Feature

With a number of large-scale clinical trials underway and researchers on the hunt for new therapies, long COVID scientists are hopeful that this is the year patients — and doctors who care for them — will finally see improvements in treating their symptoms.

Here are five bold predictions — all based on encouraging research — that could happen in 2024. At the very least, they are promising signs of progress against a debilitating and frustrating disease.

#1: We’ll gain a better understanding of each long COVID phenotype

This past year, a wide breadth of research began showing that long COVID can be defined by a number of different disease phenotypes that present a range of symptoms.

Researchers identified four clinical phenotypes: Chronic fatigue-like syndrome, headache, and memory loss; respiratory syndrome, which includes cough and difficulty breathing; chronic pain; and neurosensorial syndrome, which causes an altered sense of taste and smell.

Identifying specific diagnostic criteria for each phenotype would lead to better health outcomes for patients instead of treating them as if it were a “one-size-fits-all disease,” said Nisha Viswanathan, MD, director of the long COVID program at UCLA Health, Los Angeles, California.

Ultimately, she hopes that this year her patients will receive treatments based on the type of long COVID they’re personally experiencing, and the symptoms they have, leading to improved health outcomes and more rapid relief.

“Many new medications are focused on different pathways of long COVID, and the challenge becomes which drug is the right drug for each treatment,” said Dr. Viswanathan.

#2: Monoclonal antibodies may change the game

We’re starting to have a better understanding that what’s been called “viral persistence” as a main cause of long COVID may potentially be treated with monoclonal antibodies. These are antibodies produced by cloning unique white blood cells to target the circulating spike proteins in the blood that hang out in viral reservoirs and cause the immune system to react as if it’s still fighting acute COVID-19.

Smaller-scale studies have already shown promising results. A January 2024 study published in The American Journal of Emergency Medicine followed three patients who completely recovered from long COVID after taking monoclonal antibodies. “Remission occurred despite dissimilar past histories, sex, age, and illness duration,” wrote the study authors.

Larger clinical trials are underway at the University of California, San Francisco, California, to test targeted monoclonal antibodies. If the results of the larger study show that monoclonal antibodies are beneficial, then it could be a game changer for a large swath of patients around the world, said David F. Putrino, PhD, who runs the long COVID clinic at Mount Sinai Health System in New York City.

“The idea is that the downstream damage caused by viral persistence will resolve itself once you wipe out the virus,” said Dr. Putrino.

#3: Paxlovid could prove effective for long COVID

The US Food and Drug Administration granted approval for Paxlovid last May for the treatment of mild to moderate COVID-19 in adults at a high risk for severe disease. The medication is made up of two drugs packaged together. The first, nirmatrelvir, works by blocking a key enzyme required for virus replication. The second, ritonavir, is an antiviral that’s been used in patients with HIV and helps boost levels of antivirals in the body.

In a large-scale trial headed up by Dr. Putrino and his team, the oral antiviral is being studied for use in the post-viral stage in patients who test negative for acute COVID-19 but have persisting symptoms of long COVID.

Similar to monoclonal antibodies, the idea is to quell viral persistence. If patients have long COVID because they can’t clear SAR-CoV-2 from their bodies, Paxlovid could help. But unlike monoclonal antibodies that quash the virus, Paxlovid stops the virus from replicating. It’s a different mechanism with the same end goal.

It’s been a controversial treatment because it’s life-changing for some patients and ineffective for others. In addition, it can cause a range of side effects such as diarrhea, nausea, vomiting, and an impaired sense of taste. The goal of the trial is to see which patients with long COVID are most likely to benefit from the treatment.

#4: Anti-inflammatories like metformin could prove useful

Many of the inflammatory markers persistent in patients with long COVID were similarly present in patients with autoimmune diseases like rheumatoid arthritis, according to a July 2023 study published in JAMA.

The hope is that anti-inflammatory medications may be used to reduce inflammation causing long COVID symptoms. But drugs used to treat rheumatoid arthritis like abatacept and infliximabcan also have serious side effects, including increased risk for infection, flu-like symptoms, and burning of the skin.

“Powerful anti-inflammatories can change a number of pathways in the immune system,” said Grace McComsey, MD, who leads the long COVID RECOVER study at University Hospitals Health System in Cleveland, Ohio. Anti-inflammatories hold promise but, Dr. McComsey said, “some are more toxic with many side effects, so even if they work, there’s still a question about who should take them.”

Still, other anti-inflammatories that could work don’t have as many side effects. For example, a study published in The Lancet Infectious Diseases found that the diabetes drug metformin reduced a patient’s risk for long COVID up to 40% when the drug was taken during the acute stage.

Metformin, compared to other anti-inflammatories (also known as immune modulators), is an inexpensive and widely available drug with relatively few side effects compared with other medications.

#5: Serotonin levels — and selective serotonin reuptake inhibitors (SSRIs) — may be keys to unlocking long COVID

One of the most groundbreaking studies of the year came last November. A study published in the journal Cell found lower circulating serotonin levels in patents with long COVID than in those who did not have the condition. The study also found that the SSRI fluoxetine improved cognitive function in rat models infected with the virus.

Researchers found that the reduction in serotonin levels was partially caused by the body’s inability to absorb tryptophan, an amino acid that’s a precursor to serotonin. Overactivated blood platelets may also have played a role.

Michael Peluso, MD, an assistant research professor of infectious medicine at the UCSF School of Medicine, San Francisco, California, hopes to take the finding a step further, investigating whether increased serotonin levels in patients with long COVID will lead to improvements in symptoms.

“What we need now is a good clinical trial to see whether altering levels of serotonin in people with long COVID will lead to symptom relief,” Dr. Peluso said last month in an interview with this news organization.

If patients show an improvement in symptoms, then the next step is looking into whether SSRIs boost serotonin levels in patients and, as a result, reduce their symptoms.

A version of this article appeared on Medscape.com.

With a number of large-scale clinical trials underway and researchers on the hunt for new therapies, long COVID scientists are hopeful that this is the year patients — and doctors who care for them — will finally see improvements in treating their symptoms.

Here are five bold predictions — all based on encouraging research — that could happen in 2024. At the very least, they are promising signs of progress against a debilitating and frustrating disease.

#1: We’ll gain a better understanding of each long COVID phenotype

This past year, a wide breadth of research began showing that long COVID can be defined by a number of different disease phenotypes that present a range of symptoms.

Researchers identified four clinical phenotypes: Chronic fatigue-like syndrome, headache, and memory loss; respiratory syndrome, which includes cough and difficulty breathing; chronic pain; and neurosensorial syndrome, which causes an altered sense of taste and smell.

Identifying specific diagnostic criteria for each phenotype would lead to better health outcomes for patients instead of treating them as if it were a “one-size-fits-all disease,” said Nisha Viswanathan, MD, director of the long COVID program at UCLA Health, Los Angeles, California.

Ultimately, she hopes that this year her patients will receive treatments based on the type of long COVID they’re personally experiencing, and the symptoms they have, leading to improved health outcomes and more rapid relief.

“Many new medications are focused on different pathways of long COVID, and the challenge becomes which drug is the right drug for each treatment,” said Dr. Viswanathan.

#2: Monoclonal antibodies may change the game

We’re starting to have a better understanding that what’s been called “viral persistence” as a main cause of long COVID may potentially be treated with monoclonal antibodies. These are antibodies produced by cloning unique white blood cells to target the circulating spike proteins in the blood that hang out in viral reservoirs and cause the immune system to react as if it’s still fighting acute COVID-19.

Smaller-scale studies have already shown promising results. A January 2024 study published in The American Journal of Emergency Medicine followed three patients who completely recovered from long COVID after taking monoclonal antibodies. “Remission occurred despite dissimilar past histories, sex, age, and illness duration,” wrote the study authors.

Larger clinical trials are underway at the University of California, San Francisco, California, to test targeted monoclonal antibodies. If the results of the larger study show that monoclonal antibodies are beneficial, then it could be a game changer for a large swath of patients around the world, said David F. Putrino, PhD, who runs the long COVID clinic at Mount Sinai Health System in New York City.

“The idea is that the downstream damage caused by viral persistence will resolve itself once you wipe out the virus,” said Dr. Putrino.

#3: Paxlovid could prove effective for long COVID

The US Food and Drug Administration granted approval for Paxlovid last May for the treatment of mild to moderate COVID-19 in adults at a high risk for severe disease. The medication is made up of two drugs packaged together. The first, nirmatrelvir, works by blocking a key enzyme required for virus replication. The second, ritonavir, is an antiviral that’s been used in patients with HIV and helps boost levels of antivirals in the body.

In a large-scale trial headed up by Dr. Putrino and his team, the oral antiviral is being studied for use in the post-viral stage in patients who test negative for acute COVID-19 but have persisting symptoms of long COVID.

Similar to monoclonal antibodies, the idea is to quell viral persistence. If patients have long COVID because they can’t clear SAR-CoV-2 from their bodies, Paxlovid could help. But unlike monoclonal antibodies that quash the virus, Paxlovid stops the virus from replicating. It’s a different mechanism with the same end goal.

It’s been a controversial treatment because it’s life-changing for some patients and ineffective for others. In addition, it can cause a range of side effects such as diarrhea, nausea, vomiting, and an impaired sense of taste. The goal of the trial is to see which patients with long COVID are most likely to benefit from the treatment.

#4: Anti-inflammatories like metformin could prove useful

Many of the inflammatory markers persistent in patients with long COVID were similarly present in patients with autoimmune diseases like rheumatoid arthritis, according to a July 2023 study published in JAMA.

The hope is that anti-inflammatory medications may be used to reduce inflammation causing long COVID symptoms. But drugs used to treat rheumatoid arthritis like abatacept and infliximabcan also have serious side effects, including increased risk for infection, flu-like symptoms, and burning of the skin.

“Powerful anti-inflammatories can change a number of pathways in the immune system,” said Grace McComsey, MD, who leads the long COVID RECOVER study at University Hospitals Health System in Cleveland, Ohio. Anti-inflammatories hold promise but, Dr. McComsey said, “some are more toxic with many side effects, so even if they work, there’s still a question about who should take them.”

Still, other anti-inflammatories that could work don’t have as many side effects. For example, a study published in The Lancet Infectious Diseases found that the diabetes drug metformin reduced a patient’s risk for long COVID up to 40% when the drug was taken during the acute stage.

Metformin, compared to other anti-inflammatories (also known as immune modulators), is an inexpensive and widely available drug with relatively few side effects compared with other medications.

#5: Serotonin levels — and selective serotonin reuptake inhibitors (SSRIs) — may be keys to unlocking long COVID

One of the most groundbreaking studies of the year came last November. A study published in the journal Cell found lower circulating serotonin levels in patents with long COVID than in those who did not have the condition. The study also found that the SSRI fluoxetine improved cognitive function in rat models infected with the virus.

Researchers found that the reduction in serotonin levels was partially caused by the body’s inability to absorb tryptophan, an amino acid that’s a precursor to serotonin. Overactivated blood platelets may also have played a role.

Michael Peluso, MD, an assistant research professor of infectious medicine at the UCSF School of Medicine, San Francisco, California, hopes to take the finding a step further, investigating whether increased serotonin levels in patients with long COVID will lead to improvements in symptoms.

“What we need now is a good clinical trial to see whether altering levels of serotonin in people with long COVID will lead to symptom relief,” Dr. Peluso said last month in an interview with this news organization.

If patients show an improvement in symptoms, then the next step is looking into whether SSRIs boost serotonin levels in patients and, as a result, reduce their symptoms.

A version of this article appeared on Medscape.com.

With a number of large-scale clinical trials underway and researchers on the hunt for new therapies, long COVID scientists are hopeful that this is the year patients — and doctors who care for them — will finally see improvements in treating their symptoms.

Here are five bold predictions — all based on encouraging research — that could happen in 2024. At the very least, they are promising signs of progress against a debilitating and frustrating disease.

#1: We’ll gain a better understanding of each long COVID phenotype

This past year, a wide breadth of research began showing that long COVID can be defined by a number of different disease phenotypes that present a range of symptoms.

Researchers identified four clinical phenotypes: Chronic fatigue-like syndrome, headache, and memory loss; respiratory syndrome, which includes cough and difficulty breathing; chronic pain; and neurosensorial syndrome, which causes an altered sense of taste and smell.

Identifying specific diagnostic criteria for each phenotype would lead to better health outcomes for patients instead of treating them as if it were a “one-size-fits-all disease,” said Nisha Viswanathan, MD, director of the long COVID program at UCLA Health, Los Angeles, California.

Ultimately, she hopes that this year her patients will receive treatments based on the type of long COVID they’re personally experiencing, and the symptoms they have, leading to improved health outcomes and more rapid relief.

“Many new medications are focused on different pathways of long COVID, and the challenge becomes which drug is the right drug for each treatment,” said Dr. Viswanathan.

#2: Monoclonal antibodies may change the game

We’re starting to have a better understanding that what’s been called “viral persistence” as a main cause of long COVID may potentially be treated with monoclonal antibodies. These are antibodies produced by cloning unique white blood cells to target the circulating spike proteins in the blood that hang out in viral reservoirs and cause the immune system to react as if it’s still fighting acute COVID-19.

Smaller-scale studies have already shown promising results. A January 2024 study published in The American Journal of Emergency Medicine followed three patients who completely recovered from long COVID after taking monoclonal antibodies. “Remission occurred despite dissimilar past histories, sex, age, and illness duration,” wrote the study authors.

Larger clinical trials are underway at the University of California, San Francisco, California, to test targeted monoclonal antibodies. If the results of the larger study show that monoclonal antibodies are beneficial, then it could be a game changer for a large swath of patients around the world, said David F. Putrino, PhD, who runs the long COVID clinic at Mount Sinai Health System in New York City.

“The idea is that the downstream damage caused by viral persistence will resolve itself once you wipe out the virus,” said Dr. Putrino.

#3: Paxlovid could prove effective for long COVID

The US Food and Drug Administration granted approval for Paxlovid last May for the treatment of mild to moderate COVID-19 in adults at a high risk for severe disease. The medication is made up of two drugs packaged together. The first, nirmatrelvir, works by blocking a key enzyme required for virus replication. The second, ritonavir, is an antiviral that’s been used in patients with HIV and helps boost levels of antivirals in the body.

In a large-scale trial headed up by Dr. Putrino and his team, the oral antiviral is being studied for use in the post-viral stage in patients who test negative for acute COVID-19 but have persisting symptoms of long COVID.

Similar to monoclonal antibodies, the idea is to quell viral persistence. If patients have long COVID because they can’t clear SAR-CoV-2 from their bodies, Paxlovid could help. But unlike monoclonal antibodies that quash the virus, Paxlovid stops the virus from replicating. It’s a different mechanism with the same end goal.

It’s been a controversial treatment because it’s life-changing for some patients and ineffective for others. In addition, it can cause a range of side effects such as diarrhea, nausea, vomiting, and an impaired sense of taste. The goal of the trial is to see which patients with long COVID are most likely to benefit from the treatment.

#4: Anti-inflammatories like metformin could prove useful

Many of the inflammatory markers persistent in patients with long COVID were similarly present in patients with autoimmune diseases like rheumatoid arthritis, according to a July 2023 study published in JAMA.

The hope is that anti-inflammatory medications may be used to reduce inflammation causing long COVID symptoms. But drugs used to treat rheumatoid arthritis like abatacept and infliximabcan also have serious side effects, including increased risk for infection, flu-like symptoms, and burning of the skin.

“Powerful anti-inflammatories can change a number of pathways in the immune system,” said Grace McComsey, MD, who leads the long COVID RECOVER study at University Hospitals Health System in Cleveland, Ohio. Anti-inflammatories hold promise but, Dr. McComsey said, “some are more toxic with many side effects, so even if they work, there’s still a question about who should take them.”

Still, other anti-inflammatories that could work don’t have as many side effects. For example, a study published in The Lancet Infectious Diseases found that the diabetes drug metformin reduced a patient’s risk for long COVID up to 40% when the drug was taken during the acute stage.

Metformin, compared to other anti-inflammatories (also known as immune modulators), is an inexpensive and widely available drug with relatively few side effects compared with other medications.

#5: Serotonin levels — and selective serotonin reuptake inhibitors (SSRIs) — may be keys to unlocking long COVID

One of the most groundbreaking studies of the year came last November. A study published in the journal Cell found lower circulating serotonin levels in patents with long COVID than in those who did not have the condition. The study also found that the SSRI fluoxetine improved cognitive function in rat models infected with the virus.

Researchers found that the reduction in serotonin levels was partially caused by the body’s inability to absorb tryptophan, an amino acid that’s a precursor to serotonin. Overactivated blood platelets may also have played a role.

Michael Peluso, MD, an assistant research professor of infectious medicine at the UCSF School of Medicine, San Francisco, California, hopes to take the finding a step further, investigating whether increased serotonin levels in patients with long COVID will lead to improvements in symptoms.

“What we need now is a good clinical trial to see whether altering levels of serotonin in people with long COVID will lead to symptom relief,” Dr. Peluso said last month in an interview with this news organization.

If patients show an improvement in symptoms, then the next step is looking into whether SSRIs boost serotonin levels in patients and, as a result, reduce their symptoms.

A version of this article appeared on Medscape.com.

Circulating tumor DNA (ctDNA) has proven itself as a prognostic tool, but questions remain as to whether it can be used to guide the use of adjuvant chemotherapy in patients with colorectal cancer (CRC). Much of the uncertainty surrounds the sensitivity of ctDNA at the time when decisions regarding adjuvant therapy are being made.

Those were some of the key points made during a series of presentations and discussions on ctDNA at the ASCO Gastrointestinal Cancers Symposium.

In a morning session, Pashtoon Murtaza Kasi, MD, presented the first interim results from the multicenter, prospective observational BESPOKE CRC study, which included 689 patients with stage II or III colorectal cancer. The trial was designed to determine what effect ctDNA results would have on adjuvant chemotherapy treatment decisions. Over a median follow-up of 24.8 months, 623 patients had ctDNA results available. ctDNA positivity was associated with worse 2-year disease-free survival (DFS) at 29.86% versus 91.59% in the stage II/III combined group (hazard ratio [HR], 12.1; P < .0001) and in stage II (HR, 18.8; P < .0001) and stage III (HR, 9.9; P < .0001) analyzed separately.

In ctDNA-positive patients, adjuvant chemotherapy was associated with longer DFS than in those who did not undergo adjuvant chemotherapy (HR, 3.06; P = .0025), but there was no difference in DFS between ctDNA-negative patients who received adjuvant chemotherapy and those who didn’t. Patients who achieved ctDNA clearance had a longer median DFS (24.2 versus 13.8 months; HR, 0.4; P = .045).
 

Patient Anxiety Concerns

Dr. Kasi noted the importance of considering the patient’s view of ctDNA. There may be some concerns that such tests could cause patient anxiety, but he referenced a poster at ASCO GI which suggested the opposite. “It actually reduced anxiety, and 90% of the patients felt confident in the treatment they were receiving. They [said that] they will continue using the assay, and they value the additional information,” said Dr. Kasi, who is a medical oncologist at Weill Cornell Medicine in New York City.

During the Q&A after the talk, David Ellison, MD, a medical oncology and hematology specialist at Memorial Sloan Kettering Cancer Center, also in New York asked Dr. Kasi: “Did this [positive ctDNA] test just prompt earlier imaging? Was it any better than conventional surveillance like CEA (carcinoembryonic antigen) or imaging?” he asked.

Dr. Kasi responded that the data showed ctDNA positivity 6-9 months earlier than cancer detection through traditional imaging.

“It doesn’t necessarily replace the ongoing surveillance. This particular study did not guide or make it as a protocol as to what to do. Everything was done as part of standard of care, the usual surveillance that the cancer center follows, he said. “I think [ctDNA] would help complement the ongoing care and in conjunction with somebody who has, for example, an indeterminant lung nodule, but also has ctDNA positivity, I think it adds confidence to the decisions that one might be making.”

Eujung Kim, MD, PhD, an instructor of medicine at Harvard Medical School, Boston, Massachusetts, wondered if there might be chemoresistant tumor cells remaining that are not shedding DNA. “You have to keep the biology in mind as well make decisions in conjunction with the clinical situation, as opposed to in isolation with ctDNA results,” Dr. Kasi responded.

In the same session, Jeannie Tie, MD, described results from the AGITG DYNAMIC-Rectal trial, which was a randomized study to determine if ctDNA could inform adjuvant chemotherapy decisions in locally advanced rectal cancer. The analysis included 230 patients who were randomized to ctDNA-informed management (n = 155), with a positive test leading to adjuvant chemotherapy, or a standard arm where adjuvant therapy decisions were left to the physician (n = 75).

Adjuvant chemotherapy use was higher in the control arm (77% versus 46%; P < .001). Lymphovascular invasion was more common in the control arm (odds ratio [OR], 3.06; P = .023), and recurrence-free survival was higher in patients who remained ctDNA negative (HR, 0.29; P < .001) despite all ctDNA-positive patients and only 23% of ctDNA-negative patients undergoing chemotherapy.

The sites of relapses were also different, with 78% occurring in patients who were ctDNA negative after surgery occurring only in the lung, versus just 1% of metastases solely in the lung among those who were ctDNA positive.

In ctDNA-positive patients, 50% of relapses were only in the liver and 19% were in the liver and lung.

Over 36 months, 16% of ctDNA-negative patients developed distant relapses and 2.8% developed locoregional relapses, versus 36% and 7.1% in the ctDNA-positive group.

“Regrettably, we could not conclude about the noninferiority of [using ctDNA to guide adjuvant therapy decisions] due to the premature study closure and small sample size. We confirmed the significantly lower risk of recurrence in post-op ctDNA-negative patients compared to ctDNA-positive patients, as well as the differential pattern of relapse where lung metastases predominate in ctDNA-negative patients, while liver metastases were the dominant side of relapse in ctDNA-positive patients,” said Dr. Tie, who is a medical oncologist at the Peter MacCallum Cancer Centre, Victoria, Australia.
 

GALAXY Study Results Updated

In an afternoon session, Hiroki Yukami, MD, PhD, presented updated results of the GALAXY study, which examined 2998 patients with stage I-IV colorectal cancer who underwent ctDNA surveillance over a median 16.14 months following surgery. ctDNA-positive status was associated with worse DFS (HR, 10.53; P < .0001) in all stages as well as in stage II/III (HR, 12.05; P < .0001). The researchers also distinguished between patients with sustained ctDNA clearance and those with transient ctDNA clearance, in which a positive test occurred after an initial negative result. Recurrences occurred in 7.1% of patients with sustained ctDNA clearance, versus 85.2% of patients with transient clearance (P < .0001) and 89.4% of those with no clearance (P < .0001). “Sustained clearance indicates superior DFS compared to transient or no clearance,” said Dr. Yukami during his presentation.

Of 117 patients treated with adjuvant chemotherapy after testing ctDNA positive, subsequent ctDNA clearance was associated with better DFS (HR, 6.72; P < .0001). There were also better DFS outcomes among patients who saw a greater decline in ctDNA plasma levels after adjuvant chemotherapy (0%-50% versus 50%-100% reduction; HR, 2.41; P = .001).

