With recent expansions in its breast cancer indications, there has been an increase in the use of trastuzumab deruxtecan (T-DXd; Enhertu).

“A lot of us are using this more frequently now than we were in the past,” explained Sid Yadav, MD, a breast and gynecologic cancer specialist at the Mayo Clinic in Rochester, Minn. However, he added that managing its adverse events has been a “bit of a learning curve for all of us.”

The antibody-drug conjugate has been on the market since 2019 for metastatic human epidermal growth factor receptor (HER2)–positive breast cancer, but it was then approved in May 2022 for earlier use in this patient population and in August 2022 for patients with HER2-low disease. This latest approval was based on data showing an improvement in overall survival that was described as “practice changing.”

In addition, T-DXd is also approved for use in metastatic HER2-mutated non–small cell lung cancer and metastatic HER2-positive gastric and gastroesophageal junction adenocarcinoma.

Expanding use of this drug has led to growing awareness among oncologists of T-DXd’s considerable toxicities, Dr. Yadav told this news organization.

Among the eight or so patients he’s seen or treated over 2 months, Dr. Yadav has already seen one case of high-grade interstitial lung disease/pneumonitis, a complication that “everybody worries about” because the label for T-DXd carries a black box warning of this possibility.

There have been other issues at Mayo Clinic, as well. In one recent week, five patients were admitted for possible T-DXd adverse events, including neutropenic fever and sepsis; pneumonitis; severe nausea/vomiting with electrolyte imbalance; pneumonia, and non–ST elevation myocardial infarction with low ejection fraction.

It’s unknown what proportion of T-DXd recipients the five admissions represented. Dr. Yadav’s service has over 10 breast oncologists, so the cases could represent maybe 1%-10% of patients, he said.

His experience prompted Dr. Yadav to turn to Twitter to ask fellow oncologists what complications they’ve seen with T-DXd.

One said that his “real-world toxicity experience [has been] worse than the trial data,” which isn’t unusual, another oncologist noted, because real-world patients are often sicker than trial participants and more vulnerable to toxicities.

A third oncologist countered that she has “found [T-DXd] generally easy for patients to tolerate and [has] not needed to admit anyone” so far.

Overall, Dr. Yadav said that in his experience there are issues that need to be considered with T-DXd beyond interstitial lung disease.

As with any chemotherapy, neutropenia and infections are a concern, as the labeling notes. The interstitial lung disease case has also made Dr. Yadav have a low threshold to order CT in patients with any hints of shortness of breath and to start steroids if there’s any suspicion.

Probably the most common issue, however, is nausea and vomiting. In clinical trials, over 70% of participants reported nausea and over 40% experienced vomiting.

In response, Dr. Yadav and his colleagues have become more aggressive with prophylaxis. Pretreatment includes steroids, palonosetron, and fosaprepitant. Patients are also usually sent home with prochlorperazine, ondansetron, and lorazepam. If these don’t help, the team considers olanzapine.

They have also learned that “it’s important to spend that extra 15-20 minutes upfront” with patients before starting T-DXd to explain the risk for nausea and vomiting and how it will be managed, Dr. Yadav commented. “We do chemotherapy teaching for every patient, but I think we spend more time [now] talking about nausea and vomiting with this subset,” he said.

Dr. Yadav still starts patients on the standard breast cancer dose of T-DXd – 5.4 mg/kg every 3 weeks – but said he’s quicker now to lower the dose if patients aren’t doing well. He estimates he’s done that a couple of times so far.

Approaches at the Mayo Clinic are in line with those in a recent article on managing T-DXd toxicities by Hope Rugo, MD, from the University of California, San Francisco, and colleagues.

These authors conclude that adverse events related to T-DXd are frequent but are most commonly low grade and manageable. Nausea and vomiting are among the most common, and they note that interstitial lung disease/pneumonitis is an important adverse event, for which proactive monitoring, diagnosis, and management are key.

The review describes management practices of other health care providers and institutions with experience in using T-DXd to help with safe and effective management of the drug’s adverse events, particularly since the duration of treatment may be quite long.

Proper management of T-DXd–related adverse events will allow optimal exposure to and benefit from the drug and will help avoid premature discontinuation or improper dose reductions, Dr. Rugo and colleagues commented.

Dr. Yadav reports no relevant conflicts of interest.

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

With recent expansions in its breast cancer indications, there has been an increase in the use of trastuzumab deruxtecan (T-DXd; Enhertu).

“A lot of us are using this more frequently now than we were in the past,” explained Sid Yadav, MD, a breast and gynecologic cancer specialist at the Mayo Clinic in Rochester, Minn. However, he added that managing its adverse events has been a “bit of a learning curve for all of us.”

The antibody-drug conjugate has been on the market since 2019 for metastatic human epidermal growth factor receptor (HER2)–positive breast cancer, but it was then approved in May 2022 for earlier use in this patient population and in August 2022 for patients with HER2-low disease. This latest approval was based on data showing an improvement in overall survival that was described as “practice changing.”

In addition, T-DXd is also approved for use in metastatic HER2-mutated non–small cell lung cancer and metastatic HER2-positive gastric and gastroesophageal junction adenocarcinoma.

Expanding use of this drug has led to growing awareness among oncologists of T-DXd’s considerable toxicities, Dr. Yadav told this news organization.

Among the eight or so patients he’s seen or treated over 2 months, Dr. Yadav has already seen one case of high-grade interstitial lung disease/pneumonitis, a complication that “everybody worries about” because the label for T-DXd carries a black box warning of this possibility.

There have been other issues at Mayo Clinic, as well. In one recent week, five patients were admitted for possible T-DXd adverse events, including neutropenic fever and sepsis; pneumonitis; severe nausea/vomiting with electrolyte imbalance; pneumonia, and non–ST elevation myocardial infarction with low ejection fraction.

It’s unknown what proportion of T-DXd recipients the five admissions represented. Dr. Yadav’s service has over 10 breast oncologists, so the cases could represent maybe 1%-10% of patients, he said.

His experience prompted Dr. Yadav to turn to Twitter to ask fellow oncologists what complications they’ve seen with T-DXd.

One said that his “real-world toxicity experience [has been] worse than the trial data,” which isn’t unusual, another oncologist noted, because real-world patients are often sicker than trial participants and more vulnerable to toxicities.

A third oncologist countered that she has “found [T-DXd] generally easy for patients to tolerate and [has] not needed to admit anyone” so far.

Overall, Dr. Yadav said that in his experience there are issues that need to be considered with T-DXd beyond interstitial lung disease.

As with any chemotherapy, neutropenia and infections are a concern, as the labeling notes. The interstitial lung disease case has also made Dr. Yadav have a low threshold to order CT in patients with any hints of shortness of breath and to start steroids if there’s any suspicion.

Probably the most common issue, however, is nausea and vomiting. In clinical trials, over 70% of participants reported nausea and over 40% experienced vomiting.

In response, Dr. Yadav and his colleagues have become more aggressive with prophylaxis. Pretreatment includes steroids, palonosetron, and fosaprepitant. Patients are also usually sent home with prochlorperazine, ondansetron, and lorazepam. If these don’t help, the team considers olanzapine.

They have also learned that “it’s important to spend that extra 15-20 minutes upfront” with patients before starting T-DXd to explain the risk for nausea and vomiting and how it will be managed, Dr. Yadav commented. “We do chemotherapy teaching for every patient, but I think we spend more time [now] talking about nausea and vomiting with this subset,” he said.

Dr. Yadav still starts patients on the standard breast cancer dose of T-DXd – 5.4 mg/kg every 3 weeks – but said he’s quicker now to lower the dose if patients aren’t doing well. He estimates he’s done that a couple of times so far.

Approaches at the Mayo Clinic are in line with those in a recent article on managing T-DXd toxicities by Hope Rugo, MD, from the University of California, San Francisco, and colleagues.

These authors conclude that adverse events related to T-DXd are frequent but are most commonly low grade and manageable. Nausea and vomiting are among the most common, and they note that interstitial lung disease/pneumonitis is an important adverse event, for which proactive monitoring, diagnosis, and management are key.

The review describes management practices of other health care providers and institutions with experience in using T-DXd to help with safe and effective management of the drug’s adverse events, particularly since the duration of treatment may be quite long.

Proper management of T-DXd–related adverse events will allow optimal exposure to and benefit from the drug and will help avoid premature discontinuation or improper dose reductions, Dr. Rugo and colleagues commented.

Dr. Yadav reports no relevant conflicts of interest.

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

With recent expansions in its breast cancer indications, there has been an increase in the use of trastuzumab deruxtecan (T-DXd; Enhertu).

“A lot of us are using this more frequently now than we were in the past,” explained Sid Yadav, MD, a breast and gynecologic cancer specialist at the Mayo Clinic in Rochester, Minn. However, he added that managing its adverse events has been a “bit of a learning curve for all of us.”

The antibody-drug conjugate has been on the market since 2019 for metastatic human epidermal growth factor receptor (HER2)–positive breast cancer, but it was then approved in May 2022 for earlier use in this patient population and in August 2022 for patients with HER2-low disease. This latest approval was based on data showing an improvement in overall survival that was described as “practice changing.”

In addition, T-DXd is also approved for use in metastatic HER2-mutated non–small cell lung cancer and metastatic HER2-positive gastric and gastroesophageal junction adenocarcinoma.

Expanding use of this drug has led to growing awareness among oncologists of T-DXd’s considerable toxicities, Dr. Yadav told this news organization.

Among the eight or so patients he’s seen or treated over 2 months, Dr. Yadav has already seen one case of high-grade interstitial lung disease/pneumonitis, a complication that “everybody worries about” because the label for T-DXd carries a black box warning of this possibility.

There have been other issues at Mayo Clinic, as well. In one recent week, five patients were admitted for possible T-DXd adverse events, including neutropenic fever and sepsis; pneumonitis; severe nausea/vomiting with electrolyte imbalance; pneumonia, and non–ST elevation myocardial infarction with low ejection fraction.

It’s unknown what proportion of T-DXd recipients the five admissions represented. Dr. Yadav’s service has over 10 breast oncologists, so the cases could represent maybe 1%-10% of patients, he said.

His experience prompted Dr. Yadav to turn to Twitter to ask fellow oncologists what complications they’ve seen with T-DXd.

One said that his “real-world toxicity experience [has been] worse than the trial data,” which isn’t unusual, another oncologist noted, because real-world patients are often sicker than trial participants and more vulnerable to toxicities.

A third oncologist countered that she has “found [T-DXd] generally easy for patients to tolerate and [has] not needed to admit anyone” so far.

Overall, Dr. Yadav said that in his experience there are issues that need to be considered with T-DXd beyond interstitial lung disease.

As with any chemotherapy, neutropenia and infections are a concern, as the labeling notes. The interstitial lung disease case has also made Dr. Yadav have a low threshold to order CT in patients with any hints of shortness of breath and to start steroids if there’s any suspicion.

Probably the most common issue, however, is nausea and vomiting. In clinical trials, over 70% of participants reported nausea and over 40% experienced vomiting.

In response, Dr. Yadav and his colleagues have become more aggressive with prophylaxis. Pretreatment includes steroids, palonosetron, and fosaprepitant. Patients are also usually sent home with prochlorperazine, ondansetron, and lorazepam. If these don’t help, the team considers olanzapine.

They have also learned that “it’s important to spend that extra 15-20 minutes upfront” with patients before starting T-DXd to explain the risk for nausea and vomiting and how it will be managed, Dr. Yadav commented. “We do chemotherapy teaching for every patient, but I think we spend more time [now] talking about nausea and vomiting with this subset,” he said.

Dr. Yadav still starts patients on the standard breast cancer dose of T-DXd – 5.4 mg/kg every 3 weeks – but said he’s quicker now to lower the dose if patients aren’t doing well. He estimates he’s done that a couple of times so far.

Approaches at the Mayo Clinic are in line with those in a recent article on managing T-DXd toxicities by Hope Rugo, MD, from the University of California, San Francisco, and colleagues.

These authors conclude that adverse events related to T-DXd are frequent but are most commonly low grade and manageable. Nausea and vomiting are among the most common, and they note that interstitial lung disease/pneumonitis is an important adverse event, for which proactive monitoring, diagnosis, and management are key.

The review describes management practices of other health care providers and institutions with experience in using T-DXd to help with safe and effective management of the drug’s adverse events, particularly since the duration of treatment may be quite long.

Proper management of T-DXd–related adverse events will allow optimal exposure to and benefit from the drug and will help avoid premature discontinuation or improper dose reductions, Dr. Rugo and colleagues commented.

Dr. Yadav reports no relevant conflicts of interest.

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

If there’s one public health message Americans have heard loud and clear, it’s this one:

Move more.

Take more steps.

Spend more time doing physical activity – at least 150 minutes a week, according to the latest guidelines.

But hearing the message doesn’t mean we act on it. A whopping 25% of Americans don’t get any physical activity beyond what they do in their job, according to a CDC survey.

A new study suggests a different approach: You don’t have to do more. Just do what you’re already doing, but with a little more effort.

The study, which was published in the European Heart Journal, builds on growing evidence that suggests exercise intensity matters just as much as the amount. So, something as simple as turning a leisurely stroll into a brisk walk can, over time, lead to significant reductions in your risk of cardiovascular disease. No additional moves, steps, or minutes needed.
 

Step it up

Researchers at Cambridge University and the University of Leicester in England looked at data from 88,000 middle-aged adults who wore an activity tracking device for 7 days.

The devices tracked both the total amount of activity they did and the intensity of that movement – that is, how fast they walked or how hard they pushed themselves.

The researchers then calculated their physical activity energy expenditure (the number of calories they burned when they were up and moving) and the percentage that came from moderate to vigorous physical activity.

What’s the difference?

• Physical activity means any and every movement you do throughout the day. Mostly it’s mundane tasks like shopping, walking to the mailbox, playing with your dog, or cooking.
• Moderate-intensity physical activity includes things you do at a faster pace. Maybe you’re walking for exercise, doing yard work or household chores, or running late and just trying to get somewhere faster. You’re breathing a little harder and possibly working up a sweat.
• Vigorous-intensity physical activity is usually an exercise session – a run, a strenuous hike, a tough workout in the gym. It can also be an exhausting chore like shoveling snow, which feels like a workout. You’re definitely breathing harder, and you’re probably working up a sweat, even in the middle of winter.

Over the next 6 to 7 years, there were 4,000 new cases of cardiovascular disease among the people in the study.

Those who got at least 20% of their physical activity energy expenditure from moderate to vigorous activities had significantly less risk of heart disease, compared with those whose higher-effort activities were about 10%.

That was true even for those whose total activity was relatively low. As long as higher-effort activities reached 20% of their total, they were 14% less likely to be diagnosed with a heart condition.

And for those with relatively high activity levels, there was little extra benefit if their moderate and vigorous activities remained around 10%.

That finding surprised Paddy Dempsey, PhD, a medical research scientist at Cambridge and the study’s lead author. But it also makes sense.

“People can improve their cardiorespiratory fitness to a greater degree with higher-intensity activity,” he says. “More intensity will stress the system and lead to greater adaptation.”

The key is an increase in the amount of oxygen your heart and lungs can provide your muscles during exercise, a measure known as VO_2max.

Raising your VO_2max is the best way to reduce your risk of early death, especially death from heart disease. Simply moving up from the lowest conditioning category to a higher one will cut your risk of dying in any given year by as much as 60%.
 

Making strides

The study builds on previous research that shows the benefits of moving faster.

Walking faster will naturally increase your stride length, another predictor of longevity and future health. A review study published in 2021 found that older adults who took shorter steps were 26% more likely to have a disability, 34% more likely to have a major adverse event (like an injury that leads to a loss of independence), and 69% more likely to die over the next several years.
 

Quality versus quantity

We’ve focused so far on the quality of your physical activity – moving faster, taking longer strides.

But there’s still a lot to be said for movement quantity.

“It would be a mistake to say volume doesn’t matter,” Dr. Dempsey cautions.

A 2022 study in the journal The Lancet found that the risk of dying during a given period decreases with each increase in daily steps. The protective effect peaks at about 6,000 to 8,000 steps a day for adults 60 and over, and at 8,000 to 10,000 steps for those under 60.

“The relative value of the quality and quantity of exercise are very specific to a person’s goals,” says Chhanda Dutta, PhD, chief of the Clinical Gerontology Branch at the National Institute on Aging. “If performance is the goal, quality matters at least as much as quantity.”

Dr. Dempsey agrees that it’s not a cage match between two. Every step you take is a step in the right direction.

“People can choose or gravitate to an approach that works best for them,” he says. “It’s also helpful to think about where some everyday activities can be punctuated with intensity,” which could be as simple as walking faster when possible.

