Business of Medicine

When Mark Cucuzzella, MD, meets a new patient at the West Virginia Medical School clinic, he introduces himself as “Mark.” For one thing, says Dr. Cucuzzella, his last name is a mouthful. For another, the 56-year-old general practitioner asserts that getting on a first-name basis with his patients is integral to delivering the best care.

“I’m trying to break down the old paternalistic barriers of the doctor/patient relationship,” he says. “Titles create an environment where the doctors are making all the decisions and not involving the patient in any course of action.”

Aniruddh Setya, MD, has a different take on informality between patients and doctors: It’s not OK. “I am not your friend,” says the 35-year-old pediatrician from Florida-based KIDZ Medical Services. “There has to be a level of respect for the education and accomplishment of being a physician.”

The issue of “untitling” a doctor and failing to use their honorific is becoming increasingly common, according to a recent study published in JAMA Network Open. But that doesn’t mean most physicians support the practice. In fact, some doctors contend that it can be harmful, particularly to female physicians.

“My concern is that untitling (so termed by Amy Diehl, PhD, and Leanne Dzubinski, PhD) intrudes upon important professional boundaries and might be correlated with diminishing the value of someone’s time,” says Leah Witt, MD, a geriatrician at UCSF Health, San Francisco. Dr. Witt, along with colleague Lekshmi Santhosh, MD, a pulmonologist, offered commentary on the study results. “Studies have shown that women physicians get more patient portal messages, spend more time in the electronic health record, and have longer visits,” Dr. Witt said. “Dr. Santhosh and I wonder if untitling is a signifier of this diminished value of our time, and an assumption of increased ease of access leading to this higher workload.”

To compile the results reported in JAMA Network Open, Mayo Clinic researchers analyzed more than 90,000 emails from patients to doctors over the course of 3 years, beginning in 2018. Of those emails, more than 32% included the physician’s first name in greeting or salutation. For women physicians, the odds were twice as high that their titles would be omitted in the correspondence. The same holds true for doctors of osteopathic medicine (DOs) compared with MDs, and primary care physicians had similar odds for a title drop compared with specialists.

Dr. Witt says the findings are not surprising. “They match my experience as a woman in medicine, as Dr. Santhosh and I write in our commentary,” she says. “We think the findings could easily be replicated at other centers.”

Indeed, research on 321 speaker introductions at a medical rounds found that when female physicians introduced other physicians, they usually applied the doctor title. When the job of introducing colleagues fell to male physicians, however, the stats fell to 72.4% for male peers and only 49.2% when introducing female peers.

The Mayo Clinic study authors identified the pitfalls of patients who informally address their doctors. They wrote, “Untitling may have a negative impact on physicians, demonstrate lack of respect, and can lead to reduction in formality of the physician/patient relationship or workplace.”
 

Physician preferences vary

Although the results of the Mayo Clinic analysis didn’t and couldn’t address physician sentiments on patient informality, Dr. Setya observes that American culture is becoming less formal. “I’ve been practicing for over 10 years, and the number of people who consider doctors as equals is growing,” he says. “This has been particularly true over the last couple of years.”

This change was documented in 2015. Add in the pandemic and an entire society that is now accustomed to working from home in sweats, and it’s not a stretch to understand why some patients have become less formal in many settings. The 2015 article noted, however, that most physicians prefer to keep titles in the mix.

Perhaps most troublesome, says Dr. Setya, is that patients forgo asking whether it’s OK to use his first name and simply assume it’s acceptable. “It bothers me,” he says. “I became a doctor for more than the money.”

He suspects that his cultural background (Dr. Setya is of Indian descent) plays a role in how strongly he feels about patient-doctor informality. “As a British colony, Indian culture dictates that you pay respect to elders and to accomplishment,” he points out. “America is far looser when it comes to salutations.”

Dr. Cucuzzella largely agrees with Dr. Setya, but has a different view of the role culture plays in how physicians prefer to be addressed. “If your last name is difficult to pronounce, it can put the patient at ease if you give them an option,” he says. “I like my patients to feel comfortable and have a friendly conversation, so I don’t ask them to try to manage my last name.”

When patients revert to using Dr. Cucuzzella’s last name and title, this often breaks down along generational lines, Dr. Cucuzzella has found: Older patients might drop his title, whereas younger patients might keep it as a sign of respect. In some cases, Dr. Cucuzzella tries to bridge this gap, and offers the option of “Dr. Mark.” In his small West Virginia community, this is how people often refer to him.

Dr. Setya says that most of the older physicians he works with still prefer that patients and younger colleagues use their title, but he has witnessed exceptions to this. “My boss in residence hated to be called ‘Sir’ or ‘Doctor,’ ” he says. “In a situation like that, it is reasonable to ask, ‘How can I address you?’ But it has to be mutually agreed upon.”

Dr. Cucuzzella cites informality as the preferred mode for older patients. “If I have a 70-year-old patient, it seems natural they shouldn’t use my title,” he says. “They are worthy of equality in the community. If I’m talking to a retired CEO or state delegate, it’s uncomfortable if they call me doctor.”

Moreover, Dr. Cucuzzella maintains that establishing a less formal environment with patients leads to better outcomes. “Shared decision-making is a basic human right,” he says. “In 2022, doctors shouldn’t make decisions without patient input, unless it’s an emergency situation. Removing the title barriers makes that easier.”
 

How to handle informality

If you fall more in line with Dr. Setya, there are strategies you can use to try to keep formality in your doctor-patient relationships. Dr. Setya’s approach is indirect. “I don’t correct a patient if they use my first name, because that might seem hostile,” he says. “But I alert them in the way I address them back. A Sir, a Mrs., or a Mr. needs to go both ways.”

This particularly holds true in pediatrics, Dr. Setya has found. He has witnessed many colleagues addressing parents as “Mommy and Daddy,” something he says lacks respect and sets too informal a tone. “It’s almost universal that parents don’t like that, and we need to act accordingly.”

Dr. Witt also avoids directly correcting patients, but struggles when they drop her title. “The standard signature I use to sign every patient portal message I respond to includes my first and last name and credentials,” she says. “I maintain formality in most circumstances with that standard reply.”

Beneath the surface, however, Dr. Witt wishes it were easier. “I have struggled with answering the question, ‘Is it OK if I call you Leah?’ she says. “I want to keep our interaction anchored in professionalism without sacrificing the warmth I think is important to a productive patient-physician relationship. For this reason, I tend to say yes to this request, even though I’d rather patients didn’t make such requests.”

In the Fast Company article by Amy Diehl, PhD, and Leanne Dzubinski, PhD, on the topic of untitling professional women, the authors suggest several actions, beginning with leadership that sets expectations on the topic. They also suggest that physicians use polite corrections if patients untitle them. Supplying positive reinforcement when patients include your title can help, too. If all else fails, you can call out the offensive untitling. More often than not, especially with female physicians, the patient is demonstrating an unconscious bias rather than something deliberate.

Opinions vary on the topic of untitling, and ultimately each physician must make the decision for themselves. But creating informal cultures in an organization can have unintended consequences, especially for female peers.

Says Dr. Witt, “We all want to give our patients the best care we can, but professional boundaries are critical to time management, equitable care, and maintaining work-life balance. I would love to see a study that examines untitling by self-reported race and/or ethnicity of physicians, because we know that women of color experience higher rates of burnout and depression, and I wonder if untitling may be part of this.”

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

When Mark Cucuzzella, MD, meets a new patient at the West Virginia Medical School clinic, he introduces himself as “Mark.” For one thing, says Dr. Cucuzzella, his last name is a mouthful. For another, the 56-year-old general practitioner asserts that getting on a first-name basis with his patients is integral to delivering the best care.

“I’m trying to break down the old paternalistic barriers of the doctor/patient relationship,” he says. “Titles create an environment where the doctors are making all the decisions and not involving the patient in any course of action.”

Aniruddh Setya, MD, has a different take on informality between patients and doctors: It’s not OK. “I am not your friend,” says the 35-year-old pediatrician from Florida-based KIDZ Medical Services. “There has to be a level of respect for the education and accomplishment of being a physician.”

The issue of “untitling” a doctor and failing to use their honorific is becoming increasingly common, according to a recent study published in JAMA Network Open. But that doesn’t mean most physicians support the practice. In fact, some doctors contend that it can be harmful, particularly to female physicians.

“My concern is that untitling (so termed by Amy Diehl, PhD, and Leanne Dzubinski, PhD) intrudes upon important professional boundaries and might be correlated with diminishing the value of someone’s time,” says Leah Witt, MD, a geriatrician at UCSF Health, San Francisco. Dr. Witt, along with colleague Lekshmi Santhosh, MD, a pulmonologist, offered commentary on the study results. “Studies have shown that women physicians get more patient portal messages, spend more time in the electronic health record, and have longer visits,” Dr. Witt said. “Dr. Santhosh and I wonder if untitling is a signifier of this diminished value of our time, and an assumption of increased ease of access leading to this higher workload.”

To compile the results reported in JAMA Network Open, Mayo Clinic researchers analyzed more than 90,000 emails from patients to doctors over the course of 3 years, beginning in 2018. Of those emails, more than 32% included the physician’s first name in greeting or salutation. For women physicians, the odds were twice as high that their titles would be omitted in the correspondence. The same holds true for doctors of osteopathic medicine (DOs) compared with MDs, and primary care physicians had similar odds for a title drop compared with specialists.

Dr. Witt says the findings are not surprising. “They match my experience as a woman in medicine, as Dr. Santhosh and I write in our commentary,” she says. “We think the findings could easily be replicated at other centers.”

Indeed, research on 321 speaker introductions at a medical rounds found that when female physicians introduced other physicians, they usually applied the doctor title. When the job of introducing colleagues fell to male physicians, however, the stats fell to 72.4% for male peers and only 49.2% when introducing female peers.

The Mayo Clinic study authors identified the pitfalls of patients who informally address their doctors. They wrote, “Untitling may have a negative impact on physicians, demonstrate lack of respect, and can lead to reduction in formality of the physician/patient relationship or workplace.”
 

Physician preferences vary

Although the results of the Mayo Clinic analysis didn’t and couldn’t address physician sentiments on patient informality, Dr. Setya observes that American culture is becoming less formal. “I’ve been practicing for over 10 years, and the number of people who consider doctors as equals is growing,” he says. “This has been particularly true over the last couple of years.”

This change was documented in 2015. Add in the pandemic and an entire society that is now accustomed to working from home in sweats, and it’s not a stretch to understand why some patients have become less formal in many settings. The 2015 article noted, however, that most physicians prefer to keep titles in the mix.

Perhaps most troublesome, says Dr. Setya, is that patients forgo asking whether it’s OK to use his first name and simply assume it’s acceptable. “It bothers me,” he says. “I became a doctor for more than the money.”

He suspects that his cultural background (Dr. Setya is of Indian descent) plays a role in how strongly he feels about patient-doctor informality. “As a British colony, Indian culture dictates that you pay respect to elders and to accomplishment,” he points out. “America is far looser when it comes to salutations.”

Dr. Cucuzzella largely agrees with Dr. Setya, but has a different view of the role culture plays in how physicians prefer to be addressed. “If your last name is difficult to pronounce, it can put the patient at ease if you give them an option,” he says. “I like my patients to feel comfortable and have a friendly conversation, so I don’t ask them to try to manage my last name.”

When patients revert to using Dr. Cucuzzella’s last name and title, this often breaks down along generational lines, Dr. Cucuzzella has found: Older patients might drop his title, whereas younger patients might keep it as a sign of respect. In some cases, Dr. Cucuzzella tries to bridge this gap, and offers the option of “Dr. Mark.” In his small West Virginia community, this is how people often refer to him.

Dr. Setya says that most of the older physicians he works with still prefer that patients and younger colleagues use their title, but he has witnessed exceptions to this. “My boss in residence hated to be called ‘Sir’ or ‘Doctor,’ ” he says. “In a situation like that, it is reasonable to ask, ‘How can I address you?’ But it has to be mutually agreed upon.”

Dr. Cucuzzella cites informality as the preferred mode for older patients. “If I have a 70-year-old patient, it seems natural they shouldn’t use my title,” he says. “They are worthy of equality in the community. If I’m talking to a retired CEO or state delegate, it’s uncomfortable if they call me doctor.”

Moreover, Dr. Cucuzzella maintains that establishing a less formal environment with patients leads to better outcomes. “Shared decision-making is a basic human right,” he says. “In 2022, doctors shouldn’t make decisions without patient input, unless it’s an emergency situation. Removing the title barriers makes that easier.”
 

How to handle informality

If you fall more in line with Dr. Setya, there are strategies you can use to try to keep formality in your doctor-patient relationships. Dr. Setya’s approach is indirect. “I don’t correct a patient if they use my first name, because that might seem hostile,” he says. “But I alert them in the way I address them back. A Sir, a Mrs., or a Mr. needs to go both ways.”

This particularly holds true in pediatrics, Dr. Setya has found. He has witnessed many colleagues addressing parents as “Mommy and Daddy,” something he says lacks respect and sets too informal a tone. “It’s almost universal that parents don’t like that, and we need to act accordingly.”

Dr. Witt also avoids directly correcting patients, but struggles when they drop her title. “The standard signature I use to sign every patient portal message I respond to includes my first and last name and credentials,” she says. “I maintain formality in most circumstances with that standard reply.”

Beneath the surface, however, Dr. Witt wishes it were easier. “I have struggled with answering the question, ‘Is it OK if I call you Leah?’ she says. “I want to keep our interaction anchored in professionalism without sacrificing the warmth I think is important to a productive patient-physician relationship. For this reason, I tend to say yes to this request, even though I’d rather patients didn’t make such requests.”

In the Fast Company article by Amy Diehl, PhD, and Leanne Dzubinski, PhD, on the topic of untitling professional women, the authors suggest several actions, beginning with leadership that sets expectations on the topic. They also suggest that physicians use polite corrections if patients untitle them. Supplying positive reinforcement when patients include your title can help, too. If all else fails, you can call out the offensive untitling. More often than not, especially with female physicians, the patient is demonstrating an unconscious bias rather than something deliberate.

Opinions vary on the topic of untitling, and ultimately each physician must make the decision for themselves. But creating informal cultures in an organization can have unintended consequences, especially for female peers.

Says Dr. Witt, “We all want to give our patients the best care we can, but professional boundaries are critical to time management, equitable care, and maintaining work-life balance. I would love to see a study that examines untitling by self-reported race and/or ethnicity of physicians, because we know that women of color experience higher rates of burnout and depression, and I wonder if untitling may be part of this.”

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

When Mark Cucuzzella, MD, meets a new patient at the West Virginia Medical School clinic, he introduces himself as “Mark.” For one thing, says Dr. Cucuzzella, his last name is a mouthful. For another, the 56-year-old general practitioner asserts that getting on a first-name basis with his patients is integral to delivering the best care.

“I’m trying to break down the old paternalistic barriers of the doctor/patient relationship,” he says. “Titles create an environment where the doctors are making all the decisions and not involving the patient in any course of action.”

Aniruddh Setya, MD, has a different take on informality between patients and doctors: It’s not OK. “I am not your friend,” says the 35-year-old pediatrician from Florida-based KIDZ Medical Services. “There has to be a level of respect for the education and accomplishment of being a physician.”

The issue of “untitling” a doctor and failing to use their honorific is becoming increasingly common, according to a recent study published in JAMA Network Open. But that doesn’t mean most physicians support the practice. In fact, some doctors contend that it can be harmful, particularly to female physicians.

“My concern is that untitling (so termed by Amy Diehl, PhD, and Leanne Dzubinski, PhD) intrudes upon important professional boundaries and might be correlated with diminishing the value of someone’s time,” says Leah Witt, MD, a geriatrician at UCSF Health, San Francisco. Dr. Witt, along with colleague Lekshmi Santhosh, MD, a pulmonologist, offered commentary on the study results. “Studies have shown that women physicians get more patient portal messages, spend more time in the electronic health record, and have longer visits,” Dr. Witt said. “Dr. Santhosh and I wonder if untitling is a signifier of this diminished value of our time, and an assumption of increased ease of access leading to this higher workload.”

To compile the results reported in JAMA Network Open, Mayo Clinic researchers analyzed more than 90,000 emails from patients to doctors over the course of 3 years, beginning in 2018. Of those emails, more than 32% included the physician’s first name in greeting or salutation. For women physicians, the odds were twice as high that their titles would be omitted in the correspondence. The same holds true for doctors of osteopathic medicine (DOs) compared with MDs, and primary care physicians had similar odds for a title drop compared with specialists.

Dr. Witt says the findings are not surprising. “They match my experience as a woman in medicine, as Dr. Santhosh and I write in our commentary,” she says. “We think the findings could easily be replicated at other centers.”

Indeed, research on 321 speaker introductions at a medical rounds found that when female physicians introduced other physicians, they usually applied the doctor title. When the job of introducing colleagues fell to male physicians, however, the stats fell to 72.4% for male peers and only 49.2% when introducing female peers.

The Mayo Clinic study authors identified the pitfalls of patients who informally address their doctors. They wrote, “Untitling may have a negative impact on physicians, demonstrate lack of respect, and can lead to reduction in formality of the physician/patient relationship or workplace.”
 

Physician preferences vary

Although the results of the Mayo Clinic analysis didn’t and couldn’t address physician sentiments on patient informality, Dr. Setya observes that American culture is becoming less formal. “I’ve been practicing for over 10 years, and the number of people who consider doctors as equals is growing,” he says. “This has been particularly true over the last couple of years.”

This change was documented in 2015. Add in the pandemic and an entire society that is now accustomed to working from home in sweats, and it’s not a stretch to understand why some patients have become less formal in many settings. The 2015 article noted, however, that most physicians prefer to keep titles in the mix.

Perhaps most troublesome, says Dr. Setya, is that patients forgo asking whether it’s OK to use his first name and simply assume it’s acceptable. “It bothers me,” he says. “I became a doctor for more than the money.”

