also filed a civil complaint against the oncologist Thomas Weiner, MD, accusing him of “false health care claims and improper prescribing of controlled substances.” Among the numerous allegations, the civil complaint specifies that Dr. Weiner used his position as the chief medical oncologist at St. Peter’s Health “to order medically unnecessary treatment,” including chemotherapy, blood tests, and imaging, as well as “knowingly falsified records” to double bill for office visits.
 

When It Began

The legal troubles for Dr. Weiner, now 61, started about 4 years ago. Dr. Weiner, who was the sole oncologist at St. Peter’s Health and worked there for 24 years, was suspended in October 2020 and then fired in November 2020 for allegedly providing unnecessary treatments and failing to refer patients to other specialists for care, among other claims. 

“The magnitude of Dr. Weiner’s violations is staggering,” St. Peter’s CEO, Wade Johnson, had said in a December 2020 press statement.

At the time, Dr. Weiner had filed a lawsuit against St. Peter’s Health, claiming he was denied due process and seeking damages and a jury trial. Dr. Weiner’s lead lawyer, J. Devlan Geddes, said it was hard to believe that Dr. Weiner had suddenly become a danger to patients after more than 2 decades on the job. 

Before 2020, Dr. Weiner had a clean record with Montana’s Board of Medical Examiners and had never been the subject of an internal investigation related to quality of care, according to his lawyers. He also served on St. Peter’s board of directors and as chief of medical staff.

Dr. Weiner’s exit from St. Peter’s in 2020 led to an outpouring of support from former patients and community members who formed the Facebook group, “ We Stand With Dr. Tom Weiner.” The group soon grew to almost 4000 people.

Four years later, despite the new legal developments, community support for Dr. Weiner has held strong. Supporters continue to have regular rallies outside St. Peter’s Health as well as post messages and personal stories on two Facebook groups now devoted to the cause. 

John Larson, 76, a Helena resident who was treated by Dr. Weiner, echoed a common sentiment from supporters. “I’m completely certain that Tom Weiner is not guilty of what the government is now involved in charging him with,” Dr. Larson said in an interview.
 

$10.8 Million: ‘It’s a Big Number’

At the press conference announcing the recent settlement, Mr. Laslovich recalled a participant describe the total as jaw-dropping, he said in an interview. While there haven’t been many such recent cases in the district, he agreed it’s a big number. The only other recent case he could remember was a 2018 settlement in Kalispell for $24 million. 

The current settlement contends that St. Peter’s Health submitted false claims for payments to federal health care programs related to services performed and referred by Weiner. The infractions allegedly occurred between January 1, 2015 and December 31, 2020. 

According to the Department of Justice (DOJ), St. Peter Health’s “knew, or should have known,” that the oncologist submitted claims for office visits that were coded at a higher level of service than was performed — ie upcoded claims — or did not meet the requirements of a significant, separately identifiable service when performed on the same day chemotherapy was administered — ie non-payable claims. 

The DOJ contended that the healthcare system violated the False Claims Act “by knowingly submitting the upcoded and non-payable” claims to the Federal Health Care Programs. And, as a result, St. Peter’s compensated the oncologist with a salary based on the false claims.

“We had documents showing some of the claims that were being submitted were being done because the doctor wanted more in compensation and of course you can’t do that,” Laslovich said. “For me, the message to providers, and I said this during our press conference, is that coding is critical.” 

“The claims resolved by the settlement are allegations only,” the US Attorney’s Office press release clarified, and “there has been no determination of liability.” 

The leadership at St. Peter’s Health issued a press release on August 27, stating it relied on Dr. Weiner’s medical record documentation and billing certification, though declined to comment further on the settlement 

Bob Wade, a partner at Nelson Mullins, Nashville, Tennessee, and lead outside counsel representing St. Peter’s Health on the settlement, said in an interview that the quality issue was first identified in fall 2020. 

“I first conducted a fair market value review for their entire system and noted that he [Weiner] was an extreme outlier with regard to his productivity,” Mr. Wade said.