Aparna Raj Parikh, MD, assistant professor of medicine at Harvard Medical School, served as a discussant for the GALAXY study. She acknowledged that ctDNA is the most powerful prognostic marker in oncology, but to be clinically useful it is necessary to consider its utility at the landmark time point, which is when decisions are made whether to treat with adjuvant chemotherapy. At that time point, the sensitivity of ctDNA is about 48% in the GALAXY study, which Dr. Parikh said is consistent with other data.
 

ctDNA ‘not sensitive enough’

“We know that postoperative ctDNA is only capturing 40%-50% of patients with recurrences in non–stage IV patients in multiple datasets to date. I think it’s really important to keep in mind the sensitivity of the different time points when you’re actually thinking about how to use this in clinic. The first generation of tests are certainly promising, but I would make the argument that these are just not sensitive enough,” said Dr. Parikh.

“Landmark testing is not yet sensitive enough to deescalate care in a patient where chemotherapy would otherwise be indicated, and surveillance testing has not yet demonstrated clinical utility. I think our goal to actually deescalate care would be to try to lower the ctDNA-negative population recurrence risk to akin to stage I patients, with that 5-year DFS of 93%-95%,” Dr. Parikh said.

Dr. Parikh offered some advice on how to use ctDNA outside of a clinical trial setting. She said that positive ctDNA results can help drive the decision to initiate adjuvant chemotherapy in concert with clinical and other factors.

“I’m pretty convinced by the data that ctDNA is prognostic, and though we still need outcomes data, in particular scenarios where I’m thinking of not giving chemotherapy, a positive test may sway me in that direction,” she said. She gave examples such as patients with a single high-risk feature, or a stage III patient with marginal performance status, or an elderly patient with low-risk stage III disease.

Dr. Kasi has financial relationships with Precision Biosensors, Elicio Therapeutics, Bayer, BostonGene, Daiichi Sankyo/AstraZeneca, Delcath Systems, Eisai, Elicio Therapeutics, Exact Sciences, Foundation Medicine, Guardant Health, Illumina, Ipsen, Lilly, MSD Oncology, Natera, NeoGenomics, QED Therapeutics, SAGA Diagnostics, Seagen, SERVIER, Taiho Oncology, Taiho Pharmaceutical, Advanced Accelerator Applications, Boston Scientific, and Tersera. Dr. Tie, Dr. Kim, Dr. Ellison, and Dr. Yukami did not disclose conflicts of interest. Dr. Parikh has financial relationships with Abbvie, Bayer, Biofidelity, CheckMate Pharmaceuticals, CVS, Delcath Systems, Foundation Medicine, Guardant Health, Illumina, Lily, SAGA Diagnostics, Scarce, Seagen, Taiho Oncology, Takeda, UpToDate, and Value Analytics Labs.

Circulating tumor DNA (ctDNA) has proven itself as a prognostic tool, but questions remain as to whether it can be used to guide the use of adjuvant chemotherapy in patients with colorectal cancer (CRC). Much of the uncertainty surrounds the sensitivity of ctDNA at the time when decisions regarding adjuvant therapy are being made.

Those were some of the key points made during a series of presentations and discussions on ctDNA at the ASCO Gastrointestinal Cancers Symposium.

In a morning session, Pashtoon Murtaza Kasi, MD, presented the first interim results from the multicenter, prospective observational BESPOKE CRC study, which included 689 patients with stage II or III colorectal cancer. The trial was designed to determine what effect ctDNA results would have on adjuvant chemotherapy treatment decisions. Over a median follow-up of 24.8 months, 623 patients had ctDNA results available. ctDNA positivity was associated with worse 2-year disease-free survival (DFS) at 29.86% versus 91.59% in the stage II/III combined group (hazard ratio [HR], 12.1; P < .0001) and in stage II (HR, 18.8; P < .0001) and stage III (HR, 9.9; P < .0001) analyzed separately.

In ctDNA-positive patients, adjuvant chemotherapy was associated with longer DFS than in those who did not undergo adjuvant chemotherapy (HR, 3.06; P = .0025), but there was no difference in DFS between ctDNA-negative patients who received adjuvant chemotherapy and those who didn’t. Patients who achieved ctDNA clearance had a longer median DFS (24.2 versus 13.8 months; HR, 0.4; P = .045).
 

Patient Anxiety Concerns

Dr. Kasi noted the importance of considering the patient’s view of ctDNA. There may be some concerns that such tests could cause patient anxiety, but he referenced a poster at ASCO GI which suggested the opposite. “It actually reduced anxiety, and 90% of the patients felt confident in the treatment they were receiving. They [said that] they will continue using the assay, and they value the additional information,” said Dr. Kasi, who is a medical oncologist at Weill Cornell Medicine in New York City.

During the Q&A after the talk, David Ellison, MD, a medical oncology and hematology specialist at Memorial Sloan Kettering Cancer Center, also in New York asked Dr. Kasi: “Did this [positive ctDNA] test just prompt earlier imaging? Was it any better than conventional surveillance like CEA (carcinoembryonic antigen) or imaging?” he asked.

Dr. Kasi responded that the data showed ctDNA positivity 6-9 months earlier than cancer detection through traditional imaging.

“It doesn’t necessarily replace the ongoing surveillance. This particular study did not guide or make it as a protocol as to what to do. Everything was done as part of standard of care, the usual surveillance that the cancer center follows, he said. “I think [ctDNA] would help complement the ongoing care and in conjunction with somebody who has, for example, an indeterminant lung nodule, but also has ctDNA positivity, I think it adds confidence to the decisions that one might be making.”

Eujung Kim, MD, PhD, an instructor of medicine at Harvard Medical School, Boston, Massachusetts, wondered if there might be chemoresistant tumor cells remaining that are not shedding DNA. “You have to keep the biology in mind as well make decisions in conjunction with the clinical situation, as opposed to in isolation with ctDNA results,” Dr. Kasi responded.

In the same session, Jeannie Tie, MD, described results from the AGITG DYNAMIC-Rectal trial, which was a randomized study to determine if ctDNA could inform adjuvant chemotherapy decisions in locally advanced rectal cancer. The analysis included 230 patients who were randomized to ctDNA-informed management (n = 155), with a positive test leading to adjuvant chemotherapy, or a standard arm where adjuvant therapy decisions were left to the physician (n = 75).

Adjuvant chemotherapy use was higher in the control arm (77% versus 46%; P < .001). Lymphovascular invasion was more common in the control arm (odds ratio [OR], 3.06; P = .023), and recurrence-free survival was higher in patients who remained ctDNA negative (HR, 0.29; P < .001) despite all ctDNA-positive patients and only 23% of ctDNA-negative patients undergoing chemotherapy.

The sites of relapses were also different, with 78% occurring in patients who were ctDNA negative after surgery occurring only in the lung, versus just 1% of metastases solely in the lung among those who were ctDNA positive.

In ctDNA-positive patients, 50% of relapses were only in the liver and 19% were in the liver and lung.

Over 36 months, 16% of ctDNA-negative patients developed distant relapses and 2.8% developed locoregional relapses, versus 36% and 7.1% in the ctDNA-positive group.

“Regrettably, we could not conclude about the noninferiority of [using ctDNA to guide adjuvant therapy decisions] due to the premature study closure and small sample size. We confirmed the significantly lower risk of recurrence in post-op ctDNA-negative patients compared to ctDNA-positive patients, as well as the differential pattern of relapse where lung metastases predominate in ctDNA-negative patients, while liver metastases were the dominant side of relapse in ctDNA-positive patients,” said Dr. Tie, who is a medical oncologist at the Peter MacCallum Cancer Centre, Victoria, Australia.
 

GALAXY Study Results Updated

In an afternoon session, Hiroki Yukami, MD, PhD, presented updated results of the GALAXY study, which examined 2998 patients with stage I-IV colorectal cancer who underwent ctDNA surveillance over a median 16.14 months following surgery. ctDNA-positive status was associated with worse DFS (HR, 10.53; P < .0001) in all stages as well as in stage II/III (HR, 12.05; P < .0001). The researchers also distinguished between patients with sustained ctDNA clearance and those with transient ctDNA clearance, in which a positive test occurred after an initial negative result. Recurrences occurred in 7.1% of patients with sustained ctDNA clearance, versus 85.2% of patients with transient clearance (P < .0001) and 89.4% of those with no clearance (P < .0001). “Sustained clearance indicates superior DFS compared to transient or no clearance,” said Dr. Yukami during his presentation.

Of 117 patients treated with adjuvant chemotherapy after testing ctDNA positive, subsequent ctDNA clearance was associated with better DFS (HR, 6.72; P < .0001). There were also better DFS outcomes among patients who saw a greater decline in ctDNA plasma levels after adjuvant chemotherapy (0%-50% versus 50%-100% reduction; HR, 2.41; P = .001).

Aparna Raj Parikh, MD, assistant professor of medicine at Harvard Medical School, served as a discussant for the GALAXY study. She acknowledged that ctDNA is the most powerful prognostic marker in oncology, but to be clinically useful it is necessary to consider its utility at the landmark time point, which is when decisions are made whether to treat with adjuvant chemotherapy. At that time point, the sensitivity of ctDNA is about 48% in the GALAXY study, which Dr. Parikh said is consistent with other data.
 

ctDNA ‘not sensitive enough’

“We know that postoperative ctDNA is only capturing 40%-50% of patients with recurrences in non–stage IV patients in multiple datasets to date. I think it’s really important to keep in mind the sensitivity of the different time points when you’re actually thinking about how to use this in clinic. The first generation of tests are certainly promising, but I would make the argument that these are just not sensitive enough,” said Dr. Parikh.

“Landmark testing is not yet sensitive enough to deescalate care in a patient where chemotherapy would otherwise be indicated, and surveillance testing has not yet demonstrated clinical utility. I think our goal to actually deescalate care would be to try to lower the ctDNA-negative population recurrence risk to akin to stage I patients, with that 5-year DFS of 93%-95%,” Dr. Parikh said.

Dr. Parikh offered some advice on how to use ctDNA outside of a clinical trial setting. She said that positive ctDNA results can help drive the decision to initiate adjuvant chemotherapy in concert with clinical and other factors.

“I’m pretty convinced by the data that ctDNA is prognostic, and though we still need outcomes data, in particular scenarios where I’m thinking of not giving chemotherapy, a positive test may sway me in that direction,” she said. She gave examples such as patients with a single high-risk feature, or a stage III patient with marginal performance status, or an elderly patient with low-risk stage III disease.

Dr. Kasi has financial relationships with Precision Biosensors, Elicio Therapeutics, Bayer, BostonGene, Daiichi Sankyo/AstraZeneca, Delcath Systems, Eisai, Elicio Therapeutics, Exact Sciences, Foundation Medicine, Guardant Health, Illumina, Ipsen, Lilly, MSD Oncology, Natera, NeoGenomics, QED Therapeutics, SAGA Diagnostics, Seagen, SERVIER, Taiho Oncology, Taiho Pharmaceutical, Advanced Accelerator Applications, Boston Scientific, and Tersera. Dr. Tie, Dr. Kim, Dr. Ellison, and Dr. Yukami did not disclose conflicts of interest. Dr. Parikh has financial relationships with Abbvie, Bayer, Biofidelity, CheckMate Pharmaceuticals, CVS, Delcath Systems, Foundation Medicine, Guardant Health, Illumina, Lily, SAGA Diagnostics, Scarce, Seagen, Taiho Oncology, Takeda, UpToDate, and Value Analytics Labs.

Circulating tumor DNA (ctDNA) has proven itself as a prognostic tool, but questions remain as to whether it can be used to guide the use of adjuvant chemotherapy in patients with colorectal cancer (CRC). Much of the uncertainty surrounds the sensitivity of ctDNA at the time when decisions regarding adjuvant therapy are being made.

Those were some of the key points made during a series of presentations and discussions on ctDNA at the ASCO Gastrointestinal Cancers Symposium.

In a morning session, Pashtoon Murtaza Kasi, MD, presented the first interim results from the multicenter, prospective observational BESPOKE CRC study, which included 689 patients with stage II or III colorectal cancer. The trial was designed to determine what effect ctDNA results would have on adjuvant chemotherapy treatment decisions. Over a median follow-up of 24.8 months, 623 patients had ctDNA results available. ctDNA positivity was associated with worse 2-year disease-free survival (DFS) at 29.86% versus 91.59% in the stage II/III combined group (hazard ratio [HR], 12.1; P < .0001) and in stage II (HR, 18.8; P < .0001) and stage III (HR, 9.9; P < .0001) analyzed separately.

In ctDNA-positive patients, adjuvant chemotherapy was associated with longer DFS than in those who did not undergo adjuvant chemotherapy (HR, 3.06; P = .0025), but there was no difference in DFS between ctDNA-negative patients who received adjuvant chemotherapy and those who didn’t. Patients who achieved ctDNA clearance had a longer median DFS (24.2 versus 13.8 months; HR, 0.4; P = .045).
 

Patient Anxiety Concerns

Dr. Kasi noted the importance of considering the patient’s view of ctDNA. There may be some concerns that such tests could cause patient anxiety, but he referenced a poster at ASCO GI which suggested the opposite. “It actually reduced anxiety, and 90% of the patients felt confident in the treatment they were receiving. They [said that] they will continue using the assay, and they value the additional information,” said Dr. Kasi, who is a medical oncologist at Weill Cornell Medicine in New York City.

During the Q&A after the talk, David Ellison, MD, a medical oncology and hematology specialist at Memorial Sloan Kettering Cancer Center, also in New York asked Dr. Kasi: “Did this [positive ctDNA] test just prompt earlier imaging? Was it any better than conventional surveillance like CEA (carcinoembryonic antigen) or imaging?” he asked.

Dr. Kasi responded that the data showed ctDNA positivity 6-9 months earlier than cancer detection through traditional imaging.

“It doesn’t necessarily replace the ongoing surveillance. This particular study did not guide or make it as a protocol as to what to do. Everything was done as part of standard of care, the usual surveillance that the cancer center follows, he said. “I think [ctDNA] would help complement the ongoing care and in conjunction with somebody who has, for example, an indeterminant lung nodule, but also has ctDNA positivity, I think it adds confidence to the decisions that one might be making.”

Eujung Kim, MD, PhD, an instructor of medicine at Harvard Medical School, Boston, Massachusetts, wondered if there might be chemoresistant tumor cells remaining that are not shedding DNA. “You have to keep the biology in mind as well make decisions in conjunction with the clinical situation, as opposed to in isolation with ctDNA results,” Dr. Kasi responded.

In the same session, Jeannie Tie, MD, described results from the AGITG DYNAMIC-Rectal trial, which was a randomized study to determine if ctDNA could inform adjuvant chemotherapy decisions in locally advanced rectal cancer. The analysis included 230 patients who were randomized to ctDNA-informed management (n = 155), with a positive test leading to adjuvant chemotherapy, or a standard arm where adjuvant therapy decisions were left to the physician (n = 75).

Adjuvant chemotherapy use was higher in the control arm (77% versus 46%; P < .001). Lymphovascular invasion was more common in the control arm (odds ratio [OR], 3.06; P = .023), and recurrence-free survival was higher in patients who remained ctDNA negative (HR, 0.29; P < .001) despite all ctDNA-positive patients and only 23% of ctDNA-negative patients undergoing chemotherapy.

The sites of relapses were also different, with 78% occurring in patients who were ctDNA negative after surgery occurring only in the lung, versus just 1% of metastases solely in the lung among those who were ctDNA positive.

In ctDNA-positive patients, 50% of relapses were only in the liver and 19% were in the liver and lung.

Over 36 months, 16% of ctDNA-negative patients developed distant relapses and 2.8% developed locoregional relapses, versus 36% and 7.1% in the ctDNA-positive group.

“Regrettably, we could not conclude about the noninferiority of [using ctDNA to guide adjuvant therapy decisions] due to the premature study closure and small sample size. We confirmed the significantly lower risk of recurrence in post-op ctDNA-negative patients compared to ctDNA-positive patients, as well as the differential pattern of relapse where lung metastases predominate in ctDNA-negative patients, while liver metastases were the dominant side of relapse in ctDNA-positive patients,” said Dr. Tie, who is a medical oncologist at the Peter MacCallum Cancer Centre, Victoria, Australia.
 

GALAXY Study Results Updated

In an afternoon session, Hiroki Yukami, MD, PhD, presented updated results of the GALAXY study, which examined 2998 patients with stage I-IV colorectal cancer who underwent ctDNA surveillance over a median 16.14 months following surgery. ctDNA-positive status was associated with worse DFS (HR, 10.53; P < .0001) in all stages as well as in stage II/III (HR, 12.05; P < .0001). The researchers also distinguished between patients with sustained ctDNA clearance and those with transient ctDNA clearance, in which a positive test occurred after an initial negative result. Recurrences occurred in 7.1% of patients with sustained ctDNA clearance, versus 85.2% of patients with transient clearance (P < .0001) and 89.4% of those with no clearance (P < .0001). “Sustained clearance indicates superior DFS compared to transient or no clearance,” said Dr. Yukami during his presentation.

Of 117 patients treated with adjuvant chemotherapy after testing ctDNA positive, subsequent ctDNA clearance was associated with better DFS (HR, 6.72; P < .0001). There were also better DFS outcomes among patients who saw a greater decline in ctDNA plasma levels after adjuvant chemotherapy (0%-50% versus 50%-100% reduction; HR, 2.41; P = .001).

Aparna Raj Parikh, MD, assistant professor of medicine at Harvard Medical School, served as a discussant for the GALAXY study. She acknowledged that ctDNA is the most powerful prognostic marker in oncology, but to be clinically useful it is necessary to consider its utility at the landmark time point, which is when decisions are made whether to treat with adjuvant chemotherapy. At that time point, the sensitivity of ctDNA is about 48% in the GALAXY study, which Dr. Parikh said is consistent with other data.
 

ctDNA ‘not sensitive enough’

“We know that postoperative ctDNA is only capturing 40%-50% of patients with recurrences in non–stage IV patients in multiple datasets to date. I think it’s really important to keep in mind the sensitivity of the different time points when you’re actually thinking about how to use this in clinic. The first generation of tests are certainly promising, but I would make the argument that these are just not sensitive enough,” said Dr. Parikh.

“Landmark testing is not yet sensitive enough to deescalate care in a patient where chemotherapy would otherwise be indicated, and surveillance testing has not yet demonstrated clinical utility. I think our goal to actually deescalate care would be to try to lower the ctDNA-negative population recurrence risk to akin to stage I patients, with that 5-year DFS of 93%-95%,” Dr. Parikh said.

Dr. Parikh offered some advice on how to use ctDNA outside of a clinical trial setting. She said that positive ctDNA results can help drive the decision to initiate adjuvant chemotherapy in concert with clinical and other factors.

“I’m pretty convinced by the data that ctDNA is prognostic, and though we still need outcomes data, in particular scenarios where I’m thinking of not giving chemotherapy, a positive test may sway me in that direction,” she said. She gave examples such as patients with a single high-risk feature, or a stage III patient with marginal performance status, or an elderly patient with low-risk stage III disease.

Dr. Kasi has financial relationships with Precision Biosensors, Elicio Therapeutics, Bayer, BostonGene, Daiichi Sankyo/AstraZeneca, Delcath Systems, Eisai, Elicio Therapeutics, Exact Sciences, Foundation Medicine, Guardant Health, Illumina, Ipsen, Lilly, MSD Oncology, Natera, NeoGenomics, QED Therapeutics, SAGA Diagnostics, Seagen, SERVIER, Taiho Oncology, Taiho Pharmaceutical, Advanced Accelerator Applications, Boston Scientific, and Tersera. Dr. Tie, Dr. Kim, Dr. Ellison, and Dr. Yukami did not disclose conflicts of interest. Dr. Parikh has financial relationships with Abbvie, Bayer, Biofidelity, CheckMate Pharmaceuticals, CVS, Delcath Systems, Foundation Medicine, Guardant Health, Illumina, Lily, SAGA Diagnostics, Scarce, Seagen, Taiho Oncology, Takeda, UpToDate, and Value Analytics Labs.

Officials at Dana-Farber Cancer Institute are moving to retract at least six published research papers and correct 31 others amid allegations of data manipulation.

News of the investigation follows a blog post by British molecular biologist Sholto David, MD, who flagged almost 60 papers published between 1997 and 2017 that contained image manipulation and other errors. Some of the papers were published by Dana-Farber’s chief executive officer, Laurie Glimcher, MD, and chief operating officer, William Hahn, MD, on topics including multiple myeloma and immune cells.

Mr. David, who blogs about research integrity, highlighted numerous errors and irregularities, including copying and pasting images across multiple experiments to represent different days within the same experiment, sometimes rotating or stretching images.

In one case, Mr. David equated the manipulation with tactics used by “hapless Chinese papermills” and concluded that “a swathe of research coming out of [Dana-Farber] authored by the most senior researchers and managers appears to be hopelessly corrupt with errors that are obvious from just a cursory reading the papers.” 

“Imagine what mistakes might be found in the raw data if anyone was allowed to look!” he wrote.

Barrett Rollins, MD, PhD, Dana-Farber Cancer Institute’s research integrity officer, declined to comment on whether the errors represent scientific misconduct, according to STAT. Rollins told ScienceInsider that the “presence of image discrepancies in a paper is not evidence of an author’s intent to deceive.” 

Access to new artificial intelligence tools is making it easier for data sleuths, like Mr. David, to unearth data manipulation and errors. 

The current investigation closely follows two other investigations into the published work of Harvard University’s former president, Claudine Gay, and Stanford University’s former president, Marc Tessier-Lavigne, which led both to resign their posts. 

A version of this article appeared on Medscape.com.

Officials at Dana-Farber Cancer Institute are moving to retract at least six published research papers and correct 31 others amid allegations of data manipulation.

News of the investigation follows a blog post by British molecular biologist Sholto David, MD, who flagged almost 60 papers published between 1997 and 2017 that contained image manipulation and other errors. Some of the papers were published by Dana-Farber’s chief executive officer, Laurie Glimcher, MD, and chief operating officer, William Hahn, MD, on topics including multiple myeloma and immune cells.

Mr. David, who blogs about research integrity, highlighted numerous errors and irregularities, including copying and pasting images across multiple experiments to represent different days within the same experiment, sometimes rotating or stretching images.

In one case, Mr. David equated the manipulation with tactics used by “hapless Chinese papermills” and concluded that “a swathe of research coming out of [Dana-Farber] authored by the most senior researchers and managers appears to be hopelessly corrupt with errors that are obvious from just a cursory reading the papers.” 

“Imagine what mistakes might be found in the raw data if anyone was allowed to look!” he wrote.

Barrett Rollins, MD, PhD, Dana-Farber Cancer Institute’s research integrity officer, declined to comment on whether the errors represent scientific misconduct, according to STAT. Rollins told ScienceInsider that the “presence of image discrepancies in a paper is not evidence of an author’s intent to deceive.” 