He suspects that his cultural background (Dr. Setya is of Indian descent) plays a role in how strongly he feels about patient-doctor informality. “As a British colony, Indian culture dictates that you pay respect to elders and to accomplishment,” he points out. “America is far looser when it comes to salutations.”

Dr. Cucuzzella largely agrees with Dr. Setya, but has a different view of the role culture plays in how physicians prefer to be addressed. “If your last name is difficult to pronounce, it can put the patient at ease if you give them an option,” he says. “I like my patients to feel comfortable and have a friendly conversation, so I don’t ask them to try to manage my last name.”

When patients revert to using Dr. Cucuzzella’s last name and title, this often breaks down along generational lines, Dr. Cucuzzella has found: Older patients might drop his title, whereas younger patients might keep it as a sign of respect. In some cases, Dr. Cucuzzella tries to bridge this gap, and offers the option of “Dr. Mark.” In his small West Virginia community, this is how people often refer to him.

Dr. Setya says that most of the older physicians he works with still prefer that patients and younger colleagues use their title, but he has witnessed exceptions to this. “My boss in residence hated to be called ‘Sir’ or ‘Doctor,’ ” he says. “In a situation like that, it is reasonable to ask, ‘How can I address you?’ But it has to be mutually agreed upon.”

Dr. Cucuzzella cites informality as the preferred mode for older patients. “If I have a 70-year-old patient, it seems natural they shouldn’t use my title,” he says. “They are worthy of equality in the community. If I’m talking to a retired CEO or state delegate, it’s uncomfortable if they call me doctor.”

Moreover, Dr. Cucuzzella maintains that establishing a less formal environment with patients leads to better outcomes. “Shared decision-making is a basic human right,” he says. “In 2022, doctors shouldn’t make decisions without patient input, unless it’s an emergency situation. Removing the title barriers makes that easier.”
 

How to handle informality

If you fall more in line with Dr. Setya, there are strategies you can use to try to keep formality in your doctor-patient relationships. Dr. Setya’s approach is indirect. “I don’t correct a patient if they use my first name, because that might seem hostile,” he says. “But I alert them in the way I address them back. A Sir, a Mrs., or a Mr. needs to go both ways.”

This particularly holds true in pediatrics, Dr. Setya has found. He has witnessed many colleagues addressing parents as “Mommy and Daddy,” something he says lacks respect and sets too informal a tone. “It’s almost universal that parents don’t like that, and we need to act accordingly.”

Dr. Witt also avoids directly correcting patients, but struggles when they drop her title. “The standard signature I use to sign every patient portal message I respond to includes my first and last name and credentials,” she says. “I maintain formality in most circumstances with that standard reply.”

Beneath the surface, however, Dr. Witt wishes it were easier. “I have struggled with answering the question, ‘Is it OK if I call you Leah?’ she says. “I want to keep our interaction anchored in professionalism without sacrificing the warmth I think is important to a productive patient-physician relationship. For this reason, I tend to say yes to this request, even though I’d rather patients didn’t make such requests.”

In the Fast Company article by Amy Diehl, PhD, and Leanne Dzubinski, PhD, on the topic of untitling professional women, the authors suggest several actions, beginning with leadership that sets expectations on the topic. They also suggest that physicians use polite corrections if patients untitle them. Supplying positive reinforcement when patients include your title can help, too. If all else fails, you can call out the offensive untitling. More often than not, especially with female physicians, the patient is demonstrating an unconscious bias rather than something deliberate.

Opinions vary on the topic of untitling, and ultimately each physician must make the decision for themselves. But creating informal cultures in an organization can have unintended consequences, especially for female peers.

Says Dr. Witt, “We all want to give our patients the best care we can, but professional boundaries are critical to time management, equitable care, and maintaining work-life balance. I would love to see a study that examines untitling by self-reported race and/or ethnicity of physicians, because we know that women of color experience higher rates of burnout and depression, and I wonder if untitling may be part of this.”

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

Highly processed foods meet the same criteria as tobacco for addiction, and labeling them as such might benefit public health, according to a new U.S. study that proposes a set of criteria to assess the addictive potential of some foods.

The research suggests that health care professionals are taking steps toward framing food addiction as a clinical entity in its own right; it currently lacks validated treatment protocols and recognition as a clinical diagnosis.

Meanwhile, other data, reported by researchers at the 2022 Diabetes Professional Care conference in London also add support to the clinical recognition of food addiction.

Clinical psychologist Jen Unwin, PhD, from Southport, England, showed that a 3-month online program of low-carbohydrate diet together with psychoeducational support significantly reduced food addiction symptoms among a varied group of individuals, not all of whom were overweight or had obesity.

Dr. Unwin said her new data represent the first wide-scale clinical audit of its kind, other than a prior report of three patients with food addiction who were successfully treated with a ketogenic diet. 

“Food addiction explains so much of what we see in clinical practice, where intelligent people understand what we tell them about the physiology associated with a low-carb diet, and they follow it for a while, but then they relapse,” said Dr. Unwin, explaining the difficulties faced by around 20% of her patients who are considered to have food addiction.

Meanwhile, the authors of the U.S. study, led by Ashley N. Gearhardt, PhD, a psychologist from the University of Michigan, Ann Arbor, wrote that the ability of highly processed foods (HPFs) “to rapidly deliver high doses of refined carbohydrates and/or fat appear key to their addictive potential. Thus, we conclude that HPFs can be considered addictive substances based on scientifically established criteria.”

They asserted that the contribution to preventable deaths by a diet dominated by highly processed foods is comparable with that of tobacco products, and as such, like Dr. Unwin, the authors sought clinical recognition and a more formalized protocol to manage food addiction.

“Understanding whether addiction contributes to HPF intake may lead to new treatments, as preliminary research finds that behavioral and pharmacological interventions that target addictive mechanisms may reduce compulsive HPF intake,” they stated.

The study led by Dr. Gearhardt was published in the journal Addiction, and the study led by Unwin was also recently published in Frontiers in Psychiatry.
 

Addiction criteria similar to tobacco

HPFs can be associated with an eating phenotype “that reflects the hallmarks of addiction,” said Dr. Gearhardt and coauthors; typically, loss of control over intake, intense cravings, inability to cut down, and continued use despite negative consequences.

Acknowledging the lack of a single addictive agent, they explain that food addiction reflects mechanisms implicated in other addictive disorders such as smoking.

As such, in their study, Dr. Gearhardt and colleagues proposed a set of scientifically based criteria for the evaluation of whether certain foods are addictive. “Specifically, we propose the primary criteria used to resolve one of the last major controversies over whether a substance, tobacco products, was addictive.”

They consider certain foods according to the primary criteria that have stood the test of time after being proposed in 1988 by the U.S. Surgeon General to establish the addictive potential of tobacco: they trigger compulsive use, they have psychoactive effects, and they are reinforcing.

They have updated these criteria to include the ability to trigger urges and cravings, and added that “both these products [tobacco and HPFs] are legal, easily accessible, inexpensive, lack an intoxication syndrome, and are major causes of preventable death.”

For example, with compulsive use, tobacco meets this criterion because evidence suggests that most smokers would like to quit but are unable to do so.

Likewise, wrote Dr. Gearhardt and colleagues, even “in the face of significant diet-related health consequences (e.g., diabetes and cardiovascular disease), the majority of patients are unable to adhere to medically recommended dietary plans that require a reduction in HPF intake.”

Reinforcement, through tobacco use, is demonstrated by its ‘being sufficiently rewarding to maintain self-administration” because of its ability to deliver nicotine, they said, quoting the Surgeon General’s report, and likewise, with food addiction, “both adults and children will self-administer HPFs (e.g., potato chips, candy, and cookies) even when satiated.”
 

Online group food addiction intervention study

Dr. Unwin and coauthors want people with food addiction to be able to access a validated treatment protocol. Their study aimed to evaluate an online group intervention across multiple sites in the United States, Canada, and the United Kingdom, involving an abstinent, low-carbohydrate diet and biopsychosocial education focused on addiction and recovery in people self-identifying as having food addiction.

“Lots of people with food addiction go to GPs who don’t clinically recognize this, or if they attend addiction services and psychiatry, then they tend to only specialize in drugs, alcohol, and gambling. Eating disorder services are linked but their programs mostly don’t work for a food addict,” Dr. Unwin remarked in an interview.

“We feel running groups, as well as training professionals to run groups, is the best way to manage food addiction,” she said, reflecting on the scale of the problem, with around 10% of adults in the U.K. general population considered to have food addiction. In Dr. Unwin’s study, some people had type 2 diabetes and some overweight/obesity, but she added that some participants were underweight or of normal weight.

Initially, the 103 participants received weekly group (8-24 people) sessions for 10-14 weeks, and then monthly maintenance comprising follow-up that involved coaching participants on how to cope with relapse and get back on track.

Food addiction symptoms were assessed pre- and post program using the modified Yale Food Addiction Scale (mYFAS) 2.0; ICD-10 symptoms of food-related substance use disorder (CRAVED); and mental health well-being measured using the short version of the Warwick Edinburgh Mental Wellbeing scale and body weight.

“The program eliminates processed foods with a personalized, abstinence food plan that involves education around mechanisms involved,” said Dr. Unwin, who explained that processed foods deliver a dopamine high, and in response to this, the brain lowers the number of dopamine receptors to effectively counteract the increase in dopamine. This drop in dopamine receptors explains the depression often associated with food addiction.

Dr. Unwin reported that food addiction symptoms were significantly reduced, with the mYFAS dropping by 1.52, the CRAVED score by 1.53, and body weight by 2.34 kg (5.2 lb). Mental health, as measured by the Warwick Edinburgh Mental Wellbeing scale, improved by 2.37 points.

“We were very interested in mental health and well-being because it impacts so much across our lives, and we saw significant improvements here, but we were less interested in weight because food addicts come in all shapes and sizes with some people underweight,” said Dr. Unwin. “Food addiction symptoms were significantly improved in the group, but we now need to look at the longer-term outcomes.”

Dr. Unwin runs a low-carbohydrate program for type 2 diabetes with her husband David Unwin, MD, who is a GP in Southport, England. She said that they ask patients if they think they have food addiction, and most say they do.

“I always try to explain to patients about the dopamine high, and how this starts the craving which makes people wonder when and where they can find the next sugar hit. Just thinking about the next chocolate bar gets the dopamine running for many people, and the more they tread this path then the worse it gets because the dopamine receptors keep reducing.”

Lorraine Avery, RN, a diabetes nurse specialist for Solent NHS Trust, who attended the DPC conference, welcomed Dr. Unwin’s presentation.

“My concern as a diabetes nurse specialist is that I’m unsure all our patients recognize their food addiction, and there are often more drivers to eating than just the food in front of them,” she said in an interview. “I think there’s an emotional element, too. These people are often ‘yo-yo’ dieters, and they join lots of expert companies to help them lose weight, but these companies want them to regain and re-join their programs,” she said.

“I think there is something about helping patients recognize they have a food addiction and they need to consider that other approaches might be helpful.”

Dr. Unwin reported no relevant financial relationships; some other authors have fee-paying clients with food addiction. Dr. Gearhardt and Ms. Avery reported no relevant financial relationships.

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

Highly processed foods meet the same criteria as tobacco for addiction, and labeling them as such might benefit public health, according to a new U.S. study that proposes a set of criteria to assess the addictive potential of some foods.

The research suggests that health care professionals are taking steps toward framing food addiction as a clinical entity in its own right; it currently lacks validated treatment protocols and recognition as a clinical diagnosis.

Meanwhile, other data, reported by researchers at the 2022 Diabetes Professional Care conference in London also add support to the clinical recognition of food addiction.

Clinical psychologist Jen Unwin, PhD, from Southport, England, showed that a 3-month online program of low-carbohydrate diet together with psychoeducational support significantly reduced food addiction symptoms among a varied group of individuals, not all of whom were overweight or had obesity.

Dr. Unwin said her new data represent the first wide-scale clinical audit of its kind, other than a prior report of three patients with food addiction who were successfully treated with a ketogenic diet. 

“Food addiction explains so much of what we see in clinical practice, where intelligent people understand what we tell them about the physiology associated with a low-carb diet, and they follow it for a while, but then they relapse,” said Dr. Unwin, explaining the difficulties faced by around 20% of her patients who are considered to have food addiction.

Meanwhile, the authors of the U.S. study, led by Ashley N. Gearhardt, PhD, a psychologist from the University of Michigan, Ann Arbor, wrote that the ability of highly processed foods (HPFs) “to rapidly deliver high doses of refined carbohydrates and/or fat appear key to their addictive potential. Thus, we conclude that HPFs can be considered addictive substances based on scientifically established criteria.”

They asserted that the contribution to preventable deaths by a diet dominated by highly processed foods is comparable with that of tobacco products, and as such, like Dr. Unwin, the authors sought clinical recognition and a more formalized protocol to manage food addiction.

“Understanding whether addiction contributes to HPF intake may lead to new treatments, as preliminary research finds that behavioral and pharmacological interventions that target addictive mechanisms may reduce compulsive HPF intake,” they stated.

The study led by Dr. Gearhardt was published in the journal Addiction, and the study led by Unwin was also recently published in Frontiers in Psychiatry.
 

Addiction criteria similar to tobacco

HPFs can be associated with an eating phenotype “that reflects the hallmarks of addiction,” said Dr. Gearhardt and coauthors; typically, loss of control over intake, intense cravings, inability to cut down, and continued use despite negative consequences.

Acknowledging the lack of a single addictive agent, they explain that food addiction reflects mechanisms implicated in other addictive disorders such as smoking.

As such, in their study, Dr. Gearhardt and colleagues proposed a set of scientifically based criteria for the evaluation of whether certain foods are addictive. “Specifically, we propose the primary criteria used to resolve one of the last major controversies over whether a substance, tobacco products, was addictive.”

They consider certain foods according to the primary criteria that have stood the test of time after being proposed in 1988 by the U.S. Surgeon General to establish the addictive potential of tobacco: they trigger compulsive use, they have psychoactive effects, and they are reinforcing.

They have updated these criteria to include the ability to trigger urges and cravings, and added that “both these products [tobacco and HPFs] are legal, easily accessible, inexpensive, lack an intoxication syndrome, and are major causes of preventable death.”

For example, with compulsive use, tobacco meets this criterion because evidence suggests that most smokers would like to quit but are unable to do so.

Likewise, wrote Dr. Gearhardt and colleagues, even “in the face of significant diet-related health consequences (e.g., diabetes and cardiovascular disease), the majority of patients are unable to adhere to medically recommended dietary plans that require a reduction in HPF intake.”

Reinforcement, through tobacco use, is demonstrated by its ‘being sufficiently rewarding to maintain self-administration” because of its ability to deliver nicotine, they said, quoting the Surgeon General’s report, and likewise, with food addiction, “both adults and children will self-administer HPFs (e.g., potato chips, candy, and cookies) even when satiated.”
 

Online group food addiction intervention study

Dr. Unwin and coauthors want people with food addiction to be able to access a validated treatment protocol. Their study aimed to evaluate an online group intervention across multiple sites in the United States, Canada, and the United Kingdom, involving an abstinent, low-carbohydrate diet and biopsychosocial education focused on addiction and recovery in people self-identifying as having food addiction.

“Lots of people with food addiction go to GPs who don’t clinically recognize this, or if they attend addiction services and psychiatry, then they tend to only specialize in drugs, alcohol, and gambling. Eating disorder services are linked but their programs mostly don’t work for a food addict,” Dr. Unwin remarked in an interview.

“We feel running groups, as well as training professionals to run groups, is the best way to manage food addiction,” she said, reflecting on the scale of the problem, with around 10% of adults in the U.K. general population considered to have food addiction. In Dr. Unwin’s study, some people had type 2 diabetes and some overweight/obesity, but she added that some participants were underweight or of normal weight.

Initially, the 103 participants received weekly group (8-24 people) sessions for 10-14 weeks, and then monthly maintenance comprising follow-up that involved coaching participants on how to cope with relapse and get back on track.

Food addiction symptoms were assessed pre- and post program using the modified Yale Food Addiction Scale (mYFAS) 2.0; ICD-10 symptoms of food-related substance use disorder (CRAVED); and mental health well-being measured using the short version of the Warwick Edinburgh Mental Wellbeing scale and body weight.

“The program eliminates processed foods with a personalized, abstinence food plan that involves education around mechanisms involved,” said Dr. Unwin, who explained that processed foods deliver a dopamine high, and in response to this, the brain lowers the number of dopamine receptors to effectively counteract the increase in dopamine. This drop in dopamine receptors explains the depression often associated with food addiction.

Dr. Unwin reported that food addiction symptoms were significantly reduced, with the mYFAS dropping by 1.52, the CRAVED score by 1.53, and body weight by 2.34 kg (5.2 lb). Mental health, as measured by the Warwick Edinburgh Mental Wellbeing scale, improved by 2.37 points.

“We were very interested in mental health and well-being because it impacts so much across our lives, and we saw significant improvements here, but we were less interested in weight because food addicts come in all shapes and sizes with some people underweight,” said Dr. Unwin. “Food addiction symptoms were significantly improved in the group, but we now need to look at the longer-term outcomes.”

Dr. Unwin runs a low-carbohydrate program for type 2 diabetes with her husband David Unwin, MD, who is a GP in Southport, England. She said that they ask patients if they think they have food addiction, and most say they do.

“I always try to explain to patients about the dopamine high, and how this starts the craving which makes people wonder when and where they can find the next sugar hit. Just thinking about the next chocolate bar gets the dopamine running for many people, and the more they tread this path then the worse it gets because the dopamine receptors keep reducing.”

Lorraine Avery, RN, a diabetes nurse specialist for Solent NHS Trust, who attended the DPC conference, welcomed Dr. Unwin’s presentation.

“My concern as a diabetes nurse specialist is that I’m unsure all our patients recognize their food addiction, and there are often more drivers to eating than just the food in front of them,” she said in an interview. “I think there’s an emotional element, too. These people are often ‘yo-yo’ dieters, and they join lots of expert companies to help them lose weight, but these companies want them to regain and re-join their programs,” she said.