In a separate statement, Mr. Wade praised the integrity of the health system, saying, “when the medical record documentation and medical necessity issues related to Dr. Weiner were identified, my client, St. Peter’s Health, through the Board and Executive Leadership took decisive action and authorized me to self-report to the Office of Inspector General and Center for Medicare & Medicaid Services and fully cooperated with the Department of Justice to reach an amicable settlement.”

Dr. Weiner still faces legal issues. According to the recent civil complaint filed against Weiner, the oncologist allegedly ordered “medically unnecessary treatments” for patients, “knowingly falsified records to double bill for patient office visits,” and “directed these false claims to increase his personal income, with little regard for the potential patient harm his conduct created.”

The complaint goes on to note that Dr. Weiner saw 50-70 patients a day — about four to five times more than most oncologists see in a given day. He allegedly wanted this schedule, the civil complaint said, “because it maximized his income.” 

The civil complaint seeks treble damages, which is triple the actual damages awarded to the plaintiff, as well as civil penalties.

The Montana Board of Medical Examiners shows Dr. Weiner’s license as active, expiring March 31, 2025. 
 

A Community’s Support 

Over the past 4 years, Dr. Weiner has encountered strong, continued support from the community.

Rhonda Good, a Helena resident since 2002, is one of the nearly 4000 members of the “We Stand With Dr. Tom Weiner” public Facebook group. Her son was treated for cancer by Dr. Weiner and is doing well. 

Like other residents, she has strong opinions about the settlement.

“My feeling was, St. Peter’s Health, by settling, basically admitted that if they went to court, they wouldn’t be able to defend their billing procedures and so they settled out of court and that probably saved them money,” she said. “Since I have lived here, St. Peter’s Health billing has been a topic of conversation. And it is not a good conversation.”

Dayna Schwartz, 58, founded a private Facebook support group for Weiner, which she said has about 730 members. 

Ms. Schwartz believes the doctor was set up and she plans to continue the weekly rallies. Those who show up, she said, are only a fraction of the supporters. 

“A lot of the staunch supporters maintain a low profile,” she said, as the healthcare system employs more than 1700 residents.

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

As the deadline nears for a Montana healthcare system to pay what has been called a “jaw-dropping” settlement of nearly $11 million dollars to resolve an alleged violation of the False Claims Act, the legal troubles for the oncologist at the center of the case are ongoing and escalating.

On August 26, the US Attorney’s Office for the District of Montana and other agencies announced the settlement agreement with St. Peter’s Health, a nonprofit healthcare system in Helena, to resolve allegations that it submitted “false claims for payments to federal health care programs for services performed by an oncology doctor.”

More specifically, the government contended that St. Peter’s Health allegedly violated the False Claims Act by “knowingly submitting” upcoded and nonpayable claims from the oncologist to the Federal Health Care Program.

“This settlement would not have been possible without the cooperation of St. Peter’s Health, who voluntarily disclosed the misconduct and cooperated with federal investigators to identify the problem and amount of false billing,” said US Attorney Jesse Laslovich in a press release announcing the settlement.

On the same day, the US Attorney’s Office also filed a civil complaint against the oncologist Thomas Weiner, MD, accusing him of “false health care claims and improper prescribing of controlled substances.” Among the numerous allegations, the civil complaint specifies that Dr. Weiner used his position as the chief medical oncologist at St. Peter’s Health “to order medically unnecessary treatment,” including chemotherapy, blood tests, and imaging, as well as “knowingly falsified records” to double bill for office visits.
 

When It Began

The legal troubles for Dr. Weiner, now 61, started about 4 years ago. Dr. Weiner, who was the sole oncologist at St. Peter’s Health and worked there for 24 years, was suspended in October 2020 and then fired in November 2020 for allegedly providing unnecessary treatments and failing to refer patients to other specialists for care, among other claims. 

“The magnitude of Dr. Weiner’s violations is staggering,” St. Peter’s CEO, Wade Johnson, had said in a December 2020 press statement.

At the time, Dr. Weiner had filed a lawsuit against St. Peter’s Health, claiming he was denied due process and seeking damages and a jury trial. Dr. Weiner’s lead lawyer, J. Devlan Geddes, said it was hard to believe that Dr. Weiner had suddenly become a danger to patients after more than 2 decades on the job. 