Access to new artificial intelligence tools is making it easier for data sleuths, like Mr. David, to unearth data manipulation and errors. 

The current investigation closely follows two other investigations into the published work of Harvard University’s former president, Claudine Gay, and Stanford University’s former president, Marc Tessier-Lavigne, which led both to resign their posts. 

A version of this article appeared on Medscape.com.

Officials at Dana-Farber Cancer Institute are moving to retract at least six published research papers and correct 31 others amid allegations of data manipulation.

News of the investigation follows a blog post by British molecular biologist Sholto David, MD, who flagged almost 60 papers published between 1997 and 2017 that contained image manipulation and other errors. Some of the papers were published by Dana-Farber’s chief executive officer, Laurie Glimcher, MD, and chief operating officer, William Hahn, MD, on topics including multiple myeloma and immune cells.

Mr. David, who blogs about research integrity, highlighted numerous errors and irregularities, including copying and pasting images across multiple experiments to represent different days within the same experiment, sometimes rotating or stretching images.

In one case, Mr. David equated the manipulation with tactics used by “hapless Chinese papermills” and concluded that “a swathe of research coming out of [Dana-Farber] authored by the most senior researchers and managers appears to be hopelessly corrupt with errors that are obvious from just a cursory reading the papers.” 

“Imagine what mistakes might be found in the raw data if anyone was allowed to look!” he wrote.

Barrett Rollins, MD, PhD, Dana-Farber Cancer Institute’s research integrity officer, declined to comment on whether the errors represent scientific misconduct, according to STAT. Rollins told ScienceInsider that the “presence of image discrepancies in a paper is not evidence of an author’s intent to deceive.” 

Access to new artificial intelligence tools is making it easier for data sleuths, like Mr. David, to unearth data manipulation and errors. 

The current investigation closely follows two other investigations into the published work of Harvard University’s former president, Claudine Gay, and Stanford University’s former president, Marc Tessier-Lavigne, which led both to resign their posts. 

A version of this article appeared on Medscape.com.

Foreign-trained doctors can supplement the nation’s waning physician workforce and bring diverse perspectives to patient care, but a new study finds that most never enter comparable roles after immigration, raising questions about the feasibility of educational and licensing pathways for international medical graduates (IMGs). 

Conducted by the Federal Reserve Bank of Minneapolis and the nonprofit Upwardly Global, the study analyzed the data of 300 physicians who immigrated to the United States between 2004 and 2022. 

Although 85% of IMGs found employment, only 1 in 3 became a medical resident or doctor. 

Despite the study’s small sample size, it highlights the hurdles IMGs face, the authors noted. Even though they have a medical degree and potentially years of clinical experience in another country, they typically must start all over again in the US — passing the United States Medical Licensing Examination (USMLE), obtaining clinical experience, and securing a residency spot. 

If unable to complete these steps, IMGs may pursue other healthcare jobs for which they’re overqualified and underpaid, given their experience. The study found that 23% of IMGs who were not on track to become physicians worked as medical assistants. Others became clinical researchers, medical interpreters, and case managers. 

Russian ob/gyn Maxim Nikolaevskiy moved to the US in 2018 and understands why some IMGs switch career paths. His wife, who also trained as a physician in Russia, opted to enroll in a respiratory therapy program after they immigrated to Minnesota, whereas he found work as a research coordinator. The pressure to find housing, enroll their kids in school, and establish new routines took much of their focus. 

Dr. Nikolaevskiy told this news organization that IMGs often struggle to find a residency program willing to consider their unique career trajectory, which looks markedly different from that of someone trained in the US. 

“Multiple residency programs refuse IMGs’ applications, saying they graduated too long ago, without understanding they worked as a physician before,” he said. Immigrant doctors accepting nonphysician jobs once in the US, often out of financial necessity, only adds to this confusion. 

New federal and state legislation aim to reduce practice barriers for IMGs and shore up physician shortages and access for some of the nation›s most vulnerable counties. 

The Conrad State 30 and Physician Access Reauthorization Act, supported by the American Medical Association, would revamp the J-1 visa waiver program to permit more immigrant physicians to work in medically underserved areas instead of returning to their home countries. 

Last year, Alabama streamlined rules to allow IMGs to practice earlier. Effective July 1, those residing in Tennessee may skip residency requirements and receive a temporary medical license once they pass the state medical board and prove they have completed a 3-year postgraduate training program in their licensing country or recently fulfilled physician duties outside the US. 

Washington state now issues 2-year medical licenses to foreign-trained doctors, no residency required, with the possibility of renewal. Doctors must meet other requirements, including passing all steps of the USMLE and establishing a practice agreement with a supervising physician. Illinois recently passed a similar law that will take effect in January 2025. 

Beyond laws, communities can embrace IMGs and offer career guidance and clinical opportunities. Daniel Weber, MD, founded the International Healthcare Professionals Program in Lancaster, Pennsylvania, to provide this critical support. 

“It is daunting to master a new language and pass medical licensing and English proficiency exams while working full time to support themselves and their families,” Dr. Weber said. 

Some participants have entered US residency training programs, but Weber told this news organization that many others have earned nursing degrees and are on track to become nurse practitioners. 

More than 5 years after leaving Russia, Dr. Nikolaevskiy is inching closer to practicing medicine again. 

He recently completed the Bridge to Residency for Immigrant International Doctor Graduates (BRIIDGE) program at the University of Minnesota Medical School. The 9-month program offers clinical experiences in community settings, outpatient primary care, and inpatient general medicine and pediatrics, clearing the way for him to apply for family medicine residency and possibly match in this cycle. 

“If not for the BRIIDGE program, I would still be [doing] medical monitoring in clinical trials or pharmacovigilance jobs. I’m grateful for the clinical experience and the people and institutions ready to give me a second chance,” he said.

A version of this article appeared on Medscape.com.

Foreign-trained doctors can supplement the nation’s waning physician workforce and bring diverse perspectives to patient care, but a new study finds that most never enter comparable roles after immigration, raising questions about the feasibility of educational and licensing pathways for international medical graduates (IMGs). 

Conducted by the Federal Reserve Bank of Minneapolis and the nonprofit Upwardly Global, the study analyzed the data of 300 physicians who immigrated to the United States between 2004 and 2022. 

Although 85% of IMGs found employment, only 1 in 3 became a medical resident or doctor. 

Despite the study’s small sample size, it highlights the hurdles IMGs face, the authors noted. Even though they have a medical degree and potentially years of clinical experience in another country, they typically must start all over again in the US — passing the United States Medical Licensing Examination (USMLE), obtaining clinical experience, and securing a residency spot. 

If unable to complete these steps, IMGs may pursue other healthcare jobs for which they’re overqualified and underpaid, given their experience. The study found that 23% of IMGs who were not on track to become physicians worked as medical assistants. Others became clinical researchers, medical interpreters, and case managers. 

Russian ob/gyn Maxim Nikolaevskiy moved to the US in 2018 and understands why some IMGs switch career paths. His wife, who also trained as a physician in Russia, opted to enroll in a respiratory therapy program after they immigrated to Minnesota, whereas he found work as a research coordinator. The pressure to find housing, enroll their kids in school, and establish new routines took much of their focus. 

Dr. Nikolaevskiy told this news organization that IMGs often struggle to find a residency program willing to consider their unique career trajectory, which looks markedly different from that of someone trained in the US. 

“Multiple residency programs refuse IMGs’ applications, saying they graduated too long ago, without understanding they worked as a physician before,” he said. Immigrant doctors accepting nonphysician jobs once in the US, often out of financial necessity, only adds to this confusion. 

New federal and state legislation aim to reduce practice barriers for IMGs and shore up physician shortages and access for some of the nation›s most vulnerable counties. 

The Conrad State 30 and Physician Access Reauthorization Act, supported by the American Medical Association, would revamp the J-1 visa waiver program to permit more immigrant physicians to work in medically underserved areas instead of returning to their home countries. 

Last year, Alabama streamlined rules to allow IMGs to practice earlier. Effective July 1, those residing in Tennessee may skip residency requirements and receive a temporary medical license once they pass the state medical board and prove they have completed a 3-year postgraduate training program in their licensing country or recently fulfilled physician duties outside the US. 

Washington state now issues 2-year medical licenses to foreign-trained doctors, no residency required, with the possibility of renewal. Doctors must meet other requirements, including passing all steps of the USMLE and establishing a practice agreement with a supervising physician. Illinois recently passed a similar law that will take effect in January 2025. 

Beyond laws, communities can embrace IMGs and offer career guidance and clinical opportunities. Daniel Weber, MD, founded the International Healthcare Professionals Program in Lancaster, Pennsylvania, to provide this critical support. 

“It is daunting to master a new language and pass medical licensing and English proficiency exams while working full time to support themselves and their families,” Dr. Weber said. 

Some participants have entered US residency training programs, but Weber told this news organization that many others have earned nursing degrees and are on track to become nurse practitioners. 

More than 5 years after leaving Russia, Dr. Nikolaevskiy is inching closer to practicing medicine again. 

He recently completed the Bridge to Residency for Immigrant International Doctor Graduates (BRIIDGE) program at the University of Minnesota Medical School. The 9-month program offers clinical experiences in community settings, outpatient primary care, and inpatient general medicine and pediatrics, clearing the way for him to apply for family medicine residency and possibly match in this cycle. 

“If not for the BRIIDGE program, I would still be [doing] medical monitoring in clinical trials or pharmacovigilance jobs. I’m grateful for the clinical experience and the people and institutions ready to give me a second chance,” he said.

A version of this article appeared on Medscape.com.

Foreign-trained doctors can supplement the nation’s waning physician workforce and bring diverse perspectives to patient care, but a new study finds that most never enter comparable roles after immigration, raising questions about the feasibility of educational and licensing pathways for international medical graduates (IMGs). 

Conducted by the Federal Reserve Bank of Minneapolis and the nonprofit Upwardly Global, the study analyzed the data of 300 physicians who immigrated to the United States between 2004 and 2022. 

Although 85% of IMGs found employment, only 1 in 3 became a medical resident or doctor. 

Despite the study’s small sample size, it highlights the hurdles IMGs face, the authors noted. Even though they have a medical degree and potentially years of clinical experience in another country, they typically must start all over again in the US — passing the United States Medical Licensing Examination (USMLE), obtaining clinical experience, and securing a residency spot. 

If unable to complete these steps, IMGs may pursue other healthcare jobs for which they’re overqualified and underpaid, given their experience. The study found that 23% of IMGs who were not on track to become physicians worked as medical assistants. Others became clinical researchers, medical interpreters, and case managers. 

Russian ob/gyn Maxim Nikolaevskiy moved to the US in 2018 and understands why some IMGs switch career paths. His wife, who also trained as a physician in Russia, opted to enroll in a respiratory therapy program after they immigrated to Minnesota, whereas he found work as a research coordinator. The pressure to find housing, enroll their kids in school, and establish new routines took much of their focus. 

Dr. Nikolaevskiy told this news organization that IMGs often struggle to find a residency program willing to consider their unique career trajectory, which looks markedly different from that of someone trained in the US. 

“Multiple residency programs refuse IMGs’ applications, saying they graduated too long ago, without understanding they worked as a physician before,” he said. Immigrant doctors accepting nonphysician jobs once in the US, often out of financial necessity, only adds to this confusion. 

New federal and state legislation aim to reduce practice barriers for IMGs and shore up physician shortages and access for some of the nation›s most vulnerable counties. 

The Conrad State 30 and Physician Access Reauthorization Act, supported by the American Medical Association, would revamp the J-1 visa waiver program to permit more immigrant physicians to work in medically underserved areas instead of returning to their home countries. 

Last year, Alabama streamlined rules to allow IMGs to practice earlier. Effective July 1, those residing in Tennessee may skip residency requirements and receive a temporary medical license once they pass the state medical board and prove they have completed a 3-year postgraduate training program in their licensing country or recently fulfilled physician duties outside the US. 

Washington state now issues 2-year medical licenses to foreign-trained doctors, no residency required, with the possibility of renewal. Doctors must meet other requirements, including passing all steps of the USMLE and establishing a practice agreement with a supervising physician. Illinois recently passed a similar law that will take effect in January 2025. 

Beyond laws, communities can embrace IMGs and offer career guidance and clinical opportunities. Daniel Weber, MD, founded the International Healthcare Professionals Program in Lancaster, Pennsylvania, to provide this critical support. 

“It is daunting to master a new language and pass medical licensing and English proficiency exams while working full time to support themselves and their families,” Dr. Weber said. 

Some participants have entered US residency training programs, but Weber told this news organization that many others have earned nursing degrees and are on track to become nurse practitioners. 

More than 5 years after leaving Russia, Dr. Nikolaevskiy is inching closer to practicing medicine again. 

He recently completed the Bridge to Residency for Immigrant International Doctor Graduates (BRIIDGE) program at the University of Minnesota Medical School. The 9-month program offers clinical experiences in community settings, outpatient primary care, and inpatient general medicine and pediatrics, clearing the way for him to apply for family medicine residency and possibly match in this cycle. 

“If not for the BRIIDGE program, I would still be [doing] medical monitoring in clinical trials or pharmacovigilance jobs. I’m grateful for the clinical experience and the people and institutions ready to give me a second chance,” he said.

A version of this article appeared on Medscape.com.

With last month’s American Society of Hematology (ASH) annual conference in the rearview mirror, Ghulam Rehman “Manni” Mohyuddin, MD, a young medical oncologist who reaches out to colleagues via social media, hopes his efforts to support and inspire trainees at ASH 2023 will help propel them forward in their chosen field of medicine.

Ahead of the conference held in San Diego in December, Dr. Mohyuddin, a blood cancer specialist with a focus on multiple myeloma and medical education, put out a heartfelt appeal on X (formerly Twitter): “If you’re a trainee and interested in meeting me at #ASH23, please reach out … (especially if [international medical graduate]) I’d love to meet and offer support in whatever capacity I can! I can’t have a research project for each one of you, but happy to help/mentor in any other way possible,” he posted on X back in late November.

An international medical graduate himself, Dr. Mohyuddin recalls how overwhelmed he felt when he first attended an annual ASH conference as a trainee, so he aims to reassure others that they “don’t have to know everything.”

“It’s about networking and broadening horizons,” he said in an interview that took place between ASH sessions, his own research presentations, and meetings with the many trainees who took him up on the offer he made via X. “I’ve spent most of this ASH meeting trainees — it’s the most rewarding thing for me at these meetings.

“Reassurance is a lot of what we do in oncology,” he continued, drawing a connection between his affinity for helping trainees and providing compassionate care to patients. “For an oncologist, the single most important thing is having excellent communication skills and being able to express support and empathy. The ability to connect deeply with your patients during their time of need is profoundly important.

“You can compensate for lack of knowledge, because we have so many other sources of support for knowledge, but you simply cannot compensate for poor communication skills, and your patient suffers as a result,” he said.
 

Relationship Building

In addition to the guidance he received from mentors, Dr. Mohyuddin noted that it was the chance to build supportive, empathetic relationships that drew him to specialize in blood cancer and, in particular, to caring for patients with multiple myeloma and conducting research focused on improving the patient experience.

Dr. Mohyuddin attended medical school at the Aga Khan University in Pakistan, then completed his internal medicine residency and fellowship at the University of Kansas in Kansas City. As a chief resident there, he focused on novel approaches to education delivery and improving access to research for trainees. As a fellow, he developed clinical and research interests in multiple myeloma, which he describes as an “incredibly rewarding field” marked by “truly spectacular advances over the last two decades.”

“There are some cancers you can cure, which means you don’t get to see patients often, and there are some you can’t cure, where patients die early, and there’s not a lot of time to build a relationship,” he said. “But there are some where patients can do well even though they aren’t currently cured, and you get to form really amazing and meaningful relationships over a long period of time.

“Multiple myeloma occupies that space, and that’s why I’m drawn to it,” Dr. Mohyuddin added, noting that he doesn’t shy away from forging emotional connections with patients. “I recognize that makes me vulnerable, but I think that is essentially what your patients deserve from you — to be invested at an emotional level with them through their suffering.”
 

Improving value and the patient experience

“One thing, philosophically, that I research is value in multiple myeloma care: identifying areas where we are overtreating patients and where we can do less and get away with it,” he said.

Despite the major advances in multiple myeloma in recent years, which “represent a lot of what is going right with oncology,” this blood cancer still “also represents a lot of what is wrong with oncology,” he noted. As an example, he cited “the approval of low-value drugs, the sequencing of drugs, adding more and more drugs without responsibly addressing quality-of-life questions, and identifying more responsible ways to provide high-value efficacious care without bankrupting the economy.

“So my research and policy work apply to that,” he explained. “What can we do better? What sort of trials should we be doing? What populations do we enroll? Are we asking the right questions or looking at trivialities? Are we serving patients foremost?”

Sometimes, this means comparing multiple myeloma staging systems in a real-world cohort, or assessing whether a widely available, cheap, and safe drug like budesonide can help patients avoid diarrhea during chemotherapy, whether control arms in myeloma randomized trials are fair, whether drugs ever get approved in low- or middle-income countries after their approval in the United States, and whether smoldering myeloma, a multiple myeloma precursor, really requires treatment, as current guidelines suggest, or if patients would do just as well — or perhaps better — with a close surveillance protocol.

“Pharma won’t do those studies and many key opinion leaders feel the question [about whether smoldering myeloma needs to be treated] has already been answered, so we are launching a prospective study that will define the natural history of smoldering myeloma and allow for patients to stay off therapy while undergoing rigorous surveillance with imaging,” he said.

Another study Dr. Mohyuddin hopes to launch soon will look at a “start low, go slow” treatment approach for the frailest patients with newly diagnosed myeloma.

His upbringing in Pakistan, where there are “mind-boggling” differences in health care access, affordability, and outcomes when compared with the United States, provided a foundation for both his “enthusiasm for cost-effective care” and his desire to give back, he said.

Another aspect of life in Pakistan — an across-the-board sense of closeness and solidarity in families and communities that is sometimes lacking in the United States — contributed to his desire to build relationships.

“That is something I dearly miss,” he said. “I am very privileged and so thankful to be here in the US, but that is one thing I do deeply miss.”
 

Connecting and Making a Difference

Dr. Mohyuddin seeks connection through his relationships with patients, trainees, and his many followers on social media platforms like X, where he frequently shares his thoughts on research quality and findings, heme/onc trends, and treatment-related insight.

“How to treat myeloma after #ASH23,” he posted on X as the conference came to a close. His takeaways: Don’t treat smoldering myeloma, do quadruple therapy for transplant-eligible patients (but no cd38 maintenance therapy afterward), don’t do quads for carfilzomib in newly diagnosed frail or older patients, and don’t do a salvage autologous transplant, no matter how good the first transplant was.

Dr. Mohyuddin also works to make a difference through his research and involvement in helping to launch initiatives like Common Sense Oncology, an ambitious global effort to reform cancer clinical trials and care, and through a current project with colleagues in India and Pakistan to create a consortium for pooling data on hematologic malignancies from South Asian countries. The hope is that such a collaborative effort will lead to good prospective research relevant to the needs of participating countries, he explained.

“Those are things where I want to make a difference. Taking care of patients is number one, but more than research, the number two thing for me is teaching and hopefully inspiring trainees and others to think differently, to look at data differently,” he said, noting that despite the major advances in myeloma, the reality is that “a lot of what we offer in oncology is very marginal.”

The effect sizes of interventions are often very small, and outcomes can still be really bad, he explained, adding that “[i]t really hits you when you see a lot of death and suffering. It’s a huge wake-up call … we have so many advances, but the reality is very, very sobering.

“Critically understanding and interpreting data is something where education really fails us. I’m incredibly passionate about it. I’ve found great resources to help me interpret data better, and I want to make them more accessible and inspire others to understand better,” he said. “We need to know how to defend ourselves from the hype.”

His efforts have not gone unnoticed. Dr. Mohyuddin was the recipient of the 2023 Hematology and Medical Oncology Fellowship Faculty Teaching Award at the University of Utah, Salt Lake City, where he is currently a faculty member.

“The recognition means more than any publication or grant award,” he said. “It’s great to know that medical education is appreciated, because so often we are in a rat race of getting more papers and grants out, but teaching and inspiring people is what is really, really important to me.”

With last month’s American Society of Hematology (ASH) annual conference in the rearview mirror, Ghulam Rehman “Manni” Mohyuddin, MD, a young medical oncologist who reaches out to colleagues via social media, hopes his efforts to support and inspire trainees at ASH 2023 will help propel them forward in their chosen field of medicine.

Ahead of the conference held in San Diego in December, Dr. Mohyuddin, a blood cancer specialist with a focus on multiple myeloma and medical education, put out a heartfelt appeal on X (formerly Twitter): “If you’re a trainee and interested in meeting me at #ASH23, please reach out … (especially if [international medical graduate]) I’d love to meet and offer support in whatever capacity I can! I can’t have a research project for each one of you, but happy to help/mentor in any other way possible,” he posted on X back in late November.

An international medical graduate himself, Dr. Mohyuddin recalls how overwhelmed he felt when he first attended an annual ASH conference as a trainee, so he aims to reassure others that they “don’t have to know everything.”

“It’s about networking and broadening horizons,” he said in an interview that took place between ASH sessions, his own research presentations, and meetings with the many trainees who took him up on the offer he made via X. “I’ve spent most of this ASH meeting trainees — it’s the most rewarding thing for me at these meetings.

“Reassurance is a lot of what we do in oncology,” he continued, drawing a connection between his affinity for helping trainees and providing compassionate care to patients. “For an oncologist, the single most important thing is having excellent communication skills and being able to express support and empathy. The ability to connect deeply with your patients during their time of need is profoundly important.

“You can compensate for lack of knowledge, because we have so many other sources of support for knowledge, but you simply cannot compensate for poor communication skills, and your patient suffers as a result,” he said.
 

Relationship Building

In addition to the guidance he received from mentors, Dr. Mohyuddin noted that it was the chance to build supportive, empathetic relationships that drew him to specialize in blood cancer and, in particular, to caring for patients with multiple myeloma and conducting research focused on improving the patient experience.

Dr. Mohyuddin attended medical school at the Aga Khan University in Pakistan, then completed his internal medicine residency and fellowship at the University of Kansas in Kansas City. As a chief resident there, he focused on novel approaches to education delivery and improving access to research for trainees. As a fellow, he developed clinical and research interests in multiple myeloma, which he describes as an “incredibly rewarding field” marked by “truly spectacular advances over the last two decades.”

“There are some cancers you can cure, which means you don’t get to see patients often, and there are some you can’t cure, where patients die early, and there’s not a lot of time to build a relationship,” he said. “But there are some where patients can do well even though they aren’t currently cured, and you get to form really amazing and meaningful relationships over a long period of time.

“Multiple myeloma occupies that space, and that’s why I’m drawn to it,” Dr. Mohyuddin added, noting that he doesn’t shy away from forging emotional connections with patients. “I recognize that makes me vulnerable, but I think that is essentially what your patients deserve from you — to be invested at an emotional level with them through their suffering.”
 

Improving value and the patient experience

“One thing, philosophically, that I research is value in multiple myeloma care: identifying areas where we are overtreating patients and where we can do less and get away with it,” he said.