What matters most is that you choose something, Dr. Dutta says. “You have more to risk by not exercising.”

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

If there’s one public health message Americans have heard loud and clear, it’s this one:

Move more.

Take more steps.

Spend more time doing physical activity – at least 150 minutes a week, according to the latest guidelines.

But hearing the message doesn’t mean we act on it. A whopping 25% of Americans don’t get any physical activity beyond what they do in their job, according to a CDC survey.

A new study suggests a different approach: You don’t have to do more. Just do what you’re already doing, but with a little more effort.

The study, which was published in the European Heart Journal, builds on growing evidence that suggests exercise intensity matters just as much as the amount. So, something as simple as turning a leisurely stroll into a brisk walk can, over time, lead to significant reductions in your risk of cardiovascular disease. No additional moves, steps, or minutes needed.
 

Step it up

Researchers at Cambridge University and the University of Leicester in England looked at data from 88,000 middle-aged adults who wore an activity tracking device for 7 days.

The devices tracked both the total amount of activity they did and the intensity of that movement – that is, how fast they walked or how hard they pushed themselves.

The researchers then calculated their physical activity energy expenditure (the number of calories they burned when they were up and moving) and the percentage that came from moderate to vigorous physical activity.

What’s the difference?

• Physical activity means any and every movement you do throughout the day. Mostly it’s mundane tasks like shopping, walking to the mailbox, playing with your dog, or cooking.
• Moderate-intensity physical activity includes things you do at a faster pace. Maybe you’re walking for exercise, doing yard work or household chores, or running late and just trying to get somewhere faster. You’re breathing a little harder and possibly working up a sweat.
• Vigorous-intensity physical activity is usually an exercise session – a run, a strenuous hike, a tough workout in the gym. It can also be an exhausting chore like shoveling snow, which feels like a workout. You’re definitely breathing harder, and you’re probably working up a sweat, even in the middle of winter.

Over the next 6 to 7 years, there were 4,000 new cases of cardiovascular disease among the people in the study.

Those who got at least 20% of their physical activity energy expenditure from moderate to vigorous activities had significantly less risk of heart disease, compared with those whose higher-effort activities were about 10%.

That was true even for those whose total activity was relatively low. As long as higher-effort activities reached 20% of their total, they were 14% less likely to be diagnosed with a heart condition.

And for those with relatively high activity levels, there was little extra benefit if their moderate and vigorous activities remained around 10%.

That finding surprised Paddy Dempsey, PhD, a medical research scientist at Cambridge and the study’s lead author. But it also makes sense.

“People can improve their cardiorespiratory fitness to a greater degree with higher-intensity activity,” he says. “More intensity will stress the system and lead to greater adaptation.”

The key is an increase in the amount of oxygen your heart and lungs can provide your muscles during exercise, a measure known as VO_2max.

Raising your VO_2max is the best way to reduce your risk of early death, especially death from heart disease. Simply moving up from the lowest conditioning category to a higher one will cut your risk of dying in any given year by as much as 60%.
 

Making strides

The study builds on previous research that shows the benefits of moving faster.

Walking faster will naturally increase your stride length, another predictor of longevity and future health. A review study published in 2021 found that older adults who took shorter steps were 26% more likely to have a disability, 34% more likely to have a major adverse event (like an injury that leads to a loss of independence), and 69% more likely to die over the next several years.
 

Quality versus quantity

We’ve focused so far on the quality of your physical activity – moving faster, taking longer strides.

But there’s still a lot to be said for movement quantity.

“It would be a mistake to say volume doesn’t matter,” Dr. Dempsey cautions.

A 2022 study in the journal The Lancet found that the risk of dying during a given period decreases with each increase in daily steps. The protective effect peaks at about 6,000 to 8,000 steps a day for adults 60 and over, and at 8,000 to 10,000 steps for those under 60.

“The relative value of the quality and quantity of exercise are very specific to a person’s goals,” says Chhanda Dutta, PhD, chief of the Clinical Gerontology Branch at the National Institute on Aging. “If performance is the goal, quality matters at least as much as quantity.”

Dr. Dempsey agrees that it’s not a cage match between two. Every step you take is a step in the right direction.

“People can choose or gravitate to an approach that works best for them,” he says. “It’s also helpful to think about where some everyday activities can be punctuated with intensity,” which could be as simple as walking faster when possible.

What matters most is that you choose something, Dr. Dutta says. “You have more to risk by not exercising.”

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

If there’s one public health message Americans have heard loud and clear, it’s this one:

Move more.

Take more steps.

Spend more time doing physical activity – at least 150 minutes a week, according to the latest guidelines.

But hearing the message doesn’t mean we act on it. A whopping 25% of Americans don’t get any physical activity beyond what they do in their job, according to a CDC survey.

A new study suggests a different approach: You don’t have to do more. Just do what you’re already doing, but with a little more effort.

The study, which was published in the European Heart Journal, builds on growing evidence that suggests exercise intensity matters just as much as the amount. So, something as simple as turning a leisurely stroll into a brisk walk can, over time, lead to significant reductions in your risk of cardiovascular disease. No additional moves, steps, or minutes needed.
 

Step it up

Researchers at Cambridge University and the University of Leicester in England looked at data from 88,000 middle-aged adults who wore an activity tracking device for 7 days.

The devices tracked both the total amount of activity they did and the intensity of that movement – that is, how fast they walked or how hard they pushed themselves.

The researchers then calculated their physical activity energy expenditure (the number of calories they burned when they were up and moving) and the percentage that came from moderate to vigorous physical activity.

What’s the difference?

• Physical activity means any and every movement you do throughout the day. Mostly it’s mundane tasks like shopping, walking to the mailbox, playing with your dog, or cooking.
• Moderate-intensity physical activity includes things you do at a faster pace. Maybe you’re walking for exercise, doing yard work or household chores, or running late and just trying to get somewhere faster. You’re breathing a little harder and possibly working up a sweat.
• Vigorous-intensity physical activity is usually an exercise session – a run, a strenuous hike, a tough workout in the gym. It can also be an exhausting chore like shoveling snow, which feels like a workout. You’re definitely breathing harder, and you’re probably working up a sweat, even in the middle of winter.

Over the next 6 to 7 years, there were 4,000 new cases of cardiovascular disease among the people in the study.

Those who got at least 20% of their physical activity energy expenditure from moderate to vigorous activities had significantly less risk of heart disease, compared with those whose higher-effort activities were about 10%.

That was true even for those whose total activity was relatively low. As long as higher-effort activities reached 20% of their total, they were 14% less likely to be diagnosed with a heart condition.

And for those with relatively high activity levels, there was little extra benefit if their moderate and vigorous activities remained around 10%.

That finding surprised Paddy Dempsey, PhD, a medical research scientist at Cambridge and the study’s lead author. But it also makes sense.

“People can improve their cardiorespiratory fitness to a greater degree with higher-intensity activity,” he says. “More intensity will stress the system and lead to greater adaptation.”

The key is an increase in the amount of oxygen your heart and lungs can provide your muscles during exercise, a measure known as VO_2max.

Raising your VO_2max is the best way to reduce your risk of early death, especially death from heart disease. Simply moving up from the lowest conditioning category to a higher one will cut your risk of dying in any given year by as much as 60%.
 

Making strides

The study builds on previous research that shows the benefits of moving faster.

Walking faster will naturally increase your stride length, another predictor of longevity and future health. A review study published in 2021 found that older adults who took shorter steps were 26% more likely to have a disability, 34% more likely to have a major adverse event (like an injury that leads to a loss of independence), and 69% more likely to die over the next several years.
 

Quality versus quantity

We’ve focused so far on the quality of your physical activity – moving faster, taking longer strides.

But there’s still a lot to be said for movement quantity.

“It would be a mistake to say volume doesn’t matter,” Dr. Dempsey cautions.

A 2022 study in the journal The Lancet found that the risk of dying during a given period decreases with each increase in daily steps. The protective effect peaks at about 6,000 to 8,000 steps a day for adults 60 and over, and at 8,000 to 10,000 steps for those under 60.

“The relative value of the quality and quantity of exercise are very specific to a person’s goals,” says Chhanda Dutta, PhD, chief of the Clinical Gerontology Branch at the National Institute on Aging. “If performance is the goal, quality matters at least as much as quantity.”

Dr. Dempsey agrees that it’s not a cage match between two. Every step you take is a step in the right direction.

“People can choose or gravitate to an approach that works best for them,” he says. “It’s also helpful to think about where some everyday activities can be punctuated with intensity,” which could be as simple as walking faster when possible.

What matters most is that you choose something, Dr. Dutta says. “You have more to risk by not exercising.”

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

The Food and Drug Administration has announced it will not approve the investigational drug poziotinib (Spectrum Pharmaceuticals) for the treatment of certain patients with non–small cell lung cancer (NSCLC).

The clinical data the company submitted were deemed insufficient for approval, and additional data including a randomized clinical trial would be needed, the agency said.

The move is not a surprise, as the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 9-4 against approval when it met to discuss the drug in September, as reported at the time by this news organization.

Poziotinib was developed for patients with previously treated locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations, which occur in about 2% of patients with NSCLC.

Poziotinib is a potent oral pan-HER tyrosine kinase inhibitor with activity in patients with these mutations. Clinical data from the ZENITH20 Trial reported last year showed an overall response rate of 43.8%, and the drug was described as showing “clinically meaningful efficacy for treatment-naive NSCLC HER2 exon 20 mutations with [daily] dosing.”

“We continue to believe that poziotinib could present a meaningful treatment option for patients with this rare form of lung cancer, for whom other therapies have failed,” commented Tom Riga, president and chief executive officer of Spectrum Pharmaceuticals. 

However, following multiple interactions with the FDA, “we have made the strategic decision to immediately deprioritize the poziotinib program,” he said. The change is effective immediately, and the company is now in the process of reducing its R&D workforce by approximately 75%.
 

Drug development criticized

At the ODAC meeting, several panelists were openly critical of the approach Spectrum took in developing the drug. The FDA’s top cancer official, Richard Pazdur, MD, characterized Spectrum’s work as “poor drug development” and likened it to “building a house on quicksand.”

The FDA panel detailed several ways they felt that the poziotinib application fell short of the benchmarks needed for accelerated approval.

To win such a speedy clearance, a company needs to show that a drug provides a meaningful therapeutic benefit over existing treatments. The panel argued that, so far, poziotinib appears to be inferior to a product already available for HER2-mutant NSCLC, trastuzumab deruxtecan (Enhertu), which received accelerated approval in August.

The FDA staff contrasted a reported overall response rate for poziotinib, which was estimated at 28% (from data discussed at the meeting), with the overall response rate for trastuzumab deruxtecan, which is 58%.

Harpreet Singh, MD, a director in the FDA’s oncology division, asked the panel to consider what they would do as a physician treating a patient with this mutation, given the choices that are now available.

“That’s something we’re asking the committee to consider … to think about the context of what’s available to you in the clinic,” Dr. Singh said.

Dr. Singh said she expected that patients and physicians would prefer a drug such as trastuzumab deruxtecan, which has a more established record, regardless of the fact that treatment with poziotinib is more convenient because it is given as a tablet.

Dr. Singh and other staff also raised concerns about side effects of poziotinib, including diarrhea, as well as difficulty determining the right dose.

Katherine Scilla, MD, one of the nine ODAC panelists to vote “no,” echoed these views. Although Dr. Scilla, an oncologist at the University of Maryland, Baltimore, sympathized with the need for options for people with this rare form of lung cancer, she was not persuaded by the data on poziotinib that were presented to support accelerated approval.

“I’m not sure that this represents a meaningful therapeutic benefit over other agents,” she said at the time. 

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

The Food and Drug Administration has announced it will not approve the investigational drug poziotinib (Spectrum Pharmaceuticals) for the treatment of certain patients with non–small cell lung cancer (NSCLC).

The clinical data the company submitted were deemed insufficient for approval, and additional data including a randomized clinical trial would be needed, the agency said.

The move is not a surprise, as the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 9-4 against approval when it met to discuss the drug in September, as reported at the time by this news organization.

Poziotinib was developed for patients with previously treated locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations, which occur in about 2% of patients with NSCLC.

Poziotinib is a potent oral pan-HER tyrosine kinase inhibitor with activity in patients with these mutations. Clinical data from the ZENITH20 Trial reported last year showed an overall response rate of 43.8%, and the drug was described as showing “clinically meaningful efficacy for treatment-naive NSCLC HER2 exon 20 mutations with [daily] dosing.”

“We continue to believe that poziotinib could present a meaningful treatment option for patients with this rare form of lung cancer, for whom other therapies have failed,” commented Tom Riga, president and chief executive officer of Spectrum Pharmaceuticals. 

However, following multiple interactions with the FDA, “we have made the strategic decision to immediately deprioritize the poziotinib program,” he said. The change is effective immediately, and the company is now in the process of reducing its R&D workforce by approximately 75%.
 

Drug development criticized

At the ODAC meeting, several panelists were openly critical of the approach Spectrum took in developing the drug. The FDA’s top cancer official, Richard Pazdur, MD, characterized Spectrum’s work as “poor drug development” and likened it to “building a house on quicksand.”

The FDA panel detailed several ways they felt that the poziotinib application fell short of the benchmarks needed for accelerated approval.

To win such a speedy clearance, a company needs to show that a drug provides a meaningful therapeutic benefit over existing treatments. The panel argued that, so far, poziotinib appears to be inferior to a product already available for HER2-mutant NSCLC, trastuzumab deruxtecan (Enhertu), which received accelerated approval in August.

The FDA staff contrasted a reported overall response rate for poziotinib, which was estimated at 28% (from data discussed at the meeting), with the overall response rate for trastuzumab deruxtecan, which is 58%.

Harpreet Singh, MD, a director in the FDA’s oncology division, asked the panel to consider what they would do as a physician treating a patient with this mutation, given the choices that are now available.

“That’s something we’re asking the committee to consider … to think about the context of what’s available to you in the clinic,” Dr. Singh said.

Dr. Singh said she expected that patients and physicians would prefer a drug such as trastuzumab deruxtecan, which has a more established record, regardless of the fact that treatment with poziotinib is more convenient because it is given as a tablet.

Dr. Singh and other staff also raised concerns about side effects of poziotinib, including diarrhea, as well as difficulty determining the right dose.

Katherine Scilla, MD, one of the nine ODAC panelists to vote “no,” echoed these views. Although Dr. Scilla, an oncologist at the University of Maryland, Baltimore, sympathized with the need for options for people with this rare form of lung cancer, she was not persuaded by the data on poziotinib that were presented to support accelerated approval.

“I’m not sure that this represents a meaningful therapeutic benefit over other agents,” she said at the time. 

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

The Food and Drug Administration has announced it will not approve the investigational drug poziotinib (Spectrum Pharmaceuticals) for the treatment of certain patients with non–small cell lung cancer (NSCLC).

The clinical data the company submitted were deemed insufficient for approval, and additional data including a randomized clinical trial would be needed, the agency said.

The move is not a surprise, as the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 9-4 against approval when it met to discuss the drug in September, as reported at the time by this news organization.

Poziotinib was developed for patients with previously treated locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations, which occur in about 2% of patients with NSCLC.

Poziotinib is a potent oral pan-HER tyrosine kinase inhibitor with activity in patients with these mutations. Clinical data from the ZENITH20 Trial reported last year showed an overall response rate of 43.8%, and the drug was described as showing “clinically meaningful efficacy for treatment-naive NSCLC HER2 exon 20 mutations with [daily] dosing.”

“We continue to believe that poziotinib could present a meaningful treatment option for patients with this rare form of lung cancer, for whom other therapies have failed,” commented Tom Riga, president and chief executive officer of Spectrum Pharmaceuticals. 

However, following multiple interactions with the FDA, “we have made the strategic decision to immediately deprioritize the poziotinib program,” he said. The change is effective immediately, and the company is now in the process of reducing its R&D workforce by approximately 75%.
 

Drug development criticized

At the ODAC meeting, several panelists were openly critical of the approach Spectrum took in developing the drug. The FDA’s top cancer official, Richard Pazdur, MD, characterized Spectrum’s work as “poor drug development” and likened it to “building a house on quicksand.”

The FDA panel detailed several ways they felt that the poziotinib application fell short of the benchmarks needed for accelerated approval.

To win such a speedy clearance, a company needs to show that a drug provides a meaningful therapeutic benefit over existing treatments. The panel argued that, so far, poziotinib appears to be inferior to a product already available for HER2-mutant NSCLC, trastuzumab deruxtecan (Enhertu), which received accelerated approval in August.