“I think there is something about helping patients recognize they have a food addiction and they need to consider that other approaches might be helpful.”

Dr. Unwin reported no relevant financial relationships; some other authors have fee-paying clients with food addiction. Dr. Gearhardt and Ms. Avery reported no relevant financial relationships.

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

Highly processed foods meet the same criteria as tobacco for addiction, and labeling them as such might benefit public health, according to a new U.S. study that proposes a set of criteria to assess the addictive potential of some foods.

The research suggests that health care professionals are taking steps toward framing food addiction as a clinical entity in its own right; it currently lacks validated treatment protocols and recognition as a clinical diagnosis.

Meanwhile, other data, reported by researchers at the 2022 Diabetes Professional Care conference in London also add support to the clinical recognition of food addiction.

Clinical psychologist Jen Unwin, PhD, from Southport, England, showed that a 3-month online program of low-carbohydrate diet together with psychoeducational support significantly reduced food addiction symptoms among a varied group of individuals, not all of whom were overweight or had obesity.

Dr. Unwin said her new data represent the first wide-scale clinical audit of its kind, other than a prior report of three patients with food addiction who were successfully treated with a ketogenic diet. 

“Food addiction explains so much of what we see in clinical practice, where intelligent people understand what we tell them about the physiology associated with a low-carb diet, and they follow it for a while, but then they relapse,” said Dr. Unwin, explaining the difficulties faced by around 20% of her patients who are considered to have food addiction.

Meanwhile, the authors of the U.S. study, led by Ashley N. Gearhardt, PhD, a psychologist from the University of Michigan, Ann Arbor, wrote that the ability of highly processed foods (HPFs) “to rapidly deliver high doses of refined carbohydrates and/or fat appear key to their addictive potential. Thus, we conclude that HPFs can be considered addictive substances based on scientifically established criteria.”

They asserted that the contribution to preventable deaths by a diet dominated by highly processed foods is comparable with that of tobacco products, and as such, like Dr. Unwin, the authors sought clinical recognition and a more formalized protocol to manage food addiction.

“Understanding whether addiction contributes to HPF intake may lead to new treatments, as preliminary research finds that behavioral and pharmacological interventions that target addictive mechanisms may reduce compulsive HPF intake,” they stated.

The study led by Dr. Gearhardt was published in the journal Addiction, and the study led by Unwin was also recently published in Frontiers in Psychiatry.
 

Addiction criteria similar to tobacco

HPFs can be associated with an eating phenotype “that reflects the hallmarks of addiction,” said Dr. Gearhardt and coauthors; typically, loss of control over intake, intense cravings, inability to cut down, and continued use despite negative consequences.

Acknowledging the lack of a single addictive agent, they explain that food addiction reflects mechanisms implicated in other addictive disorders such as smoking.

As such, in their study, Dr. Gearhardt and colleagues proposed a set of scientifically based criteria for the evaluation of whether certain foods are addictive. “Specifically, we propose the primary criteria used to resolve one of the last major controversies over whether a substance, tobacco products, was addictive.”

They consider certain foods according to the primary criteria that have stood the test of time after being proposed in 1988 by the U.S. Surgeon General to establish the addictive potential of tobacco: they trigger compulsive use, they have psychoactive effects, and they are reinforcing.

They have updated these criteria to include the ability to trigger urges and cravings, and added that “both these products [tobacco and HPFs] are legal, easily accessible, inexpensive, lack an intoxication syndrome, and are major causes of preventable death.”

For example, with compulsive use, tobacco meets this criterion because evidence suggests that most smokers would like to quit but are unable to do so.

Likewise, wrote Dr. Gearhardt and colleagues, even “in the face of significant diet-related health consequences (e.g., diabetes and cardiovascular disease), the majority of patients are unable to adhere to medically recommended dietary plans that require a reduction in HPF intake.”

Reinforcement, through tobacco use, is demonstrated by its ‘being sufficiently rewarding to maintain self-administration” because of its ability to deliver nicotine, they said, quoting the Surgeon General’s report, and likewise, with food addiction, “both adults and children will self-administer HPFs (e.g., potato chips, candy, and cookies) even when satiated.”
 

Online group food addiction intervention study

Dr. Unwin and coauthors want people with food addiction to be able to access a validated treatment protocol. Their study aimed to evaluate an online group intervention across multiple sites in the United States, Canada, and the United Kingdom, involving an abstinent, low-carbohydrate diet and biopsychosocial education focused on addiction and recovery in people self-identifying as having food addiction.

“Lots of people with food addiction go to GPs who don’t clinically recognize this, or if they attend addiction services and psychiatry, then they tend to only specialize in drugs, alcohol, and gambling. Eating disorder services are linked but their programs mostly don’t work for a food addict,” Dr. Unwin remarked in an interview.

“We feel running groups, as well as training professionals to run groups, is the best way to manage food addiction,” she said, reflecting on the scale of the problem, with around 10% of adults in the U.K. general population considered to have food addiction. In Dr. Unwin’s study, some people had type 2 diabetes and some overweight/obesity, but she added that some participants were underweight or of normal weight.

Initially, the 103 participants received weekly group (8-24 people) sessions for 10-14 weeks, and then monthly maintenance comprising follow-up that involved coaching participants on how to cope with relapse and get back on track.

Food addiction symptoms were assessed pre- and post program using the modified Yale Food Addiction Scale (mYFAS) 2.0; ICD-10 symptoms of food-related substance use disorder (CRAVED); and mental health well-being measured using the short version of the Warwick Edinburgh Mental Wellbeing scale and body weight.

“The program eliminates processed foods with a personalized, abstinence food plan that involves education around mechanisms involved,” said Dr. Unwin, who explained that processed foods deliver a dopamine high, and in response to this, the brain lowers the number of dopamine receptors to effectively counteract the increase in dopamine. This drop in dopamine receptors explains the depression often associated with food addiction.

Dr. Unwin reported that food addiction symptoms were significantly reduced, with the mYFAS dropping by 1.52, the CRAVED score by 1.53, and body weight by 2.34 kg (5.2 lb). Mental health, as measured by the Warwick Edinburgh Mental Wellbeing scale, improved by 2.37 points.

“We were very interested in mental health and well-being because it impacts so much across our lives, and we saw significant improvements here, but we were less interested in weight because food addicts come in all shapes and sizes with some people underweight,” said Dr. Unwin. “Food addiction symptoms were significantly improved in the group, but we now need to look at the longer-term outcomes.”

Dr. Unwin runs a low-carbohydrate program for type 2 diabetes with her husband David Unwin, MD, who is a GP in Southport, England. She said that they ask patients if they think they have food addiction, and most say they do.

“I always try to explain to patients about the dopamine high, and how this starts the craving which makes people wonder when and where they can find the next sugar hit. Just thinking about the next chocolate bar gets the dopamine running for many people, and the more they tread this path then the worse it gets because the dopamine receptors keep reducing.”

Lorraine Avery, RN, a diabetes nurse specialist for Solent NHS Trust, who attended the DPC conference, welcomed Dr. Unwin’s presentation.

“My concern as a diabetes nurse specialist is that I’m unsure all our patients recognize their food addiction, and there are often more drivers to eating than just the food in front of them,” she said in an interview. “I think there’s an emotional element, too. These people are often ‘yo-yo’ dieters, and they join lots of expert companies to help them lose weight, but these companies want them to regain and re-join their programs,” she said.

“I think there is something about helping patients recognize they have a food addiction and they need to consider that other approaches might be helpful.”

Dr. Unwin reported no relevant financial relationships; some other authors have fee-paying clients with food addiction. Dr. Gearhardt and Ms. Avery reported no relevant financial relationships.

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

Competition between five biologic drugs and their skinny-label biosimilars saved Medicare an estimated $1.5 billion during 2015-2020. But these savings accruing to Medicare and the availability of those and other biosimilars through skinny labeling is under threat from recent court rulings, according to a research letter published online in JAMA Internal Medicine.

The authors highlighted the need for such savings by noting that, while biologics comprise less than 5% of prescription drug use, their price tag amounts to about 40% of U.S. drug spending, Biologic manufacturers often delay the availability of biosimilars for additional years beyond the original patent expiration through further patents for supplemental indications. To provide a counterbalance, federal law allows the Food and Drug Administration to approve “skinny-label” generics and biosimilars that carve out patent-protected indications or regulatory exclusivities. But once a generic drug reaches the market through this process with a skinny label, it may often be substituted for indications that go beyond the ones listed on the skinny label. In fact, some state laws mandate that pharmacists substitute interchangeable generics for brand-name drugs, helping to decrease drug prices. In response to legal threats to the skinny-label pathway, Alexander C. Egilman and colleagues at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, assessed the frequency of approval and marketing of skinny-label biosimilars from 2015 to 2021 and the resultant savings to Medicare.

TheaDesign/Thinkstock

The authors estimated annual Part B (clinician-administered) savings from skinny-label biosimilars through 2020 by comparing actual biologic and skinny-label biosimilar spending with estimated biologic spending without competition using the Medicare Dashboard. They assumed that the unit price of the biologic would increase at its 5-year compound annual growth rate prior to competition.

In that period, the FDA approved 33 biosimilars linked to 11 biologics. Among them, 22 (66.7%) had a skinny label. Of 21 biosimilars marketed before 2022, 13 (61.9%) were launched with a skinny label. Of the 8 biologics linked to these 21 biosimilars, 5 of the first-to-market biosimilars had skinny labels (bevacizumab, filgrastim, infliximab, pegfilgrastim, and rituximab), leading to earlier competition through 2021.

The estimated $1.5 billion in savings to Medicare from these skinny-label biosimilars over the 2015-2020 span represents 4.9% of the $30.2 billion that Medicare spent on the five biologics during this period. The researchers pointed out that once adalimumab (Humira) faces skinny-label biosimilar competition in 2023, savings will likely grow substantially.

In response to the research letter, an editor’s note by JAMA Internal Medicine Editorial Fellow Eric Ward, MD, and JAMA Internal Medicine Editor at Large and Online Editor Robert Steinbrook, MD, stated that, between 2015 and 2019, 24 (43%) of 56 brand-name drugs had competition from skinny-labeled generic formulations after first becoming available as generics.

The editors also referenced a JAMA Viewpoints article from 2021 that reviewed the most recent case challenging the skinny-label pathway in which GlaxoSmithKline sued Teva for its marketing of a skinny-label generic of the brand-name beta-blocker carvedilol (Coreg) that the plaintive claimed “induced physicians to prescribe carvedilol for indications that had been carved out by Teva’s skinny label, thus infringing GlaxoSmithKline’s patents.” A $235 million judgment against Teva was overturned by a district court and then reversed again by a Federal Circuit court that, after receiving criticism, reconsidered the case, and a panel affirmed the judgment against Teva.

“The Federal Circuit panel’s decision has the potential to put generic drugs that fail to adequately carve out indications from the brand name labeling at risk for damages related to infringement,” the authors wrote. Similar claims of infringement are being heard in other courts, they wrote, and they urged careful targeting of skinny-label carveouts, and suggest also that challenges to the arguments used against Teva focus on preservation of First Amendment rights as protection for lawful and accurate speech in drug labels.

“The legal uncertainties are likely to continue, as manufacturers pursue novel and complex strategies to protect the patents and regulatory exclusivities of brand-name drugs and biologics,” Dr. Ward and Dr. Steinbrook wrote, adding that “the path forward is for Congress to enact additional legislation that reaffirms and strengthens the permissibility of skinny labeling.”

The research letter’s corresponding author, Ameet Sarpatwari, PhD, JD, assistant professor at Harvard Medical School, and assistant director for the Harvard Program On Regulation, Therapeutics, And Law, echoed concerns over the Teva case in an interview. “There has certainly been concern that should the appellate decision stand, there will be a chilling effect. As the lone dissenter in that case noted, ‘no skinny-label generic is safe.’ I think many generic and biosimilar manufacturers are awaiting to see whether the Supreme Court will take the case.”

He added: “I do not believe the likelihood of skinny-label-supportive legislation making it through Congress will be greatly diminished in a divided Congress. Democrats and Republicans alike should seek to promote competition in the marketplace, which is what the skinny-labeling pathway accomplishes.”

The authors reported no relevant conflicts of interest. The research was funded by a grant from Arnold Ventures.

Competition between five biologic drugs and their skinny-label biosimilars saved Medicare an estimated $1.5 billion during 2015-2020. But these savings accruing to Medicare and the availability of those and other biosimilars through skinny labeling is under threat from recent court rulings, according to a research letter published online in JAMA Internal Medicine.

The authors highlighted the need for such savings by noting that, while biologics comprise less than 5% of prescription drug use, their price tag amounts to about 40% of U.S. drug spending, Biologic manufacturers often delay the availability of biosimilars for additional years beyond the original patent expiration through further patents for supplemental indications. To provide a counterbalance, federal law allows the Food and Drug Administration to approve “skinny-label” generics and biosimilars that carve out patent-protected indications or regulatory exclusivities. But once a generic drug reaches the market through this process with a skinny label, it may often be substituted for indications that go beyond the ones listed on the skinny label. In fact, some state laws mandate that pharmacists substitute interchangeable generics for brand-name drugs, helping to decrease drug prices. In response to legal threats to the skinny-label pathway, Alexander C. Egilman and colleagues at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, assessed the frequency of approval and marketing of skinny-label biosimilars from 2015 to 2021 and the resultant savings to Medicare.

TheaDesign/Thinkstock

The authors estimated annual Part B (clinician-administered) savings from skinny-label biosimilars through 2020 by comparing actual biologic and skinny-label biosimilar spending with estimated biologic spending without competition using the Medicare Dashboard. They assumed that the unit price of the biologic would increase at its 5-year compound annual growth rate prior to competition.

In that period, the FDA approved 33 biosimilars linked to 11 biologics. Among them, 22 (66.7%) had a skinny label. Of 21 biosimilars marketed before 2022, 13 (61.9%) were launched with a skinny label. Of the 8 biologics linked to these 21 biosimilars, 5 of the first-to-market biosimilars had skinny labels (bevacizumab, filgrastim, infliximab, pegfilgrastim, and rituximab), leading to earlier competition through 2021.

The estimated $1.5 billion in savings to Medicare from these skinny-label biosimilars over the 2015-2020 span represents 4.9% of the $30.2 billion that Medicare spent on the five biologics during this period. The researchers pointed out that once adalimumab (Humira) faces skinny-label biosimilar competition in 2023, savings will likely grow substantially.

In response to the research letter, an editor’s note by JAMA Internal Medicine Editorial Fellow Eric Ward, MD, and JAMA Internal Medicine Editor at Large and Online Editor Robert Steinbrook, MD, stated that, between 2015 and 2019, 24 (43%) of 56 brand-name drugs had competition from skinny-labeled generic formulations after first becoming available as generics.

The editors also referenced a JAMA Viewpoints article from 2021 that reviewed the most recent case challenging the skinny-label pathway in which GlaxoSmithKline sued Teva for its marketing of a skinny-label generic of the brand-name beta-blocker carvedilol (Coreg) that the plaintive claimed “induced physicians to prescribe carvedilol for indications that had been carved out by Teva’s skinny label, thus infringing GlaxoSmithKline’s patents.” A $235 million judgment against Teva was overturned by a district court and then reversed again by a Federal Circuit court that, after receiving criticism, reconsidered the case, and a panel affirmed the judgment against Teva.

“The Federal Circuit panel’s decision has the potential to put generic drugs that fail to adequately carve out indications from the brand name labeling at risk for damages related to infringement,” the authors wrote. Similar claims of infringement are being heard in other courts, they wrote, and they urged careful targeting of skinny-label carveouts, and suggest also that challenges to the arguments used against Teva focus on preservation of First Amendment rights as protection for lawful and accurate speech in drug labels.

“The legal uncertainties are likely to continue, as manufacturers pursue novel and complex strategies to protect the patents and regulatory exclusivities of brand-name drugs and biologics,” Dr. Ward and Dr. Steinbrook wrote, adding that “the path forward is for Congress to enact additional legislation that reaffirms and strengthens the permissibility of skinny labeling.”

The research letter’s corresponding author, Ameet Sarpatwari, PhD, JD, assistant professor at Harvard Medical School, and assistant director for the Harvard Program On Regulation, Therapeutics, And Law, echoed concerns over the Teva case in an interview. “There has certainly been concern that should the appellate decision stand, there will be a chilling effect. As the lone dissenter in that case noted, ‘no skinny-label generic is safe.’ I think many generic and biosimilar manufacturers are awaiting to see whether the Supreme Court will take the case.”

He added: “I do not believe the likelihood of skinny-label-supportive legislation making it through Congress will be greatly diminished in a divided Congress. Democrats and Republicans alike should seek to promote competition in the marketplace, which is what the skinny-labeling pathway accomplishes.”

The authors reported no relevant conflicts of interest. The research was funded by a grant from Arnold Ventures.

Competition between five biologic drugs and their skinny-label biosimilars saved Medicare an estimated $1.5 billion during 2015-2020. But these savings accruing to Medicare and the availability of those and other biosimilars through skinny labeling is under threat from recent court rulings, according to a research letter published online in JAMA Internal Medicine.

The authors highlighted the need for such savings by noting that, while biologics comprise less than 5% of prescription drug use, their price tag amounts to about 40% of U.S. drug spending, Biologic manufacturers often delay the availability of biosimilars for additional years beyond the original patent expiration through further patents for supplemental indications. To provide a counterbalance, federal law allows the Food and Drug Administration to approve “skinny-label” generics and biosimilars that carve out patent-protected indications or regulatory exclusivities. But once a generic drug reaches the market through this process with a skinny label, it may often be substituted for indications that go beyond the ones listed on the skinny label. In fact, some state laws mandate that pharmacists substitute interchangeable generics for brand-name drugs, helping to decrease drug prices. In response to legal threats to the skinny-label pathway, Alexander C. Egilman and colleagues at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, assessed the frequency of approval and marketing of skinny-label biosimilars from 2015 to 2021 and the resultant savings to Medicare.