Despite the major advances in multiple myeloma in recent years, which “represent a lot of what is going right with oncology,” this blood cancer still “also represents a lot of what is wrong with oncology,” he noted. As an example, he cited “the approval of low-value drugs, the sequencing of drugs, adding more and more drugs without responsibly addressing quality-of-life questions, and identifying more responsible ways to provide high-value efficacious care without bankrupting the economy.

“So my research and policy work apply to that,” he explained. “What can we do better? What sort of trials should we be doing? What populations do we enroll? Are we asking the right questions or looking at trivialities? Are we serving patients foremost?”

Sometimes, this means comparing multiple myeloma staging systems in a real-world cohort, or assessing whether a widely available, cheap, and safe drug like budesonide can help patients avoid diarrhea during chemotherapy, whether control arms in myeloma randomized trials are fair, whether drugs ever get approved in low- or middle-income countries after their approval in the United States, and whether smoldering myeloma, a multiple myeloma precursor, really requires treatment, as current guidelines suggest, or if patients would do just as well — or perhaps better — with a close surveillance protocol.

“Pharma won’t do those studies and many key opinion leaders feel the question [about whether smoldering myeloma needs to be treated] has already been answered, so we are launching a prospective study that will define the natural history of smoldering myeloma and allow for patients to stay off therapy while undergoing rigorous surveillance with imaging,” he said.

Another study Dr. Mohyuddin hopes to launch soon will look at a “start low, go slow” treatment approach for the frailest patients with newly diagnosed myeloma.

His upbringing in Pakistan, where there are “mind-boggling” differences in health care access, affordability, and outcomes when compared with the United States, provided a foundation for both his “enthusiasm for cost-effective care” and his desire to give back, he said.

Another aspect of life in Pakistan — an across-the-board sense of closeness and solidarity in families and communities that is sometimes lacking in the United States — contributed to his desire to build relationships.

“That is something I dearly miss,” he said. “I am very privileged and so thankful to be here in the US, but that is one thing I do deeply miss.”
 

Connecting and Making a Difference

Dr. Mohyuddin seeks connection through his relationships with patients, trainees, and his many followers on social media platforms like X, where he frequently shares his thoughts on research quality and findings, heme/onc trends, and treatment-related insight.

“How to treat myeloma after #ASH23,” he posted on X as the conference came to a close. His takeaways: Don’t treat smoldering myeloma, do quadruple therapy for transplant-eligible patients (but no cd38 maintenance therapy afterward), don’t do quads for carfilzomib in newly diagnosed frail or older patients, and don’t do a salvage autologous transplant, no matter how good the first transplant was.

Dr. Mohyuddin also works to make a difference through his research and involvement in helping to launch initiatives like Common Sense Oncology, an ambitious global effort to reform cancer clinical trials and care, and through a current project with colleagues in India and Pakistan to create a consortium for pooling data on hematologic malignancies from South Asian countries. The hope is that such a collaborative effort will lead to good prospective research relevant to the needs of participating countries, he explained.

“Those are things where I want to make a difference. Taking care of patients is number one, but more than research, the number two thing for me is teaching and hopefully inspiring trainees and others to think differently, to look at data differently,” he said, noting that despite the major advances in myeloma, the reality is that “a lot of what we offer in oncology is very marginal.”

The effect sizes of interventions are often very small, and outcomes can still be really bad, he explained, adding that “[i]t really hits you when you see a lot of death and suffering. It’s a huge wake-up call … we have so many advances, but the reality is very, very sobering.

“Critically understanding and interpreting data is something where education really fails us. I’m incredibly passionate about it. I’ve found great resources to help me interpret data better, and I want to make them more accessible and inspire others to understand better,” he said. “We need to know how to defend ourselves from the hype.”

His efforts have not gone unnoticed. Dr. Mohyuddin was the recipient of the 2023 Hematology and Medical Oncology Fellowship Faculty Teaching Award at the University of Utah, Salt Lake City, where he is currently a faculty member.

“The recognition means more than any publication or grant award,” he said. “It’s great to know that medical education is appreciated, because so often we are in a rat race of getting more papers and grants out, but teaching and inspiring people is what is really, really important to me.”

With last month’s American Society of Hematology (ASH) annual conference in the rearview mirror, Ghulam Rehman “Manni” Mohyuddin, MD, a young medical oncologist who reaches out to colleagues via social media, hopes his efforts to support and inspire trainees at ASH 2023 will help propel them forward in their chosen field of medicine.

Ahead of the conference held in San Diego in December, Dr. Mohyuddin, a blood cancer specialist with a focus on multiple myeloma and medical education, put out a heartfelt appeal on X (formerly Twitter): “If you’re a trainee and interested in meeting me at #ASH23, please reach out … (especially if [international medical graduate]) I’d love to meet and offer support in whatever capacity I can! I can’t have a research project for each one of you, but happy to help/mentor in any other way possible,” he posted on X back in late November.

An international medical graduate himself, Dr. Mohyuddin recalls how overwhelmed he felt when he first attended an annual ASH conference as a trainee, so he aims to reassure others that they “don’t have to know everything.”

“It’s about networking and broadening horizons,” he said in an interview that took place between ASH sessions, his own research presentations, and meetings with the many trainees who took him up on the offer he made via X. “I’ve spent most of this ASH meeting trainees — it’s the most rewarding thing for me at these meetings.

“Reassurance is a lot of what we do in oncology,” he continued, drawing a connection between his affinity for helping trainees and providing compassionate care to patients. “For an oncologist, the single most important thing is having excellent communication skills and being able to express support and empathy. The ability to connect deeply with your patients during their time of need is profoundly important.

“You can compensate for lack of knowledge, because we have so many other sources of support for knowledge, but you simply cannot compensate for poor communication skills, and your patient suffers as a result,” he said.
 

Relationship Building

In addition to the guidance he received from mentors, Dr. Mohyuddin noted that it was the chance to build supportive, empathetic relationships that drew him to specialize in blood cancer and, in particular, to caring for patients with multiple myeloma and conducting research focused on improving the patient experience.

Dr. Mohyuddin attended medical school at the Aga Khan University in Pakistan, then completed his internal medicine residency and fellowship at the University of Kansas in Kansas City. As a chief resident there, he focused on novel approaches to education delivery and improving access to research for trainees. As a fellow, he developed clinical and research interests in multiple myeloma, which he describes as an “incredibly rewarding field” marked by “truly spectacular advances over the last two decades.”

“There are some cancers you can cure, which means you don’t get to see patients often, and there are some you can’t cure, where patients die early, and there’s not a lot of time to build a relationship,” he said. “But there are some where patients can do well even though they aren’t currently cured, and you get to form really amazing and meaningful relationships over a long period of time.

“Multiple myeloma occupies that space, and that’s why I’m drawn to it,” Dr. Mohyuddin added, noting that he doesn’t shy away from forging emotional connections with patients. “I recognize that makes me vulnerable, but I think that is essentially what your patients deserve from you — to be invested at an emotional level with them through their suffering.”
 

Improving value and the patient experience

“One thing, philosophically, that I research is value in multiple myeloma care: identifying areas where we are overtreating patients and where we can do less and get away with it,” he said.

Despite the major advances in multiple myeloma in recent years, which “represent a lot of what is going right with oncology,” this blood cancer still “also represents a lot of what is wrong with oncology,” he noted. As an example, he cited “the approval of low-value drugs, the sequencing of drugs, adding more and more drugs without responsibly addressing quality-of-life questions, and identifying more responsible ways to provide high-value efficacious care without bankrupting the economy.

“So my research and policy work apply to that,” he explained. “What can we do better? What sort of trials should we be doing? What populations do we enroll? Are we asking the right questions or looking at trivialities? Are we serving patients foremost?”

Sometimes, this means comparing multiple myeloma staging systems in a real-world cohort, or assessing whether a widely available, cheap, and safe drug like budesonide can help patients avoid diarrhea during chemotherapy, whether control arms in myeloma randomized trials are fair, whether drugs ever get approved in low- or middle-income countries after their approval in the United States, and whether smoldering myeloma, a multiple myeloma precursor, really requires treatment, as current guidelines suggest, or if patients would do just as well — or perhaps better — with a close surveillance protocol.

“Pharma won’t do those studies and many key opinion leaders feel the question [about whether smoldering myeloma needs to be treated] has already been answered, so we are launching a prospective study that will define the natural history of smoldering myeloma and allow for patients to stay off therapy while undergoing rigorous surveillance with imaging,” he said.

Another study Dr. Mohyuddin hopes to launch soon will look at a “start low, go slow” treatment approach for the frailest patients with newly diagnosed myeloma.

His upbringing in Pakistan, where there are “mind-boggling” differences in health care access, affordability, and outcomes when compared with the United States, provided a foundation for both his “enthusiasm for cost-effective care” and his desire to give back, he said.

Another aspect of life in Pakistan — an across-the-board sense of closeness and solidarity in families and communities that is sometimes lacking in the United States — contributed to his desire to build relationships.

“That is something I dearly miss,” he said. “I am very privileged and so thankful to be here in the US, but that is one thing I do deeply miss.”
 

Connecting and Making a Difference

Dr. Mohyuddin seeks connection through his relationships with patients, trainees, and his many followers on social media platforms like X, where he frequently shares his thoughts on research quality and findings, heme/onc trends, and treatment-related insight.

“How to treat myeloma after #ASH23,” he posted on X as the conference came to a close. His takeaways: Don’t treat smoldering myeloma, do quadruple therapy for transplant-eligible patients (but no cd38 maintenance therapy afterward), don’t do quads for carfilzomib in newly diagnosed frail or older patients, and don’t do a salvage autologous transplant, no matter how good the first transplant was.

Dr. Mohyuddin also works to make a difference through his research and involvement in helping to launch initiatives like Common Sense Oncology, an ambitious global effort to reform cancer clinical trials and care, and through a current project with colleagues in India and Pakistan to create a consortium for pooling data on hematologic malignancies from South Asian countries. The hope is that such a collaborative effort will lead to good prospective research relevant to the needs of participating countries, he explained.

“Those are things where I want to make a difference. Taking care of patients is number one, but more than research, the number two thing for me is teaching and hopefully inspiring trainees and others to think differently, to look at data differently,” he said, noting that despite the major advances in myeloma, the reality is that “a lot of what we offer in oncology is very marginal.”

The effect sizes of interventions are often very small, and outcomes can still be really bad, he explained, adding that “[i]t really hits you when you see a lot of death and suffering. It’s a huge wake-up call … we have so many advances, but the reality is very, very sobering.

“Critically understanding and interpreting data is something where education really fails us. I’m incredibly passionate about it. I’ve found great resources to help me interpret data better, and I want to make them more accessible and inspire others to understand better,” he said. “We need to know how to defend ourselves from the hype.”

His efforts have not gone unnoticed. Dr. Mohyuddin was the recipient of the 2023 Hematology and Medical Oncology Fellowship Faculty Teaching Award at the University of Utah, Salt Lake City, where he is currently a faculty member.

“The recognition means more than any publication or grant award,” he said. “It’s great to know that medical education is appreciated, because so often we are in a rat race of getting more papers and grants out, but teaching and inspiring people is what is really, really important to me.”

Once considered a luxury, hiring a nurse, nurse practitioner, or physician assistant is becoming a necessity in many rheumatology practices.

Seeing the wait lists pile up in her Florida practice, Stacy Yonker, MBA, chief executive officer of Sarasota Arthritis Center, knew she had to make some changes. “Everyone’s aging in the boomer generations. Particularly in Florida, we have a lot of people who retire here. In the more southern demographics, it is a very difficult challenge for practices to get new patients in,” she said.

Ms. Yonker is in the process of hiring several nurse practitioners (NPs) to assist in the clinics and infusion suites, lightening the load for the practice’s 11 rheumatologists.

Hiring an advanced practice provider (APP) to support the practice is just a first step. Getting these additional personnel up to speed means an investment in education and fostering good working relationships with NPs, PAs, and the staff’s physicians. Even more importantly, practices need to set realistic expectations on workload for these new hires.

“I tried to hire them, but I couldn’t keep them,” is a statement Christine A. Stamatos, DNP, ANP-C, hears all the time from rheumatologists. Oftentimes it’s because the practice saddles the new hire with 20 patients a day, said Dr. Stamatos, director of the Fibromyalgia Wellness Center within the division of rheumatology at Northwell Health in Huntington, New York. She is also an assistant professor at Hofstra Northwell School of Graduate Nursing and Physician Assistant Studies in Hempstead, New York.

“Twenty patients a day is too much,” Dr. Stamatos said. Overload someone, and they won’t stay. Offer them the support, mentoring, and tools they need to practice in their setting ­­— and they will.
 

Why the Profession Needs APPs

Rheumatology is a much smaller specialty than most, with only a set number of rheumatologists in the field that can provide care to patients. A growing shortage is also looming. Reports from the American College of Rheumatology have projected troubling shortfalls in rheumatologists over the next decade in all regions of the United States.

Many of them aging into retirement “poses a significant issue on being able to continue providing care for the population that experiences the rheumatic disease,” said Ms. Yonker, a director of the National Organization of Rheumatology Management (NORM), a forum that promotes education and advocacy for rheumatology practice managers. People are also living longer, which means more patients are developing arthritis and autoimmune diseases.

Julia M. Swafford, PA-C, a rheumatology physician assistant in Battle Creek, Michigan, sees many advantages of hiring NPs and PAs, and not just from a financial perspective.

Salaries for PAs and NPs aren’t as high and they’re also more accessible than a rheumatologist. “You could train an NP or PA a lot quicker during that same time frame it would take to find a new rheumatology provider,” she offered. And while they may not be as experienced as rheumatologists, “you can kind of mold me on how you like to practice, what medications you may like to use, how you like to treat your patients,” Ms. Swafford said.
 

Hiring Someone With Experience

Recruiting and retaining APPs is not without its challenges.

Finding individuals compatible with this specialty isn’t easy, noted Mark Box, MD, medical director of Carondelet Rheumatology in Kansas City, Missouri. Ideally, APPs should be inquisitive, compassionate, and ready to learn. “Rheumatology is a cognitive specialty where you have to fit many pieces together. You need an APP who wants to embrace that,” he said.

The profession isn’t that “sexy” either, noted Katie Taylor, Carondelet’s practice manager. Patients are often in head-to-toe pain, and miserable. Many have been to other specialists without answers to their questions. For these reasons, rheumatology can be a hard sell for some PAs and NPs.

Nurse practitioners aren’t always comfortable with administering things such as controlled medications, for example. “It’s a hard patient population, and it’s a specialty of exclusion. You’ve got to be really smart to understand our diseases and our processes and our drugs,” Ms. Taylor said. In other words, it’s a difficult environment for an NP to walk into if their previous experience has been limited to upper respiratory issues and urinary tract infections in the primary care setting.

When hiring an APP, rheumatologists should look for someone who demonstrates an interest in lifelong learning, because the field is changing every day. They should exhibit good scores in educational training and have experience working in an emergency department or another field that translates well into rheumatology such as critical care, immunology, hematology, and orthopedics, she said.

Carondelet Rheumatology was specifically looking for an NP with rheumatology experience to support Dr. Box’s solo practice.

He was facing enormous pressure to be in the office every single day of the week. The practice had to cancel patients for its infusion suite on a regular basis when he was out of the office, Ms. Taylor said. “We couldn’t see new patients, and he wasn’t able to touch as many patients as he wanted to. The doctor takes the oath of touching as many in your community as possible, and you’re limited when you’re a one-man show.”

The practice eventually found an NP who already knew how to do joint injections. “We started her with easier diagnoses for things like osteoporosis and gout. She had an orthopedic background, so she was familiar with some of those diseases,” she said.

Even so, she often leaves with questions every day. “It’s a commitment for her to understand and learn so much,” Ms. Taylor said.

New hires will need support from the practice to get comfortable with rheumatology, Dr. Stamatos said. Responsibility should come in gradual steps.

Instead of loading an NP with 20 patients a day, 2 or 3 patients in the first quarter, eventually graduating to 6-8 patients is a more realistic expectation, Dr. Stamatos advised.
 

Shadowing the Physician

Partnerships with physicians is a critical component to this onboarding process.

A nurse practitioner recently hired at Dr. Stamatos’ practice works alongside a physician to manage a panel of 25 patients. “We make sure she gets her training, the resources she needs. I personally meet with her to make sure her education is moving forward, connecting her with radiology, pulmonary, hematology,” and other areas of the practice relevant to her training, she added.

The NP also attends weekly grand rounds and case conferences with the fellows. This is the type of well-rounded support any APP needs, she stressed. “Without proper training, you lose people.”

At Sarasota Arthritis Center, NPs help cover the suites but also get assigned to specific physicians so that they can familiarize themselves with that physician’s panel of patients.

“When we start an APP, they shadow for about twice as long as a new physician would. Usually, they’re shadowing for about 6 weeks, just kind of learning the space. There’s a lot of nurse practitioners or PAs who may not have prior rheumatology experience, so we’re essentially training them from the ground up on rheumatology,” Ms. Yonker said.

Pairing them with one provider often directs what type of disease state they focus on, she continued. This dynamic relationship helps guide decisions on whether to include these NPs in the care of patients with more complex diseases.

At least in her practice, the NPs do not see any new patients. They are simply part of the larger care team. “That’s kind of how we present it to our patients, and it makes them feel more comfortable just because they know that they’re not necessarily being handed off to somebody — that the doctor is still overseeing their care,” Ms. Yonker said.

At the same time, the NPs know that they’re supported, that they too have access to tools and mentorship if they need it, she added.

The new NP at Carondelet Rheumatology piggybacked on the doctor’s schedule for 3 months, slowly taking on infusion patients so she could get familiar with their diseases and respective drugs. Eventually, she got her own schedule and was able to take on new patients.

It’s a team effort, Ms. Taylor noted. The NP does the preliminary workup and then the physician comes in and greets the new patient. Together, they develop a follow-up plan for the patient.
 

Education Resources for Practices

In the case of Dr. Box’s one-physician practice, he was looking for an NP who was willing to be independent and cover things in his absence. “The training has to be there to accomplish that,” said Dr. Box, who likened the training of APPs to a medical residency.

Encouraging them to ask questions, do continuing medical education online and outside reading, are important steps, he added.

In a recent editorial, rheumatologists Eli M. Miloslavsky, MD, and Bethany Marston, MD, offered some strategies for better prepping the APP workforce to meet the demands of rheumatology practices. “Consideration should be given to formal curricula or training programs to help APPs achieve both competence and confidence in treating rheumatologic conditions,” they offered, suggesting an online curriculum developed by the ACR for such a purpose. Fellowship training should also focus on working effectively with APPs, they added.

“Finally, incorporating APPs more effectively into rheumatology professional societies and supporting practices in hiring and training APPs will all be important steps in addressing the rheumatology workforce shortage,” Dr. Miloslavsky and Dr. Marston wrote.

Ms. Yonker said all her APPs take various courses that the ACR and other organizations provide for rheumatology-specific, midlevel positions. “We provide as much training as possible for them to feel comfortable in this space. They are set directly with a physician for a long time and then eventually go into their own space.”

In addition to ACR, the Rheumatology Nurses Society and the Association of Women in Rheumatology offer excellent online training resources for APPs, Ms. Yonker said. “Also, the Bone Health and Osteoporosis Foundation offers an osteoporosis fracture liaison certification which we put APPs through as well,” she added.

Rheumatology practices should also look into an important clinical training grant program from the Rheumatology Research Foundation, Dr. Stamatos advised.

To date, they have “funded almost everyone that applies,” she said. Each grantee receives $25,000 to support training and education involved in onboarding an APP to a rheumatology practice. The money covers attendance at a live rheumatology conference, online educational programs, textbooks, and any society memberships while defraying the cost of training this employee. To increase awareness of the program, the foundation has since expanded the number of available submission dates and the number of grant awardees per year. Currently, the application deadlines for the grants are December 1 and March 1.

For her own health system, Dr. Stamatos has been working on a rheumatology fellowship program for APPs. Through simulation labs, leadership exercises, and other activities, these APPs will learn how to transition from being a new provider to someone who can become part of a practice, she said.

APPs themselves can also get proactive in this learning cycle, Ms. Swafford said. In her view, both APPs and rheumatologists should be conducting didactic lectures and organizing elective rotations with medical students to get them excited about the field. This would establish a good education base that would encourage PAs and NPs to choose rheumatology.

“That’s a huge thing that’s probably missing,” Ms. Swafford said.
 

Buy-in From the Doctor

No recruitment effort is going to work if the rheumatologists in the practice aren’t committed to the model of having an APP, Ms. Yonker said. “Everybody wants to know their purpose in their company and that they’re valued and they’re needed. And so, I think a pitfall would be if your rheumatologist is not sold on the model of expanding the care team. Because this takes work on behalf of the doctor.”

Rheumatologists are very busy, so it’s a hard sell for them to take time out of their busy clinics to train somebody to do a good job taking care of their patients, Ms. Taylor agreed. “I think that we need the physicians that have had success with this and allow them to coach the physicians that are still resistant.”

In his small practice, Dr. Box has encouraged his NP to assist with practice improvements, working with the office manager. These workers are providers and need to be treated as such, he said. “They need to feel like they contribute to the practice more than just grinding through patients.”

Peer support is another successful ingredient for these workers. Ms. Taylor’s NP finds the time to commiserate with her fellow nurse practitioners — other rheumatology nurses who are also learning the ropes. Rheumatologists are smart, and they can be very intimidating, Ms. Taylor said. In their small office, the rheumatologist is her only peer.

“She likes to get out and sort of integrate with other nurse practitioners that are learning too.”
 

When APPs Make a Difference

Practices that take on APPs are reporting positive metrics — mainly, shorter wait times for patients. Ms. Yonker’s physicians have been able to add on one to two new patients a day. Wait times have since dwindled from a 5-month to a 3-month wait with the addition of the NPs. “Three months is still long, but we’re working on getting it to that ideal 6-week wait period, which we’re hoping we can accomplish. So we’re able to get more new patients in for sure,” she said.

Prior to hiring an NP, Ms. Taylor’s practice had to defer acceptances for new patients by at least a year. Now, they’re able to accept about half of all new patient referrals. With the NP on board, “We can get them in within 30 days,” she said.

Sometimes, an APP will go beyond their scope of work to make a difference and better support patients.

Patients with rheumatic and osteopathic conditions are often underdiagnosed in the primary care space. As a result, they are not treated as often as they should be. Seeing a need for specialty care, Ms. Swafford took action.

She currently runs the only bone health clinic in southwest Michigan, coordinating with rheumatologists, NPs, urgent care, hospitalists, and interventional radiologists to attend to these patients more quickly and reduce wait times for care. Specialists will flag things such as nontraumatic hip fractures and vertebral fractures and refer them to Ms. Swafford’s clinic, which is part of Bronson Rheumatology Specialists.

The clinic gets quite a few referrals, and the practice is growing. “Usually, they don’t take as long as a rheumatology referral for a workup, so we can see them a little bit quicker,” usually within 3 weeks, she added.