The FDA staff contrasted a reported overall response rate for poziotinib, which was estimated at 28% (from data discussed at the meeting), with the overall response rate for trastuzumab deruxtecan, which is 58%.

Harpreet Singh, MD, a director in the FDA’s oncology division, asked the panel to consider what they would do as a physician treating a patient with this mutation, given the choices that are now available.

“That’s something we’re asking the committee to consider … to think about the context of what’s available to you in the clinic,” Dr. Singh said.

Dr. Singh said she expected that patients and physicians would prefer a drug such as trastuzumab deruxtecan, which has a more established record, regardless of the fact that treatment with poziotinib is more convenient because it is given as a tablet.

Dr. Singh and other staff also raised concerns about side effects of poziotinib, including diarrhea, as well as difficulty determining the right dose.

Katherine Scilla, MD, one of the nine ODAC panelists to vote “no,” echoed these views. Although Dr. Scilla, an oncologist at the University of Maryland, Baltimore, sympathized with the need for options for people with this rare form of lung cancer, she was not persuaded by the data on poziotinib that were presented to support accelerated approval.

“I’m not sure that this represents a meaningful therapeutic benefit over other agents,” she said at the time. 

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

CHICAGO – Discovering lung cancer early with annual low-dose computed tomography greatly improves long-term survival rates to 80%, findings from a 20-year international study indicate.

Claudia Henschke, MD, PhD, professor of radiology and director of the Early Lung and Cardiac Action Program at the Icahn School of Medicine at Mount Sinai, New York, presented research results at the annual meeting of the Radiological Society of North America.

The researchers studied lung-cancer–specific survival (LCS) of 87,416 participants enrolled in an international, prospective study named the International Early Lung Cancer Action Program.

Lung cancer is the leading cause of cancer death. The American Lung Association states the average 5-year survival rate is 18.6%. Only 16% of the cancers are caught early and more than half of people with lung cancer die within a year of diagnosis.
 

Participants’ 20-year survival rate 80%

Results of this large international study showed the overall 20-year survival rate for the 1,285 screening participants diagnosed with early-stage cancer was 80% (95% confidence interval, 77%-83%). Among the 1,285 diagnosed, 83% had stage 1 cancer, Dr. Henschke said.

Lung cancer survival (LCS) was 100% for the 139 participants with nonsolid nodule consistency and for the 155 participants with part-solid consistency. LCS was 73% (95% CI, 69%-77%) for the 991 with solid consistency, and for clinical stage IA participants LCS was 86% (95% CI, 83%-89%), regardless of consistency.

For participants with pathologic stage IA lung cancer 10 mm or less in average diameter, the 20-year survival rate with identification and resection was 92% (95% CI, 87%-96%).

No lung cancer deaths were identified in the part-solid and nonsolid cancers, the researchers report.

These results show the 10-year findings from 2006 published in the New England Journal of Medicine, which also showed 80% survival rates with low-dose CT, have persisted, she said.

At the time of the 2006 paper, 95% of Americans diagnosed with lung cancer died from it, Dr. Henschke said.

Dr. Henschke notes that by the time symptoms appear, lung cancer is often advanced, so the best tool for detecting early-stage lung cancer is enrolling in an annual screening program.

When cancer is small enough and can be surgically removed, patients can be effectively cured long-term, she said.

“In the future, perhaps blood markers will allow us to detect it in the first half of the life cycle of lung cancer instead of CT at the beginning of the second half of the life cycle,” Dr. Henschke said.

“The study raises the power of prospective data collection in the context of clinical care as recommended by the Institute of Medicine long ago,” she said.
 

Findings “very promising”

Ernest Hawk, MD, MPH, head of the division of cancer prevention and population sciences at the University of Texas MD Anderson Cancer, Houston, told this news organization the findings look “very promising.” Dr. Hawk was not involved in the study.

“This was one of the earliest studies to evaluate low-dose CT scanning. Their report that the initial benefits seem to be holding up over a longer period of observation is great,” he said.

“This bolsters the data that lung cancer screening is beneficial over a longer period of observation,” he said, noting that most of the randomized controlled trials have been shorter.

Lung cancer screening is now recommended for high-risk individuals – those with at least a 20-pack-year history of tobacco use who are between 50 and 80 years old.

So far, screening is still limited to people at high risk, Dr. Hawk said, though there’s discussion about whether benefit would extend to people exposed to asbestos, for instance, or secondhand smoke.

“The biggest challenge right now is getting the screening to those who actually meet the criteria,” Dr. Hawk said.

Medscape reported earlier this month that less than 6% of high-risk smokers have the recommended annual lung cancer screening, according to a new report from the American Lung Association.

Dr. Henschke is on the Advisory Board for LungLifeAI and is on the board for the Early Diagnosis and Treatment Research Foundation. Dr. Hawk reports no relevant financial relationships.

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

CHICAGO – Discovering lung cancer early with annual low-dose computed tomography greatly improves long-term survival rates to 80%, findings from a 20-year international study indicate.

Claudia Henschke, MD, PhD, professor of radiology and director of the Early Lung and Cardiac Action Program at the Icahn School of Medicine at Mount Sinai, New York, presented research results at the annual meeting of the Radiological Society of North America.

The researchers studied lung-cancer–specific survival (LCS) of 87,416 participants enrolled in an international, prospective study named the International Early Lung Cancer Action Program.

Lung cancer is the leading cause of cancer death. The American Lung Association states the average 5-year survival rate is 18.6%. Only 16% of the cancers are caught early and more than half of people with lung cancer die within a year of diagnosis.
 

Participants’ 20-year survival rate 80%

Results of this large international study showed the overall 20-year survival rate for the 1,285 screening participants diagnosed with early-stage cancer was 80% (95% confidence interval, 77%-83%). Among the 1,285 diagnosed, 83% had stage 1 cancer, Dr. Henschke said.

Lung cancer survival (LCS) was 100% for the 139 participants with nonsolid nodule consistency and for the 155 participants with part-solid consistency. LCS was 73% (95% CI, 69%-77%) for the 991 with solid consistency, and for clinical stage IA participants LCS was 86% (95% CI, 83%-89%), regardless of consistency.

For participants with pathologic stage IA lung cancer 10 mm or less in average diameter, the 20-year survival rate with identification and resection was 92% (95% CI, 87%-96%).

No lung cancer deaths were identified in the part-solid and nonsolid cancers, the researchers report.

These results show the 10-year findings from 2006 published in the New England Journal of Medicine, which also showed 80% survival rates with low-dose CT, have persisted, she said.

At the time of the 2006 paper, 95% of Americans diagnosed with lung cancer died from it, Dr. Henschke said.

Dr. Henschke notes that by the time symptoms appear, lung cancer is often advanced, so the best tool for detecting early-stage lung cancer is enrolling in an annual screening program.

When cancer is small enough and can be surgically removed, patients can be effectively cured long-term, she said.

“In the future, perhaps blood markers will allow us to detect it in the first half of the life cycle of lung cancer instead of CT at the beginning of the second half of the life cycle,” Dr. Henschke said.

“The study raises the power of prospective data collection in the context of clinical care as recommended by the Institute of Medicine long ago,” she said.
 

Findings “very promising”

Ernest Hawk, MD, MPH, head of the division of cancer prevention and population sciences at the University of Texas MD Anderson Cancer, Houston, told this news organization the findings look “very promising.” Dr. Hawk was not involved in the study.

“This was one of the earliest studies to evaluate low-dose CT scanning. Their report that the initial benefits seem to be holding up over a longer period of observation is great,” he said.

“This bolsters the data that lung cancer screening is beneficial over a longer period of observation,” he said, noting that most of the randomized controlled trials have been shorter.

Lung cancer screening is now recommended for high-risk individuals – those with at least a 20-pack-year history of tobacco use who are between 50 and 80 years old.

So far, screening is still limited to people at high risk, Dr. Hawk said, though there’s discussion about whether benefit would extend to people exposed to asbestos, for instance, or secondhand smoke.

“The biggest challenge right now is getting the screening to those who actually meet the criteria,” Dr. Hawk said.

Medscape reported earlier this month that less than 6% of high-risk smokers have the recommended annual lung cancer screening, according to a new report from the American Lung Association.

Dr. Henschke is on the Advisory Board for LungLifeAI and is on the board for the Early Diagnosis and Treatment Research Foundation. Dr. Hawk reports no relevant financial relationships.

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

CHICAGO – Discovering lung cancer early with annual low-dose computed tomography greatly improves long-term survival rates to 80%, findings from a 20-year international study indicate.

Claudia Henschke, MD, PhD, professor of radiology and director of the Early Lung and Cardiac Action Program at the Icahn School of Medicine at Mount Sinai, New York, presented research results at the annual meeting of the Radiological Society of North America.

The researchers studied lung-cancer–specific survival (LCS) of 87,416 participants enrolled in an international, prospective study named the International Early Lung Cancer Action Program.

Lung cancer is the leading cause of cancer death. The American Lung Association states the average 5-year survival rate is 18.6%. Only 16% of the cancers are caught early and more than half of people with lung cancer die within a year of diagnosis.
 

Participants’ 20-year survival rate 80%

Results of this large international study showed the overall 20-year survival rate for the 1,285 screening participants diagnosed with early-stage cancer was 80% (95% confidence interval, 77%-83%). Among the 1,285 diagnosed, 83% had stage 1 cancer, Dr. Henschke said.

Lung cancer survival (LCS) was 100% for the 139 participants with nonsolid nodule consistency and for the 155 participants with part-solid consistency. LCS was 73% (95% CI, 69%-77%) for the 991 with solid consistency, and for clinical stage IA participants LCS was 86% (95% CI, 83%-89%), regardless of consistency.

For participants with pathologic stage IA lung cancer 10 mm or less in average diameter, the 20-year survival rate with identification and resection was 92% (95% CI, 87%-96%).

No lung cancer deaths were identified in the part-solid and nonsolid cancers, the researchers report.

These results show the 10-year findings from 2006 published in the New England Journal of Medicine, which also showed 80% survival rates with low-dose CT, have persisted, she said.

At the time of the 2006 paper, 95% of Americans diagnosed with lung cancer died from it, Dr. Henschke said.

Dr. Henschke notes that by the time symptoms appear, lung cancer is often advanced, so the best tool for detecting early-stage lung cancer is enrolling in an annual screening program.

When cancer is small enough and can be surgically removed, patients can be effectively cured long-term, she said.

“In the future, perhaps blood markers will allow us to detect it in the first half of the life cycle of lung cancer instead of CT at the beginning of the second half of the life cycle,” Dr. Henschke said.

“The study raises the power of prospective data collection in the context of clinical care as recommended by the Institute of Medicine long ago,” she said.
 

Findings “very promising”

Ernest Hawk, MD, MPH, head of the division of cancer prevention and population sciences at the University of Texas MD Anderson Cancer, Houston, told this news organization the findings look “very promising.” Dr. Hawk was not involved in the study.

“This was one of the earliest studies to evaluate low-dose CT scanning. Their report that the initial benefits seem to be holding up over a longer period of observation is great,” he said.

“This bolsters the data that lung cancer screening is beneficial over a longer period of observation,” he said, noting that most of the randomized controlled trials have been shorter.

Lung cancer screening is now recommended for high-risk individuals – those with at least a 20-pack-year history of tobacco use who are between 50 and 80 years old.

So far, screening is still limited to people at high risk, Dr. Hawk said, though there’s discussion about whether benefit would extend to people exposed to asbestos, for instance, or secondhand smoke.

“The biggest challenge right now is getting the screening to those who actually meet the criteria,” Dr. Hawk said.

Medscape reported earlier this month that less than 6% of high-risk smokers have the recommended annual lung cancer screening, according to a new report from the American Lung Association.

Dr. Henschke is on the Advisory Board for LungLifeAI and is on the board for the Early Diagnosis and Treatment Research Foundation. Dr. Hawk reports no relevant financial relationships.

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

Atezolizumab (Tecentriq) is no longer approved in the United States for use in certain patients with bladder or urinary tract cancer.

The drug is an anti–PD-L1 inhibitor immunotherapy, and continues to be approved for use in lung and liver cancer and melanoma.

The manufacturer, Genentech, announced that it was voluntarily withdrawing the U.S. indication for atezolizumab that covered its use in adults with locally advanced or metastatic urothelial carcinoma (bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

The company said that it made the decision after consultation with the Food and Drug Administration.

“While we are disappointed with this withdrawal, we understand the need to uphold the principles of the FDA’s Accelerated Approval Program, which brings innovative medicines to patients sooner,” said Levi Garraway, MD, PhD, Genentech chief medical officer and head of Global Product Development.

Atezolizumab had been granted an accelerated approval for this indication back in 2016, based on response rate data from the IMvigor210 trial.

The company was obliged to conduct a follow-up trial to show clinical benefit, and launched IMvigor130, which it described as “the designated postmarketing requirement to convert the accelerated approval to regular approval.”

The bladder cancer indication for atezolizumab was discussed (alongside several other indications for different immunotherapy drugs) at a historic 3-day meeting of the FDA’s oncologic Drugs Advisory Committee in April 2021. At the time, ODAC voted 10-1 in favor of maintaining the indication for atezolizumab for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial.

Genentech has now said that this trial “did not meet the coprimary endpoint of overall survival for atezolizumab plus chemotherapy compared with chemotherapy alone” when used for the first-line treatment of patients with previously untreated advanced bladder cancer.

These data will be presented at an upcoming medical meeting, the company added.

“There is a considerable unmet need for effective and tolerable treatments for people living with advanced bladder cancer and so we regret that the IMvigor130 trial did not cross the statistical threshold for overall survival,” Dr. Garraway commented.

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

Atezolizumab (Tecentriq) is no longer approved in the United States for use in certain patients with bladder or urinary tract cancer.

The drug is an anti–PD-L1 inhibitor immunotherapy, and continues to be approved for use in lung and liver cancer and melanoma.

The manufacturer, Genentech, announced that it was voluntarily withdrawing the U.S. indication for atezolizumab that covered its use in adults with locally advanced or metastatic urothelial carcinoma (bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

The company said that it made the decision after consultation with the Food and Drug Administration.

“While we are disappointed with this withdrawal, we understand the need to uphold the principles of the FDA’s Accelerated Approval Program, which brings innovative medicines to patients sooner,” said Levi Garraway, MD, PhD, Genentech chief medical officer and head of Global Product Development.

Atezolizumab had been granted an accelerated approval for this indication back in 2016, based on response rate data from the IMvigor210 trial.

The company was obliged to conduct a follow-up trial to show clinical benefit, and launched IMvigor130, which it described as “the designated postmarketing requirement to convert the accelerated approval to regular approval.”

The bladder cancer indication for atezolizumab was discussed (alongside several other indications for different immunotherapy drugs) at a historic 3-day meeting of the FDA’s oncologic Drugs Advisory Committee in April 2021. At the time, ODAC voted 10-1 in favor of maintaining the indication for atezolizumab for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial.

Genentech has now said that this trial “did not meet the coprimary endpoint of overall survival for atezolizumab plus chemotherapy compared with chemotherapy alone” when used for the first-line treatment of patients with previously untreated advanced bladder cancer.

These data will be presented at an upcoming medical meeting, the company added.

“There is a considerable unmet need for effective and tolerable treatments for people living with advanced bladder cancer and so we regret that the IMvigor130 trial did not cross the statistical threshold for overall survival,” Dr. Garraway commented.

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

Atezolizumab (Tecentriq) is no longer approved in the United States for use in certain patients with bladder or urinary tract cancer.

The drug is an anti–PD-L1 inhibitor immunotherapy, and continues to be approved for use in lung and liver cancer and melanoma.

The manufacturer, Genentech, announced that it was voluntarily withdrawing the U.S. indication for atezolizumab that covered its use in adults with locally advanced or metastatic urothelial carcinoma (bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

The company said that it made the decision after consultation with the Food and Drug Administration.

“While we are disappointed with this withdrawal, we understand the need to uphold the principles of the FDA’s Accelerated Approval Program, which brings innovative medicines to patients sooner,” said Levi Garraway, MD, PhD, Genentech chief medical officer and head of Global Product Development.

Atezolizumab had been granted an accelerated approval for this indication back in 2016, based on response rate data from the IMvigor210 trial.

The company was obliged to conduct a follow-up trial to show clinical benefit, and launched IMvigor130, which it described as “the designated postmarketing requirement to convert the accelerated approval to regular approval.”

The bladder cancer indication for atezolizumab was discussed (alongside several other indications for different immunotherapy drugs) at a historic 3-day meeting of the FDA’s oncologic Drugs Advisory Committee in April 2021. At the time, ODAC voted 10-1 in favor of maintaining the indication for atezolizumab for the first-line treatment of cisplatin-ineligible patients with advanced/metastatic urothelial carcinoma, pending final overall survival results from the IMvigor130 trial.