Before 2020, Dr. Weiner had a clean record with Montana’s Board of Medical Examiners and had never been the subject of an internal investigation related to quality of care, according to his lawyers. He also served on St. Peter’s board of directors and as chief of medical staff.

Dr. Weiner’s exit from St. Peter’s in 2020 led to an outpouring of support from former patients and community members who formed the Facebook group, “ We Stand With Dr. Tom Weiner.” The group soon grew to almost 4000 people.

Four years later, despite the new legal developments, community support for Dr. Weiner has held strong. Supporters continue to have regular rallies outside St. Peter’s Health as well as post messages and personal stories on two Facebook groups now devoted to the cause. 

John Larson, 76, a Helena resident who was treated by Dr. Weiner, echoed a common sentiment from supporters. “I’m completely certain that Tom Weiner is not guilty of what the government is now involved in charging him with,” Dr. Larson said in an interview.
 

$10.8 Million: ‘It’s a Big Number’

At the press conference announcing the recent settlement, Mr. Laslovich recalled a participant describe the total as jaw-dropping, he said in an interview. While there haven’t been many such recent cases in the district, he agreed it’s a big number. The only other recent case he could remember was a 2018 settlement in Kalispell for $24 million. 

The current settlement contends that St. Peter’s Health submitted false claims for payments to federal health care programs related to services performed and referred by Weiner. The infractions allegedly occurred between January 1, 2015 and December 31, 2020. 

According to the Department of Justice (DOJ), St. Peter Health’s “knew, or should have known,” that the oncologist submitted claims for office visits that were coded at a higher level of service than was performed — ie upcoded claims — or did not meet the requirements of a significant, separately identifiable service when performed on the same day chemotherapy was administered — ie non-payable claims. 

The DOJ contended that the healthcare system violated the False Claims Act “by knowingly submitting the upcoded and non-payable” claims to the Federal Health Care Programs. And, as a result, St. Peter’s compensated the oncologist with a salary based on the false claims.

“We had documents showing some of the claims that were being submitted were being done because the doctor wanted more in compensation and of course you can’t do that,” Laslovich said. “For me, the message to providers, and I said this during our press conference, is that coding is critical.” 

“The claims resolved by the settlement are allegations only,” the US Attorney’s Office press release clarified, and “there has been no determination of liability.” 

The leadership at St. Peter’s Health issued a press release on August 27, stating it relied on Dr. Weiner’s medical record documentation and billing certification, though declined to comment further on the settlement 

Bob Wade, a partner at Nelson Mullins, Nashville, Tennessee, and lead outside counsel representing St. Peter’s Health on the settlement, said in an interview that the quality issue was first identified in fall 2020. 

“I first conducted a fair market value review for their entire system and noted that he [Weiner] was an extreme outlier with regard to his productivity,” Mr. Wade said.

In a separate statement, Mr. Wade praised the integrity of the health system, saying, “when the medical record documentation and medical necessity issues related to Dr. Weiner were identified, my client, St. Peter’s Health, through the Board and Executive Leadership took decisive action and authorized me to self-report to the Office of Inspector General and Center for Medicare & Medicaid Services and fully cooperated with the Department of Justice to reach an amicable settlement.”

Dr. Weiner still faces legal issues. According to the recent civil complaint filed against Weiner, the oncologist allegedly ordered “medically unnecessary treatments” for patients, “knowingly falsified records to double bill for patient office visits,” and “directed these false claims to increase his personal income, with little regard for the potential patient harm his conduct created.”

The complaint goes on to note that Dr. Weiner saw 50-70 patients a day — about four to five times more than most oncologists see in a given day. He allegedly wanted this schedule, the civil complaint said, “because it maximized his income.” 

The civil complaint seeks treble damages, which is triple the actual damages awarded to the plaintiff, as well as civil penalties.

The Montana Board of Medical Examiners shows Dr. Weiner’s license as active, expiring March 31, 2025. 
 