TheaDesign/Thinkstock

The authors estimated annual Part B (clinician-administered) savings from skinny-label biosimilars through 2020 by comparing actual biologic and skinny-label biosimilar spending with estimated biologic spending without competition using the Medicare Dashboard. They assumed that the unit price of the biologic would increase at its 5-year compound annual growth rate prior to competition.

In that period, the FDA approved 33 biosimilars linked to 11 biologics. Among them, 22 (66.7%) had a skinny label. Of 21 biosimilars marketed before 2022, 13 (61.9%) were launched with a skinny label. Of the 8 biologics linked to these 21 biosimilars, 5 of the first-to-market biosimilars had skinny labels (bevacizumab, filgrastim, infliximab, pegfilgrastim, and rituximab), leading to earlier competition through 2021.

The estimated $1.5 billion in savings to Medicare from these skinny-label biosimilars over the 2015-2020 span represents 4.9% of the $30.2 billion that Medicare spent on the five biologics during this period. The researchers pointed out that once adalimumab (Humira) faces skinny-label biosimilar competition in 2023, savings will likely grow substantially.

In response to the research letter, an editor’s note by JAMA Internal Medicine Editorial Fellow Eric Ward, MD, and JAMA Internal Medicine Editor at Large and Online Editor Robert Steinbrook, MD, stated that, between 2015 and 2019, 24 (43%) of 56 brand-name drugs had competition from skinny-labeled generic formulations after first becoming available as generics.

The editors also referenced a JAMA Viewpoints article from 2021 that reviewed the most recent case challenging the skinny-label pathway in which GlaxoSmithKline sued Teva for its marketing of a skinny-label generic of the brand-name beta-blocker carvedilol (Coreg) that the plaintive claimed “induced physicians to prescribe carvedilol for indications that had been carved out by Teva’s skinny label, thus infringing GlaxoSmithKline’s patents.” A $235 million judgment against Teva was overturned by a district court and then reversed again by a Federal Circuit court that, after receiving criticism, reconsidered the case, and a panel affirmed the judgment against Teva.

“The Federal Circuit panel’s decision has the potential to put generic drugs that fail to adequately carve out indications from the brand name labeling at risk for damages related to infringement,” the authors wrote. Similar claims of infringement are being heard in other courts, they wrote, and they urged careful targeting of skinny-label carveouts, and suggest also that challenges to the arguments used against Teva focus on preservation of First Amendment rights as protection for lawful and accurate speech in drug labels.

“The legal uncertainties are likely to continue, as manufacturers pursue novel and complex strategies to protect the patents and regulatory exclusivities of brand-name drugs and biologics,” Dr. Ward and Dr. Steinbrook wrote, adding that “the path forward is for Congress to enact additional legislation that reaffirms and strengthens the permissibility of skinny labeling.”

The research letter’s corresponding author, Ameet Sarpatwari, PhD, JD, assistant professor at Harvard Medical School, and assistant director for the Harvard Program On Regulation, Therapeutics, And Law, echoed concerns over the Teva case in an interview. “There has certainly been concern that should the appellate decision stand, there will be a chilling effect. As the lone dissenter in that case noted, ‘no skinny-label generic is safe.’ I think many generic and biosimilar manufacturers are awaiting to see whether the Supreme Court will take the case.”

He added: “I do not believe the likelihood of skinny-label-supportive legislation making it through Congress will be greatly diminished in a divided Congress. Democrats and Republicans alike should seek to promote competition in the marketplace, which is what the skinny-labeling pathway accomplishes.”

The authors reported no relevant conflicts of interest. The research was funded by a grant from Arnold Ventures.

Results of a new study indicate that opt-out HIV testing, in particular “notional consent testing” where a patient is not asked or counseled before conducting the test, is an effective tool for identifying undiagnosed HIV cases in populations with an HIV positivity rate greater than 0.2%.

On implementation of opt-out testing of patients aged 18-59 years admitted to the ED at St. George’s University Hospital in London, the proportion of tests performed increased from 57.9% to 69%. Upon increasing the age range to those 16 and older and implementing notional consent, overall testing coverage improved to 74.2%.

“An opt-out HIV testing program in the emergency department provides an excellent opportunity to diagnose patients who do not perceive themselves to be at risk or who have never tested before,” lead author Rebecca Marchant, MBBS, of St. George’s Hospital, said in an interview.

The study was published online in HIV Medicine.

She continued, “I think this take-away message would be applicable to other countries with prevalence of HIV greater than 2 per 1,000 people, as routine HIV testing in areas of high prevalence removes the need to target testing of specific populations, potentially preventing stigmatization.”

Despite excellent uptake of HIV testing in antenatal and sexual health services, 6% of people living in the United Kingdom are unaware of their status, and up to 42% of people living with HIV are diagnosed at a late stage of infection. Because blood is routinely drawn in EDs, it’s an excellent opportunity for increased testing. Late-stage diagnosis carries an increased risk of developing an AIDS-related illness, a sevenfold increase in risk for death in the first year after diagnosis, and increased rates of HIV transmission and health care costs.

The study was conducted in a region of London that has an HIV prevalence of 5.4 cases per 1,000 residents aged 15-59 years. Opt-out HIV testing was implemented in February 2019 for people aged 18-59, and in March 2021, this was changed to include those aged 16-plus years along with a move to notional consent.

Out of 78,333 HIV tests, there were 1054 reactive results. Of these, 728 (69%) were known people living with HIV, 8 (0.8%) were not contactable, 2 (0.2%) retested elsewhere and 3 (0.3%) declined a retest. A total of 259 false positives were determined by follow-up testing.

Of those who received a confirmed HIV diagnosis, 50 (4.8%) were newly diagnosed. HIV was suspected in only 22% of these people, and 48% had never previously tested for the virus. New diagnoses were 80% male with a median age of 42 years. CD4 counts varied widely (3 cells/mcL to 1,344 cells/mcL), with 60% diagnosed at a late stage (CD4 < 350 cells/mcL) and 40% with advanced immunosuppression (CD4 < 200 cells/mcL).

“It did not surprise me that heterosexuals made up 62% of all new diagnoses,” Dr. Marchant noted. “This is because routine opt-out testing in the ED offers the opportunity to test people who don’t perceive themselves to be at risk or who have never tested before, and I believe heterosexual people are more likely to fit into those categories. In London, new HIV diagnoses amongst men who have sex with men have fallen year on year likely due to pre-exposure prophylaxis being more readily available and a generally good awareness of HIV and testing amongst MSM.”

Michael D. Levine, MD, associate professor of emergency medicine at the University of California, Los Angeles, agreed with its main findings.

“Doing widespread screening of patients in the emergency department is a feasible option,” Dr. Levine, who was not involved with this study, said in an interview. “But it only makes sense to do this in a population with some prevalence of HIV. With some forms of testing, like rapid HIV tests, you only get a presumptive positive and you then have a confirmatory test. The presumptive positives do have false positives associated with them. So if you’re in a population with very few cases of HIV, and you have a significant number of false positives, that’s going to be problematic. It’s going to add a tremendous amount of stress to the patient.”

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

Results of a new study indicate that opt-out HIV testing, in particular “notional consent testing” where a patient is not asked or counseled before conducting the test, is an effective tool for identifying undiagnosed HIV cases in populations with an HIV positivity rate greater than 0.2%.

On implementation of opt-out testing of patients aged 18-59 years admitted to the ED at St. George’s University Hospital in London, the proportion of tests performed increased from 57.9% to 69%. Upon increasing the age range to those 16 and older and implementing notional consent, overall testing coverage improved to 74.2%.

“An opt-out HIV testing program in the emergency department provides an excellent opportunity to diagnose patients who do not perceive themselves to be at risk or who have never tested before,” lead author Rebecca Marchant, MBBS, of St. George’s Hospital, said in an interview.

The study was published online in HIV Medicine.

She continued, “I think this take-away message would be applicable to other countries with prevalence of HIV greater than 2 per 1,000 people, as routine HIV testing in areas of high prevalence removes the need to target testing of specific populations, potentially preventing stigmatization.”

Despite excellent uptake of HIV testing in antenatal and sexual health services, 6% of people living in the United Kingdom are unaware of their status, and up to 42% of people living with HIV are diagnosed at a late stage of infection. Because blood is routinely drawn in EDs, it’s an excellent opportunity for increased testing. Late-stage diagnosis carries an increased risk of developing an AIDS-related illness, a sevenfold increase in risk for death in the first year after diagnosis, and increased rates of HIV transmission and health care costs.

The study was conducted in a region of London that has an HIV prevalence of 5.4 cases per 1,000 residents aged 15-59 years. Opt-out HIV testing was implemented in February 2019 for people aged 18-59, and in March 2021, this was changed to include those aged 16-plus years along with a move to notional consent.

Out of 78,333 HIV tests, there were 1054 reactive results. Of these, 728 (69%) were known people living with HIV, 8 (0.8%) were not contactable, 2 (0.2%) retested elsewhere and 3 (0.3%) declined a retest. A total of 259 false positives were determined by follow-up testing.

Of those who received a confirmed HIV diagnosis, 50 (4.8%) were newly diagnosed. HIV was suspected in only 22% of these people, and 48% had never previously tested for the virus. New diagnoses were 80% male with a median age of 42 years. CD4 counts varied widely (3 cells/mcL to 1,344 cells/mcL), with 60% diagnosed at a late stage (CD4 < 350 cells/mcL) and 40% with advanced immunosuppression (CD4 < 200 cells/mcL).

“It did not surprise me that heterosexuals made up 62% of all new diagnoses,” Dr. Marchant noted. “This is because routine opt-out testing in the ED offers the opportunity to test people who don’t perceive themselves to be at risk or who have never tested before, and I believe heterosexual people are more likely to fit into those categories. In London, new HIV diagnoses amongst men who have sex with men have fallen year on year likely due to pre-exposure prophylaxis being more readily available and a generally good awareness of HIV and testing amongst MSM.”

Michael D. Levine, MD, associate professor of emergency medicine at the University of California, Los Angeles, agreed with its main findings.

“Doing widespread screening of patients in the emergency department is a feasible option,” Dr. Levine, who was not involved with this study, said in an interview. “But it only makes sense to do this in a population with some prevalence of HIV. With some forms of testing, like rapid HIV tests, you only get a presumptive positive and you then have a confirmatory test. The presumptive positives do have false positives associated with them. So if you’re in a population with very few cases of HIV, and you have a significant number of false positives, that’s going to be problematic. It’s going to add a tremendous amount of stress to the patient.”

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

Results of a new study indicate that opt-out HIV testing, in particular “notional consent testing” where a patient is not asked or counseled before conducting the test, is an effective tool for identifying undiagnosed HIV cases in populations with an HIV positivity rate greater than 0.2%.

On implementation of opt-out testing of patients aged 18-59 years admitted to the ED at St. George’s University Hospital in London, the proportion of tests performed increased from 57.9% to 69%. Upon increasing the age range to those 16 and older and implementing notional consent, overall testing coverage improved to 74.2%.

“An opt-out HIV testing program in the emergency department provides an excellent opportunity to diagnose patients who do not perceive themselves to be at risk or who have never tested before,” lead author Rebecca Marchant, MBBS, of St. George’s Hospital, said in an interview.

The study was published online in HIV Medicine.

She continued, “I think this take-away message would be applicable to other countries with prevalence of HIV greater than 2 per 1,000 people, as routine HIV testing in areas of high prevalence removes the need to target testing of specific populations, potentially preventing stigmatization.”

Despite excellent uptake of HIV testing in antenatal and sexual health services, 6% of people living in the United Kingdom are unaware of their status, and up to 42% of people living with HIV are diagnosed at a late stage of infection. Because blood is routinely drawn in EDs, it’s an excellent opportunity for increased testing. Late-stage diagnosis carries an increased risk of developing an AIDS-related illness, a sevenfold increase in risk for death in the first year after diagnosis, and increased rates of HIV transmission and health care costs.

The study was conducted in a region of London that has an HIV prevalence of 5.4 cases per 1,000 residents aged 15-59 years. Opt-out HIV testing was implemented in February 2019 for people aged 18-59, and in March 2021, this was changed to include those aged 16-plus years along with a move to notional consent.

Out of 78,333 HIV tests, there were 1054 reactive results. Of these, 728 (69%) were known people living with HIV, 8 (0.8%) were not contactable, 2 (0.2%) retested elsewhere and 3 (0.3%) declined a retest. A total of 259 false positives were determined by follow-up testing.

Of those who received a confirmed HIV diagnosis, 50 (4.8%) were newly diagnosed. HIV was suspected in only 22% of these people, and 48% had never previously tested for the virus. New diagnoses were 80% male with a median age of 42 years. CD4 counts varied widely (3 cells/mcL to 1,344 cells/mcL), with 60% diagnosed at a late stage (CD4 < 350 cells/mcL) and 40% with advanced immunosuppression (CD4 < 200 cells/mcL).

“It did not surprise me that heterosexuals made up 62% of all new diagnoses,” Dr. Marchant noted. “This is because routine opt-out testing in the ED offers the opportunity to test people who don’t perceive themselves to be at risk or who have never tested before, and I believe heterosexual people are more likely to fit into those categories. In London, new HIV diagnoses amongst men who have sex with men have fallen year on year likely due to pre-exposure prophylaxis being more readily available and a generally good awareness of HIV and testing amongst MSM.”

Michael D. Levine, MD, associate professor of emergency medicine at the University of California, Los Angeles, agreed with its main findings.

“Doing widespread screening of patients in the emergency department is a feasible option,” Dr. Levine, who was not involved with this study, said in an interview. “But it only makes sense to do this in a population with some prevalence of HIV. With some forms of testing, like rapid HIV tests, you only get a presumptive positive and you then have a confirmatory test. The presumptive positives do have false positives associated with them. So if you’re in a population with very few cases of HIV, and you have a significant number of false positives, that’s going to be problematic. It’s going to add a tremendous amount of stress to the patient.”

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

The 1960s marked the arrival of computers in medicine. Expensive, cumbersome hunks of plastic and metal that could (maybe) get test results to a doctor faster. The 1980s saw the first real difference-making functions computers could offer – clinical, financial, administrative – and in 1991, the Institute of Medicine published the first manifesto on what electronic health records could (and would) be.

Since then, we’ve seen computer breakthroughs across all areas of medicine, with artificial intelligence (AI), virtual reality, and telemedicine brought to the fore. But something else is brewing that not a lot of people know about yet: Quantum computing, a completely new type of computing has already begun to advance everything from drug development and disease identification to the security of electronic records.

“Think of it as transitioning from getting light through fire and candles and now having electricity, and there’s a light bulb that is lighting it all,” said Lara Jehi, MD, Cleveland Clinic’s chief research information officer.
 

What is quantum computing?

Classical computers (aka binary computers), which are the foundation of today’s devices, including artificial intelligence and machine learning, work by using information known as bits. These appear as 0 or 1 (sometimes defined as off/on or false/true). 

Quantum computers, on the other hand, use quantum bits known as qubits. And yes, the definition of “quantum” – as in: very, very small – applies.

International Business Machines, more commonly known as IBM, is currently leading this new tech. A common misconception about quantum computers is that they are “a next evolution of computers that will get faster,” said Frederik Flöther, PhD, life sciences and health care lead with IBM Quantum Industry Consulting. Instead, he wants us to look at quantum computing as something completely new “because it is fundamentally a different hardware, a different software, not just an evolution of the same.”

How does it work differently from existing computers? Quantum computing deals in nature. Therefore, qubits have to be based on the natural world. What does that mean? Nobel Prize-winning physicist Richard Feynman was famously quoted as saying: “Nature isn’t classical, dammit, and if you want to make a simulation of nature, you’d better make it quantum mechanical, and by golly it’s a wonderful problem, because it doesn’t look so easy.” 

Nature, said Dr. Jehi, doesn’t work in black and white or fit into boxes. 

“We have to convert it to zeros and ones because that’s what computers speak,” she explained. But quantum computing uses the principles of quantum mechanics. “It’s exactly how nature works, because it is based on the fundamental unit of everything in nature, which is atomic structure.”

Very, very small indeed. And that’s why quantum computing could be game-changing tech in medicine. 

“Quantum computers can be used to represent a bunch of different solutions to a problem all at the same time, and then collapse down to the optimal solution, the one that actually works,” said Tony Uttley, president and chief operating officer with Quantinuum, a collaboration between Cambridge Quantum and Honeywell Quantum Solutions that is working to drive the future of quantum computing. “And the reason it does that is because of some fabulous properties of quantum physics.”
 

Establishing a quantum computing beachhead 

Scientists around the globe are studying quantum computers looking for ways to harness this technology to make big gains in medicine. 

IBM has created the IBM Quantum Network and is partnering with different organizations, from startups to Fortune 500 companies, to develop and test technology in various settings. One of these partnerships with the Cleveland Clinic is set to establish the “Discovery Accelerator,” focused on advancing health care through high-performance computing on the hybrid cloud, quantum computing technologies, and artificial intelligence. 

Many people around the country are now using this technology on existing computers by tapping into the cloud, but with limited qubit access. IBM has researchers in places like Germany and Japan working on quantum computers and will be installing the country’s first of IBM’s next-generation 1,000+ qubit quantum systems on the Cleveland Clinic campus, which they are planning to use to help further investigate quantum computing’s many predicted benefits.

But what are those benefits? 
 

Drug discovery and development 

Quantum chemistry is one main area quantum computing is poised to help. 

“The immediate application of that would be in drug discovery,” said Dr. Jehi. When scientists make drugs, they sit in a lab and develop different chemical formulas for what might constitute that drug. 

“But for us to really know if it’s going to work, we need to be able to imagine how that chemical composition will translate into a structure,” she said. 

Even in their most powerful form, today’s supercomputers are slow in their ability to change this chemical formula on paper to a simulation of what the chemical compound will look like. And in many cases, they can’t do this type of analysis. 

“So, we end up making the drugs without knowing exactly how they’re going to look, which is not really the optimal way of creating a drug you expect to work” explained Dr. Jehi. “It’s a waste of time creating compounds that aren’t going to have any effect.”