Genentech has now said that this trial “did not meet the coprimary endpoint of overall survival for atezolizumab plus chemotherapy compared with chemotherapy alone” when used for the first-line treatment of patients with previously untreated advanced bladder cancer.

These data will be presented at an upcoming medical meeting, the company added.

“There is a considerable unmet need for effective and tolerable treatments for people living with advanced bladder cancer and so we regret that the IMvigor130 trial did not cross the statistical threshold for overall survival,” Dr. Garraway commented.

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

The Food and Drug Administration has approved the first fecal microbiota product to prevent recurrence of Clostridioides difficile infection (CDI) in people aged 18 years and older.

Rebyota (fecal microbiota, live-jslm), from Ferring Pharmaceuticals, is intended for use after an individual has completed antibiotic treatment for recurrent CDI. It is not indicated for the first occurrence of CDI.

“Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening,” Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research, said in a statement announcing approval.

As the first FDA-approved fecal microbiota product, this approval “represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” Dr. Marks added.

A panel of FDA advisors recommended approval of Rebyota in September.

The application for Rebyota received priority review and had orphan drug and breakthrough therapy designation.
 

A vicious cycle

Treatment options for recurrent CDI are limited. It’s been estimated that up to one-third of CDI cases recur, and people who suffer a recurrent bout of CDI are at a significantly higher risk for further infections.

Following the first recurrence, up to two-thirds of patients may experience a subsequent recurrence. Antibiotics used to treat CDI may contribute to a cycle of recurrence by altering the gut flora. The administration of fecal microbiota helps restore the gut flora to prevent further episodes of CDI.

Rebyota is a microbiota-based live biotherapeutic prepared from human stool collected from prescreened, qualified donors. It comes prepackaged in a single dose that is administered rectally.

The safety and efficacy of Rebyota were assessed in five clinical trials with more than 1,000 participants, the company notes in a press release.

In one trial, following a standard course of antibiotics, a one-time treatment with Rebyota was successful for three-quarters of participants at 8 weeks.

The treatment also prevented additional bouts; 84% of these initial responders remaining free of CDI at 6 months.

Two-thirds of participants reported treatment-emergent adverse events. Most events were mild to moderate in severity. Diarrhea and abdominal pain were the most common.

The data, from the ongoing PUNCH CD3-OLS study, were presented in October at the annual meeting of the American College of Gastroenterology and were published simultaneously in the journal Drugs.

“This is a positive adjunct to our current therapies for C. difficile in terms of trying to knock it out once a standard course of antibiotics has been administered,” Lisa Malter, MD, a gastroenterologist and professor of medicine at New York University Langone Health, said in an interview.

Dr. Malter acknowledged that because it’s delivered rectally, there could be “some hesitation” on the patient’s part to undergo the therapy.

However, C. difficile can be “excruciating” for patients, and they “may be more than willing to take [this agent] because it gets them feeling better,” Dr. Malter said.

Full prescribing information for Rebyota is available online.

Dr. Malter reported no relevant financial relationships.

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

The Food and Drug Administration has approved the first fecal microbiota product to prevent recurrence of Clostridioides difficile infection (CDI) in people aged 18 years and older.

Rebyota (fecal microbiota, live-jslm), from Ferring Pharmaceuticals, is intended for use after an individual has completed antibiotic treatment for recurrent CDI. It is not indicated for the first occurrence of CDI.

“Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening,” Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research, said in a statement announcing approval.

As the first FDA-approved fecal microbiota product, this approval “represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” Dr. Marks added.

A panel of FDA advisors recommended approval of Rebyota in September.

The application for Rebyota received priority review and had orphan drug and breakthrough therapy designation.
 

A vicious cycle

Treatment options for recurrent CDI are limited. It’s been estimated that up to one-third of CDI cases recur, and people who suffer a recurrent bout of CDI are at a significantly higher risk for further infections.

Following the first recurrence, up to two-thirds of patients may experience a subsequent recurrence. Antibiotics used to treat CDI may contribute to a cycle of recurrence by altering the gut flora. The administration of fecal microbiota helps restore the gut flora to prevent further episodes of CDI.

Rebyota is a microbiota-based live biotherapeutic prepared from human stool collected from prescreened, qualified donors. It comes prepackaged in a single dose that is administered rectally.

The safety and efficacy of Rebyota were assessed in five clinical trials with more than 1,000 participants, the company notes in a press release.

In one trial, following a standard course of antibiotics, a one-time treatment with Rebyota was successful for three-quarters of participants at 8 weeks.

The treatment also prevented additional bouts; 84% of these initial responders remaining free of CDI at 6 months.

Two-thirds of participants reported treatment-emergent adverse events. Most events were mild to moderate in severity. Diarrhea and abdominal pain were the most common.

The data, from the ongoing PUNCH CD3-OLS study, were presented in October at the annual meeting of the American College of Gastroenterology and were published simultaneously in the journal Drugs.

“This is a positive adjunct to our current therapies for C. difficile in terms of trying to knock it out once a standard course of antibiotics has been administered,” Lisa Malter, MD, a gastroenterologist and professor of medicine at New York University Langone Health, said in an interview.

Dr. Malter acknowledged that because it’s delivered rectally, there could be “some hesitation” on the patient’s part to undergo the therapy.

However, C. difficile can be “excruciating” for patients, and they “may be more than willing to take [this agent] because it gets them feeling better,” Dr. Malter said.

Full prescribing information for Rebyota is available online.

Dr. Malter reported no relevant financial relationships.

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

The Food and Drug Administration has approved the first fecal microbiota product to prevent recurrence of Clostridioides difficile infection (CDI) in people aged 18 years and older.

Rebyota (fecal microbiota, live-jslm), from Ferring Pharmaceuticals, is intended for use after an individual has completed antibiotic treatment for recurrent CDI. It is not indicated for the first occurrence of CDI.

“Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening,” Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research, said in a statement announcing approval.

As the first FDA-approved fecal microbiota product, this approval “represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” Dr. Marks added.

A panel of FDA advisors recommended approval of Rebyota in September.

The application for Rebyota received priority review and had orphan drug and breakthrough therapy designation.
 

A vicious cycle

Treatment options for recurrent CDI are limited. It’s been estimated that up to one-third of CDI cases recur, and people who suffer a recurrent bout of CDI are at a significantly higher risk for further infections.

Following the first recurrence, up to two-thirds of patients may experience a subsequent recurrence. Antibiotics used to treat CDI may contribute to a cycle of recurrence by altering the gut flora. The administration of fecal microbiota helps restore the gut flora to prevent further episodes of CDI.

Rebyota is a microbiota-based live biotherapeutic prepared from human stool collected from prescreened, qualified donors. It comes prepackaged in a single dose that is administered rectally.

The safety and efficacy of Rebyota were assessed in five clinical trials with more than 1,000 participants, the company notes in a press release.

In one trial, following a standard course of antibiotics, a one-time treatment with Rebyota was successful for three-quarters of participants at 8 weeks.

The treatment also prevented additional bouts; 84% of these initial responders remaining free of CDI at 6 months.

Two-thirds of participants reported treatment-emergent adverse events. Most events were mild to moderate in severity. Diarrhea and abdominal pain were the most common.

The data, from the ongoing PUNCH CD3-OLS study, were presented in October at the annual meeting of the American College of Gastroenterology and were published simultaneously in the journal Drugs.

“This is a positive adjunct to our current therapies for C. difficile in terms of trying to knock it out once a standard course of antibiotics has been administered,” Lisa Malter, MD, a gastroenterologist and professor of medicine at New York University Langone Health, said in an interview.

Dr. Malter acknowledged that because it’s delivered rectally, there could be “some hesitation” on the patient’s part to undergo the therapy.

However, C. difficile can be “excruciating” for patients, and they “may be more than willing to take [this agent] because it gets them feeling better,” Dr. Malter said.

Full prescribing information for Rebyota is available online.

Dr. Malter reported no relevant financial relationships.

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

Weight loss advice is everywhere you look on social media, but one trend sweeping TikTok has led to shortages of an important diabetes drug.

Ozempic, a weekly injection that helps boost insulin sensitivity in people with type 2 diabetes, also suppresses appetite, which leads to weight loss. Stories of celebrities using the drug off-label to lose a few pounds have led to an explosion of interest. And now people with diabetes – people whose lives could be saved by the drug – are having trouble finding it.
 

Kim Kardashian and Elon Musk

In the spring, Kim Kardashian pulled off a dramatic weight loss to fit into Marilyn Monroe’s dress for the Met Gala. Soon rumors began to circulate that she’d used Ozempic to do it. Just this week, new Twitter owner Elon Musk tweeted about his own use of Ozempic and its sibling drug, Wegovy.

Variety dubbed Ozempic “the worst kept secret in Hollywood – especially given that its most enthusiastic users are not prediabetic and do not require the drug.” The rich and famous are spending $1,200 to $1,500 a month to get access.

As so often happens, high-profile use sparked a trend. Videos on TikTok hashtagged #ozempic have amassed more than 275 million views, and #ozempicweightloss has more than 110 million.

This raises concerns about who, exactly, is watching these videos, and what message they’re receiving.

“Forty-two percent of Americans have obesity, and even more have overweight. That’s affecting our younger people and our adolescents,” says Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at the Brigham and Women’s Hospital in Boston. “They’re looking at TikTok and other social media outlets for help.”

A new study shows how damaging this can be: Researchers analyzed 1,000 videos with nutrition, food, and weight-related hashtags, with over 1 billion views combined. They found that nearly all included messages glorifying weight loss and thinness.
 

At last, an effective weight-loss drug

Ozempic is Danish drug company Novo Nordisk’s brand name for semaglutide, which works by mimicking a naturally occurring hormone known as GLP-1. It travels to your brain and helps you feel full on less food. That leads to weight loss. In one 68-week study, semaglutide helped people lose an average of 15% of their body weight. But it’s not a miracle drug: You still have to change your eating habits and stay physically active.

The FDA approved Ozempic to treat people with type 2 diabetes in 2017. Four years later, Novo Nordisk received the green light for a higher-dose version meant specifically for people with obesity. Wegovy is approved for use only if you have a BMI of at least 27 with one or more weight-related ailments, or a BMI of 30 or more with none.

“These drugs are dominating my practice, because they’re so effective,” says Amanda Velazquez, MD, director of obesity medicine at Cedars-Sinai Medical Center in Los Angeles. The drug is considered safe, “so the majority of patients are good candidates.”
 

More demand than supply

As word spread about how well Ozempic and Wegovy worked, social media posts helped drive even more people to seek out the drugs. Now demand is outpacing the supply – according to the FDA, starter doses of Ozempic will have limited availability through January. 

“In Hollywood, people are losing 10 pounds, getting it for $1,500 a month, and depleting stores for people who have such severe obesity that they have congestive heart failure and diabetes,” Dr. Apovian says. “These are people who are going to die, and you’re taking it away just for cosmetic weight loss. That is deplorable.”

In addition to huge demand, Wegovy also had a disruption in its supply chain. Right now, it isn’t available at all in lower doses, which is helping to spike off-label demand for Ozempic. Novo Nordisk expects to have these problems sorted out by the end of the year, with distribution following soon after.
 

The price of access

With a list price of $1,350 a month, Wegovy costs as much as many mortgages. And Medicaid, Medicare, and many insurance companies don’t cover it. Although obesity is a disease, the insurance industry treats weight loss as more of a vanity issue – so even if you could find the drug, you might not be able to afford it. 

“We’re seeing that roughly half the prescriptions we write aren’t being covered,” Dr. Apovian says. “And for the half that are covered, we have to do prior authorization, which takes days, and it’s laborious.” In some instances, she says, insurance companies withdraw authorization after 3 months if they don’t see enough weight coming off.

It’s not like you can take Wegovy for 3 months, lose some weight, and expect it to stay off, either. The medication requires a real commitment, potentially for life. That’s because once the semaglutide leaves your system, your appetite returns. In one study, people regained two-thirds of the weight they’d lost within a year of stopping.

Many see a double standard in the insurance companies’ refusal to cover a drug that could prevent serious illness or death.

“They’re saying it’s not cost-effective to give the 42% of Americans who have a BMI over 30 Wegovy. Did they say this when statins came out?” Dr. Apovian says. “Why are they doing this with antiobesity agents? It’s the culture. The culture isn’t ready to adopt obesity as the disease that it is.”

Unpleasant side effects

Let’s assume you’re one of the lucky ones – your insurance covers Wegovy, and you can actually find some. You might discover that using it is no walk in the park. Common side effects include gastrointestinal issues like nausea, vomiting, and diarrhea.

“The way we counteract that is to start very slowly at a low dose of these medications,” Dr. Apovian says. “We only go up when the patient doesn’t have nausea or it gets better.”

Elise Davenport was excited to try Wegovy. “I did my online research. I’m the type who’s interested in early adoption, tech gadgets and stuff,” says the 40-year-old technical writer. “I wanted to try it because I’d tried so many other things that failed, or hadn’t worked long-term.”

With a BMI over 30, Ms. Davenport qualified for the drug. She signed up for an online program that guaranteed insurance coverage and started taking it in October 2021. At first, the side effects were mild, just a touch of nausea and diarrhea. And the results were impressive. She found it easy to feel satisfied with smaller portions and lost her cravings for sugar and highly processed foods. The weight fell off, roughly 5 pounds a week.

It turns out, that’s too much, too fast. Dr. Apovian and Dr. Velazquez say their patients lose more like 2 pounds each week, with careful monitoring. 

By early December, Ms. Davenport’s side effects were ramping up. Because of shortages in lower dosages, the online program wasn’t able to adjust hers right away. She felt nauseated all the time, bad enough that brushing her teeth made her vomit and she had to force herself to eat. Some weeks, she managed less than 500 calories a day. Her sleep patterns became erratic. And then her depression, which medication had kept under control for years, spiraled.

“I remember sitting on the floor of my bathroom crying, thinking I’d rather carry the extra weight,” she says. “I used to take a lot of enjoyment from food, and I had none of that anymore. It was such a joyless experience at that point.”

Eventually, her dosage was reduced and the symptoms let up, but her primary care doctor encouraged her to stop. By the time she did, in March, she’d lost 55 pounds. So far, she’s gained back about 10.
 

More than just weight loss

Even though Ms. Davenport’s experience wasn’t a good one, with better monitoring, she’d be willing to try again. For one thing, seeing how easy it was to eat less with medical help helped to undo years of shame.

“Our culture treats obesity like a moral failing. I realized I’d been made to feel that way by doctors and programs – that I wasn’t doing enough,” she says. “This drug made me realize there are legit physiological things going on in my body, things that are often excluded from the conversation.”

Dr. Apovian and Dr. Velazquez say their patients regularly discover similar things.

“Obesity is not a disease of willpower. Medications are not the easy way out,” Dr. Velazquez says. “This is a chronic, relapsing medical condition, and because of that, we should treat it how we treat diabetes, high blood pressure, all these other conditions. We’d never hold back medication for individuals coming in with high blood pressure, tell them to work on willpower and withhold drugs they’d qualify for.”

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

Weight loss advice is everywhere you look on social media, but one trend sweeping TikTok has led to shortages of an important diabetes drug.

Ozempic, a weekly injection that helps boost insulin sensitivity in people with type 2 diabetes, also suppresses appetite, which leads to weight loss. Stories of celebrities using the drug off-label to lose a few pounds have led to an explosion of interest. And now people with diabetes – people whose lives could be saved by the drug – are having trouble finding it.
 

Kim Kardashian and Elon Musk

In the spring, Kim Kardashian pulled off a dramatic weight loss to fit into Marilyn Monroe’s dress for the Met Gala. Soon rumors began to circulate that she’d used Ozempic to do it. Just this week, new Twitter owner Elon Musk tweeted about his own use of Ozempic and its sibling drug, Wegovy.

Variety dubbed Ozempic “the worst kept secret in Hollywood – especially given that its most enthusiastic users are not prediabetic and do not require the drug.” The rich and famous are spending $1,200 to $1,500 a month to get access.

As so often happens, high-profile use sparked a trend. Videos on TikTok hashtagged #ozempic have amassed more than 275 million views, and #ozempicweightloss has more than 110 million.

This raises concerns about who, exactly, is watching these videos, and what message they’re receiving.

“Forty-two percent of Americans have obesity, and even more have overweight. That’s affecting our younger people and our adolescents,” says Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at the Brigham and Women’s Hospital in Boston. “They’re looking at TikTok and other social media outlets for help.”

A new study shows how damaging this can be: Researchers analyzed 1,000 videos with nutrition, food, and weight-related hashtags, with over 1 billion views combined. They found that nearly all included messages glorifying weight loss and thinness.
 