APPs have an opportunity to make their mark in rheumatology at a time when the profession is experiencing significant gaps in care, Ms. Swafford continued. “Unless we find a way to fill that niche, we’re going to be in a world of trouble in the next 10, 20 years.”

None of the sources reported any disclosures or conflicts of interest.

Once considered a luxury, hiring a nurse, nurse practitioner, or physician assistant is becoming a necessity in many rheumatology practices.

Seeing the wait lists pile up in her Florida practice, Stacy Yonker, MBA, chief executive officer of Sarasota Arthritis Center, knew she had to make some changes. “Everyone’s aging in the boomer generations. Particularly in Florida, we have a lot of people who retire here. In the more southern demographics, it is a very difficult challenge for practices to get new patients in,” she said.

Ms. Yonker is in the process of hiring several nurse practitioners (NPs) to assist in the clinics and infusion suites, lightening the load for the practice’s 11 rheumatologists.

Hiring an advanced practice provider (APP) to support the practice is just a first step. Getting these additional personnel up to speed means an investment in education and fostering good working relationships with NPs, PAs, and the staff’s physicians. Even more importantly, practices need to set realistic expectations on workload for these new hires.

“I tried to hire them, but I couldn’t keep them,” is a statement Christine A. Stamatos, DNP, ANP-C, hears all the time from rheumatologists. Oftentimes it’s because the practice saddles the new hire with 20 patients a day, said Dr. Stamatos, director of the Fibromyalgia Wellness Center within the division of rheumatology at Northwell Health in Huntington, New York. She is also an assistant professor at Hofstra Northwell School of Graduate Nursing and Physician Assistant Studies in Hempstead, New York.

“Twenty patients a day is too much,” Dr. Stamatos said. Overload someone, and they won’t stay. Offer them the support, mentoring, and tools they need to practice in their setting ­­— and they will.
 

Why the Profession Needs APPs

Rheumatology is a much smaller specialty than most, with only a set number of rheumatologists in the field that can provide care to patients. A growing shortage is also looming. Reports from the American College of Rheumatology have projected troubling shortfalls in rheumatologists over the next decade in all regions of the United States.

Many of them aging into retirement “poses a significant issue on being able to continue providing care for the population that experiences the rheumatic disease,” said Ms. Yonker, a director of the National Organization of Rheumatology Management (NORM), a forum that promotes education and advocacy for rheumatology practice managers. People are also living longer, which means more patients are developing arthritis and autoimmune diseases.

Julia M. Swafford, PA-C, a rheumatology physician assistant in Battle Creek, Michigan, sees many advantages of hiring NPs and PAs, and not just from a financial perspective.

Salaries for PAs and NPs aren’t as high and they’re also more accessible than a rheumatologist. “You could train an NP or PA a lot quicker during that same time frame it would take to find a new rheumatology provider,” she offered. And while they may not be as experienced as rheumatologists, “you can kind of mold me on how you like to practice, what medications you may like to use, how you like to treat your patients,” Ms. Swafford said.
 

Hiring Someone With Experience

Recruiting and retaining APPs is not without its challenges.

Finding individuals compatible with this specialty isn’t easy, noted Mark Box, MD, medical director of Carondelet Rheumatology in Kansas City, Missouri. Ideally, APPs should be inquisitive, compassionate, and ready to learn. “Rheumatology is a cognitive specialty where you have to fit many pieces together. You need an APP who wants to embrace that,” he said.

The profession isn’t that “sexy” either, noted Katie Taylor, Carondelet’s practice manager. Patients are often in head-to-toe pain, and miserable. Many have been to other specialists without answers to their questions. For these reasons, rheumatology can be a hard sell for some PAs and NPs.

Nurse practitioners aren’t always comfortable with administering things such as controlled medications, for example. “It’s a hard patient population, and it’s a specialty of exclusion. You’ve got to be really smart to understand our diseases and our processes and our drugs,” Ms. Taylor said. In other words, it’s a difficult environment for an NP to walk into if their previous experience has been limited to upper respiratory issues and urinary tract infections in the primary care setting.

When hiring an APP, rheumatologists should look for someone who demonstrates an interest in lifelong learning, because the field is changing every day. They should exhibit good scores in educational training and have experience working in an emergency department or another field that translates well into rheumatology such as critical care, immunology, hematology, and orthopedics, she said.

Carondelet Rheumatology was specifically looking for an NP with rheumatology experience to support Dr. Box’s solo practice.

He was facing enormous pressure to be in the office every single day of the week. The practice had to cancel patients for its infusion suite on a regular basis when he was out of the office, Ms. Taylor said. “We couldn’t see new patients, and he wasn’t able to touch as many patients as he wanted to. The doctor takes the oath of touching as many in your community as possible, and you’re limited when you’re a one-man show.”

The practice eventually found an NP who already knew how to do joint injections. “We started her with easier diagnoses for things like osteoporosis and gout. She had an orthopedic background, so she was familiar with some of those diseases,” she said.

Even so, she often leaves with questions every day. “It’s a commitment for her to understand and learn so much,” Ms. Taylor said.

New hires will need support from the practice to get comfortable with rheumatology, Dr. Stamatos said. Responsibility should come in gradual steps.

Instead of loading an NP with 20 patients a day, 2 or 3 patients in the first quarter, eventually graduating to 6-8 patients is a more realistic expectation, Dr. Stamatos advised.
 

Shadowing the Physician

Partnerships with physicians is a critical component to this onboarding process.

A nurse practitioner recently hired at Dr. Stamatos’ practice works alongside a physician to manage a panel of 25 patients. “We make sure she gets her training, the resources she needs. I personally meet with her to make sure her education is moving forward, connecting her with radiology, pulmonary, hematology,” and other areas of the practice relevant to her training, she added.

The NP also attends weekly grand rounds and case conferences with the fellows. This is the type of well-rounded support any APP needs, she stressed. “Without proper training, you lose people.”

At Sarasota Arthritis Center, NPs help cover the suites but also get assigned to specific physicians so that they can familiarize themselves with that physician’s panel of patients.

“When we start an APP, they shadow for about twice as long as a new physician would. Usually, they’re shadowing for about 6 weeks, just kind of learning the space. There’s a lot of nurse practitioners or PAs who may not have prior rheumatology experience, so we’re essentially training them from the ground up on rheumatology,” Ms. Yonker said.

Pairing them with one provider often directs what type of disease state they focus on, she continued. This dynamic relationship helps guide decisions on whether to include these NPs in the care of patients with more complex diseases.

At least in her practice, the NPs do not see any new patients. They are simply part of the larger care team. “That’s kind of how we present it to our patients, and it makes them feel more comfortable just because they know that they’re not necessarily being handed off to somebody — that the doctor is still overseeing their care,” Ms. Yonker said.

At the same time, the NPs know that they’re supported, that they too have access to tools and mentorship if they need it, she added.

The new NP at Carondelet Rheumatology piggybacked on the doctor’s schedule for 3 months, slowly taking on infusion patients so she could get familiar with their diseases and respective drugs. Eventually, she got her own schedule and was able to take on new patients.

It’s a team effort, Ms. Taylor noted. The NP does the preliminary workup and then the physician comes in and greets the new patient. Together, they develop a follow-up plan for the patient.
 

Education Resources for Practices

In the case of Dr. Box’s one-physician practice, he was looking for an NP who was willing to be independent and cover things in his absence. “The training has to be there to accomplish that,” said Dr. Box, who likened the training of APPs to a medical residency.

Encouraging them to ask questions, do continuing medical education online and outside reading, are important steps, he added.

In a recent editorial, rheumatologists Eli M. Miloslavsky, MD, and Bethany Marston, MD, offered some strategies for better prepping the APP workforce to meet the demands of rheumatology practices. “Consideration should be given to formal curricula or training programs to help APPs achieve both competence and confidence in treating rheumatologic conditions,” they offered, suggesting an online curriculum developed by the ACR for such a purpose. Fellowship training should also focus on working effectively with APPs, they added.

“Finally, incorporating APPs more effectively into rheumatology professional societies and supporting practices in hiring and training APPs will all be important steps in addressing the rheumatology workforce shortage,” Dr. Miloslavsky and Dr. Marston wrote.

Ms. Yonker said all her APPs take various courses that the ACR and other organizations provide for rheumatology-specific, midlevel positions. “We provide as much training as possible for them to feel comfortable in this space. They are set directly with a physician for a long time and then eventually go into their own space.”

In addition to ACR, the Rheumatology Nurses Society and the Association of Women in Rheumatology offer excellent online training resources for APPs, Ms. Yonker said. “Also, the Bone Health and Osteoporosis Foundation offers an osteoporosis fracture liaison certification which we put APPs through as well,” she added.

Rheumatology practices should also look into an important clinical training grant program from the Rheumatology Research Foundation, Dr. Stamatos advised.

To date, they have “funded almost everyone that applies,” she said. Each grantee receives $25,000 to support training and education involved in onboarding an APP to a rheumatology practice. The money covers attendance at a live rheumatology conference, online educational programs, textbooks, and any society memberships while defraying the cost of training this employee. To increase awareness of the program, the foundation has since expanded the number of available submission dates and the number of grant awardees per year. Currently, the application deadlines for the grants are December 1 and March 1.

For her own health system, Dr. Stamatos has been working on a rheumatology fellowship program for APPs. Through simulation labs, leadership exercises, and other activities, these APPs will learn how to transition from being a new provider to someone who can become part of a practice, she said.

APPs themselves can also get proactive in this learning cycle, Ms. Swafford said. In her view, both APPs and rheumatologists should be conducting didactic lectures and organizing elective rotations with medical students to get them excited about the field. This would establish a good education base that would encourage PAs and NPs to choose rheumatology.

“That’s a huge thing that’s probably missing,” Ms. Swafford said.
 

Buy-in From the Doctor

No recruitment effort is going to work if the rheumatologists in the practice aren’t committed to the model of having an APP, Ms. Yonker said. “Everybody wants to know their purpose in their company and that they’re valued and they’re needed. And so, I think a pitfall would be if your rheumatologist is not sold on the model of expanding the care team. Because this takes work on behalf of the doctor.”

Rheumatologists are very busy, so it’s a hard sell for them to take time out of their busy clinics to train somebody to do a good job taking care of their patients, Ms. Taylor agreed. “I think that we need the physicians that have had success with this and allow them to coach the physicians that are still resistant.”

In his small practice, Dr. Box has encouraged his NP to assist with practice improvements, working with the office manager. These workers are providers and need to be treated as such, he said. “They need to feel like they contribute to the practice more than just grinding through patients.”

Peer support is another successful ingredient for these workers. Ms. Taylor’s NP finds the time to commiserate with her fellow nurse practitioners — other rheumatology nurses who are also learning the ropes. Rheumatologists are smart, and they can be very intimidating, Ms. Taylor said. In their small office, the rheumatologist is her only peer.

“She likes to get out and sort of integrate with other nurse practitioners that are learning too.”
 

When APPs Make a Difference

Practices that take on APPs are reporting positive metrics — mainly, shorter wait times for patients. Ms. Yonker’s physicians have been able to add on one to two new patients a day. Wait times have since dwindled from a 5-month to a 3-month wait with the addition of the NPs. “Three months is still long, but we’re working on getting it to that ideal 6-week wait period, which we’re hoping we can accomplish. So we’re able to get more new patients in for sure,” she said.

Prior to hiring an NP, Ms. Taylor’s practice had to defer acceptances for new patients by at least a year. Now, they’re able to accept about half of all new patient referrals. With the NP on board, “We can get them in within 30 days,” she said.

Sometimes, an APP will go beyond their scope of work to make a difference and better support patients.

Patients with rheumatic and osteopathic conditions are often underdiagnosed in the primary care space. As a result, they are not treated as often as they should be. Seeing a need for specialty care, Ms. Swafford took action.

She currently runs the only bone health clinic in southwest Michigan, coordinating with rheumatologists, NPs, urgent care, hospitalists, and interventional radiologists to attend to these patients more quickly and reduce wait times for care. Specialists will flag things such as nontraumatic hip fractures and vertebral fractures and refer them to Ms. Swafford’s clinic, which is part of Bronson Rheumatology Specialists.

The clinic gets quite a few referrals, and the practice is growing. “Usually, they don’t take as long as a rheumatology referral for a workup, so we can see them a little bit quicker,” usually within 3 weeks, she added.

APPs have an opportunity to make their mark in rheumatology at a time when the profession is experiencing significant gaps in care, Ms. Swafford continued. “Unless we find a way to fill that niche, we’re going to be in a world of trouble in the next 10, 20 years.”

None of the sources reported any disclosures or conflicts of interest.

Once considered a luxury, hiring a nurse, nurse practitioner, or physician assistant is becoming a necessity in many rheumatology practices.

Seeing the wait lists pile up in her Florida practice, Stacy Yonker, MBA, chief executive officer of Sarasota Arthritis Center, knew she had to make some changes. “Everyone’s aging in the boomer generations. Particularly in Florida, we have a lot of people who retire here. In the more southern demographics, it is a very difficult challenge for practices to get new patients in,” she said.

Ms. Yonker is in the process of hiring several nurse practitioners (NPs) to assist in the clinics and infusion suites, lightening the load for the practice’s 11 rheumatologists.

Hiring an advanced practice provider (APP) to support the practice is just a first step. Getting these additional personnel up to speed means an investment in education and fostering good working relationships with NPs, PAs, and the staff’s physicians. Even more importantly, practices need to set realistic expectations on workload for these new hires.

“I tried to hire them, but I couldn’t keep them,” is a statement Christine A. Stamatos, DNP, ANP-C, hears all the time from rheumatologists. Oftentimes it’s because the practice saddles the new hire with 20 patients a day, said Dr. Stamatos, director of the Fibromyalgia Wellness Center within the division of rheumatology at Northwell Health in Huntington, New York. She is also an assistant professor at Hofstra Northwell School of Graduate Nursing and Physician Assistant Studies in Hempstead, New York.

“Twenty patients a day is too much,” Dr. Stamatos said. Overload someone, and they won’t stay. Offer them the support, mentoring, and tools they need to practice in their setting ­­— and they will.
 

Why the Profession Needs APPs

Rheumatology is a much smaller specialty than most, with only a set number of rheumatologists in the field that can provide care to patients. A growing shortage is also looming. Reports from the American College of Rheumatology have projected troubling shortfalls in rheumatologists over the next decade in all regions of the United States.

Many of them aging into retirement “poses a significant issue on being able to continue providing care for the population that experiences the rheumatic disease,” said Ms. Yonker, a director of the National Organization of Rheumatology Management (NORM), a forum that promotes education and advocacy for rheumatology practice managers. People are also living longer, which means more patients are developing arthritis and autoimmune diseases.

Julia M. Swafford, PA-C, a rheumatology physician assistant in Battle Creek, Michigan, sees many advantages of hiring NPs and PAs, and not just from a financial perspective.

Salaries for PAs and NPs aren’t as high and they’re also more accessible than a rheumatologist. “You could train an NP or PA a lot quicker during that same time frame it would take to find a new rheumatology provider,” she offered. And while they may not be as experienced as rheumatologists, “you can kind of mold me on how you like to practice, what medications you may like to use, how you like to treat your patients,” Ms. Swafford said.
 

Hiring Someone With Experience

Recruiting and retaining APPs is not without its challenges.

Finding individuals compatible with this specialty isn’t easy, noted Mark Box, MD, medical director of Carondelet Rheumatology in Kansas City, Missouri. Ideally, APPs should be inquisitive, compassionate, and ready to learn. “Rheumatology is a cognitive specialty where you have to fit many pieces together. You need an APP who wants to embrace that,” he said.

The profession isn’t that “sexy” either, noted Katie Taylor, Carondelet’s practice manager. Patients are often in head-to-toe pain, and miserable. Many have been to other specialists without answers to their questions. For these reasons, rheumatology can be a hard sell for some PAs and NPs.

Nurse practitioners aren’t always comfortable with administering things such as controlled medications, for example. “It’s a hard patient population, and it’s a specialty of exclusion. You’ve got to be really smart to understand our diseases and our processes and our drugs,” Ms. Taylor said. In other words, it’s a difficult environment for an NP to walk into if their previous experience has been limited to upper respiratory issues and urinary tract infections in the primary care setting.

When hiring an APP, rheumatologists should look for someone who demonstrates an interest in lifelong learning, because the field is changing every day. They should exhibit good scores in educational training and have experience working in an emergency department or another field that translates well into rheumatology such as critical care, immunology, hematology, and orthopedics, she said.

Carondelet Rheumatology was specifically looking for an NP with rheumatology experience to support Dr. Box’s solo practice.

He was facing enormous pressure to be in the office every single day of the week. The practice had to cancel patients for its infusion suite on a regular basis when he was out of the office, Ms. Taylor said. “We couldn’t see new patients, and he wasn’t able to touch as many patients as he wanted to. The doctor takes the oath of touching as many in your community as possible, and you’re limited when you’re a one-man show.”

The practice eventually found an NP who already knew how to do joint injections. “We started her with easier diagnoses for things like osteoporosis and gout. She had an orthopedic background, so she was familiar with some of those diseases,” she said.

Even so, she often leaves with questions every day. “It’s a commitment for her to understand and learn so much,” Ms. Taylor said.

New hires will need support from the practice to get comfortable with rheumatology, Dr. Stamatos said. Responsibility should come in gradual steps.

Instead of loading an NP with 20 patients a day, 2 or 3 patients in the first quarter, eventually graduating to 6-8 patients is a more realistic expectation, Dr. Stamatos advised.
 

Shadowing the Physician

Partnerships with physicians is a critical component to this onboarding process.

A nurse practitioner recently hired at Dr. Stamatos’ practice works alongside a physician to manage a panel of 25 patients. “We make sure she gets her training, the resources she needs. I personally meet with her to make sure her education is moving forward, connecting her with radiology, pulmonary, hematology,” and other areas of the practice relevant to her training, she added.

The NP also attends weekly grand rounds and case conferences with the fellows. This is the type of well-rounded support any APP needs, she stressed. “Without proper training, you lose people.”

At Sarasota Arthritis Center, NPs help cover the suites but also get assigned to specific physicians so that they can familiarize themselves with that physician’s panel of patients.

“When we start an APP, they shadow for about twice as long as a new physician would. Usually, they’re shadowing for about 6 weeks, just kind of learning the space. There’s a lot of nurse practitioners or PAs who may not have prior rheumatology experience, so we’re essentially training them from the ground up on rheumatology,” Ms. Yonker said.

Pairing them with one provider often directs what type of disease state they focus on, she continued. This dynamic relationship helps guide decisions on whether to include these NPs in the care of patients with more complex diseases.

At least in her practice, the NPs do not see any new patients. They are simply part of the larger care team. “That’s kind of how we present it to our patients, and it makes them feel more comfortable just because they know that they’re not necessarily being handed off to somebody — that the doctor is still overseeing their care,” Ms. Yonker said.

At the same time, the NPs know that they’re supported, that they too have access to tools and mentorship if they need it, she added.

The new NP at Carondelet Rheumatology piggybacked on the doctor’s schedule for 3 months, slowly taking on infusion patients so she could get familiar with their diseases and respective drugs. Eventually, she got her own schedule and was able to take on new patients.

It’s a team effort, Ms. Taylor noted. The NP does the preliminary workup and then the physician comes in and greets the new patient. Together, they develop a follow-up plan for the patient.
 

Education Resources for Practices

In the case of Dr. Box’s one-physician practice, he was looking for an NP who was willing to be independent and cover things in his absence. “The training has to be there to accomplish that,” said Dr. Box, who likened the training of APPs to a medical residency.

Encouraging them to ask questions, do continuing medical education online and outside reading, are important steps, he added.

In a recent editorial, rheumatologists Eli M. Miloslavsky, MD, and Bethany Marston, MD, offered some strategies for better prepping the APP workforce to meet the demands of rheumatology practices. “Consideration should be given to formal curricula or training programs to help APPs achieve both competence and confidence in treating rheumatologic conditions,” they offered, suggesting an online curriculum developed by the ACR for such a purpose. Fellowship training should also focus on working effectively with APPs, they added.

“Finally, incorporating APPs more effectively into rheumatology professional societies and supporting practices in hiring and training APPs will all be important steps in addressing the rheumatology workforce shortage,” Dr. Miloslavsky and Dr. Marston wrote.

Ms. Yonker said all her APPs take various courses that the ACR and other organizations provide for rheumatology-specific, midlevel positions. “We provide as much training as possible for them to feel comfortable in this space. They are set directly with a physician for a long time and then eventually go into their own space.”

In addition to ACR, the Rheumatology Nurses Society and the Association of Women in Rheumatology offer excellent online training resources for APPs, Ms. Yonker said. “Also, the Bone Health and Osteoporosis Foundation offers an osteoporosis fracture liaison certification which we put APPs through as well,” she added.

Rheumatology practices should also look into an important clinical training grant program from the Rheumatology Research Foundation, Dr. Stamatos advised.

To date, they have “funded almost everyone that applies,” she said. Each grantee receives $25,000 to support training and education involved in onboarding an APP to a rheumatology practice. The money covers attendance at a live rheumatology conference, online educational programs, textbooks, and any society memberships while defraying the cost of training this employee. To increase awareness of the program, the foundation has since expanded the number of available submission dates and the number of grant awardees per year. Currently, the application deadlines for the grants are December 1 and March 1.

For her own health system, Dr. Stamatos has been working on a rheumatology fellowship program for APPs. Through simulation labs, leadership exercises, and other activities, these APPs will learn how to transition from being a new provider to someone who can become part of a practice, she said.

APPs themselves can also get proactive in this learning cycle, Ms. Swafford said. In her view, both APPs and rheumatologists should be conducting didactic lectures and organizing elective rotations with medical students to get them excited about the field. This would establish a good education base that would encourage PAs and NPs to choose rheumatology.

“That’s a huge thing that’s probably missing,” Ms. Swafford said.
 

Buy-in From the Doctor

No recruitment effort is going to work if the rheumatologists in the practice aren’t committed to the model of having an APP, Ms. Yonker said. “Everybody wants to know their purpose in their company and that they’re valued and they’re needed. And so, I think a pitfall would be if your rheumatologist is not sold on the model of expanding the care team. Because this takes work on behalf of the doctor.”

Rheumatologists are very busy, so it’s a hard sell for them to take time out of their busy clinics to train somebody to do a good job taking care of their patients, Ms. Taylor agreed. “I think that we need the physicians that have had success with this and allow them to coach the physicians that are still resistant.”

In his small practice, Dr. Box has encouraged his NP to assist with practice improvements, working with the office manager. These workers are providers and need to be treated as such, he said. “They need to feel like they contribute to the practice more than just grinding through patients.”

Peer support is another successful ingredient for these workers. Ms. Taylor’s NP finds the time to commiserate with her fellow nurse practitioners — other rheumatology nurses who are also learning the ropes. Rheumatologists are smart, and they can be very intimidating, Ms. Taylor said. In their small office, the rheumatologist is her only peer.

“She likes to get out and sort of integrate with other nurse practitioners that are learning too.”
 