A Community’s Support 

Over the past 4 years, Dr. Weiner has encountered strong, continued support from the community.

Rhonda Good, a Helena resident since 2002, is one of the nearly 4000 members of the “We Stand With Dr. Tom Weiner” public Facebook group. Her son was treated for cancer by Dr. Weiner and is doing well. 

Like other residents, she has strong opinions about the settlement.

“My feeling was, St. Peter’s Health, by settling, basically admitted that if they went to court, they wouldn’t be able to defend their billing procedures and so they settled out of court and that probably saved them money,” she said. “Since I have lived here, St. Peter’s Health billing has been a topic of conversation. And it is not a good conversation.”

Dayna Schwartz, 58, founded a private Facebook support group for Weiner, which she said has about 730 members. 

Ms. Schwartz believes the doctor was set up and she plans to continue the weekly rallies. Those who show up, she said, are only a fraction of the supporters. 

“A lot of the staunch supporters maintain a low profile,” she said, as the healthcare system employs more than 1700 residents.

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

As the deadline nears for a Montana healthcare system to pay what has been called a “jaw-dropping” settlement of nearly $11 million dollars to resolve an alleged violation of the False Claims Act, the legal troubles for the oncologist at the center of the case are ongoing and escalating.

On August 26, the US Attorney’s Office for the District of Montana and other agencies announced the settlement agreement with St. Peter’s Health, a nonprofit healthcare system in Helena, to resolve allegations that it submitted “false claims for payments to federal health care programs for services performed by an oncology doctor.”

More specifically, the government contended that St. Peter’s Health allegedly violated the False Claims Act by “knowingly submitting” upcoded and nonpayable claims from the oncologist to the Federal Health Care Program.

“This settlement would not have been possible without the cooperation of St. Peter’s Health, who voluntarily disclosed the misconduct and cooperated with federal investigators to identify the problem and amount of false billing,” said US Attorney Jesse Laslovich in a press release announcing the settlement.

On the same day, the US Attorney’s Office also filed a civil complaint against the oncologist Thomas Weiner, MD, accusing him of “false health care claims and improper prescribing of controlled substances.” Among the numerous allegations, the civil complaint specifies that Dr. Weiner used his position as the chief medical oncologist at St. Peter’s Health “to order medically unnecessary treatment,” including chemotherapy, blood tests, and imaging, as well as “knowingly falsified records” to double bill for office visits.
 

When It Began

The legal troubles for Dr. Weiner, now 61, started about 4 years ago. Dr. Weiner, who was the sole oncologist at St. Peter’s Health and worked there for 24 years, was suspended in October 2020 and then fired in November 2020 for allegedly providing unnecessary treatments and failing to refer patients to other specialists for care, among other claims. 

“The magnitude of Dr. Weiner’s violations is staggering,” St. Peter’s CEO, Wade Johnson, had said in a December 2020 press statement.

At the time, Dr. Weiner had filed a lawsuit against St. Peter’s Health, claiming he was denied due process and seeking damages and a jury trial. Dr. Weiner’s lead lawyer, J. Devlan Geddes, said it was hard to believe that Dr. Weiner had suddenly become a danger to patients after more than 2 decades on the job. 

Before 2020, Dr. Weiner had a clean record with Montana’s Board of Medical Examiners and had never been the subject of an internal investigation related to quality of care, according to his lawyers. He also served on St. Peter’s board of directors and as chief of medical staff.

Dr. Weiner’s exit from St. Peter’s in 2020 led to an outpouring of support from former patients and community members who formed the Facebook group, “ We Stand With Dr. Tom Weiner.” The group soon grew to almost 4000 people.

Four years later, despite the new legal developments, community support for Dr. Weiner has held strong. Supporters continue to have regular rallies outside St. Peter’s Health as well as post messages and personal stories on two Facebook groups now devoted to the cause. 

John Larson, 76, a Helena resident who was treated by Dr. Weiner, echoed a common sentiment from supporters. “I’m completely certain that Tom Weiner is not guilty of what the government is now involved in charging him with,” Dr. Larson said in an interview.
 