Quantum computers will allow researchers to create and see these molecular structures and know how they bind and interact with the human body. In effect, they’ll know if a potential drug will work before ever having to physically make it.

Because of its differences from classic computing, quantum computers are not limited in their ability to simulate how different compounds can appear. Being able to simulate the compounds that drugs are made of can lead to a faster discovery of medications to treat a wide range of conditions. 
 

Disease analysis 

Eventually, this technology could assist with disease analysis, working on a molecular level to allow computers/AI to contemplate, for example, cancer molecules and gain a deeper understanding of how they function. 

Dr. Jehi said quantum computing can also be used to study things like chronic illnesses. These are conditions that people must live with and manage, and how a person is feeling in this instance can vary day to day, based on things like what a person is eating, the weather, or medications they are taking. 

“There are so many different possibilities for what could change a patient’s trajectory in one way versus another,” said Dr. Jehi.

She stressed that, if one has a group of patients, and everything that’s happened to them along their disease journey has been captured, it’s very challenging to mimic what that group looks like, and then study the effects of these different interventions on it using traditional computing. 

“It just gets way too complicated, and the computers that we have can’t keep up with analyzing the effects of the different possibilities. It gets jumbled up,” Dr. Jehi said. 

But quantum computing can offer quantum machine learning, meaning you use this special quantum ability to handle different simulations and different possibilities. 

The Cleveland Clinic, for instance, is looking at how some patients who undergo general surgeries have heart complications after their procedures. 

“It would be transformative if we could identify ahead of time who is at highest risk of having a heart attack after surgery, as so we could take care of those people better,” she said. 

The clinic’s current data set includes records for 450,000 patients, and current AI/machine learning makes sifting through this very slow and complex. The clinic is using machine learning approaches to create a synthetic data set, a smaller group that is a replica of the much larger one. Quantum technology could improve and speed this analysis to produce models that better perform.
 

Disease detection 

“Imagine you go get a CT scan,” said Mr. Uttley. “There are already AI solutions that you can run that set of images through and ask: ‘Does this look like something that would be cancer?’ ” This existing technology works well on things that are typical and have been identified before, because that’s how machine learning works. If AI has seen something 100,000 times, it can often find something else that looks like it. 

But today’s classical computers aren’t equipped to identify something unfamiliar. “Those are places where quantum computers can be much better at thinking of images and being able to say: ‘I can detect rare cancers or rare conditions that you don’t have a huge library of things that look like that,’ ” Mr. Uttley said. 

This is also where researchers can use a quantum computer to be able to figure out what things could look like. 

“The beauty of quantum computing is that it is a bias formation in quantum physics, this more probabilistic design. And so you can take advantage of that probabilistic design to help them think about this,” Mr. Uttley said. 
 

How far out are we? 

Mr. Uttley said we’re in an emergent era of quantum computing. Quantum computers exist and that’s a big deal, but a lot of this technology is still in fairly early stages. 

“It’s a little bit like we’re at the beginning of the internet and saying, how are things going to play out,” he explained. 

Right now, companies like Quantinuum are striving to perform computations on both a quantum and classic computer, compare the results, and say: “We’re getting the same answer.” 

“So, this is the era where we’re able to build trust and say these quantum computers are actually working correctly,” Mr. Uttley explained.

In the future, he said, we can possibly imagine something like a quantum MRI that is able to understand your body in a way that transmits that data to a quantum computer to detect what’s wrong, and be able to tell the difference between cancerous and noncancerous. That will allow faster treatments and tailoring them to specific patient populations.

“What we’re doing today might seem slightly less sexy than that, but is maybe even equally important,” said Mr. Uttley. 

This is using quantum computers to make the best encryption keys that can be made. The medical community, which is already using quantum computing to execute this, is excited about this being a better means of keeping patient data as secure as possible. 

In June, Quantinuum launched InQuanto, which is quantum computing software that is allowing computational chemists, who, until now, only had classical computers at their fingertips. The move created an opportunity to start thinking about the problems that they worked on and what they would do with a quantum computer. As quantum computers become higher performing over the years, Mr. Uttley said the software will go from tasks like isolating one molecule to solving larger problems. 

“That will happen over this next decade, where I think we’ll see the first kind of real use cases come out in the next likely 2 to 3 years,” he said. For now, this technology will likely be used in tandem with classical computers.

Mr. Uttley said that progress in the quantum world and medicine will continue to grow at a slow and steady pace, and in years to come, we’ll likely see things start to click and then eventually take off “full force.”

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

The 1960s marked the arrival of computers in medicine. Expensive, cumbersome hunks of plastic and metal that could (maybe) get test results to a doctor faster. The 1980s saw the first real difference-making functions computers could offer – clinical, financial, administrative – and in 1991, the Institute of Medicine published the first manifesto on what electronic health records could (and would) be.

Since then, we’ve seen computer breakthroughs across all areas of medicine, with artificial intelligence (AI), virtual reality, and telemedicine brought to the fore. But something else is brewing that not a lot of people know about yet: Quantum computing, a completely new type of computing has already begun to advance everything from drug development and disease identification to the security of electronic records.

“Think of it as transitioning from getting light through fire and candles and now having electricity, and there’s a light bulb that is lighting it all,” said Lara Jehi, MD, Cleveland Clinic’s chief research information officer.
 

What is quantum computing?

Classical computers (aka binary computers), which are the foundation of today’s devices, including artificial intelligence and machine learning, work by using information known as bits. These appear as 0 or 1 (sometimes defined as off/on or false/true). 

Quantum computers, on the other hand, use quantum bits known as qubits. And yes, the definition of “quantum” – as in: very, very small – applies.

International Business Machines, more commonly known as IBM, is currently leading this new tech. A common misconception about quantum computers is that they are “a next evolution of computers that will get faster,” said Frederik Flöther, PhD, life sciences and health care lead with IBM Quantum Industry Consulting. Instead, he wants us to look at quantum computing as something completely new “because it is fundamentally a different hardware, a different software, not just an evolution of the same.”

How does it work differently from existing computers? Quantum computing deals in nature. Therefore, qubits have to be based on the natural world. What does that mean? Nobel Prize-winning physicist Richard Feynman was famously quoted as saying: “Nature isn’t classical, dammit, and if you want to make a simulation of nature, you’d better make it quantum mechanical, and by golly it’s a wonderful problem, because it doesn’t look so easy.” 

Nature, said Dr. Jehi, doesn’t work in black and white or fit into boxes. 

“We have to convert it to zeros and ones because that’s what computers speak,” she explained. But quantum computing uses the principles of quantum mechanics. “It’s exactly how nature works, because it is based on the fundamental unit of everything in nature, which is atomic structure.”

Very, very small indeed. And that’s why quantum computing could be game-changing tech in medicine. 

“Quantum computers can be used to represent a bunch of different solutions to a problem all at the same time, and then collapse down to the optimal solution, the one that actually works,” said Tony Uttley, president and chief operating officer with Quantinuum, a collaboration between Cambridge Quantum and Honeywell Quantum Solutions that is working to drive the future of quantum computing. “And the reason it does that is because of some fabulous properties of quantum physics.”
 

Establishing a quantum computing beachhead 

Scientists around the globe are studying quantum computers looking for ways to harness this technology to make big gains in medicine. 

IBM has created the IBM Quantum Network and is partnering with different organizations, from startups to Fortune 500 companies, to develop and test technology in various settings. One of these partnerships with the Cleveland Clinic is set to establish the “Discovery Accelerator,” focused on advancing health care through high-performance computing on the hybrid cloud, quantum computing technologies, and artificial intelligence. 

Many people around the country are now using this technology on existing computers by tapping into the cloud, but with limited qubit access. IBM has researchers in places like Germany and Japan working on quantum computers and will be installing the country’s first of IBM’s next-generation 1,000+ qubit quantum systems on the Cleveland Clinic campus, which they are planning to use to help further investigate quantum computing’s many predicted benefits.

But what are those benefits? 
 

Drug discovery and development 

Quantum chemistry is one main area quantum computing is poised to help. 

“The immediate application of that would be in drug discovery,” said Dr. Jehi. When scientists make drugs, they sit in a lab and develop different chemical formulas for what might constitute that drug. 

“But for us to really know if it’s going to work, we need to be able to imagine how that chemical composition will translate into a structure,” she said. 

Even in their most powerful form, today’s supercomputers are slow in their ability to change this chemical formula on paper to a simulation of what the chemical compound will look like. And in many cases, they can’t do this type of analysis. 

“So, we end up making the drugs without knowing exactly how they’re going to look, which is not really the optimal way of creating a drug you expect to work” explained Dr. Jehi. “It’s a waste of time creating compounds that aren’t going to have any effect.”

Quantum computers will allow researchers to create and see these molecular structures and know how they bind and interact with the human body. In effect, they’ll know if a potential drug will work before ever having to physically make it.

Because of its differences from classic computing, quantum computers are not limited in their ability to simulate how different compounds can appear. Being able to simulate the compounds that drugs are made of can lead to a faster discovery of medications to treat a wide range of conditions. 
 

Disease analysis 

Eventually, this technology could assist with disease analysis, working on a molecular level to allow computers/AI to contemplate, for example, cancer molecules and gain a deeper understanding of how they function. 

Dr. Jehi said quantum computing can also be used to study things like chronic illnesses. These are conditions that people must live with and manage, and how a person is feeling in this instance can vary day to day, based on things like what a person is eating, the weather, or medications they are taking. 

“There are so many different possibilities for what could change a patient’s trajectory in one way versus another,” said Dr. Jehi.

She stressed that, if one has a group of patients, and everything that’s happened to them along their disease journey has been captured, it’s very challenging to mimic what that group looks like, and then study the effects of these different interventions on it using traditional computing. 

“It just gets way too complicated, and the computers that we have can’t keep up with analyzing the effects of the different possibilities. It gets jumbled up,” Dr. Jehi said. 

But quantum computing can offer quantum machine learning, meaning you use this special quantum ability to handle different simulations and different possibilities. 

The Cleveland Clinic, for instance, is looking at how some patients who undergo general surgeries have heart complications after their procedures. 

“It would be transformative if we could identify ahead of time who is at highest risk of having a heart attack after surgery, as so we could take care of those people better,” she said. 

The clinic’s current data set includes records for 450,000 patients, and current AI/machine learning makes sifting through this very slow and complex. The clinic is using machine learning approaches to create a synthetic data set, a smaller group that is a replica of the much larger one. Quantum technology could improve and speed this analysis to produce models that better perform.
 

Disease detection 

“Imagine you go get a CT scan,” said Mr. Uttley. “There are already AI solutions that you can run that set of images through and ask: ‘Does this look like something that would be cancer?’ ” This existing technology works well on things that are typical and have been identified before, because that’s how machine learning works. If AI has seen something 100,000 times, it can often find something else that looks like it. 

But today’s classical computers aren’t equipped to identify something unfamiliar. “Those are places where quantum computers can be much better at thinking of images and being able to say: ‘I can detect rare cancers or rare conditions that you don’t have a huge library of things that look like that,’ ” Mr. Uttley said. 

This is also where researchers can use a quantum computer to be able to figure out what things could look like. 

“The beauty of quantum computing is that it is a bias formation in quantum physics, this more probabilistic design. And so you can take advantage of that probabilistic design to help them think about this,” Mr. Uttley said. 
 

How far out are we? 

Mr. Uttley said we’re in an emergent era of quantum computing. Quantum computers exist and that’s a big deal, but a lot of this technology is still in fairly early stages. 

“It’s a little bit like we’re at the beginning of the internet and saying, how are things going to play out,” he explained. 

Right now, companies like Quantinuum are striving to perform computations on both a quantum and classic computer, compare the results, and say: “We’re getting the same answer.” 

“So, this is the era where we’re able to build trust and say these quantum computers are actually working correctly,” Mr. Uttley explained.

In the future, he said, we can possibly imagine something like a quantum MRI that is able to understand your body in a way that transmits that data to a quantum computer to detect what’s wrong, and be able to tell the difference between cancerous and noncancerous. That will allow faster treatments and tailoring them to specific patient populations.

“What we’re doing today might seem slightly less sexy than that, but is maybe even equally important,” said Mr. Uttley. 

This is using quantum computers to make the best encryption keys that can be made. The medical community, which is already using quantum computing to execute this, is excited about this being a better means of keeping patient data as secure as possible. 

In June, Quantinuum launched InQuanto, which is quantum computing software that is allowing computational chemists, who, until now, only had classical computers at their fingertips. The move created an opportunity to start thinking about the problems that they worked on and what they would do with a quantum computer. As quantum computers become higher performing over the years, Mr. Uttley said the software will go from tasks like isolating one molecule to solving larger problems. 

“That will happen over this next decade, where I think we’ll see the first kind of real use cases come out in the next likely 2 to 3 years,” he said. For now, this technology will likely be used in tandem with classical computers.

Mr. Uttley said that progress in the quantum world and medicine will continue to grow at a slow and steady pace, and in years to come, we’ll likely see things start to click and then eventually take off “full force.”

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

The 1960s marked the arrival of computers in medicine. Expensive, cumbersome hunks of plastic and metal that could (maybe) get test results to a doctor faster. The 1980s saw the first real difference-making functions computers could offer – clinical, financial, administrative – and in 1991, the Institute of Medicine published the first manifesto on what electronic health records could (and would) be.

Since then, we’ve seen computer breakthroughs across all areas of medicine, with artificial intelligence (AI), virtual reality, and telemedicine brought to the fore. But something else is brewing that not a lot of people know about yet: Quantum computing, a completely new type of computing has already begun to advance everything from drug development and disease identification to the security of electronic records.

“Think of it as transitioning from getting light through fire and candles and now having electricity, and there’s a light bulb that is lighting it all,” said Lara Jehi, MD, Cleveland Clinic’s chief research information officer.
 

What is quantum computing?

Classical computers (aka binary computers), which are the foundation of today’s devices, including artificial intelligence and machine learning, work by using information known as bits. These appear as 0 or 1 (sometimes defined as off/on or false/true). 

Quantum computers, on the other hand, use quantum bits known as qubits. And yes, the definition of “quantum” – as in: very, very small – applies.

International Business Machines, more commonly known as IBM, is currently leading this new tech. A common misconception about quantum computers is that they are “a next evolution of computers that will get faster,” said Frederik Flöther, PhD, life sciences and health care lead with IBM Quantum Industry Consulting. Instead, he wants us to look at quantum computing as something completely new “because it is fundamentally a different hardware, a different software, not just an evolution of the same.”

How does it work differently from existing computers? Quantum computing deals in nature. Therefore, qubits have to be based on the natural world. What does that mean? Nobel Prize-winning physicist Richard Feynman was famously quoted as saying: “Nature isn’t classical, dammit, and if you want to make a simulation of nature, you’d better make it quantum mechanical, and by golly it’s a wonderful problem, because it doesn’t look so easy.” 

Nature, said Dr. Jehi, doesn’t work in black and white or fit into boxes. 

“We have to convert it to zeros and ones because that’s what computers speak,” she explained. But quantum computing uses the principles of quantum mechanics. “It’s exactly how nature works, because it is based on the fundamental unit of everything in nature, which is atomic structure.”

Very, very small indeed. And that’s why quantum computing could be game-changing tech in medicine. 

“Quantum computers can be used to represent a bunch of different solutions to a problem all at the same time, and then collapse down to the optimal solution, the one that actually works,” said Tony Uttley, president and chief operating officer with Quantinuum, a collaboration between Cambridge Quantum and Honeywell Quantum Solutions that is working to drive the future of quantum computing. “And the reason it does that is because of some fabulous properties of quantum physics.”
 

Establishing a quantum computing beachhead 

Scientists around the globe are studying quantum computers looking for ways to harness this technology to make big gains in medicine. 

IBM has created the IBM Quantum Network and is partnering with different organizations, from startups to Fortune 500 companies, to develop and test technology in various settings. One of these partnerships with the Cleveland Clinic is set to establish the “Discovery Accelerator,” focused on advancing health care through high-performance computing on the hybrid cloud, quantum computing technologies, and artificial intelligence. 

Many people around the country are now using this technology on existing computers by tapping into the cloud, but with limited qubit access. IBM has researchers in places like Germany and Japan working on quantum computers and will be installing the country’s first of IBM’s next-generation 1,000+ qubit quantum systems on the Cleveland Clinic campus, which they are planning to use to help further investigate quantum computing’s many predicted benefits.

But what are those benefits? 
 

Drug discovery and development 

Quantum chemistry is one main area quantum computing is poised to help. 

“The immediate application of that would be in drug discovery,” said Dr. Jehi. When scientists make drugs, they sit in a lab and develop different chemical formulas for what might constitute that drug. 

“But for us to really know if it’s going to work, we need to be able to imagine how that chemical composition will translate into a structure,” she said. 

Even in their most powerful form, today’s supercomputers are slow in their ability to change this chemical formula on paper to a simulation of what the chemical compound will look like. And in many cases, they can’t do this type of analysis. 

“So, we end up making the drugs without knowing exactly how they’re going to look, which is not really the optimal way of creating a drug you expect to work” explained Dr. Jehi. “It’s a waste of time creating compounds that aren’t going to have any effect.”

Quantum computers will allow researchers to create and see these molecular structures and know how they bind and interact with the human body. In effect, they’ll know if a potential drug will work before ever having to physically make it.

Because of its differences from classic computing, quantum computers are not limited in their ability to simulate how different compounds can appear. Being able to simulate the compounds that drugs are made of can lead to a faster discovery of medications to treat a wide range of conditions. 
 

Disease analysis 

Eventually, this technology could assist with disease analysis, working on a molecular level to allow computers/AI to contemplate, for example, cancer molecules and gain a deeper understanding of how they function. 

Dr. Jehi said quantum computing can also be used to study things like chronic illnesses. These are conditions that people must live with and manage, and how a person is feeling in this instance can vary day to day, based on things like what a person is eating, the weather, or medications they are taking. 

“There are so many different possibilities for what could change a patient’s trajectory in one way versus another,” said Dr. Jehi.