At last, an effective weight-loss drug

Ozempic is Danish drug company Novo Nordisk’s brand name for semaglutide, which works by mimicking a naturally occurring hormone known as GLP-1. It travels to your brain and helps you feel full on less food. That leads to weight loss. In one 68-week study, semaglutide helped people lose an average of 15% of their body weight. But it’s not a miracle drug: You still have to change your eating habits and stay physically active.

The FDA approved Ozempic to treat people with type 2 diabetes in 2017. Four years later, Novo Nordisk received the green light for a higher-dose version meant specifically for people with obesity. Wegovy is approved for use only if you have a BMI of at least 27 with one or more weight-related ailments, or a BMI of 30 or more with none.

“These drugs are dominating my practice, because they’re so effective,” says Amanda Velazquez, MD, director of obesity medicine at Cedars-Sinai Medical Center in Los Angeles. The drug is considered safe, “so the majority of patients are good candidates.”
 

More demand than supply

As word spread about how well Ozempic and Wegovy worked, social media posts helped drive even more people to seek out the drugs. Now demand is outpacing the supply – according to the FDA, starter doses of Ozempic will have limited availability through January. 

“In Hollywood, people are losing 10 pounds, getting it for $1,500 a month, and depleting stores for people who have such severe obesity that they have congestive heart failure and diabetes,” Dr. Apovian says. “These are people who are going to die, and you’re taking it away just for cosmetic weight loss. That is deplorable.”

In addition to huge demand, Wegovy also had a disruption in its supply chain. Right now, it isn’t available at all in lower doses, which is helping to spike off-label demand for Ozempic. Novo Nordisk expects to have these problems sorted out by the end of the year, with distribution following soon after.
 

The price of access

With a list price of $1,350 a month, Wegovy costs as much as many mortgages. And Medicaid, Medicare, and many insurance companies don’t cover it. Although obesity is a disease, the insurance industry treats weight loss as more of a vanity issue – so even if you could find the drug, you might not be able to afford it. 

“We’re seeing that roughly half the prescriptions we write aren’t being covered,” Dr. Apovian says. “And for the half that are covered, we have to do prior authorization, which takes days, and it’s laborious.” In some instances, she says, insurance companies withdraw authorization after 3 months if they don’t see enough weight coming off.

It’s not like you can take Wegovy for 3 months, lose some weight, and expect it to stay off, either. The medication requires a real commitment, potentially for life. That’s because once the semaglutide leaves your system, your appetite returns. In one study, people regained two-thirds of the weight they’d lost within a year of stopping.

Many see a double standard in the insurance companies’ refusal to cover a drug that could prevent serious illness or death.

“They’re saying it’s not cost-effective to give the 42% of Americans who have a BMI over 30 Wegovy. Did they say this when statins came out?” Dr. Apovian says. “Why are they doing this with antiobesity agents? It’s the culture. The culture isn’t ready to adopt obesity as the disease that it is.”

Unpleasant side effects

Let’s assume you’re one of the lucky ones – your insurance covers Wegovy, and you can actually find some. You might discover that using it is no walk in the park. Common side effects include gastrointestinal issues like nausea, vomiting, and diarrhea.

“The way we counteract that is to start very slowly at a low dose of these medications,” Dr. Apovian says. “We only go up when the patient doesn’t have nausea or it gets better.”

Elise Davenport was excited to try Wegovy. “I did my online research. I’m the type who’s interested in early adoption, tech gadgets and stuff,” says the 40-year-old technical writer. “I wanted to try it because I’d tried so many other things that failed, or hadn’t worked long-term.”

With a BMI over 30, Ms. Davenport qualified for the drug. She signed up for an online program that guaranteed insurance coverage and started taking it in October 2021. At first, the side effects were mild, just a touch of nausea and diarrhea. And the results were impressive. She found it easy to feel satisfied with smaller portions and lost her cravings for sugar and highly processed foods. The weight fell off, roughly 5 pounds a week.

It turns out, that’s too much, too fast. Dr. Apovian and Dr. Velazquez say their patients lose more like 2 pounds each week, with careful monitoring. 

By early December, Ms. Davenport’s side effects were ramping up. Because of shortages in lower dosages, the online program wasn’t able to adjust hers right away. She felt nauseated all the time, bad enough that brushing her teeth made her vomit and she had to force herself to eat. Some weeks, she managed less than 500 calories a day. Her sleep patterns became erratic. And then her depression, which medication had kept under control for years, spiraled.

“I remember sitting on the floor of my bathroom crying, thinking I’d rather carry the extra weight,” she says. “I used to take a lot of enjoyment from food, and I had none of that anymore. It was such a joyless experience at that point.”

Eventually, her dosage was reduced and the symptoms let up, but her primary care doctor encouraged her to stop. By the time she did, in March, she’d lost 55 pounds. So far, she’s gained back about 10.
 

More than just weight loss

Even though Ms. Davenport’s experience wasn’t a good one, with better monitoring, she’d be willing to try again. For one thing, seeing how easy it was to eat less with medical help helped to undo years of shame.

“Our culture treats obesity like a moral failing. I realized I’d been made to feel that way by doctors and programs – that I wasn’t doing enough,” she says. “This drug made me realize there are legit physiological things going on in my body, things that are often excluded from the conversation.”

Dr. Apovian and Dr. Velazquez say their patients regularly discover similar things.

“Obesity is not a disease of willpower. Medications are not the easy way out,” Dr. Velazquez says. “This is a chronic, relapsing medical condition, and because of that, we should treat it how we treat diabetes, high blood pressure, all these other conditions. We’d never hold back medication for individuals coming in with high blood pressure, tell them to work on willpower and withhold drugs they’d qualify for.”

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

Weight loss advice is everywhere you look on social media, but one trend sweeping TikTok has led to shortages of an important diabetes drug.

Ozempic, a weekly injection that helps boost insulin sensitivity in people with type 2 diabetes, also suppresses appetite, which leads to weight loss. Stories of celebrities using the drug off-label to lose a few pounds have led to an explosion of interest. And now people with diabetes – people whose lives could be saved by the drug – are having trouble finding it.
 

Kim Kardashian and Elon Musk

In the spring, Kim Kardashian pulled off a dramatic weight loss to fit into Marilyn Monroe’s dress for the Met Gala. Soon rumors began to circulate that she’d used Ozempic to do it. Just this week, new Twitter owner Elon Musk tweeted about his own use of Ozempic and its sibling drug, Wegovy.

Variety dubbed Ozempic “the worst kept secret in Hollywood – especially given that its most enthusiastic users are not prediabetic and do not require the drug.” The rich and famous are spending $1,200 to $1,500 a month to get access.

As so often happens, high-profile use sparked a trend. Videos on TikTok hashtagged #ozempic have amassed more than 275 million views, and #ozempicweightloss has more than 110 million.

This raises concerns about who, exactly, is watching these videos, and what message they’re receiving.

“Forty-two percent of Americans have obesity, and even more have overweight. That’s affecting our younger people and our adolescents,” says Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at the Brigham and Women’s Hospital in Boston. “They’re looking at TikTok and other social media outlets for help.”

A new study shows how damaging this can be: Researchers analyzed 1,000 videos with nutrition, food, and weight-related hashtags, with over 1 billion views combined. They found that nearly all included messages glorifying weight loss and thinness.
 

At last, an effective weight-loss drug

Ozempic is Danish drug company Novo Nordisk’s brand name for semaglutide, which works by mimicking a naturally occurring hormone known as GLP-1. It travels to your brain and helps you feel full on less food. That leads to weight loss. In one 68-week study, semaglutide helped people lose an average of 15% of their body weight. But it’s not a miracle drug: You still have to change your eating habits and stay physically active.

The FDA approved Ozempic to treat people with type 2 diabetes in 2017. Four years later, Novo Nordisk received the green light for a higher-dose version meant specifically for people with obesity. Wegovy is approved for use only if you have a BMI of at least 27 with one or more weight-related ailments, or a BMI of 30 or more with none.

“These drugs are dominating my practice, because they’re so effective,” says Amanda Velazquez, MD, director of obesity medicine at Cedars-Sinai Medical Center in Los Angeles. The drug is considered safe, “so the majority of patients are good candidates.”
 

More demand than supply

As word spread about how well Ozempic and Wegovy worked, social media posts helped drive even more people to seek out the drugs. Now demand is outpacing the supply – according to the FDA, starter doses of Ozempic will have limited availability through January. 

“In Hollywood, people are losing 10 pounds, getting it for $1,500 a month, and depleting stores for people who have such severe obesity that they have congestive heart failure and diabetes,” Dr. Apovian says. “These are people who are going to die, and you’re taking it away just for cosmetic weight loss. That is deplorable.”

In addition to huge demand, Wegovy also had a disruption in its supply chain. Right now, it isn’t available at all in lower doses, which is helping to spike off-label demand for Ozempic. Novo Nordisk expects to have these problems sorted out by the end of the year, with distribution following soon after.
 

The price of access

With a list price of $1,350 a month, Wegovy costs as much as many mortgages. And Medicaid, Medicare, and many insurance companies don’t cover it. Although obesity is a disease, the insurance industry treats weight loss as more of a vanity issue – so even if you could find the drug, you might not be able to afford it. 

“We’re seeing that roughly half the prescriptions we write aren’t being covered,” Dr. Apovian says. “And for the half that are covered, we have to do prior authorization, which takes days, and it’s laborious.” In some instances, she says, insurance companies withdraw authorization after 3 months if they don’t see enough weight coming off.

It’s not like you can take Wegovy for 3 months, lose some weight, and expect it to stay off, either. The medication requires a real commitment, potentially for life. That’s because once the semaglutide leaves your system, your appetite returns. In one study, people regained two-thirds of the weight they’d lost within a year of stopping.

Many see a double standard in the insurance companies’ refusal to cover a drug that could prevent serious illness or death.

“They’re saying it’s not cost-effective to give the 42% of Americans who have a BMI over 30 Wegovy. Did they say this when statins came out?” Dr. Apovian says. “Why are they doing this with antiobesity agents? It’s the culture. The culture isn’t ready to adopt obesity as the disease that it is.”

Unpleasant side effects

Let’s assume you’re one of the lucky ones – your insurance covers Wegovy, and you can actually find some. You might discover that using it is no walk in the park. Common side effects include gastrointestinal issues like nausea, vomiting, and diarrhea.

“The way we counteract that is to start very slowly at a low dose of these medications,” Dr. Apovian says. “We only go up when the patient doesn’t have nausea or it gets better.”

Elise Davenport was excited to try Wegovy. “I did my online research. I’m the type who’s interested in early adoption, tech gadgets and stuff,” says the 40-year-old technical writer. “I wanted to try it because I’d tried so many other things that failed, or hadn’t worked long-term.”

With a BMI over 30, Ms. Davenport qualified for the drug. She signed up for an online program that guaranteed insurance coverage and started taking it in October 2021. At first, the side effects were mild, just a touch of nausea and diarrhea. And the results were impressive. She found it easy to feel satisfied with smaller portions and lost her cravings for sugar and highly processed foods. The weight fell off, roughly 5 pounds a week.

It turns out, that’s too much, too fast. Dr. Apovian and Dr. Velazquez say their patients lose more like 2 pounds each week, with careful monitoring. 

By early December, Ms. Davenport’s side effects were ramping up. Because of shortages in lower dosages, the online program wasn’t able to adjust hers right away. She felt nauseated all the time, bad enough that brushing her teeth made her vomit and she had to force herself to eat. Some weeks, she managed less than 500 calories a day. Her sleep patterns became erratic. And then her depression, which medication had kept under control for years, spiraled.

“I remember sitting on the floor of my bathroom crying, thinking I’d rather carry the extra weight,” she says. “I used to take a lot of enjoyment from food, and I had none of that anymore. It was such a joyless experience at that point.”

Eventually, her dosage was reduced and the symptoms let up, but her primary care doctor encouraged her to stop. By the time she did, in March, she’d lost 55 pounds. So far, she’s gained back about 10.
 

More than just weight loss

Even though Ms. Davenport’s experience wasn’t a good one, with better monitoring, she’d be willing to try again. For one thing, seeing how easy it was to eat less with medical help helped to undo years of shame.

“Our culture treats obesity like a moral failing. I realized I’d been made to feel that way by doctors and programs – that I wasn’t doing enough,” she says. “This drug made me realize there are legit physiological things going on in my body, things that are often excluded from the conversation.”

Dr. Apovian and Dr. Velazquez say their patients regularly discover similar things.

“Obesity is not a disease of willpower. Medications are not the easy way out,” Dr. Velazquez says. “This is a chronic, relapsing medical condition, and because of that, we should treat it how we treat diabetes, high blood pressure, all these other conditions. We’d never hold back medication for individuals coming in with high blood pressure, tell them to work on willpower and withhold drugs they’d qualify for.”

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

The recent approval of teplizumab-mzwv (Tzield, Provention Bio) for the delay of type 1 diabetes by the Food and Drug Administration is expected to advance efforts to increase screening to cost effectively identify those at risk for the condition who would be eligible to receive the new treatment.

The anti-CD3 monoclonal antibody was approved Nov. 17 as the first disease-modifying therapy for impeding progression of type 1 diabetes. In a clinical trial, teplizumab delayed the onset of clinical (stage 3) type 1 diabetes by approximately 2 years, and longer in some cases.

It is administered by intravenous infusion once daily for 14 consecutive days and is expected to cost in the region of $200,000 for the course of treatment.

The specific indication is “to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.” In stage 2 type 1 diabetes, the individual has two or more islet autoantibodies and abnormal glycemia but is as yet asymptomatic. It is associated with a nearly 100% lifetime risk of progression to clinical (stage 3) type 1 diabetes and a 75% risk of developing the condition within 5 years.

Currently, most people who are screened for type 1 diabetes autoantibodies are first-degree relatives of those with the condition through TrialNet, other local programs, or more recently, a $55 test offered by the research and advocacy organization JDRF.

But because 85%-90% of people who develop type 1 diabetes don’t have first-degree relatives with the condition, broader population screening will be necessary to identify eligible candidates for teplizumab.

During an investor call on Nov. 18, Provention Bio chief commercial officer Jason Hoitt said that among the company’s “strategic initiatives” were “advancing awareness and screening for autoantibodies in at-risk individuals, and ultimately, routine screening during pediatric well visits for the general population,” as well as “[health care provider] belief in teplizumab and desire to prescribe it for their patients.” 

Without broad population-based screening, first-degree relatives of people with type 1 diabetes are likely to be the first to be screened and those with stage 2 identified for receipt of teplizumab. Today, that population is estimated at about 30,000 in the United States, Mr. Hoitt said, adding, “with this approval we hope that more stage 2 patients can be readily identified so the course of the disease can be changed.”

During the call, Mr. Hoitt also announced that the wholesale acquisition cost of Tzield would be $13,850 per vial, which translates to $193,900 per 14-vial continuous regimen, anticipated to be a sufficient dose for most patients. The company also launched a program called COMPASS to help patients navigate insurance reimbursement, as well as provide some with financial assistance.

Cost aside, JDRF CEO Aaron Kowalski, PhD, said in an interview that clinicians shouldn’t doubt the value of delaying type 1 diabetes onset, even if not completely preventing it. “This is the first drug ever to treat the underlying disease. There is this undercurrent that insulin is enough. Why would you undertake an additional risk of an immunotherapy? Type 1 is hard to live with. I think sometimes the clinical community doesn’t appreciate that insulin is not enough. It’s very difficult, and opening this door is important. ... We believe very strongly that the delay of onset of type 1 diabetes is clinically meaningful. We hear that from every family we’ve talked to. Clinicians should appreciate this and not discount it.”
 

How would screening happen? 

While the path to universal screening for type 1 diabetes risk isn’t yet clear, quite a bit of thought and research has gone into it even before teplizumab and other immune-modulating agents showed promise in forestalling the condition.

Data from a universal screening program of schoolchildren implemented in Bavaria, Germany, and a screening program in Denver, suggest that even without such an intervention, identifying people at high risk for developing type 1 diabetes could be cost effective by allowing for education of the individual and family members about the signs of type 1 diabetes, thereby reducing the likelihood that the person would progress to developing diabetic ketoacidosis (DKA) prior to diagnosis.

Another study that used data from the United States and Western Europe, found that screening children for type 1 diabetes–associated islet autoantibodies at ages 2 and 6 years would identify most of those who go on to develop the disease by midadolescence.

However, using a genetic risk score at birth to identify those who would go on to autoantibody testing is potentially a more cost-effective approach, William A. Hagopian, MD, PhD, director of diabetes programs, Pacific Northwest Research Institute, Seattle, said in an interview.