$10.8 Million: ‘It’s a Big Number’

At the press conference announcing the recent settlement, Mr. Laslovich recalled a participant describe the total as jaw-dropping, he said in an interview. While there haven’t been many such recent cases in the district, he agreed it’s a big number. The only other recent case he could remember was a 2018 settlement in Kalispell for $24 million. 

The current settlement contends that St. Peter’s Health submitted false claims for payments to federal health care programs related to services performed and referred by Weiner. The infractions allegedly occurred between January 1, 2015 and December 31, 2020. 

According to the Department of Justice (DOJ), St. Peter Health’s “knew, or should have known,” that the oncologist submitted claims for office visits that were coded at a higher level of service than was performed — ie upcoded claims — or did not meet the requirements of a significant, separately identifiable service when performed on the same day chemotherapy was administered — ie non-payable claims. 

The DOJ contended that the healthcare system violated the False Claims Act “by knowingly submitting the upcoded and non-payable” claims to the Federal Health Care Programs. And, as a result, St. Peter’s compensated the oncologist with a salary based on the false claims.

“We had documents showing some of the claims that were being submitted were being done because the doctor wanted more in compensation and of course you can’t do that,” Laslovich said. “For me, the message to providers, and I said this during our press conference, is that coding is critical.” 

“The claims resolved by the settlement are allegations only,” the US Attorney’s Office press release clarified, and “there has been no determination of liability.” 

The leadership at St. Peter’s Health issued a press release on August 27, stating it relied on Dr. Weiner’s medical record documentation and billing certification, though declined to comment further on the settlement 

Bob Wade, a partner at Nelson Mullins, Nashville, Tennessee, and lead outside counsel representing St. Peter’s Health on the settlement, said in an interview that the quality issue was first identified in fall 2020. 

“I first conducted a fair market value review for their entire system and noted that he [Weiner] was an extreme outlier with regard to his productivity,” Mr. Wade said.

In a separate statement, Mr. Wade praised the integrity of the health system, saying, “when the medical record documentation and medical necessity issues related to Dr. Weiner were identified, my client, St. Peter’s Health, through the Board and Executive Leadership took decisive action and authorized me to self-report to the Office of Inspector General and Center for Medicare & Medicaid Services and fully cooperated with the Department of Justice to reach an amicable settlement.”

Dr. Weiner still faces legal issues. According to the recent civil complaint filed against Weiner, the oncologist allegedly ordered “medically unnecessary treatments” for patients, “knowingly falsified records to double bill for patient office visits,” and “directed these false claims to increase his personal income, with little regard for the potential patient harm his conduct created.”

The complaint goes on to note that Dr. Weiner saw 50-70 patients a day — about four to five times more than most oncologists see in a given day. He allegedly wanted this schedule, the civil complaint said, “because it maximized his income.” 

The civil complaint seeks treble damages, which is triple the actual damages awarded to the plaintiff, as well as civil penalties.

The Montana Board of Medical Examiners shows Dr. Weiner’s license as active, expiring March 31, 2025. 
 

A Community’s Support 

Over the past 4 years, Dr. Weiner has encountered strong, continued support from the community.

Rhonda Good, a Helena resident since 2002, is one of the nearly 4000 members of the “We Stand With Dr. Tom Weiner” public Facebook group. Her son was treated for cancer by Dr. Weiner and is doing well. 

Like other residents, she has strong opinions about the settlement.

“My feeling was, St. Peter’s Health, by settling, basically admitted that if they went to court, they wouldn’t be able to defend their billing procedures and so they settled out of court and that probably saved them money,” she said. “Since I have lived here, St. Peter’s Health billing has been a topic of conversation. And it is not a good conversation.”

Dayna Schwartz, 58, founded a private Facebook support group for Weiner, which she said has about 730 members. 

Ms. Schwartz believes the doctor was set up and she plans to continue the weekly rallies. Those who show up, she said, are only a fraction of the supporters. 

“A lot of the staunch supporters maintain a low profile,” she said, as the healthcare system employs more than 1700 residents.

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

The FDA has launched an investigation of the potential exposure to heavy metals when using tampons, the agency announced.