She stressed that, if one has a group of patients, and everything that’s happened to them along their disease journey has been captured, it’s very challenging to mimic what that group looks like, and then study the effects of these different interventions on it using traditional computing. 

“It just gets way too complicated, and the computers that we have can’t keep up with analyzing the effects of the different possibilities. It gets jumbled up,” Dr. Jehi said. 

But quantum computing can offer quantum machine learning, meaning you use this special quantum ability to handle different simulations and different possibilities. 

The Cleveland Clinic, for instance, is looking at how some patients who undergo general surgeries have heart complications after their procedures. 

“It would be transformative if we could identify ahead of time who is at highest risk of having a heart attack after surgery, as so we could take care of those people better,” she said. 

The clinic’s current data set includes records for 450,000 patients, and current AI/machine learning makes sifting through this very slow and complex. The clinic is using machine learning approaches to create a synthetic data set, a smaller group that is a replica of the much larger one. Quantum technology could improve and speed this analysis to produce models that better perform.
 

Disease detection 

“Imagine you go get a CT scan,” said Mr. Uttley. “There are already AI solutions that you can run that set of images through and ask: ‘Does this look like something that would be cancer?’ ” This existing technology works well on things that are typical and have been identified before, because that’s how machine learning works. If AI has seen something 100,000 times, it can often find something else that looks like it. 

But today’s classical computers aren’t equipped to identify something unfamiliar. “Those are places where quantum computers can be much better at thinking of images and being able to say: ‘I can detect rare cancers or rare conditions that you don’t have a huge library of things that look like that,’ ” Mr. Uttley said. 

This is also where researchers can use a quantum computer to be able to figure out what things could look like. 

“The beauty of quantum computing is that it is a bias formation in quantum physics, this more probabilistic design. And so you can take advantage of that probabilistic design to help them think about this,” Mr. Uttley said. 
 

How far out are we? 

Mr. Uttley said we’re in an emergent era of quantum computing. Quantum computers exist and that’s a big deal, but a lot of this technology is still in fairly early stages. 

“It’s a little bit like we’re at the beginning of the internet and saying, how are things going to play out,” he explained. 

Right now, companies like Quantinuum are striving to perform computations on both a quantum and classic computer, compare the results, and say: “We’re getting the same answer.” 

“So, this is the era where we’re able to build trust and say these quantum computers are actually working correctly,” Mr. Uttley explained.

In the future, he said, we can possibly imagine something like a quantum MRI that is able to understand your body in a way that transmits that data to a quantum computer to detect what’s wrong, and be able to tell the difference between cancerous and noncancerous. That will allow faster treatments and tailoring them to specific patient populations.

“What we’re doing today might seem slightly less sexy than that, but is maybe even equally important,” said Mr. Uttley. 

This is using quantum computers to make the best encryption keys that can be made. The medical community, which is already using quantum computing to execute this, is excited about this being a better means of keeping patient data as secure as possible. 

In June, Quantinuum launched InQuanto, which is quantum computing software that is allowing computational chemists, who, until now, only had classical computers at their fingertips. The move created an opportunity to start thinking about the problems that they worked on and what they would do with a quantum computer. As quantum computers become higher performing over the years, Mr. Uttley said the software will go from tasks like isolating one molecule to solving larger problems. 

“That will happen over this next decade, where I think we’ll see the first kind of real use cases come out in the next likely 2 to 3 years,” he said. For now, this technology will likely be used in tandem with classical computers.

Mr. Uttley said that progress in the quantum world and medicine will continue to grow at a slow and steady pace, and in years to come, we’ll likely see things start to click and then eventually take off “full force.”

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

To boost their pay, many nurses pick up extra shifts. But juggling extra work and racking up 50-plus hours a week can take a toll on a nurse’s physical and mental health. Plus, it can diminish quality of care and lead to patient errors.

Medscape’s RN/LPN Compensation Report 2022 found that more than half of RNs and LPNs don’t think they get paid enough. Even though many nurses saw pay increases over the past 2 years, many were still dissatisfied with their earnings. They blamed job stress, staffing shortages, and benefits that cut into their wages.
 

Why do nurses pick up extra shifts?

Most nurses work extra hours for the money. Incentives like getting paid time and a half or scoring a $200 bonus are hard to pass up.

“I’m a single mother with two kids,” said Cynthia West, a critical care nurse in Atlanta. “I want to be able to pay my bills and enjoy my life, too.” So, Ms. West picks up two to three extra shifts a month. She also works on-call for a sexual assault center, earning $350 per exam.

But money isn’t the only reason for some nurses. Trang Robinson travels from her home in Atlanta to Palo Alto, Calif., every other week for her job as a labor and delivery RN.

“If my unit needs extra help, I want to help,” she said. “It’s not about the extra money, although that helps my family; it’s that we’ve been so short-staffed. My colleagues are burned out. Staff members are burned out. When I’m there, I work as much as I can to help out my unit.”

Leslie Wysong, an Atlanta postanesthesia nurse, worked in intensive care during much of COVID. She said the chance to make level 3 pay was rewarding for many nurses, but most weren’t doing it for the money.

“We were doing it to alleviate the strain on our fellow nurses, to get closer to a 2:1 patient/nurse ratio rather than the 3:1 we were dealing with over the pandemic,” she said. “It was to help out our colleagues during a desperate situation.”
 

What are the risks?

The U.S. Occupational Safety and Health Administration states that a work shift that lasts more than 8 hours can disrupt the body’s sleep/wake cycle. It can also lead to physical and mental fatigue resulting in errors, injuries, and accidents.

And a study published in the American Association of Occupational Health Nurses found that extended shifts or shift work impacted nurses in many ways, including more medication errors, falling asleep during work hours, decreased productivity in the last 4 shift hours (of a 12-hour shift), increased risk of mistakes and near-errors associated with decreased vigilance, critical thinking impairment, and more needlestick injuries.

Another study, published in Rehabilitation Nursing Journal, found even more adverse effects, such as sleep disorders like insomnia and excessive sleepiness; cognitive impairment such as the reduced ability to concentrate, slower reactions times, and reduced ability to remember information; higher rates of injury while on the job; being more likely to engage in overeating and alcohol misuse; GI issues such as abdominal pain, constipation, and heartburn; higher rates of heart disease and high blood pressure; higher risk for breast and prostate cancers, and higher rates of depression and anxiety.

These are risks some nurses aren’t willing to take. For example, Caitlin Riley, a pediatric ED nurse in Ocala, Fla., only picks up extra shifts when she must, like when Hurricane Ian swept through Central Florida.

“I think working extra hours can compromise your quality of care,” she said. “You may make mistakes with things like math calculations or not catch something if you’re not totally ‘in’ it mentally. At the end of the day, it’s your nursing license. Sure, the money is great, but I won’t do anything to compromise losing my license or patient care.”
 

How can nurses boost pay without working extra shifts?

Instead, Ms. Riley returned to school and earned an MSN in health care leadership/management, knowing that an advanced degree could lead to higher-paying work. According to the Medscape report, RNs with master’s and doctoral degrees earned over $10,000 more than those with bachelor’s, associate’s, or RN diplomas.

The report also compiled the following earnings data. The data may help nurses find other ways to raise their salaries without taking on extra shifts.

• Salaried RNs and LPNs made more than hourly paid nurses.
• In-patient hospital RNs and skilled nursing facility LPNs got paid more than nurses in other settings.
• Specialty certifications helped RNs earn more money than nurses without specialty certificates.
• Union RNs and LPNs earned more than nonunion nurses.
• RNs and LPNs who work in big cities or suburbs make more money than those in rural areas.

How to prevent burnout and exhaustion when you work extra shifts

While burnout can happen in any profession, an investigation published in JAMA Network Open suggests it’s prevalent among US nurses. The study found that nurses who worked over 40 hours a week were more likely to experience burnout. However, researchers say that adequate staffing and limiting shift hours may alleviate the problem. Here’s how the nurses in the survey dealt with battle burnout:

• Change departments. Ms. Wysong stepped away from the ICU after COVID and switched to postanesthesia. “The move has made my work life much less stressful,” said Ms. Wysong. “They are all happy endings in postanesthesia.”
• Leave work at work. Ms. Riley said she mentally clocks out as she leaves the hospital. “When I put my papers in my shredder at the end of my shift, I let it go. I walk away knowing I did the best for my patients. Once I’m home, it’s time for me to be with the people I love and to refuel my own sense of happiness with the people that mean the most to me.”
• Take time off. “When I’m burned out, I just don’t come in,” said Ms. Robinson. “If I’m mentally or emotionally drained, I give myself a shift off to decompress, or I don’t pick up extra shifts.”
• Engage in relaxing hobbies. Kris Coleman, an ED nurse in Hardeeville, S.C., typically works three 12-hours shifts and only picks up an extra 4-hour shift once a week. When he’s off, he takes advantage of his time away from work. He said: “Do the things that help you relax on your time off. For me, it’s golfing, fishing, and spending time with my family.”
• Build a support system. “I have a group of friends at work,” said Ms. West. “We talk to each other and vent. Having a good support system, people that are in it with you who get what you’re going through is a helpful way to manage burnout.”

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

To boost their pay, many nurses pick up extra shifts. But juggling extra work and racking up 50-plus hours a week can take a toll on a nurse’s physical and mental health. Plus, it can diminish quality of care and lead to patient errors.

Medscape’s RN/LPN Compensation Report 2022 found that more than half of RNs and LPNs don’t think they get paid enough. Even though many nurses saw pay increases over the past 2 years, many were still dissatisfied with their earnings. They blamed job stress, staffing shortages, and benefits that cut into their wages.
 

Why do nurses pick up extra shifts?

Most nurses work extra hours for the money. Incentives like getting paid time and a half or scoring a $200 bonus are hard to pass up.

“I’m a single mother with two kids,” said Cynthia West, a critical care nurse in Atlanta. “I want to be able to pay my bills and enjoy my life, too.” So, Ms. West picks up two to three extra shifts a month. She also works on-call for a sexual assault center, earning $350 per exam.

But money isn’t the only reason for some nurses. Trang Robinson travels from her home in Atlanta to Palo Alto, Calif., every other week for her job as a labor and delivery RN.

“If my unit needs extra help, I want to help,” she said. “It’s not about the extra money, although that helps my family; it’s that we’ve been so short-staffed. My colleagues are burned out. Staff members are burned out. When I’m there, I work as much as I can to help out my unit.”

Leslie Wysong, an Atlanta postanesthesia nurse, worked in intensive care during much of COVID. She said the chance to make level 3 pay was rewarding for many nurses, but most weren’t doing it for the money.

“We were doing it to alleviate the strain on our fellow nurses, to get closer to a 2:1 patient/nurse ratio rather than the 3:1 we were dealing with over the pandemic,” she said. “It was to help out our colleagues during a desperate situation.”
 

What are the risks?

The U.S. Occupational Safety and Health Administration states that a work shift that lasts more than 8 hours can disrupt the body’s sleep/wake cycle. It can also lead to physical and mental fatigue resulting in errors, injuries, and accidents.

And a study published in the American Association of Occupational Health Nurses found that extended shifts or shift work impacted nurses in many ways, including more medication errors, falling asleep during work hours, decreased productivity in the last 4 shift hours (of a 12-hour shift), increased risk of mistakes and near-errors associated with decreased vigilance, critical thinking impairment, and more needlestick injuries.

Another study, published in Rehabilitation Nursing Journal, found even more adverse effects, such as sleep disorders like insomnia and excessive sleepiness; cognitive impairment such as the reduced ability to concentrate, slower reactions times, and reduced ability to remember information; higher rates of injury while on the job; being more likely to engage in overeating and alcohol misuse; GI issues such as abdominal pain, constipation, and heartburn; higher rates of heart disease and high blood pressure; higher risk for breast and prostate cancers, and higher rates of depression and anxiety.

These are risks some nurses aren’t willing to take. For example, Caitlin Riley, a pediatric ED nurse in Ocala, Fla., only picks up extra shifts when she must, like when Hurricane Ian swept through Central Florida.

“I think working extra hours can compromise your quality of care,” she said. “You may make mistakes with things like math calculations or not catch something if you’re not totally ‘in’ it mentally. At the end of the day, it’s your nursing license. Sure, the money is great, but I won’t do anything to compromise losing my license or patient care.”
 

How can nurses boost pay without working extra shifts?

Instead, Ms. Riley returned to school and earned an MSN in health care leadership/management, knowing that an advanced degree could lead to higher-paying work. According to the Medscape report, RNs with master’s and doctoral degrees earned over $10,000 more than those with bachelor’s, associate’s, or RN diplomas.

The report also compiled the following earnings data. The data may help nurses find other ways to raise their salaries without taking on extra shifts.

• Salaried RNs and LPNs made more than hourly paid nurses.
• In-patient hospital RNs and skilled nursing facility LPNs got paid more than nurses in other settings.
• Specialty certifications helped RNs earn more money than nurses without specialty certificates.
• Union RNs and LPNs earned more than nonunion nurses.
• RNs and LPNs who work in big cities or suburbs make more money than those in rural areas.

How to prevent burnout and exhaustion when you work extra shifts

While burnout can happen in any profession, an investigation published in JAMA Network Open suggests it’s prevalent among US nurses. The study found that nurses who worked over 40 hours a week were more likely to experience burnout. However, researchers say that adequate staffing and limiting shift hours may alleviate the problem. Here’s how the nurses in the survey dealt with battle burnout:

• Change departments. Ms. Wysong stepped away from the ICU after COVID and switched to postanesthesia. “The move has made my work life much less stressful,” said Ms. Wysong. “They are all happy endings in postanesthesia.”
• Leave work at work. Ms. Riley said she mentally clocks out as she leaves the hospital. “When I put my papers in my shredder at the end of my shift, I let it go. I walk away knowing I did the best for my patients. Once I’m home, it’s time for me to be with the people I love and to refuel my own sense of happiness with the people that mean the most to me.”
• Take time off. “When I’m burned out, I just don’t come in,” said Ms. Robinson. “If I’m mentally or emotionally drained, I give myself a shift off to decompress, or I don’t pick up extra shifts.”
• Engage in relaxing hobbies. Kris Coleman, an ED nurse in Hardeeville, S.C., typically works three 12-hours shifts and only picks up an extra 4-hour shift once a week. When he’s off, he takes advantage of his time away from work. He said: “Do the things that help you relax on your time off. For me, it’s golfing, fishing, and spending time with my family.”
• Build a support system. “I have a group of friends at work,” said Ms. West. “We talk to each other and vent. Having a good support system, people that are in it with you who get what you’re going through is a helpful way to manage burnout.”

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

To boost their pay, many nurses pick up extra shifts. But juggling extra work and racking up 50-plus hours a week can take a toll on a nurse’s physical and mental health. Plus, it can diminish quality of care and lead to patient errors.

Medscape’s RN/LPN Compensation Report 2022 found that more than half of RNs and LPNs don’t think they get paid enough. Even though many nurses saw pay increases over the past 2 years, many were still dissatisfied with their earnings. They blamed job stress, staffing shortages, and benefits that cut into their wages.
 

Why do nurses pick up extra shifts?

Most nurses work extra hours for the money. Incentives like getting paid time and a half or scoring a $200 bonus are hard to pass up.

“I’m a single mother with two kids,” said Cynthia West, a critical care nurse in Atlanta. “I want to be able to pay my bills and enjoy my life, too.” So, Ms. West picks up two to three extra shifts a month. She also works on-call for a sexual assault center, earning $350 per exam.

But money isn’t the only reason for some nurses. Trang Robinson travels from her home in Atlanta to Palo Alto, Calif., every other week for her job as a labor and delivery RN.

“If my unit needs extra help, I want to help,” she said. “It’s not about the extra money, although that helps my family; it’s that we’ve been so short-staffed. My colleagues are burned out. Staff members are burned out. When I’m there, I work as much as I can to help out my unit.”

Leslie Wysong, an Atlanta postanesthesia nurse, worked in intensive care during much of COVID. She said the chance to make level 3 pay was rewarding for many nurses, but most weren’t doing it for the money.

“We were doing it to alleviate the strain on our fellow nurses, to get closer to a 2:1 patient/nurse ratio rather than the 3:1 we were dealing with over the pandemic,” she said. “It was to help out our colleagues during a desperate situation.”
 

What are the risks?

The U.S. Occupational Safety and Health Administration states that a work shift that lasts more than 8 hours can disrupt the body’s sleep/wake cycle. It can also lead to physical and mental fatigue resulting in errors, injuries, and accidents.

And a study published in the American Association of Occupational Health Nurses found that extended shifts or shift work impacted nurses in many ways, including more medication errors, falling asleep during work hours, decreased productivity in the last 4 shift hours (of a 12-hour shift), increased risk of mistakes and near-errors associated with decreased vigilance, critical thinking impairment, and more needlestick injuries.

Another study, published in Rehabilitation Nursing Journal, found even more adverse effects, such as sleep disorders like insomnia and excessive sleepiness; cognitive impairment such as the reduced ability to concentrate, slower reactions times, and reduced ability to remember information; higher rates of injury while on the job; being more likely to engage in overeating and alcohol misuse; GI issues such as abdominal pain, constipation, and heartburn; higher rates of heart disease and high blood pressure; higher risk for breast and prostate cancers, and higher rates of depression and anxiety.

These are risks some nurses aren’t willing to take. For example, Caitlin Riley, a pediatric ED nurse in Ocala, Fla., only picks up extra shifts when she must, like when Hurricane Ian swept through Central Florida.

“I think working extra hours can compromise your quality of care,” she said. “You may make mistakes with things like math calculations or not catch something if you’re not totally ‘in’ it mentally. At the end of the day, it’s your nursing license. Sure, the money is great, but I won’t do anything to compromise losing my license or patient care.”
 

How can nurses boost pay without working extra shifts?

Instead, Ms. Riley returned to school and earned an MSN in health care leadership/management, knowing that an advanced degree could lead to higher-paying work. According to the Medscape report, RNs with master’s and doctoral degrees earned over $10,000 more than those with bachelor’s, associate’s, or RN diplomas.