The score – based on human leukocyte antigen haplotypes and their interactions as well as non-HLA genes – can stratify nearly 80% of childhood type 1 diabetes within the top 10% of all newborns. Thus, only the top 10% would then go on to receive the more expensive autoantibody testing.

“I’ve been working with U.K. colleagues for the past 3-4 years to develop a strategy using genetic risk scores followed by autoantibody screening. I feel strongly that that’s the cost-effective way to go. It’s relatively inexpensive, scalable, and can be applied commercially in newborn screening labs. To be successful an approach must be cost effective. Payors are willing to pay for newborn screening, but not so much on testing 100% of kids for antibodies,” Dr. Hagopian said.

He is now working with Washington State newborn screening labs to demonstrate feasibility of the approach using dried blood samples from actual neonatal screening after obtaining informed consent from the mothers in postpartum wards in several hospitals. Those found to be at high risk using the genetic risk score are contacted for follow-up with autoantibody screening. The program will continue for another year and a half. “I think it actually has a chance of being accepted into their regular program,” he said.

And then, he hopes, other states will follow, and eventually, the strategy will be added to the Recommended Uniform Screening Panel for universal newborn screening programs, as recommended by the Department of Health & Human Services.

“New newborn screenings for additional diseases are implemented regularly,” Dr. Hagopian said. “Most are far less common than type 1 diabetes. So even if our approach is less than 100% sensitive, this condition is a lot more common than the many inborn errors of metabolism, so we’re still going to be identifying a lot of cases. ... This is my hope for how universal type 1 diabetes screening will unfold. I see a way this may work quite well.”

A two-pronged approach to screening could work best

Meanwhile, JDRF, which supported the teplizumab research as well as others working in the space, is focusing on both genetic and autoantibody screening, Dr. Kowalski said.

“JDRF is working on both pathways – testing kids at birth for genetic predisposition and also antibody screening. We have huge programs focused on general population antibody screening.”

Dr. Kowalski said that, while the two-pronged approach certainly is worth exploring – and JDRF is doing that – he also thinks that universal autoantibody screening could be cost effective if done efficiently, such as with less expensive assays than the one used in TrialNet.

“We have programs where you do the genetic screening and keep an eye on people. We also have programs, like the one we’re funding in Germany, that are doing broad autoantibody screening of all kids. We’re hopeful that will be very cost effective if we move to cheaper assays.”

He noted that the proportion of children with new-onset type 1 diabetes who present in DKA rose from 40% pre–COVID-19 to 50% during the early days of the pandemic. On the other hand, “With screening you can get that to near zero, like they did in Bavaria. Here [in the United States], one ICU visit for DKA [costs] $100,000.”

While JDRF and others have been working on this for years, the new availability of teplizumab will be “multifold in helping things along. ... I think you’re going to see a lot of work on the cost-effectiveness of teplizumab. I think the case will be pretty straightforward that there’s huge upside to delaying the disease from a near-term and a long-term cost perspective. This is the first time we’ve had a drug out there with a price attached to it.”

But it may not happen quickly, Kowalski cautioned. “I feel there’s a ... series of events that has to happen to drive towards universal screening. Here in the U.S. it’s complicated because we have a very discrepant health care system with all these different payers, public and private.”

During the investor call, Mr. Hoitt said that Provention Bio is also exploring use of Tzield in younger patients and newly diagnosed patients, and the potential benefit of redosing or combining with other treatments.

Mr. Hoitt is an employee of Provention Bio. Dr. Kowalski is an employee of JDRF. Dr. Hagopian has reported receiving study funding from Janssen.

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

The recent approval of teplizumab-mzwv (Tzield, Provention Bio) for the delay of type 1 diabetes by the Food and Drug Administration is expected to advance efforts to increase screening to cost effectively identify those at risk for the condition who would be eligible to receive the new treatment.

The anti-CD3 monoclonal antibody was approved Nov. 17 as the first disease-modifying therapy for impeding progression of type 1 diabetes. In a clinical trial, teplizumab delayed the onset of clinical (stage 3) type 1 diabetes by approximately 2 years, and longer in some cases.

It is administered by intravenous infusion once daily for 14 consecutive days and is expected to cost in the region of $200,000 for the course of treatment.

The specific indication is “to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.” In stage 2 type 1 diabetes, the individual has two or more islet autoantibodies and abnormal glycemia but is as yet asymptomatic. It is associated with a nearly 100% lifetime risk of progression to clinical (stage 3) type 1 diabetes and a 75% risk of developing the condition within 5 years.

Currently, most people who are screened for type 1 diabetes autoantibodies are first-degree relatives of those with the condition through TrialNet, other local programs, or more recently, a $55 test offered by the research and advocacy organization JDRF.

But because 85%-90% of people who develop type 1 diabetes don’t have first-degree relatives with the condition, broader population screening will be necessary to identify eligible candidates for teplizumab.

During an investor call on Nov. 18, Provention Bio chief commercial officer Jason Hoitt said that among the company’s “strategic initiatives” were “advancing awareness and screening for autoantibodies in at-risk individuals, and ultimately, routine screening during pediatric well visits for the general population,” as well as “[health care provider] belief in teplizumab and desire to prescribe it for their patients.” 

Without broad population-based screening, first-degree relatives of people with type 1 diabetes are likely to be the first to be screened and those with stage 2 identified for receipt of teplizumab. Today, that population is estimated at about 30,000 in the United States, Mr. Hoitt said, adding, “with this approval we hope that more stage 2 patients can be readily identified so the course of the disease can be changed.”

During the call, Mr. Hoitt also announced that the wholesale acquisition cost of Tzield would be $13,850 per vial, which translates to $193,900 per 14-vial continuous regimen, anticipated to be a sufficient dose for most patients. The company also launched a program called COMPASS to help patients navigate insurance reimbursement, as well as provide some with financial assistance.

Cost aside, JDRF CEO Aaron Kowalski, PhD, said in an interview that clinicians shouldn’t doubt the value of delaying type 1 diabetes onset, even if not completely preventing it. “This is the first drug ever to treat the underlying disease. There is this undercurrent that insulin is enough. Why would you undertake an additional risk of an immunotherapy? Type 1 is hard to live with. I think sometimes the clinical community doesn’t appreciate that insulin is not enough. It’s very difficult, and opening this door is important. ... We believe very strongly that the delay of onset of type 1 diabetes is clinically meaningful. We hear that from every family we’ve talked to. Clinicians should appreciate this and not discount it.”
 

How would screening happen? 

While the path to universal screening for type 1 diabetes risk isn’t yet clear, quite a bit of thought and research has gone into it even before teplizumab and other immune-modulating agents showed promise in forestalling the condition.

Data from a universal screening program of schoolchildren implemented in Bavaria, Germany, and a screening program in Denver, suggest that even without such an intervention, identifying people at high risk for developing type 1 diabetes could be cost effective by allowing for education of the individual and family members about the signs of type 1 diabetes, thereby reducing the likelihood that the person would progress to developing diabetic ketoacidosis (DKA) prior to diagnosis.

Another study that used data from the United States and Western Europe, found that screening children for type 1 diabetes–associated islet autoantibodies at ages 2 and 6 years would identify most of those who go on to develop the disease by midadolescence.

However, using a genetic risk score at birth to identify those who would go on to autoantibody testing is potentially a more cost-effective approach, William A. Hagopian, MD, PhD, director of diabetes programs, Pacific Northwest Research Institute, Seattle, said in an interview.

The score – based on human leukocyte antigen haplotypes and their interactions as well as non-HLA genes – can stratify nearly 80% of childhood type 1 diabetes within the top 10% of all newborns. Thus, only the top 10% would then go on to receive the more expensive autoantibody testing.

“I’ve been working with U.K. colleagues for the past 3-4 years to develop a strategy using genetic risk scores followed by autoantibody screening. I feel strongly that that’s the cost-effective way to go. It’s relatively inexpensive, scalable, and can be applied commercially in newborn screening labs. To be successful an approach must be cost effective. Payors are willing to pay for newborn screening, but not so much on testing 100% of kids for antibodies,” Dr. Hagopian said.

He is now working with Washington State newborn screening labs to demonstrate feasibility of the approach using dried blood samples from actual neonatal screening after obtaining informed consent from the mothers in postpartum wards in several hospitals. Those found to be at high risk using the genetic risk score are contacted for follow-up with autoantibody screening. The program will continue for another year and a half. “I think it actually has a chance of being accepted into their regular program,” he said.

And then, he hopes, other states will follow, and eventually, the strategy will be added to the Recommended Uniform Screening Panel for universal newborn screening programs, as recommended by the Department of Health & Human Services.

“New newborn screenings for additional diseases are implemented regularly,” Dr. Hagopian said. “Most are far less common than type 1 diabetes. So even if our approach is less than 100% sensitive, this condition is a lot more common than the many inborn errors of metabolism, so we’re still going to be identifying a lot of cases. ... This is my hope for how universal type 1 diabetes screening will unfold. I see a way this may work quite well.”

A two-pronged approach to screening could work best

Meanwhile, JDRF, which supported the teplizumab research as well as others working in the space, is focusing on both genetic and autoantibody screening, Dr. Kowalski said.

“JDRF is working on both pathways – testing kids at birth for genetic predisposition and also antibody screening. We have huge programs focused on general population antibody screening.”

Dr. Kowalski said that, while the two-pronged approach certainly is worth exploring – and JDRF is doing that – he also thinks that universal autoantibody screening could be cost effective if done efficiently, such as with less expensive assays than the one used in TrialNet.

“We have programs where you do the genetic screening and keep an eye on people. We also have programs, like the one we’re funding in Germany, that are doing broad autoantibody screening of all kids. We’re hopeful that will be very cost effective if we move to cheaper assays.”

He noted that the proportion of children with new-onset type 1 diabetes who present in DKA rose from 40% pre–COVID-19 to 50% during the early days of the pandemic. On the other hand, “With screening you can get that to near zero, like they did in Bavaria. Here [in the United States], one ICU visit for DKA [costs] $100,000.”

While JDRF and others have been working on this for years, the new availability of teplizumab will be “multifold in helping things along. ... I think you’re going to see a lot of work on the cost-effectiveness of teplizumab. I think the case will be pretty straightforward that there’s huge upside to delaying the disease from a near-term and a long-term cost perspective. This is the first time we’ve had a drug out there with a price attached to it.”

But it may not happen quickly, Kowalski cautioned. “I feel there’s a ... series of events that has to happen to drive towards universal screening. Here in the U.S. it’s complicated because we have a very discrepant health care system with all these different payers, public and private.”

During the investor call, Mr. Hoitt said that Provention Bio is also exploring use of Tzield in younger patients and newly diagnosed patients, and the potential benefit of redosing or combining with other treatments.

Mr. Hoitt is an employee of Provention Bio. Dr. Kowalski is an employee of JDRF. Dr. Hagopian has reported receiving study funding from Janssen.

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

The recent approval of teplizumab-mzwv (Tzield, Provention Bio) for the delay of type 1 diabetes by the Food and Drug Administration is expected to advance efforts to increase screening to cost effectively identify those at risk for the condition who would be eligible to receive the new treatment.

The anti-CD3 monoclonal antibody was approved Nov. 17 as the first disease-modifying therapy for impeding progression of type 1 diabetes. In a clinical trial, teplizumab delayed the onset of clinical (stage 3) type 1 diabetes by approximately 2 years, and longer in some cases.

It is administered by intravenous infusion once daily for 14 consecutive days and is expected to cost in the region of $200,000 for the course of treatment.

The specific indication is “to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.” In stage 2 type 1 diabetes, the individual has two or more islet autoantibodies and abnormal glycemia but is as yet asymptomatic. It is associated with a nearly 100% lifetime risk of progression to clinical (stage 3) type 1 diabetes and a 75% risk of developing the condition within 5 years.

Currently, most people who are screened for type 1 diabetes autoantibodies are first-degree relatives of those with the condition through TrialNet, other local programs, or more recently, a $55 test offered by the research and advocacy organization JDRF.

But because 85%-90% of people who develop type 1 diabetes don’t have first-degree relatives with the condition, broader population screening will be necessary to identify eligible candidates for teplizumab.

During an investor call on Nov. 18, Provention Bio chief commercial officer Jason Hoitt said that among the company’s “strategic initiatives” were “advancing awareness and screening for autoantibodies in at-risk individuals, and ultimately, routine screening during pediatric well visits for the general population,” as well as “[health care provider] belief in teplizumab and desire to prescribe it for their patients.” 

Without broad population-based screening, first-degree relatives of people with type 1 diabetes are likely to be the first to be screened and those with stage 2 identified for receipt of teplizumab. Today, that population is estimated at about 30,000 in the United States, Mr. Hoitt said, adding, “with this approval we hope that more stage 2 patients can be readily identified so the course of the disease can be changed.”

During the call, Mr. Hoitt also announced that the wholesale acquisition cost of Tzield would be $13,850 per vial, which translates to $193,900 per 14-vial continuous regimen, anticipated to be a sufficient dose for most patients. The company also launched a program called COMPASS to help patients navigate insurance reimbursement, as well as provide some with financial assistance.

Cost aside, JDRF CEO Aaron Kowalski, PhD, said in an interview that clinicians shouldn’t doubt the value of delaying type 1 diabetes onset, even if not completely preventing it. “This is the first drug ever to treat the underlying disease. There is this undercurrent that insulin is enough. Why would you undertake an additional risk of an immunotherapy? Type 1 is hard to live with. I think sometimes the clinical community doesn’t appreciate that insulin is not enough. It’s very difficult, and opening this door is important. ... We believe very strongly that the delay of onset of type 1 diabetes is clinically meaningful. We hear that from every family we’ve talked to. Clinicians should appreciate this and not discount it.”
 

How would screening happen? 

While the path to universal screening for type 1 diabetes risk isn’t yet clear, quite a bit of thought and research has gone into it even before teplizumab and other immune-modulating agents showed promise in forestalling the condition.

Data from a universal screening program of schoolchildren implemented in Bavaria, Germany, and a screening program in Denver, suggest that even without such an intervention, identifying people at high risk for developing type 1 diabetes could be cost effective by allowing for education of the individual and family members about the signs of type 1 diabetes, thereby reducing the likelihood that the person would progress to developing diabetic ketoacidosis (DKA) prior to diagnosis.

Another study that used data from the United States and Western Europe, found that screening children for type 1 diabetes–associated islet autoantibodies at ages 2 and 6 years would identify most of those who go on to develop the disease by midadolescence.

However, using a genetic risk score at birth to identify those who would go on to autoantibody testing is potentially a more cost-effective approach, William A. Hagopian, MD, PhD, director of diabetes programs, Pacific Northwest Research Institute, Seattle, said in an interview.

The score – based on human leukocyte antigen haplotypes and their interactions as well as non-HLA genes – can stratify nearly 80% of childhood type 1 diabetes within the top 10% of all newborns. Thus, only the top 10% would then go on to receive the more expensive autoantibody testing.

“I’ve been working with U.K. colleagues for the past 3-4 years to develop a strategy using genetic risk scores followed by autoantibody screening. I feel strongly that that’s the cost-effective way to go. It’s relatively inexpensive, scalable, and can be applied commercially in newborn screening labs. To be successful an approach must be cost effective. Payors are willing to pay for newborn screening, but not so much on testing 100% of kids for antibodies,” Dr. Hagopian said.

He is now working with Washington State newborn screening labs to demonstrate feasibility of the approach using dried blood samples from actual neonatal screening after obtaining informed consent from the mothers in postpartum wards in several hospitals. Those found to be at high risk using the genetic risk score are contacted for follow-up with autoantibody screening. The program will continue for another year and a half. “I think it actually has a chance of being accepted into their regular program,” he said.

And then, he hopes, other states will follow, and eventually, the strategy will be added to the Recommended Uniform Screening Panel for universal newborn screening programs, as recommended by the Department of Health & Human Services.

“New newborn screenings for additional diseases are implemented regularly,” Dr. Hagopian said. “Most are far less common than type 1 diabetes. So even if our approach is less than 100% sensitive, this condition is a lot more common than the many inborn errors of metabolism, so we’re still going to be identifying a lot of cases. ... This is my hope for how universal type 1 diabetes screening will unfold. I see a way this may work quite well.”

A two-pronged approach to screening could work best

Meanwhile, JDRF, which supported the teplizumab research as well as others working in the space, is focusing on both genetic and autoantibody screening, Dr. Kowalski said.

“JDRF is working on both pathways – testing kids at birth for genetic predisposition and also antibody screening. We have huge programs focused on general population antibody screening.”