The move follows the publication earlier this year of concerning laboratory test results that detected the presence of more than a dozen metals in a variety of popular nonorganic and organic tampon products. That small study was a combined effort by researchers from Columbia University, Michigan State University, and the University of California, Berkeley.

“We want the public to know that before tampons can be legally sold in the US, they must meet FDA requirements for safety and effectiveness. Manufacturers must test the product and its component materials before, during, and after manufacturing,” the FDA wrote in the announcement of its own upcoming study. “Before a product is allowed onto the market, biocompatibility testing is undertaken by the manufacturing company, which is part of safety testing, and is reviewed by the FDA prior to market authorization.”

There will be two studies, the FDA said. One of the studies will involve laboratory tests to evaluate metals in tampons and potential exposure people may experience when using them. The other study will be a review of current research regarding the health effects of metals that may be found in tampons.

The earlier study, published by the journal Environment International, found levels of lead in every product the researchers tested and detectable levels of more than a dozen other metals like arsenic and cadmium.

The researchers tested 24 tampon products from a range of major brands as well as store brands. The tampons were purchased at stores and online between September 2022 and March 2023. Metal content tended to differ by whether or not a product was labeled as organic, the researchers reported. Lead concentrations were higher in nonorganic tampons, and organic tampons had higher levels of arsenic.

There is no safe level of lead exposure, the US Environmental Protection Agency says, and the effects are cumulative throughout the course of life. The study authors noted that the average age that girls begin menstruation is 12 years old, and the onset of menopause occurs, on average, at age 51. One study mentioned by the researchers estimated that between 52% and 86% of people who menstruate use tampons.

The FDA plans a more expansive set of analyses than the earlier study, the agency announced.

“While the study found metals in some tampons, the study did not test whether metals are released from tampons when used. It also did not test for metals being released, absorbed into the vaginal lining, and getting into the bloodstream during tampon use,” the FDA announcement stated. “The FDA’s laboratory study will measure the amount of metals that come out of tampons under conditions that more closely mimic normal use.”

The absorbent materials in tampons, like cotton, rayon, and viscose, are potential sources of the metals. Cotton plants are particularly known to readily take up metals from the soil, although there are other ways that metals may enter the products, like during the manufacturing process.

Exposure to metals found in the initial analysis can affect a range of body systems and processes, including the brain, the kidneys, the heart, blood, and the reproductive and immune systems.

The vagina, the researchers noted, is highly permeable and substances absorbed there do not get filtered for toxins, such as by being metabolized or passing through the liver, before entering the body’s circulatory system.

The FDA announcement did not specify a timeframe for the completion of its investigation.

A version of this article first appeared on WebMD.

The FDA has launched an investigation of the potential exposure to heavy metals when using tampons, the agency announced.

The move follows the publication earlier this year of concerning laboratory test results that detected the presence of more than a dozen metals in a variety of popular nonorganic and organic tampon products. That small study was a combined effort by researchers from Columbia University, Michigan State University, and the University of California, Berkeley.

“We want the public to know that before tampons can be legally sold in the US, they must meet FDA requirements for safety and effectiveness. Manufacturers must test the product and its component materials before, during, and after manufacturing,” the FDA wrote in the announcement of its own upcoming study. “Before a product is allowed onto the market, biocompatibility testing is undertaken by the manufacturing company, which is part of safety testing, and is reviewed by the FDA prior to market authorization.”

There will be two studies, the FDA said. One of the studies will involve laboratory tests to evaluate metals in tampons and potential exposure people may experience when using them. The other study will be a review of current research regarding the health effects of metals that may be found in tampons.

The earlier study, published by the journal Environment International, found levels of lead in every product the researchers tested and detectable levels of more than a dozen other metals like arsenic and cadmium.

The researchers tested 24 tampon products from a range of major brands as well as store brands. The tampons were purchased at stores and online between September 2022 and March 2023. Metal content tended to differ by whether or not a product was labeled as organic, the researchers reported. Lead concentrations were higher in nonorganic tampons, and organic tampons had higher levels of arsenic.