When APPs Make a Difference

Practices that take on APPs are reporting positive metrics — mainly, shorter wait times for patients. Ms. Yonker’s physicians have been able to add on one to two new patients a day. Wait times have since dwindled from a 5-month to a 3-month wait with the addition of the NPs. “Three months is still long, but we’re working on getting it to that ideal 6-week wait period, which we’re hoping we can accomplish. So we’re able to get more new patients in for sure,” she said.

Prior to hiring an NP, Ms. Taylor’s practice had to defer acceptances for new patients by at least a year. Now, they’re able to accept about half of all new patient referrals. With the NP on board, “We can get them in within 30 days,” she said.

Sometimes, an APP will go beyond their scope of work to make a difference and better support patients.

Patients with rheumatic and osteopathic conditions are often underdiagnosed in the primary care space. As a result, they are not treated as often as they should be. Seeing a need for specialty care, Ms. Swafford took action.

She currently runs the only bone health clinic in southwest Michigan, coordinating with rheumatologists, NPs, urgent care, hospitalists, and interventional radiologists to attend to these patients more quickly and reduce wait times for care. Specialists will flag things such as nontraumatic hip fractures and vertebral fractures and refer them to Ms. Swafford’s clinic, which is part of Bronson Rheumatology Specialists.

The clinic gets quite a few referrals, and the practice is growing. “Usually, they don’t take as long as a rheumatology referral for a workup, so we can see them a little bit quicker,” usually within 3 weeks, she added.

APPs have an opportunity to make their mark in rheumatology at a time when the profession is experiencing significant gaps in care, Ms. Swafford continued. “Unless we find a way to fill that niche, we’re going to be in a world of trouble in the next 10, 20 years.”

None of the sources reported any disclosures or conflicts of interest.

Radiation oncologists from the largest professional societies have come together to lobby for Medicare payment reform.

The American Society for Radiation Oncology (ASTRO) recently announced its partnership with three other groups — the American College of Radiation Oncology, the American College of Radiology, and the American Society of Clinical Oncology — to change how the specialty is paid for services. 

Over the past decade, radiation oncologists have seen a 23% drop in Medicare reimbursement for radiation therapy services, with more cuts to come, according to a press release from ASTRO.

Traditionally, Medicare has reimbursed on the basis of the fraction of radiation delivered. But with moves toward hypofractionated regimens, deescalated therapy, and other changes in the field, reimbursement has continued to dwindle. 

The cuts have led to practice consolidation and closures that threaten patient access especially in rural and underserved areas, a spokesperson for the group told this news organization.

To reverse this trend, ASTRO recently proposed the Radiation Oncology Case Rate program, a legislative initiative to base reimbursements on patient volumes instead of fractions delivered. 

ASTRO is currently drafting a congressional bill to change the current payment structure, which “has become untenable,” the spokesperson said. 

A version of this article appeared on Medscape.com.

Radiation oncologists from the largest professional societies have come together to lobby for Medicare payment reform.

The American Society for Radiation Oncology (ASTRO) recently announced its partnership with three other groups — the American College of Radiation Oncology, the American College of Radiology, and the American Society of Clinical Oncology — to change how the specialty is paid for services. 

Over the past decade, radiation oncologists have seen a 23% drop in Medicare reimbursement for radiation therapy services, with more cuts to come, according to a press release from ASTRO.

Traditionally, Medicare has reimbursed on the basis of the fraction of radiation delivered. But with moves toward hypofractionated regimens, deescalated therapy, and other changes in the field, reimbursement has continued to dwindle. 

The cuts have led to practice consolidation and closures that threaten patient access especially in rural and underserved areas, a spokesperson for the group told this news organization.

To reverse this trend, ASTRO recently proposed the Radiation Oncology Case Rate program, a legislative initiative to base reimbursements on patient volumes instead of fractions delivered. 

ASTRO is currently drafting a congressional bill to change the current payment structure, which “has become untenable,” the spokesperson said. 

A version of this article appeared on Medscape.com.

Radiation oncologists from the largest professional societies have come together to lobby for Medicare payment reform.

The American Society for Radiation Oncology (ASTRO) recently announced its partnership with three other groups — the American College of Radiation Oncology, the American College of Radiology, and the American Society of Clinical Oncology — to change how the specialty is paid for services. 

Over the past decade, radiation oncologists have seen a 23% drop in Medicare reimbursement for radiation therapy services, with more cuts to come, according to a press release from ASTRO.

Traditionally, Medicare has reimbursed on the basis of the fraction of radiation delivered. But with moves toward hypofractionated regimens, deescalated therapy, and other changes in the field, reimbursement has continued to dwindle. 

The cuts have led to practice consolidation and closures that threaten patient access especially in rural and underserved areas, a spokesperson for the group told this news organization.

To reverse this trend, ASTRO recently proposed the Radiation Oncology Case Rate program, a legislative initiative to base reimbursements on patient volumes instead of fractions delivered. 

ASTRO is currently drafting a congressional bill to change the current payment structure, which “has become untenable,” the spokesperson said. 

A version of this article appeared on Medscape.com.

For years, oncologist John DiPersio, MD, PhD, had faced frustrating encounters with insurers that only cover medications through a process called white bagging.

Instead of the traditional buy-and-bill pathway where oncologists purchase specialty drugs, such as infusion medications, directly from the distributor or manufacturer, white bagging requires physicians to receive these drugs from a specialty pharmacy.

On its face, the differences may seem minor. However, as Dr. DiPersio knows well, the consequences for oncologists and patients are not.

White bagging, research showed, leads to higher costs for patients and lower reimbursement for oncology practices. The practice can also create safety issues for patients.

That is why Dr. DiPersio’s cancer center does not allow white bagging.

And when insurers refuse to reconsider the white bagging policy, his cancer team is left with few options.

“Sometimes, we have to redirect patients to other places,” said Dr. DiPersio, a bone marrow transplant specialist at Siteman Cancer Center, Washington University, St. Louis.

In emergency instances where patients cannot wait, Dr. DiPersio’s team will administer their own stock of a drug. In such cases, “we accept the fact that by not allowing white bagging, there may be nonpayment. We take the hit as far as cost.”

Increasingly, white bagging mandates are becoming harder for practices to avoid.

In a 2021 survey, 87% of Association of Community Cancer Centers members said white bagging has become an insurer mandate for some of their patients.

A 2023 analysis from Adam J. Fein, PhD, of Drug Channels Institute, Philadelphia, found that white bagging accounted for 17% of infused oncology product sourcing from clinics and 38% from hospital outpatient departments, up from 15% to 28% in 2019. Another practice called brown bagging, where specialty pharmacies send drugs directly to patients, creates many of the same issues but is much less prevalent than white bagging.

This change reflects “the broader battle over oncology margins” and insurers’ “attempts to shift costs to providers, patients, and manufacturers,” Dr. Fein wrote in his 2023 report.
 

White Bagging: Who Benefits?

At its core, white bagging changes how drugs are covered and reimbursed. Under buy and bill, drugs fall under a patient’s medical benefit. Oncologists purchase drugs directly from the manufacturer or distributor and receive reimbursement from the insurance company for both the cost of the drug as well as for administering it to patients.

Under white bagging, drugs fall under a patient’s pharmacy benefit. In these instances, a specialty pharmacy prepares the infusion ahead of time and ships it directly to the physician’s office or clinic. Because oncologists do not purchase the drug directly, they cannot bill insurers for it; instead, the pharmacy receives reimbursement for the drug and the provider is reimbursed for administering it.

Insurance companies argue that white bagging reduces patients’ out-of-pocket costs “by preventing hospitals and physicians from charging exorbitant fees to buy and store specialty medicines themselves,” according to advocacy group America’s Health Insurance Plans (AHIP).

Data from AHIP suggested that hospitals mark up the price of cancer drugs considerably, charging about twice as much as a specialty pharmacy, and that physician’s offices also charge about 23% more. However, these figures highlight how much insurers are billed, not necessarily how much patients ultimately pay.

Other evidence shows that white bagging raises costs for patients while reducing reimbursement for oncologists and saving insurance companies money.

A recent analysis in JAMA Network Open, which looked at 50 cancer drugs associated with the highest total spending from the 2020 Medicare Part B, found that mean insurance payments to providers were more than $2000 lower for drugs distributed under bagging than traditional buy and bill: $7405 vs $9547 per patient per month. Investigators found the same pattern in median insurance payments: $5746 vs $6681. Patients also paid more out-of-pocket each month with bagging vs buy and bill: $315 vs $145.

For patients with private insurance, “out-of-pocket costs were higher under bagging practice than the traditional buy-and-bill practice,” said lead author Ya-Chen Tina Shih, PhD, a professor in the department of radiation oncology at UCLA Health, Los Angeles.

White bagging is entirely for the profit of health insurers, specialty pharmacies, and pharmacy benefit managers, the middlemen who negotiate drug prices on behalf of payers.

Many people may not realize the underlying money-making strategies behind white bagging, explained Ted Okon, executive director for Community Oncology Alliance, which opposes the practice. Often, an insurer, pharmacy benefit manager, and mail order pharmacy involved in the process are all affiliated with the same corporation. In such cases, an insurer has a financial motive to control the source of medications and steer business to its affiliated pharmacies, Mr. Okon said.

When a single corporation owns numerous parts of the drug supply chain, insurers end up having “sway over what drug to use and then how the patient is going to get it,” Mr. Okon said. If the specialty pharmacy is a 340B contract pharmacy, it likely also receives a sizable discount on the drug and can make more money through white bagging.
 

Dangerous to Patients?

On the safety front, proponents of white bagging say the process is safe and efficient.

Specialty pharmacies are used only for prescription drugs that can be safely delivered, said AHIP spokesman David Allen.

In addition to having the same supply chain safety requirements as any other dispensing pharmacy, “specialty pharmacies also must meet additional safety requirements for specialty drugs” to ensure “the safe storage, handling, and dispensing of the drugs,” Mr. Allen explained.

However, oncologists argue that white bagging can be dangerous.

With white bagging, specialty pharmacies send a specified dose to practices, which does not allow practices to source and mix the drug themselves or make essential last-minute dose-related changes — something that happens every day in the clinic, said Debra Patt, MD, PhD, MBA, executive vice president for policy and strategy for Texas Oncology, Dallas.

White bagging also increases the risk for drug contamination, results in drug waste if the medication can’t be used, and can create delays in care.

Essentially, white bagging takes control away from oncologists and makes patient care more unpredictable and complex, explained Dr. Patt, president of the Texas Society of Clinical Oncology, Rockville, Maryland.

Dr. Patt, who does not allow white bagging in her practice, recalled a recent patient with metastatic breast cancer who came to the clinic for trastuzumab deruxtecan. The patient had been experiencing acute abdominal pain. After an exam and CT, Dr. Patt found the breast cancer had grown and moved into the patient’s liver.

“I had to discontinue that plan and change to a different chemotherapy,” she said. “If we had white bagged, that would have been a waste of several thousand dollars. Also, the patient would have to wait for the new medication to be white bagged, a delay that would be at least a week and the patient would have to come back at another time.”

When asked about the safety concerns associated with white bagging, Lemrey “Al” Carter, MS, PharmD, RPh, executive director of the National Association of Boards of Pharmacy (NABP), said the NABP “acknowledges that all these issues exist.

“It is unfortunate if patient care or costs are negatively impacted,” Dr. Carter said, adding that “boards of pharmacy can investigate if they are made aware of safety concerns at the pharmacy level. If a violation of the pharmacy laws or rules is found, boards can take action.”
 

More Legislation to Prevent Bagging

As white bagging mandates from insurance companies ramp up, more practices and states are banning it.

In the Association of Community Cancer Centers’ 2021 survey, 59% of members said their cancer program or practice does not allow white bagging.

At least 15 states have introduced legislation that restricts and/or prohibits white and brown bagging practices, according to a 2023 report by the Institute for Clinical and Economic Review. Some of the proposed laws would restrict mandates by stipulating that physicians are reimbursed at the contracted amount for clinician-administered drugs, whether obtained from a pharmacy or the manufacturer.

Louisiana, Vermont, and Minnesota were the first to enact anti–white bagging laws. Louisiana’s law, for example, enacted in 2021, bans white bagging and requires insurers to reimburse providers for physician-administered drugs if obtained from out-of-network pharmacies.

When the legislation passed, white bagging was just starting to enter the healthcare market in Louisiana, and the state wanted to act proactively, said Kathy W. Oubre, MS, CEO of the Pontchartrain Cancer Center, Covington, Louisiana, and president of the Coalition of Hematology and Oncology Practices, Mountain View, California.

“We recognized the growing concern around it,” Ms. Oubre said. The state legislature at the time included physicians and pharmacists who “really understood from a practice and patient perspective, the harm that policy could do.”

Ms. Oubre would like to see more legislation in other states and believes Louisiana’s law is a good model.

At the federal level, the American Hospital Association and American Society of Health-System Pharmacists have also urged the US Food and Drug Administration to take appropriate enforcement action to protect patients from white bagging.

Legislation that bars white bagging mandates is the most reasonable way to support timely and appropriate access to cancer care, Dr. Patt said. In the absence of such legislation, she said oncologists can only opt out of insurance contracts that may require the practice.

“That is a difficult position to put oncologists in,” she said.

A version of this article appeared on Medscape.com.

For years, oncologist John DiPersio, MD, PhD, had faced frustrating encounters with insurers that only cover medications through a process called white bagging.

Instead of the traditional buy-and-bill pathway where oncologists purchase specialty drugs, such as infusion medications, directly from the distributor or manufacturer, white bagging requires physicians to receive these drugs from a specialty pharmacy.

On its face, the differences may seem minor. However, as Dr. DiPersio knows well, the consequences for oncologists and patients are not.

White bagging, research showed, leads to higher costs for patients and lower reimbursement for oncology practices. The practice can also create safety issues for patients.

That is why Dr. DiPersio’s cancer center does not allow white bagging.

And when insurers refuse to reconsider the white bagging policy, his cancer team is left with few options.

“Sometimes, we have to redirect patients to other places,” said Dr. DiPersio, a bone marrow transplant specialist at Siteman Cancer Center, Washington University, St. Louis.

In emergency instances where patients cannot wait, Dr. DiPersio’s team will administer their own stock of a drug. In such cases, “we accept the fact that by not allowing white bagging, there may be nonpayment. We take the hit as far as cost.”

Increasingly, white bagging mandates are becoming harder for practices to avoid.

In a 2021 survey, 87% of Association of Community Cancer Centers members said white bagging has become an insurer mandate for some of their patients.

A 2023 analysis from Adam J. Fein, PhD, of Drug Channels Institute, Philadelphia, found that white bagging accounted for 17% of infused oncology product sourcing from clinics and 38% from hospital outpatient departments, up from 15% to 28% in 2019. Another practice called brown bagging, where specialty pharmacies send drugs directly to patients, creates many of the same issues but is much less prevalent than white bagging.

This change reflects “the broader battle over oncology margins” and insurers’ “attempts to shift costs to providers, patients, and manufacturers,” Dr. Fein wrote in his 2023 report.
 

White Bagging: Who Benefits?

At its core, white bagging changes how drugs are covered and reimbursed. Under buy and bill, drugs fall under a patient’s medical benefit. Oncologists purchase drugs directly from the manufacturer or distributor and receive reimbursement from the insurance company for both the cost of the drug as well as for administering it to patients.

Under white bagging, drugs fall under a patient’s pharmacy benefit. In these instances, a specialty pharmacy prepares the infusion ahead of time and ships it directly to the physician’s office or clinic. Because oncologists do not purchase the drug directly, they cannot bill insurers for it; instead, the pharmacy receives reimbursement for the drug and the provider is reimbursed for administering it.

Insurance companies argue that white bagging reduces patients’ out-of-pocket costs “by preventing hospitals and physicians from charging exorbitant fees to buy and store specialty medicines themselves,” according to advocacy group America’s Health Insurance Plans (AHIP).

Data from AHIP suggested that hospitals mark up the price of cancer drugs considerably, charging about twice as much as a specialty pharmacy, and that physician’s offices also charge about 23% more. However, these figures highlight how much insurers are billed, not necessarily how much patients ultimately pay.

Other evidence shows that white bagging raises costs for patients while reducing reimbursement for oncologists and saving insurance companies money.

A recent analysis in JAMA Network Open, which looked at 50 cancer drugs associated with the highest total spending from the 2020 Medicare Part B, found that mean insurance payments to providers were more than $2000 lower for drugs distributed under bagging than traditional buy and bill: $7405 vs $9547 per patient per month. Investigators found the same pattern in median insurance payments: $5746 vs $6681. Patients also paid more out-of-pocket each month with bagging vs buy and bill: $315 vs $145.

For patients with private insurance, “out-of-pocket costs were higher under bagging practice than the traditional buy-and-bill practice,” said lead author Ya-Chen Tina Shih, PhD, a professor in the department of radiation oncology at UCLA Health, Los Angeles.

White bagging is entirely for the profit of health insurers, specialty pharmacies, and pharmacy benefit managers, the middlemen who negotiate drug prices on behalf of payers.

Many people may not realize the underlying money-making strategies behind white bagging, explained Ted Okon, executive director for Community Oncology Alliance, which opposes the practice. Often, an insurer, pharmacy benefit manager, and mail order pharmacy involved in the process are all affiliated with the same corporation. In such cases, an insurer has a financial motive to control the source of medications and steer business to its affiliated pharmacies, Mr. Okon said.

When a single corporation owns numerous parts of the drug supply chain, insurers end up having “sway over what drug to use and then how the patient is going to get it,” Mr. Okon said. If the specialty pharmacy is a 340B contract pharmacy, it likely also receives a sizable discount on the drug and can make more money through white bagging.
 

Dangerous to Patients?

On the safety front, proponents of white bagging say the process is safe and efficient.

Specialty pharmacies are used only for prescription drugs that can be safely delivered, said AHIP spokesman David Allen.

In addition to having the same supply chain safety requirements as any other dispensing pharmacy, “specialty pharmacies also must meet additional safety requirements for specialty drugs” to ensure “the safe storage, handling, and dispensing of the drugs,” Mr. Allen explained.

However, oncologists argue that white bagging can be dangerous.

With white bagging, specialty pharmacies send a specified dose to practices, which does not allow practices to source and mix the drug themselves or make essential last-minute dose-related changes — something that happens every day in the clinic, said Debra Patt, MD, PhD, MBA, executive vice president for policy and strategy for Texas Oncology, Dallas.

White bagging also increases the risk for drug contamination, results in drug waste if the medication can’t be used, and can create delays in care.

Essentially, white bagging takes control away from oncologists and makes patient care more unpredictable and complex, explained Dr. Patt, president of the Texas Society of Clinical Oncology, Rockville, Maryland.

Dr. Patt, who does not allow white bagging in her practice, recalled a recent patient with metastatic breast cancer who came to the clinic for trastuzumab deruxtecan. The patient had been experiencing acute abdominal pain. After an exam and CT, Dr. Patt found the breast cancer had grown and moved into the patient’s liver.

“I had to discontinue that plan and change to a different chemotherapy,” she said. “If we had white bagged, that would have been a waste of several thousand dollars. Also, the patient would have to wait for the new medication to be white bagged, a delay that would be at least a week and the patient would have to come back at another time.”

When asked about the safety concerns associated with white bagging, Lemrey “Al” Carter, MS, PharmD, RPh, executive director of the National Association of Boards of Pharmacy (NABP), said the NABP “acknowledges that all these issues exist.

“It is unfortunate if patient care or costs are negatively impacted,” Dr. Carter said, adding that “boards of pharmacy can investigate if they are made aware of safety concerns at the pharmacy level. If a violation of the pharmacy laws or rules is found, boards can take action.”
 

More Legislation to Prevent Bagging

As white bagging mandates from insurance companies ramp up, more practices and states are banning it.

In the Association of Community Cancer Centers’ 2021 survey, 59% of members said their cancer program or practice does not allow white bagging.

At least 15 states have introduced legislation that restricts and/or prohibits white and brown bagging practices, according to a 2023 report by the Institute for Clinical and Economic Review. Some of the proposed laws would restrict mandates by stipulating that physicians are reimbursed at the contracted amount for clinician-administered drugs, whether obtained from a pharmacy or the manufacturer.

Louisiana, Vermont, and Minnesota were the first to enact anti–white bagging laws. Louisiana’s law, for example, enacted in 2021, bans white bagging and requires insurers to reimburse providers for physician-administered drugs if obtained from out-of-network pharmacies.

When the legislation passed, white bagging was just starting to enter the healthcare market in Louisiana, and the state wanted to act proactively, said Kathy W. Oubre, MS, CEO of the Pontchartrain Cancer Center, Covington, Louisiana, and president of the Coalition of Hematology and Oncology Practices, Mountain View, California.

“We recognized the growing concern around it,” Ms. Oubre said. The state legislature at the time included physicians and pharmacists who “really understood from a practice and patient perspective, the harm that policy could do.”

Ms. Oubre would like to see more legislation in other states and believes Louisiana’s law is a good model.

At the federal level, the American Hospital Association and American Society of Health-System Pharmacists have also urged the US Food and Drug Administration to take appropriate enforcement action to protect patients from white bagging.

Legislation that bars white bagging mandates is the most reasonable way to support timely and appropriate access to cancer care, Dr. Patt said. In the absence of such legislation, she said oncologists can only opt out of insurance contracts that may require the practice.

“That is a difficult position to put oncologists in,” she said.

A version of this article appeared on Medscape.com.

For years, oncologist John DiPersio, MD, PhD, had faced frustrating encounters with insurers that only cover medications through a process called white bagging.

Instead of the traditional buy-and-bill pathway where oncologists purchase specialty drugs, such as infusion medications, directly from the distributor or manufacturer, white bagging requires physicians to receive these drugs from a specialty pharmacy.

On its face, the differences may seem minor. However, as Dr. DiPersio knows well, the consequences for oncologists and patients are not.

White bagging, research showed, leads to higher costs for patients and lower reimbursement for oncology practices. The practice can also create safety issues for patients.

That is why Dr. DiPersio’s cancer center does not allow white bagging.

And when insurers refuse to reconsider the white bagging policy, his cancer team is left with few options.

“Sometimes, we have to redirect patients to other places,” said Dr. DiPersio, a bone marrow transplant specialist at Siteman Cancer Center, Washington University, St. Louis.

In emergency instances where patients cannot wait, Dr. DiPersio’s team will administer their own stock of a drug. In such cases, “we accept the fact that by not allowing white bagging, there may be nonpayment. We take the hit as far as cost.”

Increasingly, white bagging mandates are becoming harder for practices to avoid.

In a 2021 survey, 87% of Association of Community Cancer Centers members said white bagging has become an insurer mandate for some of their patients.

A 2023 analysis from Adam J. Fein, PhD, of Drug Channels Institute, Philadelphia, found that white bagging accounted for 17% of infused oncology product sourcing from clinics and 38% from hospital outpatient departments, up from 15% to 28% in 2019. Another practice called brown bagging, where specialty pharmacies send drugs directly to patients, creates many of the same issues but is much less prevalent than white bagging.