Dr. Kowalski said that, while the two-pronged approach certainly is worth exploring – and JDRF is doing that – he also thinks that universal autoantibody screening could be cost effective if done efficiently, such as with less expensive assays than the one used in TrialNet.

“We have programs where you do the genetic screening and keep an eye on people. We also have programs, like the one we’re funding in Germany, that are doing broad autoantibody screening of all kids. We’re hopeful that will be very cost effective if we move to cheaper assays.”

He noted that the proportion of children with new-onset type 1 diabetes who present in DKA rose from 40% pre–COVID-19 to 50% during the early days of the pandemic. On the other hand, “With screening you can get that to near zero, like they did in Bavaria. Here [in the United States], one ICU visit for DKA [costs] $100,000.”

While JDRF and others have been working on this for years, the new availability of teplizumab will be “multifold in helping things along. ... I think you’re going to see a lot of work on the cost-effectiveness of teplizumab. I think the case will be pretty straightforward that there’s huge upside to delaying the disease from a near-term and a long-term cost perspective. This is the first time we’ve had a drug out there with a price attached to it.”

But it may not happen quickly, Kowalski cautioned. “I feel there’s a ... series of events that has to happen to drive towards universal screening. Here in the U.S. it’s complicated because we have a very discrepant health care system with all these different payers, public and private.”

During the investor call, Mr. Hoitt said that Provention Bio is also exploring use of Tzield in younger patients and newly diagnosed patients, and the potential benefit of redosing or combining with other treatments.

Mr. Hoitt is an employee of Provention Bio. Dr. Kowalski is an employee of JDRF. Dr. Hagopian has reported receiving study funding from Janssen.

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

Change is inevitable in residency as well as in life. Every year on July 1, the atmosphere and social structure of residencies change with the new postgraduate year 2 class. Each class brings a unique perspective and energy. Residents come together from different backgrounds and life situations. Some residents are single, some are engaged or married, and some are starting or expanding their families. Some residents will have prior careers, others will have graduate degrees or expertise in various fields. They will have different ethnic backgrounds, religious and/or spiritual beliefs, familial upbringings, personalities, and methods of communicating. These differences all are important to consider when developing a mindset of inclusion and camaraderie. As residents start their journey together, it is important to remember that residency is a team endeavor. The principles of teamwork apply directly to residents and are founded on creating a climate of trust and building strong relationships with one another._¹ Trust is the foundation of good relationships in the workplace; it allows people to communicate freely and foster the belief that everyone is working for each other’s best interests. Being open and sharing knowledge about networking opportunities, scholarships, and research projects is one way to foster collaboration and trust in residency.

Diversity, equity, and inclusion in dermatology is a work in progress. In the 2020-2021 dermatology application cycle, only 4.8% of applicants identified as Hispanic or Latino, and 7.8% identified as Black or African American.² The American Academy of Dermatology took an active role in promoting diversity by creating a task force in 2018 to increase the exposure and recruitment into dermatology of medical students who are underrepresented in medicine.2 As standards for diversity are met in dermatology, we will have the wonderful opportunity to welcome even more diversity into our lives.

Listening, showing curiosity about your co-residents’ lives outside of work, and asking questions can help build respect, friendships, and camaraderie. Ask your co-residents what makes them happy and what their goals are in residency. Finding common goals and cultivating the mindset that you all work together to achieve your goals is key to the success of a residency class. Now that we discussed accepting and welcoming differences, how do you foster camaraderie in a social setting?

Establish a Social Committee

As a class, consider 1 or 2 residents who are always excited to try new activities such as attend restaurant openings, exercise classes, concerts, or movie nights. Consider nominating these co-residents along with one attending to be social chairs of your residency. The social chairs should meet and establish at least 1 social event per season, with 4 total for the academic year. There are only 2 rules with social events: (1) they must be held outside of clinic, and (2) everyone should try their best to attend.

Social chairs should try to prioritize a location-specific event that allows the residents who are not from the area to experience something local, which can be anything from apple picking at an orchard in the fall to beach volleyball in the summer. Planning these parties gives everyone an event to look forward to and a chance to spend time together and grow closer. The memories and inside jokes that arise from these outings are invaluable and increase joy inside and outside of clinic.

Utilize Social Media

Another project can be developing a social media account for your program with the approval of your faculty. @unmcdermatology, @uwderm, and @gwdermres can help foster social relationships by establishing a lighthearted space to celebrate the residency’s achievements, new publications, volunteer events, or social gatherings.

Encourage Local and National Conference Attendance

All residents should be encouraged to submit abstracts to local and national conferences and attend with their co-residents. Conferences are peak opportunities to foster camaraderie within residency classes, as they involve a sense of togetherness in the specialty along with the excitement of traveling to a new city and meeting other like-minded individuals. Conferences allow collaboration within the specialty on a national level and foster relationships between residency programs.

In addition, national groups such as the Women’s Dermatologic Society, the Skin of Color Society, and the American Academy of Dermatology Diversity, Equity, and Inclusion task force meet at the national conferences and discuss their next initiatives and projects. Joining a society of your interest can lead to many new networks and relationships you may not have had before. Even if you are not interested in specializing after general dermatology, consider attending a surgery, dermatopathology, or pediatric or cosmetic dermatology conference to learn more about the field from the experts.

Repair Conflicts and Build a Climate of Collaboration

Conflicts and disagreements unfortunately are inevitable during residency. Whether they involve planning vacation times or coordinating call schedules, everyone will not agree on every decision. Learning how to handle and approach conflict with co-residents is of utmost importance to maintaining the hard work you have put in to create trust, camaraderie, and a good social atmosphere. If you are having an issue with a circumstance involving a co-resident, holding a grudge will only sour your experience and the experience of others. Talking to your co-resident directly about your concerns before escalating the issue to a chief resident or faculty member is a great start. Consider asking them about their thought process and show concern for their point of view. Listen to them openly before going into your preferences. It is important to remember that working as a team requires sacrifices, and sometimes you will not be satisfied with the outcome of a conflict.

It also is important to remember that feelings change, and an issue you feel you must address immediately can wait to be addressed at a better time when you have calmed down. You may even find that you decide not to address it at all. At the end of the day, if a conflict cannot be worked out between those involved, consider confiding in a chief resident or a faculty mentor for advice on the next steps to take to resolve the problem. Ultimately, having a good foundation of respect and strong bonds with your residents will help tremendously when conflicts arise.

Final Thoughts

Fostering camaraderie in residency will improve the overall experience and lives of the residents, as well as the experience of the faculty, staff, and patients by the trickle-down effect. Creating a cheerful and fun atmosphere filled with inside jokes and excitement regarding upcoming social events or conferences will certainly result in a time you will cherish for the rest of your life.

Change is inevitable in residency as well as in life. Every year on July 1, the atmosphere and social structure of residencies change with the new postgraduate year 2 class. Each class brings a unique perspective and energy. Residents come together from different backgrounds and life situations. Some residents are single, some are engaged or married, and some are starting or expanding their families. Some residents will have prior careers, others will have graduate degrees or expertise in various fields. They will have different ethnic backgrounds, religious and/or spiritual beliefs, familial upbringings, personalities, and methods of communicating. These differences all are important to consider when developing a mindset of inclusion and camaraderie. As residents start their journey together, it is important to remember that residency is a team endeavor. The principles of teamwork apply directly to residents and are founded on creating a climate of trust and building strong relationships with one another._¹ Trust is the foundation of good relationships in the workplace; it allows people to communicate freely and foster the belief that everyone is working for each other’s best interests. Being open and sharing knowledge about networking opportunities, scholarships, and research projects is one way to foster collaboration and trust in residency.

Diversity, equity, and inclusion in dermatology is a work in progress. In the 2020-2021 dermatology application cycle, only 4.8% of applicants identified as Hispanic or Latino, and 7.8% identified as Black or African American.² The American Academy of Dermatology took an active role in promoting diversity by creating a task force in 2018 to increase the exposure and recruitment into dermatology of medical students who are underrepresented in medicine.2 As standards for diversity are met in dermatology, we will have the wonderful opportunity to welcome even more diversity into our lives.

Listening, showing curiosity about your co-residents’ lives outside of work, and asking questions can help build respect, friendships, and camaraderie. Ask your co-residents what makes them happy and what their goals are in residency. Finding common goals and cultivating the mindset that you all work together to achieve your goals is key to the success of a residency class. Now that we discussed accepting and welcoming differences, how do you foster camaraderie in a social setting?

Establish a Social Committee

As a class, consider 1 or 2 residents who are always excited to try new activities such as attend restaurant openings, exercise classes, concerts, or movie nights. Consider nominating these co-residents along with one attending to be social chairs of your residency. The social chairs should meet and establish at least 1 social event per season, with 4 total for the academic year. There are only 2 rules with social events: (1) they must be held outside of clinic, and (2) everyone should try their best to attend.

Social chairs should try to prioritize a location-specific event that allows the residents who are not from the area to experience something local, which can be anything from apple picking at an orchard in the fall to beach volleyball in the summer. Planning these parties gives everyone an event to look forward to and a chance to spend time together and grow closer. The memories and inside jokes that arise from these outings are invaluable and increase joy inside and outside of clinic.

Utilize Social Media

Another project can be developing a social media account for your program with the approval of your faculty. @unmcdermatology, @uwderm, and @gwdermres can help foster social relationships by establishing a lighthearted space to celebrate the residency’s achievements, new publications, volunteer events, or social gatherings.

Encourage Local and National Conference Attendance

All residents should be encouraged to submit abstracts to local and national conferences and attend with their co-residents. Conferences are peak opportunities to foster camaraderie within residency classes, as they involve a sense of togetherness in the specialty along with the excitement of traveling to a new city and meeting other like-minded individuals. Conferences allow collaboration within the specialty on a national level and foster relationships between residency programs.

In addition, national groups such as the Women’s Dermatologic Society, the Skin of Color Society, and the American Academy of Dermatology Diversity, Equity, and Inclusion task force meet at the national conferences and discuss their next initiatives and projects. Joining a society of your interest can lead to many new networks and relationships you may not have had before. Even if you are not interested in specializing after general dermatology, consider attending a surgery, dermatopathology, or pediatric or cosmetic dermatology conference to learn more about the field from the experts.

Repair Conflicts and Build a Climate of Collaboration

Conflicts and disagreements unfortunately are inevitable during residency. Whether they involve planning vacation times or coordinating call schedules, everyone will not agree on every decision. Learning how to handle and approach conflict with co-residents is of utmost importance to maintaining the hard work you have put in to create trust, camaraderie, and a good social atmosphere. If you are having an issue with a circumstance involving a co-resident, holding a grudge will only sour your experience and the experience of others. Talking to your co-resident directly about your concerns before escalating the issue to a chief resident or faculty member is a great start. Consider asking them about their thought process and show concern for their point of view. Listen to them openly before going into your preferences. It is important to remember that working as a team requires sacrifices, and sometimes you will not be satisfied with the outcome of a conflict.

It also is important to remember that feelings change, and an issue you feel you must address immediately can wait to be addressed at a better time when you have calmed down. You may even find that you decide not to address it at all. At the end of the day, if a conflict cannot be worked out between those involved, consider confiding in a chief resident or a faculty mentor for advice on the next steps to take to resolve the problem. Ultimately, having a good foundation of respect and strong bonds with your residents will help tremendously when conflicts arise.

Final Thoughts

Fostering camaraderie in residency will improve the overall experience and lives of the residents, as well as the experience of the faculty, staff, and patients by the trickle-down effect. Creating a cheerful and fun atmosphere filled with inside jokes and excitement regarding upcoming social events or conferences will certainly result in a time you will cherish for the rest of your life.

Change is inevitable in residency as well as in life. Every year on July 1, the atmosphere and social structure of residencies change with the new postgraduate year 2 class. Each class brings a unique perspective and energy. Residents come together from different backgrounds and life situations. Some residents are single, some are engaged or married, and some are starting or expanding their families. Some residents will have prior careers, others will have graduate degrees or expertise in various fields. They will have different ethnic backgrounds, religious and/or spiritual beliefs, familial upbringings, personalities, and methods of communicating. These differences all are important to consider when developing a mindset of inclusion and camaraderie. As residents start their journey together, it is important to remember that residency is a team endeavor. The principles of teamwork apply directly to residents and are founded on creating a climate of trust and building strong relationships with one another._¹ Trust is the foundation of good relationships in the workplace; it allows people to communicate freely and foster the belief that everyone is working for each other’s best interests. Being open and sharing knowledge about networking opportunities, scholarships, and research projects is one way to foster collaboration and trust in residency.

Diversity, equity, and inclusion in dermatology is a work in progress. In the 2020-2021 dermatology application cycle, only 4.8% of applicants identified as Hispanic or Latino, and 7.8% identified as Black or African American.² The American Academy of Dermatology took an active role in promoting diversity by creating a task force in 2018 to increase the exposure and recruitment into dermatology of medical students who are underrepresented in medicine.2 As standards for diversity are met in dermatology, we will have the wonderful opportunity to welcome even more diversity into our lives.

Listening, showing curiosity about your co-residents’ lives outside of work, and asking questions can help build respect, friendships, and camaraderie. Ask your co-residents what makes them happy and what their goals are in residency. Finding common goals and cultivating the mindset that you all work together to achieve your goals is key to the success of a residency class. Now that we discussed accepting and welcoming differences, how do you foster camaraderie in a social setting?

Establish a Social Committee

As a class, consider 1 or 2 residents who are always excited to try new activities such as attend restaurant openings, exercise classes, concerts, or movie nights. Consider nominating these co-residents along with one attending to be social chairs of your residency. The social chairs should meet and establish at least 1 social event per season, with 4 total for the academic year. There are only 2 rules with social events: (1) they must be held outside of clinic, and (2) everyone should try their best to attend.

Social chairs should try to prioritize a location-specific event that allows the residents who are not from the area to experience something local, which can be anything from apple picking at an orchard in the fall to beach volleyball in the summer. Planning these parties gives everyone an event to look forward to and a chance to spend time together and grow closer. The memories and inside jokes that arise from these outings are invaluable and increase joy inside and outside of clinic.

Utilize Social Media

Another project can be developing a social media account for your program with the approval of your faculty. @unmcdermatology, @uwderm, and @gwdermres can help foster social relationships by establishing a lighthearted space to celebrate the residency’s achievements, new publications, volunteer events, or social gatherings.

Encourage Local and National Conference Attendance

All residents should be encouraged to submit abstracts to local and national conferences and attend with their co-residents. Conferences are peak opportunities to foster camaraderie within residency classes, as they involve a sense of togetherness in the specialty along with the excitement of traveling to a new city and meeting other like-minded individuals. Conferences allow collaboration within the specialty on a national level and foster relationships between residency programs.

In addition, national groups such as the Women’s Dermatologic Society, the Skin of Color Society, and the American Academy of Dermatology Diversity, Equity, and Inclusion task force meet at the national conferences and discuss their next initiatives and projects. Joining a society of your interest can lead to many new networks and relationships you may not have had before. Even if you are not interested in specializing after general dermatology, consider attending a surgery, dermatopathology, or pediatric or cosmetic dermatology conference to learn more about the field from the experts.

Repair Conflicts and Build a Climate of Collaboration

Conflicts and disagreements unfortunately are inevitable during residency. Whether they involve planning vacation times or coordinating call schedules, everyone will not agree on every decision. Learning how to handle and approach conflict with co-residents is of utmost importance to maintaining the hard work you have put in to create trust, camaraderie, and a good social atmosphere. If you are having an issue with a circumstance involving a co-resident, holding a grudge will only sour your experience and the experience of others. Talking to your co-resident directly about your concerns before escalating the issue to a chief resident or faculty member is a great start. Consider asking them about their thought process and show concern for their point of view. Listen to them openly before going into your preferences. It is important to remember that working as a team requires sacrifices, and sometimes you will not be satisfied with the outcome of a conflict.

It also is important to remember that feelings change, and an issue you feel you must address immediately can wait to be addressed at a better time when you have calmed down. You may even find that you decide not to address it at all. At the end of the day, if a conflict cannot be worked out between those involved, consider confiding in a chief resident or a faculty mentor for advice on the next steps to take to resolve the problem. Ultimately, having a good foundation of respect and strong bonds with your residents will help tremendously when conflicts arise.

Final Thoughts

Fostering camaraderie in residency will improve the overall experience and lives of the residents, as well as the experience of the faculty, staff, and patients by the trickle-down effect. Creating a cheerful and fun atmosphere filled with inside jokes and excitement regarding upcoming social events or conferences will certainly result in a time you will cherish for the rest of your life.

Low energy–density diets that are based either on potatoes or beans similarly reduced insulin resistance in adults with poor blood glucose control, according to a controlled feeding study in 36 individuals.