There is no safe level of lead exposure, the US Environmental Protection Agency says, and the effects are cumulative throughout the course of life. The study authors noted that the average age that girls begin menstruation is 12 years old, and the onset of menopause occurs, on average, at age 51. One study mentioned by the researchers estimated that between 52% and 86% of people who menstruate use tampons.

The FDA plans a more expansive set of analyses than the earlier study, the agency announced.

“While the study found metals in some tampons, the study did not test whether metals are released from tampons when used. It also did not test for metals being released, absorbed into the vaginal lining, and getting into the bloodstream during tampon use,” the FDA announcement stated. “The FDA’s laboratory study will measure the amount of metals that come out of tampons under conditions that more closely mimic normal use.”

The absorbent materials in tampons, like cotton, rayon, and viscose, are potential sources of the metals. Cotton plants are particularly known to readily take up metals from the soil, although there are other ways that metals may enter the products, like during the manufacturing process.

Exposure to metals found in the initial analysis can affect a range of body systems and processes, including the brain, the kidneys, the heart, blood, and the reproductive and immune systems.

The vagina, the researchers noted, is highly permeable and substances absorbed there do not get filtered for toxins, such as by being metabolized or passing through the liver, before entering the body’s circulatory system.

The FDA announcement did not specify a timeframe for the completion of its investigation.

A version of this article first appeared on WebMD.

The FDA has launched an investigation of the potential exposure to heavy metals when using tampons, the agency announced.

The move follows the publication earlier this year of concerning laboratory test results that detected the presence of more than a dozen metals in a variety of popular nonorganic and organic tampon products. That small study was a combined effort by researchers from Columbia University, Michigan State University, and the University of California, Berkeley.

“We want the public to know that before tampons can be legally sold in the US, they must meet FDA requirements for safety and effectiveness. Manufacturers must test the product and its component materials before, during, and after manufacturing,” the FDA wrote in the announcement of its own upcoming study. “Before a product is allowed onto the market, biocompatibility testing is undertaken by the manufacturing company, which is part of safety testing, and is reviewed by the FDA prior to market authorization.”

There will be two studies, the FDA said. One of the studies will involve laboratory tests to evaluate metals in tampons and potential exposure people may experience when using them. The other study will be a review of current research regarding the health effects of metals that may be found in tampons.

The earlier study, published by the journal Environment International, found levels of lead in every product the researchers tested and detectable levels of more than a dozen other metals like arsenic and cadmium.

The researchers tested 24 tampon products from a range of major brands as well as store brands. The tampons were purchased at stores and online between September 2022 and March 2023. Metal content tended to differ by whether or not a product was labeled as organic, the researchers reported. Lead concentrations were higher in nonorganic tampons, and organic tampons had higher levels of arsenic.

There is no safe level of lead exposure, the US Environmental Protection Agency says, and the effects are cumulative throughout the course of life. The study authors noted that the average age that girls begin menstruation is 12 years old, and the onset of menopause occurs, on average, at age 51. One study mentioned by the researchers estimated that between 52% and 86% of people who menstruate use tampons.

The FDA plans a more expansive set of analyses than the earlier study, the agency announced.

“While the study found metals in some tampons, the study did not test whether metals are released from tampons when used. It also did not test for metals being released, absorbed into the vaginal lining, and getting into the bloodstream during tampon use,” the FDA announcement stated. “The FDA’s laboratory study will measure the amount of metals that come out of tampons under conditions that more closely mimic normal use.”

The absorbent materials in tampons, like cotton, rayon, and viscose, are potential sources of the metals. Cotton plants are particularly known to readily take up metals from the soil, although there are other ways that metals may enter the products, like during the manufacturing process.

Exposure to metals found in the initial analysis can affect a range of body systems and processes, including the brain, the kidneys, the heart, blood, and the reproductive and immune systems.

The vagina, the researchers noted, is highly permeable and substances absorbed there do not get filtered for toxins, such as by being metabolized or passing through the liver, before entering the body’s circulatory system.

The FDA announcement did not specify a timeframe for the completion of its investigation.

A version of this article first appeared on WebMD.