This change reflects “the broader battle over oncology margins” and insurers’ “attempts to shift costs to providers, patients, and manufacturers,” Dr. Fein wrote in his 2023 report.
 

White Bagging: Who Benefits?

At its core, white bagging changes how drugs are covered and reimbursed. Under buy and bill, drugs fall under a patient’s medical benefit. Oncologists purchase drugs directly from the manufacturer or distributor and receive reimbursement from the insurance company for both the cost of the drug as well as for administering it to patients.

Under white bagging, drugs fall under a patient’s pharmacy benefit. In these instances, a specialty pharmacy prepares the infusion ahead of time and ships it directly to the physician’s office or clinic. Because oncologists do not purchase the drug directly, they cannot bill insurers for it; instead, the pharmacy receives reimbursement for the drug and the provider is reimbursed for administering it.

Insurance companies argue that white bagging reduces patients’ out-of-pocket costs “by preventing hospitals and physicians from charging exorbitant fees to buy and store specialty medicines themselves,” according to advocacy group America’s Health Insurance Plans (AHIP).

Data from AHIP suggested that hospitals mark up the price of cancer drugs considerably, charging about twice as much as a specialty pharmacy, and that physician’s offices also charge about 23% more. However, these figures highlight how much insurers are billed, not necessarily how much patients ultimately pay.

Other evidence shows that white bagging raises costs for patients while reducing reimbursement for oncologists and saving insurance companies money.

A recent analysis in JAMA Network Open, which looked at 50 cancer drugs associated with the highest total spending from the 2020 Medicare Part B, found that mean insurance payments to providers were more than $2000 lower for drugs distributed under bagging than traditional buy and bill: $7405 vs $9547 per patient per month. Investigators found the same pattern in median insurance payments: $5746 vs $6681. Patients also paid more out-of-pocket each month with bagging vs buy and bill: $315 vs $145.

For patients with private insurance, “out-of-pocket costs were higher under bagging practice than the traditional buy-and-bill practice,” said lead author Ya-Chen Tina Shih, PhD, a professor in the department of radiation oncology at UCLA Health, Los Angeles.

White bagging is entirely for the profit of health insurers, specialty pharmacies, and pharmacy benefit managers, the middlemen who negotiate drug prices on behalf of payers.

Many people may not realize the underlying money-making strategies behind white bagging, explained Ted Okon, executive director for Community Oncology Alliance, which opposes the practice. Often, an insurer, pharmacy benefit manager, and mail order pharmacy involved in the process are all affiliated with the same corporation. In such cases, an insurer has a financial motive to control the source of medications and steer business to its affiliated pharmacies, Mr. Okon said.

When a single corporation owns numerous parts of the drug supply chain, insurers end up having “sway over what drug to use and then how the patient is going to get it,” Mr. Okon said. If the specialty pharmacy is a 340B contract pharmacy, it likely also receives a sizable discount on the drug and can make more money through white bagging.
 

Dangerous to Patients?

On the safety front, proponents of white bagging say the process is safe and efficient.

Specialty pharmacies are used only for prescription drugs that can be safely delivered, said AHIP spokesman David Allen.

In addition to having the same supply chain safety requirements as any other dispensing pharmacy, “specialty pharmacies also must meet additional safety requirements for specialty drugs” to ensure “the safe storage, handling, and dispensing of the drugs,” Mr. Allen explained.

However, oncologists argue that white bagging can be dangerous.

With white bagging, specialty pharmacies send a specified dose to practices, which does not allow practices to source and mix the drug themselves or make essential last-minute dose-related changes — something that happens every day in the clinic, said Debra Patt, MD, PhD, MBA, executive vice president for policy and strategy for Texas Oncology, Dallas.

White bagging also increases the risk for drug contamination, results in drug waste if the medication can’t be used, and can create delays in care.

Essentially, white bagging takes control away from oncologists and makes patient care more unpredictable and complex, explained Dr. Patt, president of the Texas Society of Clinical Oncology, Rockville, Maryland.

Dr. Patt, who does not allow white bagging in her practice, recalled a recent patient with metastatic breast cancer who came to the clinic for trastuzumab deruxtecan. The patient had been experiencing acute abdominal pain. After an exam and CT, Dr. Patt found the breast cancer had grown and moved into the patient’s liver.

“I had to discontinue that plan and change to a different chemotherapy,” she said. “If we had white bagged, that would have been a waste of several thousand dollars. Also, the patient would have to wait for the new medication to be white bagged, a delay that would be at least a week and the patient would have to come back at another time.”

When asked about the safety concerns associated with white bagging, Lemrey “Al” Carter, MS, PharmD, RPh, executive director of the National Association of Boards of Pharmacy (NABP), said the NABP “acknowledges that all these issues exist.

“It is unfortunate if patient care or costs are negatively impacted,” Dr. Carter said, adding that “boards of pharmacy can investigate if they are made aware of safety concerns at the pharmacy level. If a violation of the pharmacy laws or rules is found, boards can take action.”
 

More Legislation to Prevent Bagging

As white bagging mandates from insurance companies ramp up, more practices and states are banning it.

In the Association of Community Cancer Centers’ 2021 survey, 59% of members said their cancer program or practice does not allow white bagging.

At least 15 states have introduced legislation that restricts and/or prohibits white and brown bagging practices, according to a 2023 report by the Institute for Clinical and Economic Review. Some of the proposed laws would restrict mandates by stipulating that physicians are reimbursed at the contracted amount for clinician-administered drugs, whether obtained from a pharmacy or the manufacturer.

Louisiana, Vermont, and Minnesota were the first to enact anti–white bagging laws. Louisiana’s law, for example, enacted in 2021, bans white bagging and requires insurers to reimburse providers for physician-administered drugs if obtained from out-of-network pharmacies.

When the legislation passed, white bagging was just starting to enter the healthcare market in Louisiana, and the state wanted to act proactively, said Kathy W. Oubre, MS, CEO of the Pontchartrain Cancer Center, Covington, Louisiana, and president of the Coalition of Hematology and Oncology Practices, Mountain View, California.

“We recognized the growing concern around it,” Ms. Oubre said. The state legislature at the time included physicians and pharmacists who “really understood from a practice and patient perspective, the harm that policy could do.”

Ms. Oubre would like to see more legislation in other states and believes Louisiana’s law is a good model.

At the federal level, the American Hospital Association and American Society of Health-System Pharmacists have also urged the US Food and Drug Administration to take appropriate enforcement action to protect patients from white bagging.

Legislation that bars white bagging mandates is the most reasonable way to support timely and appropriate access to cancer care, Dr. Patt said. In the absence of such legislation, she said oncologists can only opt out of insurance contracts that may require the practice.

“That is a difficult position to put oncologists in,” she said.

A version of this article appeared on Medscape.com.

France did it 5 years ago and now, from January 1, the Dutch have followed suit, banning devices such as mobile phones and tablets in classrooms unless needed during lessons, for medical reasons, or by students with disabilities. The ban aims to limit distractions during the school day. 

We could all surely do with some device detox, but the question remains whether too much screen time has an impact on child development. Karen Mansfield, PhD, a postdoctoral researcher on adolescent well-being in the digital age at Oxford University, told this news organization, “The evidence is definitely not set in stone. There have been some recent reviews of screen time effects on children, demonstrating very mixed findings.”

The latest research, said Dr. Mansfield, is still young, lacking consistency in findings, and rife with misinterpretation.

Tiziana Metitieri, a cognitive neuropsychologist at the Meyer Hospital in Florence, Italy, echoed these sentiments, suggesting that the sheer quantity of screen time is an insufficient metric for understanding its impact on cognitive and psychological development. “There are two main reasons for this,” she explained to this news organization. “Firstly, because the current measurements of screen time rely on self-report data, which can be affected by an overestimation or underestimation of objective usage due to social desirability bias. Secondly, because digital experiences differ in terms of content, device used, context, location, and individuals involved.”
 

Are Politicians in Too Much of a Rush?

UNESCO’s most recent report on technology in education highlighted a correlation between excessive mobile phone use and reduced educational performance and emotional stability.

The OECD report “Empowering Young Children in the Digital Age,” rightly suggested there is a need to improve protection in digital environments, bridge the digital divide, and educate parents and teachers on safe digital practices.

But Dr. Mansfield said, “Currently, policy implementation is racing far ahead of the evidence, with similar suggestions to ban smartphones in schools in the United Kingdom and Canada. However, there is no available evidence on the long-term benefits of banning smartphones. Much of the research behind the OECD and UNESCO policies is observational in nature, which limits causal interpretation more than with interventions.”

While most governments are not pursuing restrictive practices, Dr. Metitieri said that “their approaches are based on their political ideology, often using moral panic as a means to rally support, showing their heartfelt commitment to defending against the invasions of digital technology ruining human civilizations.” 

Sakshi Ghai, PhD, Dr. Mansfield’s fellow postdoctoral researcher at Oxford University, reiterated Dr. Metitieri’s concerns, “Screen time as a concept has limitations, and policy guidance needs to be careful when drawing insights from such limited evidence. What do we mean by screen time? How can time spent on different activities be clearly delineated? An oversimplistic focus on screen time may overlook the nuances and complexity of digital media use.”
 

The Key Is the What and Where

Digital screens can be productive for children, such as when used for educational purposes, be it to join a class over Zoom or partake in extracurricular educational activities. However, Dr. Ghai emphasized the importance of identifying what constitutes reasonable consumption of digital media. “Screens can help disadvantaged children achieve positive educational outcomes, particularly those with learning difficulties,” said Dr. Ghai. “Using media to interact with other children can also bring positive social connections to racially diverse children or those from the LGBTQ community, which reiterates why finding the balance that allows children to reap the benefits of digital technology while safeguarding their mental, physical, and social health, is crucial.”

On the other hand, Dr. Metitieri explained that there is evidence that passive exposure to educational content does not necessarily lead to growth benefits. “The key is the relational environment in which these digital experiences occur,” she said. 

Dr. Mansfield said a lot of research describes excessive use of digital media as a form of addiction. “Some studies have attempted to validate and test ‘smartphone addiction’ scales for adolescent. Besides pathologizing an increasingly common activity, such self-report scales are highly subjective, implying serious limitations when attempting to define ‘cut offs’ or diagnostic thresholds.”

Previous efforts to determine benchmarks for screen time usage, focusing on the relationship between historical screen usage and present mental well-being, have overlooked the nature of the digital interaction and the social and technological backdrop. “Effects of screen time on children is a continuously changing, rapidly developing research field, and other contextual factors have been shown to play a greater role on mental health,” explained Dr. Mansfield.
 

Are School Bans Too Restrictive?

Implementing nationwide policies that warrant a dramatic shift in how we approach activities that have become second nature, such as using a mobile phone, is profoundly difficult, particularly as evidence is inconclusive and inconsistent. “The long-term effects of different types of digital content on children’s learning are yet to be clear, and most education-related research so far has been carried out with college students,” said Dr. Mansfield.

For concerned parents and schools, Dr. Metitieri advised against overly restrictive approaches. “Children and adolescents can find ways around restrictions at home and school, meaning that an overly restrictive approach is limited in its effectiveness,” she said. “The best way to adapt to the changes happening in education, relationships, work, and leisure is through a combination of experiences offline and digital education.”

Mirroring Dr. Metitieri’s outlook, Dr. Mansfield suggested, “Restricting the use of smartphones and other personal devices is one method to reduce distraction, but ultimately, children will need to learn to optimize their use of digital devices.”

Recent Dutch media reports cited government ministers’ consultations with neuropsychiatrist Theo Compernolle, MD, PhD, who compared children’s current smartphone usage patterns to addiction and suggested that such habits may hinder the development of the prefrontal cortex. However, Dr. Mansfield said, “There is no evidence to back up this claim.” Although she acknowledged the potential short-term benefits of a screen time ban in enhancing classroom concentration, she said, “One study directly tested this hypothesis and found no association between social media use and brain development, meaning that any claims of long-term effects remain purely speculative.”

The issue of children’s screen time is complex. Understanding the content and context of screen time, educating parents and teachers, and integrating digital experiences with offline activities seem to be the way forward. While governments contend with the complexities of managing this rather modern challenge, the balance between digital engagement and cognitive development remains a critical topic for continued research and thoughtful policymaking. Dr. Metitieri summed it up, “As adult members of the digital society, it is important for us to educate ourselves on how to effectively use online platforms before sharing our experiences and concerns about the online world with children and adolescents.”

A version of this article appeared on Medscape.com.

France did it 5 years ago and now, from January 1, the Dutch have followed suit, banning devices such as mobile phones and tablets in classrooms unless needed during lessons, for medical reasons, or by students with disabilities. The ban aims to limit distractions during the school day. 

We could all surely do with some device detox, but the question remains whether too much screen time has an impact on child development. Karen Mansfield, PhD, a postdoctoral researcher on adolescent well-being in the digital age at Oxford University, told this news organization, “The evidence is definitely not set in stone. There have been some recent reviews of screen time effects on children, demonstrating very mixed findings.”

The latest research, said Dr. Mansfield, is still young, lacking consistency in findings, and rife with misinterpretation.

Tiziana Metitieri, a cognitive neuropsychologist at the Meyer Hospital in Florence, Italy, echoed these sentiments, suggesting that the sheer quantity of screen time is an insufficient metric for understanding its impact on cognitive and psychological development. “There are two main reasons for this,” she explained to this news organization. “Firstly, because the current measurements of screen time rely on self-report data, which can be affected by an overestimation or underestimation of objective usage due to social desirability bias. Secondly, because digital experiences differ in terms of content, device used, context, location, and individuals involved.”
 

Are Politicians in Too Much of a Rush?

UNESCO’s most recent report on technology in education highlighted a correlation between excessive mobile phone use and reduced educational performance and emotional stability.

The OECD report “Empowering Young Children in the Digital Age,” rightly suggested there is a need to improve protection in digital environments, bridge the digital divide, and educate parents and teachers on safe digital practices.

But Dr. Mansfield said, “Currently, policy implementation is racing far ahead of the evidence, with similar suggestions to ban smartphones in schools in the United Kingdom and Canada. However, there is no available evidence on the long-term benefits of banning smartphones. Much of the research behind the OECD and UNESCO policies is observational in nature, which limits causal interpretation more than with interventions.”

While most governments are not pursuing restrictive practices, Dr. Metitieri said that “their approaches are based on their political ideology, often using moral panic as a means to rally support, showing their heartfelt commitment to defending against the invasions of digital technology ruining human civilizations.” 

Sakshi Ghai, PhD, Dr. Mansfield’s fellow postdoctoral researcher at Oxford University, reiterated Dr. Metitieri’s concerns, “Screen time as a concept has limitations, and policy guidance needs to be careful when drawing insights from such limited evidence. What do we mean by screen time? How can time spent on different activities be clearly delineated? An oversimplistic focus on screen time may overlook the nuances and complexity of digital media use.”
 

The Key Is the What and Where

Digital screens can be productive for children, such as when used for educational purposes, be it to join a class over Zoom or partake in extracurricular educational activities. However, Dr. Ghai emphasized the importance of identifying what constitutes reasonable consumption of digital media. “Screens can help disadvantaged children achieve positive educational outcomes, particularly those with learning difficulties,” said Dr. Ghai. “Using media to interact with other children can also bring positive social connections to racially diverse children or those from the LGBTQ community, which reiterates why finding the balance that allows children to reap the benefits of digital technology while safeguarding their mental, physical, and social health, is crucial.”

On the other hand, Dr. Metitieri explained that there is evidence that passive exposure to educational content does not necessarily lead to growth benefits. “The key is the relational environment in which these digital experiences occur,” she said. 

Dr. Mansfield said a lot of research describes excessive use of digital media as a form of addiction. “Some studies have attempted to validate and test ‘smartphone addiction’ scales for adolescent. Besides pathologizing an increasingly common activity, such self-report scales are highly subjective, implying serious limitations when attempting to define ‘cut offs’ or diagnostic thresholds.”

Previous efforts to determine benchmarks for screen time usage, focusing on the relationship between historical screen usage and present mental well-being, have overlooked the nature of the digital interaction and the social and technological backdrop. “Effects of screen time on children is a continuously changing, rapidly developing research field, and other contextual factors have been shown to play a greater role on mental health,” explained Dr. Mansfield.
 

Are School Bans Too Restrictive?

Implementing nationwide policies that warrant a dramatic shift in how we approach activities that have become second nature, such as using a mobile phone, is profoundly difficult, particularly as evidence is inconclusive and inconsistent. “The long-term effects of different types of digital content on children’s learning are yet to be clear, and most education-related research so far has been carried out with college students,” said Dr. Mansfield.

For concerned parents and schools, Dr. Metitieri advised against overly restrictive approaches. “Children and adolescents can find ways around restrictions at home and school, meaning that an overly restrictive approach is limited in its effectiveness,” she said. “The best way to adapt to the changes happening in education, relationships, work, and leisure is through a combination of experiences offline and digital education.”

Mirroring Dr. Metitieri’s outlook, Dr. Mansfield suggested, “Restricting the use of smartphones and other personal devices is one method to reduce distraction, but ultimately, children will need to learn to optimize their use of digital devices.”

Recent Dutch media reports cited government ministers’ consultations with neuropsychiatrist Theo Compernolle, MD, PhD, who compared children’s current smartphone usage patterns to addiction and suggested that such habits may hinder the development of the prefrontal cortex. However, Dr. Mansfield said, “There is no evidence to back up this claim.” Although she acknowledged the potential short-term benefits of a screen time ban in enhancing classroom concentration, she said, “One study directly tested this hypothesis and found no association between social media use and brain development, meaning that any claims of long-term effects remain purely speculative.”

The issue of children’s screen time is complex. Understanding the content and context of screen time, educating parents and teachers, and integrating digital experiences with offline activities seem to be the way forward. While governments contend with the complexities of managing this rather modern challenge, the balance between digital engagement and cognitive development remains a critical topic for continued research and thoughtful policymaking. Dr. Metitieri summed it up, “As adult members of the digital society, it is important for us to educate ourselves on how to effectively use online platforms before sharing our experiences and concerns about the online world with children and adolescents.”

A version of this article appeared on Medscape.com.

France did it 5 years ago and now, from January 1, the Dutch have followed suit, banning devices such as mobile phones and tablets in classrooms unless needed during lessons, for medical reasons, or by students with disabilities. The ban aims to limit distractions during the school day. 

We could all surely do with some device detox, but the question remains whether too much screen time has an impact on child development. Karen Mansfield, PhD, a postdoctoral researcher on adolescent well-being in the digital age at Oxford University, told this news organization, “The evidence is definitely not set in stone. There have been some recent reviews of screen time effects on children, demonstrating very mixed findings.”

The latest research, said Dr. Mansfield, is still young, lacking consistency in findings, and rife with misinterpretation.

Tiziana Metitieri, a cognitive neuropsychologist at the Meyer Hospital in Florence, Italy, echoed these sentiments, suggesting that the sheer quantity of screen time is an insufficient metric for understanding its impact on cognitive and psychological development. “There are two main reasons for this,” she explained to this news organization. “Firstly, because the current measurements of screen time rely on self-report data, which can be affected by an overestimation or underestimation of objective usage due to social desirability bias. Secondly, because digital experiences differ in terms of content, device used, context, location, and individuals involved.”
 

Are Politicians in Too Much of a Rush?

UNESCO’s most recent report on technology in education highlighted a correlation between excessive mobile phone use and reduced educational performance and emotional stability.

The OECD report “Empowering Young Children in the Digital Age,” rightly suggested there is a need to improve protection in digital environments, bridge the digital divide, and educate parents and teachers on safe digital practices.

But Dr. Mansfield said, “Currently, policy implementation is racing far ahead of the evidence, with similar suggestions to ban smartphones in schools in the United Kingdom and Canada. However, there is no available evidence on the long-term benefits of banning smartphones. Much of the research behind the OECD and UNESCO policies is observational in nature, which limits causal interpretation more than with interventions.”

While most governments are not pursuing restrictive practices, Dr. Metitieri said that “their approaches are based on their political ideology, often using moral panic as a means to rally support, showing their heartfelt commitment to defending against the invasions of digital technology ruining human civilizations.” 

Sakshi Ghai, PhD, Dr. Mansfield’s fellow postdoctoral researcher at Oxford University, reiterated Dr. Metitieri’s concerns, “Screen time as a concept has limitations, and policy guidance needs to be careful when drawing insights from such limited evidence. What do we mean by screen time? How can time spent on different activities be clearly delineated? An oversimplistic focus on screen time may overlook the nuances and complexity of digital media use.”
 

The Key Is the What and Where

Digital screens can be productive for children, such as when used for educational purposes, be it to join a class over Zoom or partake in extracurricular educational activities. However, Dr. Ghai emphasized the importance of identifying what constitutes reasonable consumption of digital media. “Screens can help disadvantaged children achieve positive educational outcomes, particularly those with learning difficulties,” said Dr. Ghai. “Using media to interact with other children can also bring positive social connections to racially diverse children or those from the LGBTQ community, which reiterates why finding the balance that allows children to reap the benefits of digital technology while safeguarding their mental, physical, and social health, is crucial.”

On the other hand, Dr. Metitieri explained that there is evidence that passive exposure to educational content does not necessarily lead to growth benefits. “The key is the relational environment in which these digital experiences occur,” she said. 

Dr. Mansfield said a lot of research describes excessive use of digital media as a form of addiction. “Some studies have attempted to validate and test ‘smartphone addiction’ scales for adolescent. Besides pathologizing an increasingly common activity, such self-report scales are highly subjective, implying serious limitations when attempting to define ‘cut offs’ or diagnostic thresholds.”

Previous efforts to determine benchmarks for screen time usage, focusing on the relationship between historical screen usage and present mental well-being, have overlooked the nature of the digital interaction and the social and technological backdrop. “Effects of screen time on children is a continuously changing, rapidly developing research field, and other contextual factors have been shown to play a greater role on mental health,” explained Dr. Mansfield.
 

Are School Bans Too Restrictive?

Implementing nationwide policies that warrant a dramatic shift in how we approach activities that have become second nature, such as using a mobile phone, is profoundly difficult, particularly as evidence is inconclusive and inconsistent. “The long-term effects of different types of digital content on children’s learning are yet to be clear, and most education-related research so far has been carried out with college students,” said Dr. Mansfield.

For concerned parents and schools, Dr. Metitieri advised against overly restrictive approaches. “Children and adolescents can find ways around restrictions at home and school, meaning that an overly restrictive approach is limited in its effectiveness,” she said. “The best way to adapt to the changes happening in education, relationships, work, and leisure is through a combination of experiences offline and digital education.”

Mirroring Dr. Metitieri’s outlook, Dr. Mansfield suggested, “Restricting the use of smartphones and other personal devices is one method to reduce distraction, but ultimately, children will need to learn to optimize their use of digital devices.”