The report also compiled the following earnings data. The data may help nurses find other ways to raise their salaries without taking on extra shifts.

• Salaried RNs and LPNs made more than hourly paid nurses.
• In-patient hospital RNs and skilled nursing facility LPNs got paid more than nurses in other settings.
• Specialty certifications helped RNs earn more money than nurses without specialty certificates.
• Union RNs and LPNs earned more than nonunion nurses.
• RNs and LPNs who work in big cities or suburbs make more money than those in rural areas.

How to prevent burnout and exhaustion when you work extra shifts

While burnout can happen in any profession, an investigation published in JAMA Network Open suggests it’s prevalent among US nurses. The study found that nurses who worked over 40 hours a week were more likely to experience burnout. However, researchers say that adequate staffing and limiting shift hours may alleviate the problem. Here’s how the nurses in the survey dealt with battle burnout:

• Change departments. Ms. Wysong stepped away from the ICU after COVID and switched to postanesthesia. “The move has made my work life much less stressful,” said Ms. Wysong. “They are all happy endings in postanesthesia.”
• Leave work at work. Ms. Riley said she mentally clocks out as she leaves the hospital. “When I put my papers in my shredder at the end of my shift, I let it go. I walk away knowing I did the best for my patients. Once I’m home, it’s time for me to be with the people I love and to refuel my own sense of happiness with the people that mean the most to me.”
• Take time off. “When I’m burned out, I just don’t come in,” said Ms. Robinson. “If I’m mentally or emotionally drained, I give myself a shift off to decompress, or I don’t pick up extra shifts.”
• Engage in relaxing hobbies. Kris Coleman, an ED nurse in Hardeeville, S.C., typically works three 12-hours shifts and only picks up an extra 4-hour shift once a week. When he’s off, he takes advantage of his time away from work. He said: “Do the things that help you relax on your time off. For me, it’s golfing, fishing, and spending time with my family.”
• Build a support system. “I have a group of friends at work,” said Ms. West. “We talk to each other and vent. Having a good support system, people that are in it with you who get what you’re going through is a helpful way to manage burnout.”

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

A drug used in the treatment of relapsed/refractory multiple myeloma (RRMM) is in the process of being pulled off the U.S. market by its manufacturer.

The drug is belantamab mafodotin-blmf (Blenrep), an antibody drug conjugate that targets B-cell maturation antigen (BCMA).

The manufacturer, GSK, announced that it has started the process of withdrawing this drug from the market at the request of the U.S. Food and Drug Administration (FDA).

This request follows disappointing results from a large confirmatory trial, known as DREAMM-3, in which the drug failed to meet the primary endpoint of showing an improvement in progression-free survival (PFS).

The company was obliged to carry out this confirmatory trial after the FDA granted an accelerated approval for the drug in August 2020.

The accelerated approval was based on response data, and it was dependent on later trials’ confirming a clinical benefit. In this case, those trials did not confirm a clinical benefit.

“We respect the Agency’s approach to the accelerated approval regulations and associated process,” commented the GSK Chief Medical Officer Sabine Luik.

The company will continue to “work with the U.S. FDA on a path forward for this important treatment option for patients with multiple myeloma.”

Further clinical trials in the DREAMM program are still underway. Results from the DREAMM-7 and DREAMM-8 trials are expected in early 2023.

The company had high hopes for the drug when it was launched. At that time, belanatamab mafodotin-blmf was the only drug on the market that targeted BCMA, and so it was the first drug in its class.

However, it is no longer unique. In the 2 years that it has been available, several other products that target BCMA have been launched for use in the treatment of multiple myeloma. These include the two chimeric antigen receptor T-cell products, idecabtagene vicleucel (Abecma) and ciltacabtagene autoleucel (Carvykti), as well as the bispecific antibody teclistamab (Tecvayli).
 

For relapsed/refractory disease

Belantamab mafodotin-blmf was approved for use in patients with RRMM who had already undergone treatment with one of the three major classes of drugs, namely, an immunomodulatory agent, a proteasome inhibitor, and a CD-38 monoclonal antibody.

Patients who are currently taking the drug and would like to continue doing so will have the option to enroll in a compassionate use program to retain their access to treatment, the company said.

“GSK continues to believe, based on the totality of data available from the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) development program, that the benefit-risk profile of belantamab mafodotin remains favorable in this hard-to-treat RRMM patient population. Patients responding to belantamab mafodotin experienced durable clinical benefit, and safety remains consistent with the known safety profile,” the company said.
 

Details of DREAMM-3 results

DREAMM-3 was a phase 3 trial that compared single-agent belantamab mafodotin to pomalidomide (Pomalyst) in combination with low-dose dexamethasone (PomDex) for patients with RRMM.

The results for the primary endpoint of PFS did not reach statistical significance: median PFS was 11.2 vs. 7 months with PomDex (hazard ratio, 1.03; 95% confidence interval, 0.72-1.47).

At the time of the primary analysis, the overall survival (OS) data had only achieved 37.5% overall maturity. The median OS was 21.2 vs. 21.1 months with PomDex (HR, 1.14; 95% CI, 0.77-1.68).

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

A drug used in the treatment of relapsed/refractory multiple myeloma (RRMM) is in the process of being pulled off the U.S. market by its manufacturer.

The drug is belantamab mafodotin-blmf (Blenrep), an antibody drug conjugate that targets B-cell maturation antigen (BCMA).

The manufacturer, GSK, announced that it has started the process of withdrawing this drug from the market at the request of the U.S. Food and Drug Administration (FDA).

This request follows disappointing results from a large confirmatory trial, known as DREAMM-3, in which the drug failed to meet the primary endpoint of showing an improvement in progression-free survival (PFS).

The company was obliged to carry out this confirmatory trial after the FDA granted an accelerated approval for the drug in August 2020.

The accelerated approval was based on response data, and it was dependent on later trials’ confirming a clinical benefit. In this case, those trials did not confirm a clinical benefit.

“We respect the Agency’s approach to the accelerated approval regulations and associated process,” commented the GSK Chief Medical Officer Sabine Luik.

The company will continue to “work with the U.S. FDA on a path forward for this important treatment option for patients with multiple myeloma.”

Further clinical trials in the DREAMM program are still underway. Results from the DREAMM-7 and DREAMM-8 trials are expected in early 2023.

The company had high hopes for the drug when it was launched. At that time, belanatamab mafodotin-blmf was the only drug on the market that targeted BCMA, and so it was the first drug in its class.

However, it is no longer unique. In the 2 years that it has been available, several other products that target BCMA have been launched for use in the treatment of multiple myeloma. These include the two chimeric antigen receptor T-cell products, idecabtagene vicleucel (Abecma) and ciltacabtagene autoleucel (Carvykti), as well as the bispecific antibody teclistamab (Tecvayli).
 

For relapsed/refractory disease

Belantamab mafodotin-blmf was approved for use in patients with RRMM who had already undergone treatment with one of the three major classes of drugs, namely, an immunomodulatory agent, a proteasome inhibitor, and a CD-38 monoclonal antibody.

Patients who are currently taking the drug and would like to continue doing so will have the option to enroll in a compassionate use program to retain their access to treatment, the company said.

“GSK continues to believe, based on the totality of data available from the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) development program, that the benefit-risk profile of belantamab mafodotin remains favorable in this hard-to-treat RRMM patient population. Patients responding to belantamab mafodotin experienced durable clinical benefit, and safety remains consistent with the known safety profile,” the company said.
 

Details of DREAMM-3 results

DREAMM-3 was a phase 3 trial that compared single-agent belantamab mafodotin to pomalidomide (Pomalyst) in combination with low-dose dexamethasone (PomDex) for patients with RRMM.

The results for the primary endpoint of PFS did not reach statistical significance: median PFS was 11.2 vs. 7 months with PomDex (hazard ratio, 1.03; 95% confidence interval, 0.72-1.47).

At the time of the primary analysis, the overall survival (OS) data had only achieved 37.5% overall maturity. The median OS was 21.2 vs. 21.1 months with PomDex (HR, 1.14; 95% CI, 0.77-1.68).

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

A drug used in the treatment of relapsed/refractory multiple myeloma (RRMM) is in the process of being pulled off the U.S. market by its manufacturer.

The drug is belantamab mafodotin-blmf (Blenrep), an antibody drug conjugate that targets B-cell maturation antigen (BCMA).

The manufacturer, GSK, announced that it has started the process of withdrawing this drug from the market at the request of the U.S. Food and Drug Administration (FDA).

This request follows disappointing results from a large confirmatory trial, known as DREAMM-3, in which the drug failed to meet the primary endpoint of showing an improvement in progression-free survival (PFS).

The company was obliged to carry out this confirmatory trial after the FDA granted an accelerated approval for the drug in August 2020.

The accelerated approval was based on response data, and it was dependent on later trials’ confirming a clinical benefit. In this case, those trials did not confirm a clinical benefit.

“We respect the Agency’s approach to the accelerated approval regulations and associated process,” commented the GSK Chief Medical Officer Sabine Luik.

The company will continue to “work with the U.S. FDA on a path forward for this important treatment option for patients with multiple myeloma.”

Further clinical trials in the DREAMM program are still underway. Results from the DREAMM-7 and DREAMM-8 trials are expected in early 2023.

The company had high hopes for the drug when it was launched. At that time, belanatamab mafodotin-blmf was the only drug on the market that targeted BCMA, and so it was the first drug in its class.

However, it is no longer unique. In the 2 years that it has been available, several other products that target BCMA have been launched for use in the treatment of multiple myeloma. These include the two chimeric antigen receptor T-cell products, idecabtagene vicleucel (Abecma) and ciltacabtagene autoleucel (Carvykti), as well as the bispecific antibody teclistamab (Tecvayli).
 

For relapsed/refractory disease

Belantamab mafodotin-blmf was approved for use in patients with RRMM who had already undergone treatment with one of the three major classes of drugs, namely, an immunomodulatory agent, a proteasome inhibitor, and a CD-38 monoclonal antibody.

Patients who are currently taking the drug and would like to continue doing so will have the option to enroll in a compassionate use program to retain their access to treatment, the company said.

“GSK continues to believe, based on the totality of data available from the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) development program, that the benefit-risk profile of belantamab mafodotin remains favorable in this hard-to-treat RRMM patient population. Patients responding to belantamab mafodotin experienced durable clinical benefit, and safety remains consistent with the known safety profile,” the company said.
 

Details of DREAMM-3 results

DREAMM-3 was a phase 3 trial that compared single-agent belantamab mafodotin to pomalidomide (Pomalyst) in combination with low-dose dexamethasone (PomDex) for patients with RRMM.

The results for the primary endpoint of PFS did not reach statistical significance: median PFS was 11.2 vs. 7 months with PomDex (hazard ratio, 1.03; 95% confidence interval, 0.72-1.47).

At the time of the primary analysis, the overall survival (OS) data had only achieved 37.5% overall maturity. The median OS was 21.2 vs. 21.1 months with PomDex (HR, 1.14; 95% CI, 0.77-1.68).

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

A report from a well-respected nonprofit group may bolster efforts to have Medicare, the largest U.S. purchaser of prescription drugs, cover obesity medicines, for which there has been accumulating evidence of significant benefit.

The Institute for Clinical and Economic Review (ICER) released a report last month on obesity medicines, based on extensive review of research done to date and input from clinicians, drug-makers, and members of the public.

Of the treatments reviewed, the ICER report gave the best ratings to two Novo Nordisk products, a B+ for semaglutide (Wegovy) and a B for liraglutide (Saxenda), while also making the case for price cuts. At an annual U.S. net price estimated at $13,618, semaglutide exceeds what ICER considers typical cost-effectiveness thresholds. ICER suggested a benchmark annual price range for semaglutide of between $7,500 and $9,800.

The ICER report also directs insurers in general to provide more generous coverage of obesity medicines, with a specific recommendation for the U.S. Congress to pass a pending bill known as the Treat and Reduce Obesity Act of 2021. The bill would undo a restriction on weight-loss drugs in the Medicare Part D plans, which covered about 49 million people last year. Sen. Tom Carper (D-Del.) and Sen. Bill Cassidy, MD, (R-La.) have repeatedly introduced versions of the bill since 2013.

“In both chambers of Congress and with bipartisan support, we’ve pushed to expand Medicare coverage of additional therapies and medications to treat obesity,” Sen. Cassidy said in an email. “This report confirms what we’ve worked on for nearly a decade – our legislation will help improve lives.”

The current House version of the bill has the backing of more than a third of the members of that chamber, with 113 Democratic and 40 Republican cosponsors. The Senate version has 22 sponsors.
 

Changing views

The ICER report comes amid a broader change in how clinicians view obesity. 

The American Academy of Pediatrics is readying a new Clinical Practice Guideline for the Evaluation and Treatment of Pediatric Obesity that will mark a major shift in approach. Aaron S. Kelly, PhD, a professor of pediatrics at the University of Minnesota, Minneapolis, described it as a “sea change,” with obesity now seen as “a chronic, refractory, relapsing disease,” for which watchful waiting is no longer appropriate.

But the field of obesity treatment looked quite different in the early 2000s when Congress worked on a plan to add a pharmacy benefit to Medicare.

The deliberate omission of obesity medicine in the Medicare Part D benefit reflected both the state of science at the time and U.S. experience with a dangerous weight-loss drug combo in the late 1990s.

Initial expectations for weight-loss pills were high after the Food and Drug Administration cleared dexfenfluramine HCl (Redux) in 1996, which was part of the popular fen-phen combination. “Newly Approved Diet Drug Promises to Help Millions of Obese Americans – But Is No Magic Bullet,” read a headline about the Redux approval in The Washington Post

When work began in the 2000s to create a Medicare pharmacy benefit, lawmakers and congressional staff had a pool of about $400 billion available to establish what became the Part D program, Joel White, a former House staffer who helped draft the law, told this news organization in an email exchange.

Given the state of obesity research at the time, it seemed to make sense to exclude weight-loss medications, wrote Mr. White. Mr. White is now chief executive of the consulting firm Horizon, which has clients in the drug industry including the Pharmaceutical Research and Manufacturers of America.

“Now we know that obesity is a chronic disease of epidemic proportions. Decades of research have produced a series of advances in the way we understand and treat obesity. While scientists and many who work directly with those impacted by this epidemic understand how treatments have advanced, the law lags behind,” Mr. White said.

XXXCurrent payment policies for obesity treatments are based on “outdated information and ongoing misperception,” he noted. “While Part D has been a resounding success, our Medicare approach to obesity is not.”

“In addition, it makes no sense that Medicare covers the most drastic procedure (bariatric surgery) but not less-invasive, effective treatments,” he added. “We should have long ago lifted restrictions based on advances in science and medicine.”
 

Overcoming the stigma

Scott Kahan, MD, MPH, agreed and hopes that the new ICER report will help more patients secure needed medications, raising a “call to arms” about the need for better coverage of obesity drugs.

Dr. Kahan is director of the National Center for Weight and Wellness, a private clinic in Washington, and chair of the clinical committee for The Obesity Society. He also served as a member of a policy roundtable that ICER convened as part of research on the report on obesity drugs. Dr. Kahan, who also serves on the faculty at the Johns Hopkins Bloomberg School of Public Health, Baltimore, has received fees from drug makers such as Eli Lilly.

The ICER report may help what Dr. Kahan described as well-founded caution about obesity treatments in general.

“When it comes to weight loss, there are all of these magical treatments that are sold on social media and traditional media. There are a lot of bad actors in terms of people calling themselves experts and gurus and promising all kinds of crazy stuff,” said Dr. Kahan.

And there are long-standing stigmas about obesity, he stressed.

“That underlies a lot of the backward policies, including poor coverage for medications and the noncoverage by Medicare,” Dr. Kahan said. “There’s a societal ingrained set of beliefs and misperceptions and biases. That takes time to unwind, and I think we’re on the way, but we’re not quite there yet.”
 

Lifestyle changes not enough to tackle obesity

AHIP (formerly America’s Health Insurance Plans) told this news organization its members consider ICER reports when making decisions about which products to cover. “And health plans already cover obesity treatments that they consider medically necessary,” said David Allen, an AHIP spokesperson.

“It is important to note that every treatment does not work for every patient, and many patients experience adverse events and may discontinue treatment,” he added in an email. “Health insurance providers play an important role in helping [health care] providers and patients identify the treatment options that are most likely to be effective as well as affordable.”

Separately, the nonprofit watchdog group Public Citizen cautioned against liraglutide on its Worst Pills, Best Pills website. In its view, the drug is minimally effective and has many dangerous adverse effects, which are even more frequent with the higher-dose weight-loss version (a lower-dose version is approved for type 2 diabetes).

“There is currently no medication that can be used safely to achieve weight loss effortlessly and without dangerous adverse effects,” the group said. “Rather than focus on losing weight by turning to risky drugs, overweight and obese adults seeking to achieve better health should make reasonable and sustainable changes to their lifestyle, such as eating a healthy diet and getting regular exercise.”

Yet, many people find there is little help available for making lifestyle changes, and some patients and physicians say these modifications by themselves are not enough.

“The vast majority of people with obesity cannot achieve sustained weight loss through diet and exercise alone,” said David Rind, MD, chief medical officer of ICER, in an Oct. 20 statement. “As such, obesity, and its resulting physical health, mental health, and social burdens, is not a choice or failing, but a medical condition.”

The focus should now be on assuring that effective medications “are priced in alignment with their benefits so that they are accessible and affordable across U.S. society,” Dr. Rind urges.
 

‘My own demise with a fork and knife’

ICER sought public feedback on a draft version of the report before finalizing it.

In their comments on ICER’s work, several pharmaceutical researchers and Novo Nordisk questioned the calculations used in making judgments about the value of obesity drugs. In a statement, Novo Nordisk told this news organization that the company’s view is that ICER’s modeling “does not adequately address the real-world complexities of obesity, and consequently underestimates the health and societal impact medical treatments can have.”