PxHere

Potatoes have gotten a bad rap for their high glycemic index, but they have little fat and a low energy density, wrote the study investigators. In fact, “cooling of gelatinized potatoes generates appreciable levels of slowly digested starch (resistant starch type 3) and substantially lowers the blood glucose response that potatoes elicit.”

“There is a view that potatoes are a less healthy plant food, but there is very little empirical data from randomized trials to support this view,” senior investigator John P. Kirwan, PhD, said in an interview.

Dry beans and peas (known as pulses) also contain resistant starch that improves insulin sensitivity and glucose tolerance, and multiple studies support pulses as part of a low-glycemic diet to improve glucose control in adults, the researchers explained, but because the density of food often guides how much people eat, they hypothesized that potatoes could substitute for beans and provide similar glucose control benefits.

In a study published in the Journal of Medicinal Food, the researchers randomized 36 adults aged 18-60 years with insulin resistance to 8 weeks of a low energy–density diet (1 kcal/g) high in either potatoes or beans. The baseline body mass index ranged from 25 to 40 kg/m². Insulin resistance was defined using the homeostatic model assessment of insulin resistance (HOMA-IR) with a score greater than 2.

The controlled diet consisted of 50%-55% carbohydrates, 30%-35% fats, and 15%-20% protein. Each meal in the potato group included a side of potatoes, and each meal in the bean group included a side of beans.

The primary outcome was the mean change in blood glucose concentration; the researchers also assessed weight loss.

A total of 14 individuals in the potato group and 17 in the bean group completed the study; but data from the 18 individuals in each group were included in an intent-to-treat analysis.

Among study completers, HOMA-IR in the bean group showed an average decrease of 1.4 from baseline (P = .02 ); a similar decrease of 1.3 occurred in the potato group (P < .05) with no significant difference between the two diets.

Overall compliance with both diets was roughly 88%. Body weight reductions were similar in both groups and significantly reduced from baseline over the study period, with average reductions in intent-to-treat analysis of 5.82 kg in the potato group and 4.0 kg in the bean group. BMI also was significantly reduced from baseline in both potato and bean groups (2.04 kg/m² and 1.35 kg/m², respectively). Although baseline differences were not significant, “BMI at baseline was higher and the reduction in response to the treatment was significantly greater in the potato diet compared with the bean diet,” the researchers noted. The effect on blood glucose response was not significantly different between the two groups or from baseline, they said.

The findings were limited by several factors including the small size, relatively short study period, and controlled nature of the study diet, the researchers noted. “The addition of a typical Western diet would have enhanced our understanding of the effect of low energy–dense diets on metabolic outcomes,” they noted in their discussion.

However, both diets led to a reduction in body weight, and the low energy density of both potato and bean diets promoted weight loss without affecting appetite or requiring calorie restriction, the researchers explained. Therefore, “this weight loss if sustained over time could have a substantial impact on body weight,” they said.

“We hypothesized that there would be equivalence between the potato and bean diet and this hypothesis proved to be correct,” said Dr. Kirwan, of the Pennington Biomedical Research Center, Baton Rouge, La., in an interview.

The take-home message for clinicians is that, though small, the study was very well-controlled, Dr. Kirwan emphasized. “Clinicians ought to consider the health benefits of the potato when it is cooked and served appropriately.”

Looking ahead, larger randomized controlled trials with additional control arms, longer time of at least 12 weeks, and different patient populations are needed, Dr. Kirwan added.
 

Findings mitigate food myths

The debate continues about whether there are foods that are “good” or “evil;” or foods that one “should not eat” or “should eat,” said Amy Rothberg, MD, associate professor of internal medicine and of nutritional sciences at the University of Michigan, Ann Arbor, in an interview.

“This study dispels the myth that incorporating a small portion of potato into the diet (although these are not potatoes that are fried, or are topped with cheese, bacon, sour cream, etc.) results in deleterious metabolic outcomes when compared to a diet that is comprised of beans (pulses) as part of a low energy–dense diet,” she explained.

“The diet in both groups was of low energy density, which has been shown to result in fewer calories consumed, weight loss, and improvement in insulin resistance,” so the similarity in results was not so surprising, said Dr. Rothberg.  

For the clinical takeaway, Dr. Rothberg agreed with the study authors: “Clinicians may counsel their patients that they can still consume a small potato (with the caveat above regarding cooking methods and toppings) as part of a balanced meal so long as they are keeping their overall calories low and not exceeding their metabolic requirements based on body weight/BMI,” she said.

As for additional research, studies with a longer time frame and a larger and more diverse study population are needed, including populations with common insulin resistance comorbidities such as type 2 diabetes, fatty liver disease, and cardiovascular disease, Dr. Rothberg noted.
 

Consumer considerations, with caveats

The key message for consumers is that, “based on this very small study of short duration, consuming a small portion of potato as part of an overall balanced, low-energy diet did not produce adverse effects on glucose or insulin when compared to a diet of pulses known to have favorable effects on glucose and insulin,” Dr. Rothberg told this news organization. However, “consumers should note that, although the results from this small study are encouraging, it would be premature to extrapolate the findings from this study to other populations,” she said. Also, keep in mind that the study was supported in part by the Alliance for Potato Research, although the authors stated that none of the funders (Alliance for Potato Research and Education and the National Institutes of Health) had any role in the design, analysis, or writing of the article, she added.

The study was supported in part by the Alliance for Potato Research and Education and the National Institutes of Health, which funds the Louisiana Clinical and Translational Science Center. The researchers and Dr. Rothberg had no financial conflicts to disclose.

Low energy–density diets that are based either on potatoes or beans similarly reduced insulin resistance in adults with poor blood glucose control, according to a controlled feeding study in 36 individuals.

PxHere

Potatoes have gotten a bad rap for their high glycemic index, but they have little fat and a low energy density, wrote the study investigators. In fact, “cooling of gelatinized potatoes generates appreciable levels of slowly digested starch (resistant starch type 3) and substantially lowers the blood glucose response that potatoes elicit.”

“There is a view that potatoes are a less healthy plant food, but there is very little empirical data from randomized trials to support this view,” senior investigator John P. Kirwan, PhD, said in an interview.

Dry beans and peas (known as pulses) also contain resistant starch that improves insulin sensitivity and glucose tolerance, and multiple studies support pulses as part of a low-glycemic diet to improve glucose control in adults, the researchers explained, but because the density of food often guides how much people eat, they hypothesized that potatoes could substitute for beans and provide similar glucose control benefits.

In a study published in the Journal of Medicinal Food, the researchers randomized 36 adults aged 18-60 years with insulin resistance to 8 weeks of a low energy–density diet (1 kcal/g) high in either potatoes or beans. The baseline body mass index ranged from 25 to 40 kg/m². Insulin resistance was defined using the homeostatic model assessment of insulin resistance (HOMA-IR) with a score greater than 2.

The controlled diet consisted of 50%-55% carbohydrates, 30%-35% fats, and 15%-20% protein. Each meal in the potato group included a side of potatoes, and each meal in the bean group included a side of beans.

The primary outcome was the mean change in blood glucose concentration; the researchers also assessed weight loss.

A total of 14 individuals in the potato group and 17 in the bean group completed the study; but data from the 18 individuals in each group were included in an intent-to-treat analysis.

Among study completers, HOMA-IR in the bean group showed an average decrease of 1.4 from baseline (P = .02 ); a similar decrease of 1.3 occurred in the potato group (P < .05) with no significant difference between the two diets.

Overall compliance with both diets was roughly 88%. Body weight reductions were similar in both groups and significantly reduced from baseline over the study period, with average reductions in intent-to-treat analysis of 5.82 kg in the potato group and 4.0 kg in the bean group. BMI also was significantly reduced from baseline in both potato and bean groups (2.04 kg/m² and 1.35 kg/m², respectively). Although baseline differences were not significant, “BMI at baseline was higher and the reduction in response to the treatment was significantly greater in the potato diet compared with the bean diet,” the researchers noted. The effect on blood glucose response was not significantly different between the two groups or from baseline, they said.

The findings were limited by several factors including the small size, relatively short study period, and controlled nature of the study diet, the researchers noted. “The addition of a typical Western diet would have enhanced our understanding of the effect of low energy–dense diets on metabolic outcomes,” they noted in their discussion.

However, both diets led to a reduction in body weight, and the low energy density of both potato and bean diets promoted weight loss without affecting appetite or requiring calorie restriction, the researchers explained. Therefore, “this weight loss if sustained over time could have a substantial impact on body weight,” they said.

“We hypothesized that there would be equivalence between the potato and bean diet and this hypothesis proved to be correct,” said Dr. Kirwan, of the Pennington Biomedical Research Center, Baton Rouge, La., in an interview.

The take-home message for clinicians is that, though small, the study was very well-controlled, Dr. Kirwan emphasized. “Clinicians ought to consider the health benefits of the potato when it is cooked and served appropriately.”

Looking ahead, larger randomized controlled trials with additional control arms, longer time of at least 12 weeks, and different patient populations are needed, Dr. Kirwan added.
 

Findings mitigate food myths

The debate continues about whether there are foods that are “good” or “evil;” or foods that one “should not eat” or “should eat,” said Amy Rothberg, MD, associate professor of internal medicine and of nutritional sciences at the University of Michigan, Ann Arbor, in an interview.

“This study dispels the myth that incorporating a small portion of potato into the diet (although these are not potatoes that are fried, or are topped with cheese, bacon, sour cream, etc.) results in deleterious metabolic outcomes when compared to a diet that is comprised of beans (pulses) as part of a low energy–dense diet,” she explained.

“The diet in both groups was of low energy density, which has been shown to result in fewer calories consumed, weight loss, and improvement in insulin resistance,” so the similarity in results was not so surprising, said Dr. Rothberg.  

For the clinical takeaway, Dr. Rothberg agreed with the study authors: “Clinicians may counsel their patients that they can still consume a small potato (with the caveat above regarding cooking methods and toppings) as part of a balanced meal so long as they are keeping their overall calories low and not exceeding their metabolic requirements based on body weight/BMI,” she said.

As for additional research, studies with a longer time frame and a larger and more diverse study population are needed, including populations with common insulin resistance comorbidities such as type 2 diabetes, fatty liver disease, and cardiovascular disease, Dr. Rothberg noted.
 

Consumer considerations, with caveats

The key message for consumers is that, “based on this very small study of short duration, consuming a small portion of potato as part of an overall balanced, low-energy diet did not produce adverse effects on glucose or insulin when compared to a diet of pulses known to have favorable effects on glucose and insulin,” Dr. Rothberg told this news organization. However, “consumers should note that, although the results from this small study are encouraging, it would be premature to extrapolate the findings from this study to other populations,” she said. Also, keep in mind that the study was supported in part by the Alliance for Potato Research, although the authors stated that none of the funders (Alliance for Potato Research and Education and the National Institutes of Health) had any role in the design, analysis, or writing of the article, she added.

The study was supported in part by the Alliance for Potato Research and Education and the National Institutes of Health, which funds the Louisiana Clinical and Translational Science Center. The researchers and Dr. Rothberg had no financial conflicts to disclose.

Low energy–density diets that are based either on potatoes or beans similarly reduced insulin resistance in adults with poor blood glucose control, according to a controlled feeding study in 36 individuals.

PxHere

Potatoes have gotten a bad rap for their high glycemic index, but they have little fat and a low energy density, wrote the study investigators. In fact, “cooling of gelatinized potatoes generates appreciable levels of slowly digested starch (resistant starch type 3) and substantially lowers the blood glucose response that potatoes elicit.”

“There is a view that potatoes are a less healthy plant food, but there is very little empirical data from randomized trials to support this view,” senior investigator John P. Kirwan, PhD, said in an interview.

Dry beans and peas (known as pulses) also contain resistant starch that improves insulin sensitivity and glucose tolerance, and multiple studies support pulses as part of a low-glycemic diet to improve glucose control in adults, the researchers explained, but because the density of food often guides how much people eat, they hypothesized that potatoes could substitute for beans and provide similar glucose control benefits.

In a study published in the Journal of Medicinal Food, the researchers randomized 36 adults aged 18-60 years with insulin resistance to 8 weeks of a low energy–density diet (1 kcal/g) high in either potatoes or beans. The baseline body mass index ranged from 25 to 40 kg/m². Insulin resistance was defined using the homeostatic model assessment of insulin resistance (HOMA-IR) with a score greater than 2.

The controlled diet consisted of 50%-55% carbohydrates, 30%-35% fats, and 15%-20% protein. Each meal in the potato group included a side of potatoes, and each meal in the bean group included a side of beans.

The primary outcome was the mean change in blood glucose concentration; the researchers also assessed weight loss.

A total of 14 individuals in the potato group and 17 in the bean group completed the study; but data from the 18 individuals in each group were included in an intent-to-treat analysis.

Among study completers, HOMA-IR in the bean group showed an average decrease of 1.4 from baseline (P = .02 ); a similar decrease of 1.3 occurred in the potato group (P < .05) with no significant difference between the two diets.

Overall compliance with both diets was roughly 88%. Body weight reductions were similar in both groups and significantly reduced from baseline over the study period, with average reductions in intent-to-treat analysis of 5.82 kg in the potato group and 4.0 kg in the bean group. BMI also was significantly reduced from baseline in both potato and bean groups (2.04 kg/m² and 1.35 kg/m², respectively). Although baseline differences were not significant, “BMI at baseline was higher and the reduction in response to the treatment was significantly greater in the potato diet compared with the bean diet,” the researchers noted. The effect on blood glucose response was not significantly different between the two groups or from baseline, they said.

The findings were limited by several factors including the small size, relatively short study period, and controlled nature of the study diet, the researchers noted. “The addition of a typical Western diet would have enhanced our understanding of the effect of low energy–dense diets on metabolic outcomes,” they noted in their discussion.

However, both diets led to a reduction in body weight, and the low energy density of both potato and bean diets promoted weight loss without affecting appetite or requiring calorie restriction, the researchers explained. Therefore, “this weight loss if sustained over time could have a substantial impact on body weight,” they said.

“We hypothesized that there would be equivalence between the potato and bean diet and this hypothesis proved to be correct,” said Dr. Kirwan, of the Pennington Biomedical Research Center, Baton Rouge, La., in an interview.

The take-home message for clinicians is that, though small, the study was very well-controlled, Dr. Kirwan emphasized. “Clinicians ought to consider the health benefits of the potato when it is cooked and served appropriately.”

Looking ahead, larger randomized controlled trials with additional control arms, longer time of at least 12 weeks, and different patient populations are needed, Dr. Kirwan added.
 

Findings mitigate food myths

The debate continues about whether there are foods that are “good” or “evil;” or foods that one “should not eat” or “should eat,” said Amy Rothberg, MD, associate professor of internal medicine and of nutritional sciences at the University of Michigan, Ann Arbor, in an interview.

“This study dispels the myth that incorporating a small portion of potato into the diet (although these are not potatoes that are fried, or are topped with cheese, bacon, sour cream, etc.) results in deleterious metabolic outcomes when compared to a diet that is comprised of beans (pulses) as part of a low energy–dense diet,” she explained.

“The diet in both groups was of low energy density, which has been shown to result in fewer calories consumed, weight loss, and improvement in insulin resistance,” so the similarity in results was not so surprising, said Dr. Rothberg.  

For the clinical takeaway, Dr. Rothberg agreed with the study authors: “Clinicians may counsel their patients that they can still consume a small potato (with the caveat above regarding cooking methods and toppings) as part of a balanced meal so long as they are keeping their overall calories low and not exceeding their metabolic requirements based on body weight/BMI,” she said.

As for additional research, studies with a longer time frame and a larger and more diverse study population are needed, including populations with common insulin resistance comorbidities such as type 2 diabetes, fatty liver disease, and cardiovascular disease, Dr. Rothberg noted.
 

Consumer considerations, with caveats

The key message for consumers is that, “based on this very small study of short duration, consuming a small portion of potato as part of an overall balanced, low-energy diet did not produce adverse effects on glucose or insulin when compared to a diet of pulses known to have favorable effects on glucose and insulin,” Dr. Rothberg told this news organization. However, “consumers should note that, although the results from this small study are encouraging, it would be premature to extrapolate the findings from this study to other populations,” she said. Also, keep in mind that the study was supported in part by the Alliance for Potato Research, although the authors stated that none of the funders (Alliance for Potato Research and Education and the National Institutes of Health) had any role in the design, analysis, or writing of the article, she added.

The study was supported in part by the Alliance for Potato Research and Education and the National Institutes of Health, which funds the Louisiana Clinical and Translational Science Center. The researchers and Dr. Rothberg had no financial conflicts to disclose.