Recent Dutch media reports cited government ministers’ consultations with neuropsychiatrist Theo Compernolle, MD, PhD, who compared children’s current smartphone usage patterns to addiction and suggested that such habits may hinder the development of the prefrontal cortex. However, Dr. Mansfield said, “There is no evidence to back up this claim.” Although she acknowledged the potential short-term benefits of a screen time ban in enhancing classroom concentration, she said, “One study directly tested this hypothesis and found no association between social media use and brain development, meaning that any claims of long-term effects remain purely speculative.”

The issue of children’s screen time is complex. Understanding the content and context of screen time, educating parents and teachers, and integrating digital experiences with offline activities seem to be the way forward. While governments contend with the complexities of managing this rather modern challenge, the balance between digital engagement and cognitive development remains a critical topic for continued research and thoughtful policymaking. Dr. Metitieri summed it up, “As adult members of the digital society, it is important for us to educate ourselves on how to effectively use online platforms before sharing our experiences and concerns about the online world with children and adolescents.”

A version of this article appeared on Medscape.com.

Intake of protein, especially from plants, in middle age is associated with higher odds of healthy aging and positive mental and physical health status in older women, a recent analysis of the Nurses’ Health Study (NHS) data suggests.

The study is said to be the first to examine the long-term impact of midlife protein consumption on later health status.

Writing in the American Journal of Clinical Nutrition, a team led by Andres V. Ardisson Korat, DSc, a nutritional epidemiologist at the USDA Human Nutrition Research Center on Aging at Tufts University in Boston, Massachusetts, found the following midlife protein–related odds ratios (ORs) for later healthy aging measured at ages 70-93.

For each 3% energy increment from various protein sources:

• 1.05 (95% confidence interval, 1.01-1.10) for total protein
• 1.07 (1.02-1.11) for animal protein
• 1.14 (1.06-1.23) for dairy protein
• 1.38 (1.24-1.54) for plant protein 

In substitution analyses, significant positive associations were observed for the isocaloric replacement of animal or dairy protein, carbohydrate, or fat with plant protein — with increased ORs for healthy aging of 1.22-1.58 for each 3% of energy replacement.

On the measure of physical function, for example, replacing calories from all macronutrient variables with equivalent calories from plant protein was associated with 20%-60% higher odds of having no physical function limitations. Plant protein was also associated with higher odds for good mental status.

“Other studies have looked at protein intake in older adults, but we felt midlife was a more relevant etiological window,” Dr. Ardisson Korat said in an interview. “Our findings generally align, however, with those of protein intake in older populations, which have shown that protein can reduce the risk of frailty.”

He added that the benefits of protein, especially from plant sources, would likely apply to men as well and increasing plant protein intake is not difficult. “If you want a snack during the day, eat a handful of nuts instead of potato chips,” he advised. And eating several meals a week featuring beans, peas, lentils, tofu, whole grains, or seeds is an easy way to boost dietary plant protein, which comes with health-promoting soluble and insoluble fiber as well as antioxidant and anti-inflammatory polyphenols and other phytochemicals.

Conversely, plant but not animal protein consumption in older adulthood was linked to a lower risk of frailty in a previous NHS trial.

Higher plant protein intake was associated with a better probability of achieving healthy aging defined by changes in functional impairments, self-reported health/vitality, mental health, and use of health services in the Spanish Seniors-Estudio Sobre Nutricion y Riesgo Cardiovascular.

In contrast, animal protein intake in middle adulthood has been linked to an increased risk of premature death from chronic diseases driven by cardiovascular disease mortality.

The present findings are consistent with those observed for protein intakes in older adulthood, Dr. Ardisson Korat said.

“This study underscores the health advantages for midlife adults consuming adequate dietary protein — particularly plant protein — as one component of pursuing a healthy lifestyle,” said Douglas R. Dirschl, MD, chair of orthopedic surgery at Baylor College of Medicine in Houston, Texas. Most Americans consume adequate amounts of protein, but according to Dr. Dirschl, who treats many older patients for osteoporotic fractures and other musculoskeletal conditions, many US diets are subpar in this nutrient.

While protein is essential for bone and muscle formation and maintenance, “a surprising number of Americans are protein deficient, even those who seem hale and are overweight,” he said.


 

Dietary Recommendations for Midlife Patients

Physicians should therefore advise midlife patients to meet or perhaps modestly exceed the recommended dietary allowance (RDA) for protein of 0.8 g/kg per day and to make plant protein a substantial component of daily dietary protein intake, Dr. Dirschl said.

Luke D. Kim, MD, MEd, a geriatrician at the Cleveland Clinic in Cleveland, Ohio, noted that patients with lower socioeconomic status or with difficulty in day-to-day functioning are likely to have suboptimal protein intake. Such patients may need encouragement to eat more protein. “But we should keep in mind that showing a higher associated odds ratio of better health with increased protein take does not mean causality,” he said.

According to Rachel L. Amdur, MD, an internist at Northwestern Medicine in Chicago, Illinois, the long-term follow-up data from the NHS are uniquely helpful. “Middle-aged persons may think they no longer need much dietary protein and need to be reminded. Sometimes eating carbohydrates is just easier,” she said in an interview. Physicians need to asses and counsel patients on nutrition at all stages of life. “As I tell my patients, it’s best to think of your future self now.”

In agreement is Louis J. Morledge, MD, an internist at Northwell Health in New York City. “I firmly counsel my patients about adequate and often increased protein intake in middle life. But this is always within a larger framework of overall nutritional health.” He added that middle-aged persons often find themselves “stuck in food ruts,” and one of his clinical focuses is to advise patients about the importance of healthier food choices so they can better adjust to mental, emotional, physical, and skeletal changes as they age.
 

Study Details

The NHS analysis drew on prospective data from 48,762 nurses under age 60 in 1984. Total protein, animal protein, dairy protein, and plant protein were derived from validated food-frequency questionnaires.

Adjusting for lifestyle, demographics, and health status, the investigators identified 3721 (7.6% of cohort) eligible participants. The mean age of participants at baseline was 48.6 years; 38.6% had body mass indexes (BMI; in kg/m²) greater than 25; 22.9% were current smokers; and 88.2% were married.

Healthy aging was defined as freedom from 11 major chronic diseases, good mental health, and no impairments in cognitive or physical function, as assessed in the 2014 or 2016 NHS participant questionnaires. Diseases/treatments included cancer, type 2 diabetes, myocardial infarction, coronary artery bypass graft or coronary angioplasty, congestive heart failure, stroke, kidney failure, chronic obstructive pulmonary disease, Parkinson disease, multiple sclerosis, and amyotrophic lateral sclerosis.

Mean total protein consumption as a percentage of energy was 18.3% (standard deviation 3%), slightly higher than the average 16% in the US diet. Of this, 13.3% derived from animals, 3.6% from dairy products, and 4.9% from plants.

Total protein intake was positively associated with higher education levels, being physically active, higher BMI, and a baseline history of hypertension and hypercholesterolemia. Conversely, total protein intake was inversely associated with intakes of total carbohydrates, nuts, alcohol, and sugar-sweetened beverages.

The associations between protein intake and healthy aging are complex and not fully understood, the authors stated.
 

Effects of Protein Intake

In studies of older adult populations lower protein intake has been associated with lean mass loss. Animal protein supplementation studies in older adults have shown lean mass gains potentially related to amino acid composition.

In terms of mechanisms, evidence suggests that protein-related activation of the rapamycin complex 1 pathway may play a role, the authors suggested. The activity of this signaling pathway decreases with age.

Rapamycin, a compound used to prevent organ transplant rejection, has been associated with delayed aging. In the body, dietary protein and exercise activate this pathway, thereby stimulating muscle protein synthesis and possibly improving physical function.

As for the differential associations of plant and animal protein on the chronic disease domain of the healthy aging phenotype, Dr. Ardisson Korat and coauthors said plant protein has been associated with favorable levels of important risk factors for cardiometabolic diseases, such as reduced LDL cholesterol, lower blood pressure, and insulin sensitivity, as well as decreased levels of proinflammatory markers.

Conversely, total and animal protein intakes have been positively associated with concentrations of insulin-like growth factor 1, which is implicated in the growth of malignant cells in breast and prostate tissue.

This study is the first step in evaluating the long-term health effect of protein intake in midlife, the relevant development window for most chronic conditions, the NHS study authors said. More research is needed, however, to corroborate the study findings in other populations and identify underlying mechanisms.

This study was supported by the USDA Agricultural Research Service and the National Institutes of Health. The authors reported no conflicts of interest. The commentators disclosed no relevant competing interests.

Intake of protein, especially from plants, in middle age is associated with higher odds of healthy aging and positive mental and physical health status in older women, a recent analysis of the Nurses’ Health Study (NHS) data suggests.

The study is said to be the first to examine the long-term impact of midlife protein consumption on later health status.

Writing in the American Journal of Clinical Nutrition, a team led by Andres V. Ardisson Korat, DSc, a nutritional epidemiologist at the USDA Human Nutrition Research Center on Aging at Tufts University in Boston, Massachusetts, found the following midlife protein–related odds ratios (ORs) for later healthy aging measured at ages 70-93.

For each 3% energy increment from various protein sources:

• 1.05 (95% confidence interval, 1.01-1.10) for total protein
• 1.07 (1.02-1.11) for animal protein
• 1.14 (1.06-1.23) for dairy protein
• 1.38 (1.24-1.54) for plant protein 

In substitution analyses, significant positive associations were observed for the isocaloric replacement of animal or dairy protein, carbohydrate, or fat with plant protein — with increased ORs for healthy aging of 1.22-1.58 for each 3% of energy replacement.

On the measure of physical function, for example, replacing calories from all macronutrient variables with equivalent calories from plant protein was associated with 20%-60% higher odds of having no physical function limitations. Plant protein was also associated with higher odds for good mental status.

“Other studies have looked at protein intake in older adults, but we felt midlife was a more relevant etiological window,” Dr. Ardisson Korat said in an interview. “Our findings generally align, however, with those of protein intake in older populations, which have shown that protein can reduce the risk of frailty.”

He added that the benefits of protein, especially from plant sources, would likely apply to men as well and increasing plant protein intake is not difficult. “If you want a snack during the day, eat a handful of nuts instead of potato chips,” he advised. And eating several meals a week featuring beans, peas, lentils, tofu, whole grains, or seeds is an easy way to boost dietary plant protein, which comes with health-promoting soluble and insoluble fiber as well as antioxidant and anti-inflammatory polyphenols and other phytochemicals.

Conversely, plant but not animal protein consumption in older adulthood was linked to a lower risk of frailty in a previous NHS trial.

Higher plant protein intake was associated with a better probability of achieving healthy aging defined by changes in functional impairments, self-reported health/vitality, mental health, and use of health services in the Spanish Seniors-Estudio Sobre Nutricion y Riesgo Cardiovascular.

In contrast, animal protein intake in middle adulthood has been linked to an increased risk of premature death from chronic diseases driven by cardiovascular disease mortality.

The present findings are consistent with those observed for protein intakes in older adulthood, Dr. Ardisson Korat said.

“This study underscores the health advantages for midlife adults consuming adequate dietary protein — particularly plant protein — as one component of pursuing a healthy lifestyle,” said Douglas R. Dirschl, MD, chair of orthopedic surgery at Baylor College of Medicine in Houston, Texas. Most Americans consume adequate amounts of protein, but according to Dr. Dirschl, who treats many older patients for osteoporotic fractures and other musculoskeletal conditions, many US diets are subpar in this nutrient.

While protein is essential for bone and muscle formation and maintenance, “a surprising number of Americans are protein deficient, even those who seem hale and are overweight,” he said.


 

Dietary Recommendations for Midlife Patients

Physicians should therefore advise midlife patients to meet or perhaps modestly exceed the recommended dietary allowance (RDA) for protein of 0.8 g/kg per day and to make plant protein a substantial component of daily dietary protein intake, Dr. Dirschl said.

Luke D. Kim, MD, MEd, a geriatrician at the Cleveland Clinic in Cleveland, Ohio, noted that patients with lower socioeconomic status or with difficulty in day-to-day functioning are likely to have suboptimal protein intake. Such patients may need encouragement to eat more protein. “But we should keep in mind that showing a higher associated odds ratio of better health with increased protein take does not mean causality,” he said.

According to Rachel L. Amdur, MD, an internist at Northwestern Medicine in Chicago, Illinois, the long-term follow-up data from the NHS are uniquely helpful. “Middle-aged persons may think they no longer need much dietary protein and need to be reminded. Sometimes eating carbohydrates is just easier,” she said in an interview. Physicians need to asses and counsel patients on nutrition at all stages of life. “As I tell my patients, it’s best to think of your future self now.”

In agreement is Louis J. Morledge, MD, an internist at Northwell Health in New York City. “I firmly counsel my patients about adequate and often increased protein intake in middle life. But this is always within a larger framework of overall nutritional health.” He added that middle-aged persons often find themselves “stuck in food ruts,” and one of his clinical focuses is to advise patients about the importance of healthier food choices so they can better adjust to mental, emotional, physical, and skeletal changes as they age.
 

Study Details

The NHS analysis drew on prospective data from 48,762 nurses under age 60 in 1984. Total protein, animal protein, dairy protein, and plant protein were derived from validated food-frequency questionnaires.

Adjusting for lifestyle, demographics, and health status, the investigators identified 3721 (7.6% of cohort) eligible participants. The mean age of participants at baseline was 48.6 years; 38.6% had body mass indexes (BMI; in kg/m²) greater than 25; 22.9% were current smokers; and 88.2% were married.

Healthy aging was defined as freedom from 11 major chronic diseases, good mental health, and no impairments in cognitive or physical function, as assessed in the 2014 or 2016 NHS participant questionnaires. Diseases/treatments included cancer, type 2 diabetes, myocardial infarction, coronary artery bypass graft or coronary angioplasty, congestive heart failure, stroke, kidney failure, chronic obstructive pulmonary disease, Parkinson disease, multiple sclerosis, and amyotrophic lateral sclerosis.

Mean total protein consumption as a percentage of energy was 18.3% (standard deviation 3%), slightly higher than the average 16% in the US diet. Of this, 13.3% derived from animals, 3.6% from dairy products, and 4.9% from plants.

Total protein intake was positively associated with higher education levels, being physically active, higher BMI, and a baseline history of hypertension and hypercholesterolemia. Conversely, total protein intake was inversely associated with intakes of total carbohydrates, nuts, alcohol, and sugar-sweetened beverages.

The associations between protein intake and healthy aging are complex and not fully understood, the authors stated.
 

Effects of Protein Intake

In studies of older adult populations lower protein intake has been associated with lean mass loss. Animal protein supplementation studies in older adults have shown lean mass gains potentially related to amino acid composition.

In terms of mechanisms, evidence suggests that protein-related activation of the rapamycin complex 1 pathway may play a role, the authors suggested. The activity of this signaling pathway decreases with age.

Rapamycin, a compound used to prevent organ transplant rejection, has been associated with delayed aging. In the body, dietary protein and exercise activate this pathway, thereby stimulating muscle protein synthesis and possibly improving physical function.

As for the differential associations of plant and animal protein on the chronic disease domain of the healthy aging phenotype, Dr. Ardisson Korat and coauthors said plant protein has been associated with favorable levels of important risk factors for cardiometabolic diseases, such as reduced LDL cholesterol, lower blood pressure, and insulin sensitivity, as well as decreased levels of proinflammatory markers.

Conversely, total and animal protein intakes have been positively associated with concentrations of insulin-like growth factor 1, which is implicated in the growth of malignant cells in breast and prostate tissue.

This study is the first step in evaluating the long-term health effect of protein intake in midlife, the relevant development window for most chronic conditions, the NHS study authors said. More research is needed, however, to corroborate the study findings in other populations and identify underlying mechanisms.

This study was supported by the USDA Agricultural Research Service and the National Institutes of Health. The authors reported no conflicts of interest. The commentators disclosed no relevant competing interests.

Intake of protein, especially from plants, in middle age is associated with higher odds of healthy aging and positive mental and physical health status in older women, a recent analysis of the Nurses’ Health Study (NHS) data suggests.

The study is said to be the first to examine the long-term impact of midlife protein consumption on later health status.

Writing in the American Journal of Clinical Nutrition, a team led by Andres V. Ardisson Korat, DSc, a nutritional epidemiologist at the USDA Human Nutrition Research Center on Aging at Tufts University in Boston, Massachusetts, found the following midlife protein–related odds ratios (ORs) for later healthy aging measured at ages 70-93.

For each 3% energy increment from various protein sources:

• 1.05 (95% confidence interval, 1.01-1.10) for total protein
• 1.07 (1.02-1.11) for animal protein
• 1.14 (1.06-1.23) for dairy protein
• 1.38 (1.24-1.54) for plant protein 

In substitution analyses, significant positive associations were observed for the isocaloric replacement of animal or dairy protein, carbohydrate, or fat with plant protein — with increased ORs for healthy aging of 1.22-1.58 for each 3% of energy replacement.

On the measure of physical function, for example, replacing calories from all macronutrient variables with equivalent calories from plant protein was associated with 20%-60% higher odds of having no physical function limitations. Plant protein was also associated with higher odds for good mental status.

“Other studies have looked at protein intake in older adults, but we felt midlife was a more relevant etiological window,” Dr. Ardisson Korat said in an interview. “Our findings generally align, however, with those of protein intake in older populations, which have shown that protein can reduce the risk of frailty.”

He added that the benefits of protein, especially from plant sources, would likely apply to men as well and increasing plant protein intake is not difficult. “If you want a snack during the day, eat a handful of nuts instead of potato chips,” he advised. And eating several meals a week featuring beans, peas, lentils, tofu, whole grains, or seeds is an easy way to boost dietary plant protein, which comes with health-promoting soluble and insoluble fiber as well as antioxidant and anti-inflammatory polyphenols and other phytochemicals.

Conversely, plant but not animal protein consumption in older adulthood was linked to a lower risk of frailty in a previous NHS trial.

Higher plant protein intake was associated with a better probability of achieving healthy aging defined by changes in functional impairments, self-reported health/vitality, mental health, and use of health services in the Spanish Seniors-Estudio Sobre Nutricion y Riesgo Cardiovascular.

In contrast, animal protein intake in middle adulthood has been linked to an increased risk of premature death from chronic diseases driven by cardiovascular disease mortality.

The present findings are consistent with those observed for protein intakes in older adulthood, Dr. Ardisson Korat said.

“This study underscores the health advantages for midlife adults consuming adequate dietary protein — particularly plant protein — as one component of pursuing a healthy lifestyle,” said Douglas R. Dirschl, MD, chair of orthopedic surgery at Baylor College of Medicine in Houston, Texas. Most Americans consume adequate amounts of protein, but according to Dr. Dirschl, who treats many older patients for osteoporotic fractures and other musculoskeletal conditions, many US diets are subpar in this nutrient.

While protein is essential for bone and muscle formation and maintenance, “a surprising number of Americans are protein deficient, even those who seem hale and are overweight,” he said.


 

Dietary Recommendations for Midlife Patients

Physicians should therefore advise midlife patients to meet or perhaps modestly exceed the recommended dietary allowance (RDA) for protein of 0.8 g/kg per day and to make plant protein a substantial component of daily dietary protein intake, Dr. Dirschl said.

Luke D. Kim, MD, MEd, a geriatrician at the Cleveland Clinic in Cleveland, Ohio, noted that patients with lower socioeconomic status or with difficulty in day-to-day functioning are likely to have suboptimal protein intake. Such patients may need encouragement to eat more protein. “But we should keep in mind that showing a higher associated odds ratio of better health with increased protein take does not mean causality,” he said.

According to Rachel L. Amdur, MD, an internist at Northwestern Medicine in Chicago, Illinois, the long-term follow-up data from the NHS are uniquely helpful. “Middle-aged persons may think they no longer need much dietary protein and need to be reminded. Sometimes eating carbohydrates is just easier,” she said in an interview. Physicians need to asses and counsel patients on nutrition at all stages of life. “As I tell my patients, it’s best to think of your future self now.”

In agreement is Louis J. Morledge, MD, an internist at Northwell Health in New York City. “I firmly counsel my patients about adequate and often increased protein intake in middle life. But this is always within a larger framework of overall nutritional health.” He added that middle-aged persons often find themselves “stuck in food ruts,” and one of his clinical focuses is to advise patients about the importance of healthier food choices so they can better adjust to mental, emotional, physical, and skeletal changes as they age.
 

Study Details

The NHS analysis drew on prospective data from 48,762 nurses under age 60 in 1984. Total protein, animal protein, dairy protein, and plant protein were derived from validated food-frequency questionnaires.

Adjusting for lifestyle, demographics, and health status, the investigators identified 3721 (7.6% of cohort) eligible participants. The mean age of participants at baseline was 48.6 years; 38.6% had body mass indexes (BMI; in kg/m²) greater than 25; 22.9% were current smokers; and 88.2% were married.

Healthy aging was defined as freedom from 11 major chronic diseases, good mental health, and no impairments in cognitive or physical function, as assessed in the 2014 or 2016 NHS participant questionnaires. Diseases/treatments included cancer, type 2 diabetes, myocardial infarction, coronary artery bypass graft or coronary angioplasty, congestive heart failure, stroke, kidney failure, chronic obstructive pulmonary disease, Parkinson disease, multiple sclerosis, and amyotrophic lateral sclerosis.

Mean total protein consumption as a percentage of energy was 18.3% (standard deviation 3%), slightly higher than the average 16% in the US diet. Of this, 13.3% derived from animals, 3.6% from dairy products, and 4.9% from plants.

Total protein intake was positively associated with higher education levels, being physically active, higher BMI, and a baseline history of hypertension and hypercholesterolemia. Conversely, total protein intake was inversely associated with intakes of total carbohydrates, nuts, alcohol, and sugar-sweetened beverages.

The associations between protein intake and healthy aging are complex and not fully understood, the authors stated.
 

Effects of Protein Intake

In studies of older adult populations lower protein intake has been associated with lean mass loss. Animal protein supplementation studies in older adults have shown lean mass gains potentially related to amino acid composition.

In terms of mechanisms, evidence suggests that protein-related activation of the rapamycin complex 1 pathway may play a role, the authors suggested. The activity of this signaling pathway decreases with age.

Rapamycin, a compound used to prevent organ transplant rejection, has been associated with delayed aging. In the body, dietary protein and exercise activate this pathway, thereby stimulating muscle protein synthesis and possibly improving physical function.

As for the differential associations of plant and animal protein on the chronic disease domain of the healthy aging phenotype, Dr. Ardisson Korat and coauthors said plant protein has been associated with favorable levels of important risk factors for cardiometabolic diseases, such as reduced LDL cholesterol, lower blood pressure, and insulin sensitivity, as well as decreased levels of proinflammatory markers.

Conversely, total and animal protein intakes have been positively associated with concentrations of insulin-like growth factor 1, which is implicated in the growth of malignant cells in breast and prostate tissue.

This study is the first step in evaluating the long-term health effect of protein intake in midlife, the relevant development window for most chronic conditions, the NHS study authors said. More research is needed, however, to corroborate the study findings in other populations and identify underlying mechanisms.

This study was supported by the USDA Agricultural Research Service and the National Institutes of Health. The authors reported no conflicts of interest. The commentators disclosed no relevant competing interests.