Commenters also dug into aspects of ICER’s calculations, including ones that consider quality-adjusted life-years (QALYs). ICER describes QALY as an academic standard for measuring how well all different types of medical treatments can extend or improve patients’ lives. In an explainer on its website, ICER says this metric has served as a fundamental component of cost-effectiveness analyses in the United States and around the world for more than 30 years.

ICER and drug makers have been at odds for some time, with PhRMA having criticized the nonprofit group. A 2020 Reuters article detailed public relations strategies used by firms paid by drug makers to raise questions about ICER’s work. Critics accuse it of allying with insurers.

ICER’s list of its recent financial supporters includes Blue Cross Blue Shield of Massachusetts and the Kaiser Foundation Health Plan, but also many other groups, such as the U.S. Department of Veterans Affairs, the American Academy of Neurology, and the American College of Rheumatology.

The public comments on the ICER report also include one from an unidentified woman who wrote of her past struggles to lose weight.

She said her health plan wouldn’t cover behavioral programs or semaglutide as a weight-loss drug but did cover it eventually because of signs that she had developed insulin resistance. The patient said the drug worked for her, whereas other approaches to control weight had failed.

“To put it simply, I now experience hunger and satiety in a way that I can only assume people with normal metabolism do. I am 49 years old and approaching the age where serious comorbidities associated with obesity begin to manifest,” the patient wrote.

“I no longer worry about bringing about my own demise with a fork and knife because of misfiring hunger cues.”

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

A report from a well-respected nonprofit group may bolster efforts to have Medicare, the largest U.S. purchaser of prescription drugs, cover obesity medicines, for which there has been accumulating evidence of significant benefit.

The Institute for Clinical and Economic Review (ICER) released a report last month on obesity medicines, based on extensive review of research done to date and input from clinicians, drug-makers, and members of the public.

Of the treatments reviewed, the ICER report gave the best ratings to two Novo Nordisk products, a B+ for semaglutide (Wegovy) and a B for liraglutide (Saxenda), while also making the case for price cuts. At an annual U.S. net price estimated at $13,618, semaglutide exceeds what ICER considers typical cost-effectiveness thresholds. ICER suggested a benchmark annual price range for semaglutide of between $7,500 and $9,800.

The ICER report also directs insurers in general to provide more generous coverage of obesity medicines, with a specific recommendation for the U.S. Congress to pass a pending bill known as the Treat and Reduce Obesity Act of 2021. The bill would undo a restriction on weight-loss drugs in the Medicare Part D plans, which covered about 49 million people last year. Sen. Tom Carper (D-Del.) and Sen. Bill Cassidy, MD, (R-La.) have repeatedly introduced versions of the bill since 2013.

“In both chambers of Congress and with bipartisan support, we’ve pushed to expand Medicare coverage of additional therapies and medications to treat obesity,” Sen. Cassidy said in an email. “This report confirms what we’ve worked on for nearly a decade – our legislation will help improve lives.”

The current House version of the bill has the backing of more than a third of the members of that chamber, with 113 Democratic and 40 Republican cosponsors. The Senate version has 22 sponsors.
 

Changing views

The ICER report comes amid a broader change in how clinicians view obesity. 

The American Academy of Pediatrics is readying a new Clinical Practice Guideline for the Evaluation and Treatment of Pediatric Obesity that will mark a major shift in approach. Aaron S. Kelly, PhD, a professor of pediatrics at the University of Minnesota, Minneapolis, described it as a “sea change,” with obesity now seen as “a chronic, refractory, relapsing disease,” for which watchful waiting is no longer appropriate.

But the field of obesity treatment looked quite different in the early 2000s when Congress worked on a plan to add a pharmacy benefit to Medicare.

The deliberate omission of obesity medicine in the Medicare Part D benefit reflected both the state of science at the time and U.S. experience with a dangerous weight-loss drug combo in the late 1990s.

Initial expectations for weight-loss pills were high after the Food and Drug Administration cleared dexfenfluramine HCl (Redux) in 1996, which was part of the popular fen-phen combination. “Newly Approved Diet Drug Promises to Help Millions of Obese Americans – But Is No Magic Bullet,” read a headline about the Redux approval in The Washington Post

When work began in the 2000s to create a Medicare pharmacy benefit, lawmakers and congressional staff had a pool of about $400 billion available to establish what became the Part D program, Joel White, a former House staffer who helped draft the law, told this news organization in an email exchange.

Given the state of obesity research at the time, it seemed to make sense to exclude weight-loss medications, wrote Mr. White. Mr. White is now chief executive of the consulting firm Horizon, which has clients in the drug industry including the Pharmaceutical Research and Manufacturers of America.

“Now we know that obesity is a chronic disease of epidemic proportions. Decades of research have produced a series of advances in the way we understand and treat obesity. While scientists and many who work directly with those impacted by this epidemic understand how treatments have advanced, the law lags behind,” Mr. White said.

XXXCurrent payment policies for obesity treatments are based on “outdated information and ongoing misperception,” he noted. “While Part D has been a resounding success, our Medicare approach to obesity is not.”

“In addition, it makes no sense that Medicare covers the most drastic procedure (bariatric surgery) but not less-invasive, effective treatments,” he added. “We should have long ago lifted restrictions based on advances in science and medicine.”
 

Overcoming the stigma

Scott Kahan, MD, MPH, agreed and hopes that the new ICER report will help more patients secure needed medications, raising a “call to arms” about the need for better coverage of obesity drugs.

Dr. Kahan is director of the National Center for Weight and Wellness, a private clinic in Washington, and chair of the clinical committee for The Obesity Society. He also served as a member of a policy roundtable that ICER convened as part of research on the report on obesity drugs. Dr. Kahan, who also serves on the faculty at the Johns Hopkins Bloomberg School of Public Health, Baltimore, has received fees from drug makers such as Eli Lilly.

The ICER report may help what Dr. Kahan described as well-founded caution about obesity treatments in general.

“When it comes to weight loss, there are all of these magical treatments that are sold on social media and traditional media. There are a lot of bad actors in terms of people calling themselves experts and gurus and promising all kinds of crazy stuff,” said Dr. Kahan.

And there are long-standing stigmas about obesity, he stressed.

“That underlies a lot of the backward policies, including poor coverage for medications and the noncoverage by Medicare,” Dr. Kahan said. “There’s a societal ingrained set of beliefs and misperceptions and biases. That takes time to unwind, and I think we’re on the way, but we’re not quite there yet.”
 

Lifestyle changes not enough to tackle obesity

AHIP (formerly America’s Health Insurance Plans) told this news organization its members consider ICER reports when making decisions about which products to cover. “And health plans already cover obesity treatments that they consider medically necessary,” said David Allen, an AHIP spokesperson.

“It is important to note that every treatment does not work for every patient, and many patients experience adverse events and may discontinue treatment,” he added in an email. “Health insurance providers play an important role in helping [health care] providers and patients identify the treatment options that are most likely to be effective as well as affordable.”

Separately, the nonprofit watchdog group Public Citizen cautioned against liraglutide on its Worst Pills, Best Pills website. In its view, the drug is minimally effective and has many dangerous adverse effects, which are even more frequent with the higher-dose weight-loss version (a lower-dose version is approved for type 2 diabetes).

“There is currently no medication that can be used safely to achieve weight loss effortlessly and without dangerous adverse effects,” the group said. “Rather than focus on losing weight by turning to risky drugs, overweight and obese adults seeking to achieve better health should make reasonable and sustainable changes to their lifestyle, such as eating a healthy diet and getting regular exercise.”

Yet, many people find there is little help available for making lifestyle changes, and some patients and physicians say these modifications by themselves are not enough.

“The vast majority of people with obesity cannot achieve sustained weight loss through diet and exercise alone,” said David Rind, MD, chief medical officer of ICER, in an Oct. 20 statement. “As such, obesity, and its resulting physical health, mental health, and social burdens, is not a choice or failing, but a medical condition.”

The focus should now be on assuring that effective medications “are priced in alignment with their benefits so that they are accessible and affordable across U.S. society,” Dr. Rind urges.
 

‘My own demise with a fork and knife’

ICER sought public feedback on a draft version of the report before finalizing it.

In their comments on ICER’s work, several pharmaceutical researchers and Novo Nordisk questioned the calculations used in making judgments about the value of obesity drugs. In a statement, Novo Nordisk told this news organization that the company’s view is that ICER’s modeling “does not adequately address the real-world complexities of obesity, and consequently underestimates the health and societal impact medical treatments can have.”

Commenters also dug into aspects of ICER’s calculations, including ones that consider quality-adjusted life-years (QALYs). ICER describes QALY as an academic standard for measuring how well all different types of medical treatments can extend or improve patients’ lives. In an explainer on its website, ICER says this metric has served as a fundamental component of cost-effectiveness analyses in the United States and around the world for more than 30 years.

ICER and drug makers have been at odds for some time, with PhRMA having criticized the nonprofit group. A 2020 Reuters article detailed public relations strategies used by firms paid by drug makers to raise questions about ICER’s work. Critics accuse it of allying with insurers.

ICER’s list of its recent financial supporters includes Blue Cross Blue Shield of Massachusetts and the Kaiser Foundation Health Plan, but also many other groups, such as the U.S. Department of Veterans Affairs, the American Academy of Neurology, and the American College of Rheumatology.

The public comments on the ICER report also include one from an unidentified woman who wrote of her past struggles to lose weight.

She said her health plan wouldn’t cover behavioral programs or semaglutide as a weight-loss drug but did cover it eventually because of signs that she had developed insulin resistance. The patient said the drug worked for her, whereas other approaches to control weight had failed.

“To put it simply, I now experience hunger and satiety in a way that I can only assume people with normal metabolism do. I am 49 years old and approaching the age where serious comorbidities associated with obesity begin to manifest,” the patient wrote.

“I no longer worry about bringing about my own demise with a fork and knife because of misfiring hunger cues.”

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

A report from a well-respected nonprofit group may bolster efforts to have Medicare, the largest U.S. purchaser of prescription drugs, cover obesity medicines, for which there has been accumulating evidence of significant benefit.

The Institute for Clinical and Economic Review (ICER) released a report last month on obesity medicines, based on extensive review of research done to date and input from clinicians, drug-makers, and members of the public.

Of the treatments reviewed, the ICER report gave the best ratings to two Novo Nordisk products, a B+ for semaglutide (Wegovy) and a B for liraglutide (Saxenda), while also making the case for price cuts. At an annual U.S. net price estimated at $13,618, semaglutide exceeds what ICER considers typical cost-effectiveness thresholds. ICER suggested a benchmark annual price range for semaglutide of between $7,500 and $9,800.

The ICER report also directs insurers in general to provide more generous coverage of obesity medicines, with a specific recommendation for the U.S. Congress to pass a pending bill known as the Treat and Reduce Obesity Act of 2021. The bill would undo a restriction on weight-loss drugs in the Medicare Part D plans, which covered about 49 million people last year. Sen. Tom Carper (D-Del.) and Sen. Bill Cassidy, MD, (R-La.) have repeatedly introduced versions of the bill since 2013.

“In both chambers of Congress and with bipartisan support, we’ve pushed to expand Medicare coverage of additional therapies and medications to treat obesity,” Sen. Cassidy said in an email. “This report confirms what we’ve worked on for nearly a decade – our legislation will help improve lives.”

The current House version of the bill has the backing of more than a third of the members of that chamber, with 113 Democratic and 40 Republican cosponsors. The Senate version has 22 sponsors.
 

Changing views

The ICER report comes amid a broader change in how clinicians view obesity. 

The American Academy of Pediatrics is readying a new Clinical Practice Guideline for the Evaluation and Treatment of Pediatric Obesity that will mark a major shift in approach. Aaron S. Kelly, PhD, a professor of pediatrics at the University of Minnesota, Minneapolis, described it as a “sea change,” with obesity now seen as “a chronic, refractory, relapsing disease,” for which watchful waiting is no longer appropriate.

But the field of obesity treatment looked quite different in the early 2000s when Congress worked on a plan to add a pharmacy benefit to Medicare.

The deliberate omission of obesity medicine in the Medicare Part D benefit reflected both the state of science at the time and U.S. experience with a dangerous weight-loss drug combo in the late 1990s.

Initial expectations for weight-loss pills were high after the Food and Drug Administration cleared dexfenfluramine HCl (Redux) in 1996, which was part of the popular fen-phen combination. “Newly Approved Diet Drug Promises to Help Millions of Obese Americans – But Is No Magic Bullet,” read a headline about the Redux approval in The Washington Post

When work began in the 2000s to create a Medicare pharmacy benefit, lawmakers and congressional staff had a pool of about $400 billion available to establish what became the Part D program, Joel White, a former House staffer who helped draft the law, told this news organization in an email exchange.

Given the state of obesity research at the time, it seemed to make sense to exclude weight-loss medications, wrote Mr. White. Mr. White is now chief executive of the consulting firm Horizon, which has clients in the drug industry including the Pharmaceutical Research and Manufacturers of America.

“Now we know that obesity is a chronic disease of epidemic proportions. Decades of research have produced a series of advances in the way we understand and treat obesity. While scientists and many who work directly with those impacted by this epidemic understand how treatments have advanced, the law lags behind,” Mr. White said.

XXXCurrent payment policies for obesity treatments are based on “outdated information and ongoing misperception,” he noted. “While Part D has been a resounding success, our Medicare approach to obesity is not.”

“In addition, it makes no sense that Medicare covers the most drastic procedure (bariatric surgery) but not less-invasive, effective treatments,” he added. “We should have long ago lifted restrictions based on advances in science and medicine.”
 

Overcoming the stigma

Scott Kahan, MD, MPH, agreed and hopes that the new ICER report will help more patients secure needed medications, raising a “call to arms” about the need for better coverage of obesity drugs.

Dr. Kahan is director of the National Center for Weight and Wellness, a private clinic in Washington, and chair of the clinical committee for The Obesity Society. He also served as a member of a policy roundtable that ICER convened as part of research on the report on obesity drugs. Dr. Kahan, who also serves on the faculty at the Johns Hopkins Bloomberg School of Public Health, Baltimore, has received fees from drug makers such as Eli Lilly.

The ICER report may help what Dr. Kahan described as well-founded caution about obesity treatments in general.

“When it comes to weight loss, there are all of these magical treatments that are sold on social media and traditional media. There are a lot of bad actors in terms of people calling themselves experts and gurus and promising all kinds of crazy stuff,” said Dr. Kahan.

And there are long-standing stigmas about obesity, he stressed.

“That underlies a lot of the backward policies, including poor coverage for medications and the noncoverage by Medicare,” Dr. Kahan said. “There’s a societal ingrained set of beliefs and misperceptions and biases. That takes time to unwind, and I think we’re on the way, but we’re not quite there yet.”
 

Lifestyle changes not enough to tackle obesity

AHIP (formerly America’s Health Insurance Plans) told this news organization its members consider ICER reports when making decisions about which products to cover. “And health plans already cover obesity treatments that they consider medically necessary,” said David Allen, an AHIP spokesperson.

“It is important to note that every treatment does not work for every patient, and many patients experience adverse events and may discontinue treatment,” he added in an email. “Health insurance providers play an important role in helping [health care] providers and patients identify the treatment options that are most likely to be effective as well as affordable.”

Separately, the nonprofit watchdog group Public Citizen cautioned against liraglutide on its Worst Pills, Best Pills website. In its view, the drug is minimally effective and has many dangerous adverse effects, which are even more frequent with the higher-dose weight-loss version (a lower-dose version is approved for type 2 diabetes).

“There is currently no medication that can be used safely to achieve weight loss effortlessly and without dangerous adverse effects,” the group said. “Rather than focus on losing weight by turning to risky drugs, overweight and obese adults seeking to achieve better health should make reasonable and sustainable changes to their lifestyle, such as eating a healthy diet and getting regular exercise.”

Yet, many people find there is little help available for making lifestyle changes, and some patients and physicians say these modifications by themselves are not enough.

“The vast majority of people with obesity cannot achieve sustained weight loss through diet and exercise alone,” said David Rind, MD, chief medical officer of ICER, in an Oct. 20 statement. “As such, obesity, and its resulting physical health, mental health, and social burdens, is not a choice or failing, but a medical condition.”

The focus should now be on assuring that effective medications “are priced in alignment with their benefits so that they are accessible and affordable across U.S. society,” Dr. Rind urges.
 

‘My own demise with a fork and knife’

ICER sought public feedback on a draft version of the report before finalizing it.

In their comments on ICER’s work, several pharmaceutical researchers and Novo Nordisk questioned the calculations used in making judgments about the value of obesity drugs. In a statement, Novo Nordisk told this news organization that the company’s view is that ICER’s modeling “does not adequately address the real-world complexities of obesity, and consequently underestimates the health and societal impact medical treatments can have.”

Commenters also dug into aspects of ICER’s calculations, including ones that consider quality-adjusted life-years (QALYs). ICER describes QALY as an academic standard for measuring how well all different types of medical treatments can extend or improve patients’ lives. In an explainer on its website, ICER says this metric has served as a fundamental component of cost-effectiveness analyses in the United States and around the world for more than 30 years.

ICER and drug makers have been at odds for some time, with PhRMA having criticized the nonprofit group. A 2020 Reuters article detailed public relations strategies used by firms paid by drug makers to raise questions about ICER’s work. Critics accuse it of allying with insurers.

ICER’s list of its recent financial supporters includes Blue Cross Blue Shield of Massachusetts and the Kaiser Foundation Health Plan, but also many other groups, such as the U.S. Department of Veterans Affairs, the American Academy of Neurology, and the American College of Rheumatology.

The public comments on the ICER report also include one from an unidentified woman who wrote of her past struggles to lose weight.

She said her health plan wouldn’t cover behavioral programs or semaglutide as a weight-loss drug but did cover it eventually because of signs that she had developed insulin resistance. The patient said the drug worked for her, whereas other approaches to control weight had failed.

“To put it simply, I now experience hunger and satiety in a way that I can only assume people with normal metabolism do. I am 49 years old and approaching the age where serious comorbidities associated with obesity begin to manifest,” the patient wrote.

“I no longer worry about bringing about my own demise with a fork and knife because of misfiring hunger cues.”

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