After more than 5 decades of trying, the drug industry is on the verge of providing effective immunizations against the respiratory syncytial virus (RSV), which has put an estimated 90,000 U.S. infants and small children in the hospital since the start of October.

But only one of the shots is designed to be given to babies, and a glitch in congressional language may make it difficult to allow children from low-income families to get it as readily as the well insured.

Since 1994, routine vaccination has been a childhood entitlement under the Vaccines for Children program, through which the federal government buys millions of vaccines and provides them free through pediatricians and clinics to children who are uninsured, underinsured, or on Medicaid – more than half of all American kids.

The 1993 law creating the program didn’t specifically include antibody shots, which were used only as rare emergency therapy at the time the bill was written.

But the first medication of its kind likely to be available to babies, called nirsevimab (it was approved in Europe in December, and Food and Drug Administration approval is expected in the summer of 2023), is not a vaccine but rather a monoclonal antibody that neutralizes RSV in the bloodstream.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is certain to recommend giving the antibody to infants, said Kelly Moore, MD, president of the advocacy group Immunize.org. The CDC is currently assessing whether nirsevimab would be eligible for the Vaccines for Children program, agency spokesperson Kristen Nordlund told KHN.

Failing to do so would “consign thousands upon thousands of infants to hospitalization and serious illness for semantic reasons despite existence of an immunization that functionally performs just like a seasonal vaccine,” Dr. Moore said.

Officials from Sanofi, which is producing the nirsevimab injection along with AstraZeneca, declined to state a price but said the range would be similar to that of a pediatric vaccine course. The CDC pays about $650 for the most expensive routine vaccine, the four shots against pneumococcal infection. In other words, FDA approval would make nirsevimab a blockbuster drug worth billions annually if it’s given to a large share of the 3.7 million or so children born in the U.S. each year.

Pfizer and GlaxoSmithKline are making traditional vaccines against RSV and expect FDA approval later in 2023. Pfizer’s shot initially would be given to pregnant women – to shield their babies from the disease – while GSK’s would be given to the elderly.

Vaccines designed for infants are in the pipeline, but some experts are still nervous about them. A 1966 RSV vaccine trial failed spectacularly, killing two toddlers, and immunologists aren’t totally in agreement over the cause, said Barney Graham, MD, PhD, the retired National Institutes of Health scientist whose studies of the episode contributed to successful COVID-19 and RSV vaccines.

After 2 years of COVID lockdowns and masking slowed its transmission, RSV exploded across the United States in 2023, swamping pediatric intensive care units.

Sanofi and AstraZeneca hope to have nirsevimab approved by the FDA, recommended by the CDC, and deployed nationwide by fall to prevent future RSV epidemics.

Their product is designed to be provided before a baby’s first winter RSV season. In clinical trials, the antibodies provided up to 5 months of protection. Most children wouldn’t need a second dose because the virus is not a mortal danger to healthy kids over a year old, said Jon Heinrichs, a senior member of Sanofi’s vaccines division.

If the antibody treatment is not accepted for the Vaccines for Children program, that will limit access to the shot for the uninsured and those on Medicaid, the majority of whom represent racial or ethnic minorities, Dr. Moore said. The drugmakers would have to negotiate with each state’s Medicaid program to get it on their formularies.

Excluding the shot from Vaccines for Children “would only worsen existing health disparities,” said Sean O’Leary, MD, a professor of pediatrics at the University of Colorado at Denver, Aurora, and chair of the infectious diseases committee of the American Academy of Pediatrics.

RSV affects babies of all social classes but tends to hit poor, crowded households hardest, said Dr. Graham. “Family history of asthma or allergy makes it worse,” he said, and premature babies are also at higher risk.

While 2%-3% of U.S. infants are hospitalized with RSV each year, only a few hundred don’t survive. But as many as 10,000 people 65 and older perish because of an infection every year, and a little-discussed legal change will make RSV and other vaccines more available to this group.

A section of the 2022 Inflation Reduction Act that went into effect Jan. 1 ends out-of-pocket payments for all vaccines by Medicare patients – including RSV vaccines, if they are licensed for this group.

Before, “if you hadn’t met your deductible, it could be very expensive,” said Leonard Friedland, MD, vice president for scientific affairs and public health in GSK’s vaccines division, which also makes shingles and combination tetanus-diphtheria-whooping cough boosters covered by the new law. “It’s a tremendously important advance.”

Of course, high levels of vaccine hesitancy are likely to blunt uptake of the shots regardless of who pays, said Jennifer Reich, a sociologist at the University of Colorado who studies vaccination attitudes.

New types of shots, like the Sanofi-AstraZeneca antibodies, often alarm parents, and Pfizer’s shot for pregnant women is likely to push fear buttons as well, she said.

Public health officials “don’t seem very savvy about how to get ahead” of claims that vaccines undermine fertility or otherwise harm people, said Ms. Reich.

On the other hand, this winter’s RSV epidemic will be persuasive to many parents, said Heidi Larson, leader of the Vaccine Confidence Project and a professor of anthropology at the London School of Hygiene and Tropical Medicine.

“It’s a scary thing to have your kid hospitalized with RSV,” she said.

While unfortunate, “the high number of children who died or were admitted to the ICU in the past season with RSV – in some ways that’s helpful,” said Laura Riley, MD, chair of obstetrics and gynecology at Weill Cornell Medicine, New York.

Specialists in her field haven’t really started talking about how to communicate with women about the vaccine, said Dr. Riley, who chairs the immunization group at the American College of Obstetricians and Gynecologists.

“Everyone’s been waiting to see if it gets approved,” she said. “The education has to start soon, but it’s hard to roll out education before you roll out the shot.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

After more than 5 decades of trying, the drug industry is on the verge of providing effective immunizations against the respiratory syncytial virus (RSV), which has put an estimated 90,000 U.S. infants and small children in the hospital since the start of October.

But only one of the shots is designed to be given to babies, and a glitch in congressional language may make it difficult to allow children from low-income families to get it as readily as the well insured.

Since 1994, routine vaccination has been a childhood entitlement under the Vaccines for Children program, through which the federal government buys millions of vaccines and provides them free through pediatricians and clinics to children who are uninsured, underinsured, or on Medicaid – more than half of all American kids.

The 1993 law creating the program didn’t specifically include antibody shots, which were used only as rare emergency therapy at the time the bill was written.

But the first medication of its kind likely to be available to babies, called nirsevimab (it was approved in Europe in December, and Food and Drug Administration approval is expected in the summer of 2023), is not a vaccine but rather a monoclonal antibody that neutralizes RSV in the bloodstream.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is certain to recommend giving the antibody to infants, said Kelly Moore, MD, president of the advocacy group Immunize.org. The CDC is currently assessing whether nirsevimab would be eligible for the Vaccines for Children program, agency spokesperson Kristen Nordlund told KHN.

Failing to do so would “consign thousands upon thousands of infants to hospitalization and serious illness for semantic reasons despite existence of an immunization that functionally performs just like a seasonal vaccine,” Dr. Moore said.

Officials from Sanofi, which is producing the nirsevimab injection along with AstraZeneca, declined to state a price but said the range would be similar to that of a pediatric vaccine course. The CDC pays about $650 for the most expensive routine vaccine, the four shots against pneumococcal infection. In other words, FDA approval would make nirsevimab a blockbuster drug worth billions annually if it’s given to a large share of the 3.7 million or so children born in the U.S. each year.

Pfizer and GlaxoSmithKline are making traditional vaccines against RSV and expect FDA approval later in 2023. Pfizer’s shot initially would be given to pregnant women – to shield their babies from the disease – while GSK’s would be given to the elderly.

Vaccines designed for infants are in the pipeline, but some experts are still nervous about them. A 1966 RSV vaccine trial failed spectacularly, killing two toddlers, and immunologists aren’t totally in agreement over the cause, said Barney Graham, MD, PhD, the retired National Institutes of Health scientist whose studies of the episode contributed to successful COVID-19 and RSV vaccines.

After 2 years of COVID lockdowns and masking slowed its transmission, RSV exploded across the United States in 2023, swamping pediatric intensive care units.

Sanofi and AstraZeneca hope to have nirsevimab approved by the FDA, recommended by the CDC, and deployed nationwide by fall to prevent future RSV epidemics.

Their product is designed to be provided before a baby’s first winter RSV season. In clinical trials, the antibodies provided up to 5 months of protection. Most children wouldn’t need a second dose because the virus is not a mortal danger to healthy kids over a year old, said Jon Heinrichs, a senior member of Sanofi’s vaccines division.

If the antibody treatment is not accepted for the Vaccines for Children program, that will limit access to the shot for the uninsured and those on Medicaid, the majority of whom represent racial or ethnic minorities, Dr. Moore said. The drugmakers would have to negotiate with each state’s Medicaid program to get it on their formularies.

Excluding the shot from Vaccines for Children “would only worsen existing health disparities,” said Sean O’Leary, MD, a professor of pediatrics at the University of Colorado at Denver, Aurora, and chair of the infectious diseases committee of the American Academy of Pediatrics.

RSV affects babies of all social classes but tends to hit poor, crowded households hardest, said Dr. Graham. “Family history of asthma or allergy makes it worse,” he said, and premature babies are also at higher risk.

While 2%-3% of U.S. infants are hospitalized with RSV each year, only a few hundred don’t survive. But as many as 10,000 people 65 and older perish because of an infection every year, and a little-discussed legal change will make RSV and other vaccines more available to this group.

A section of the 2022 Inflation Reduction Act that went into effect Jan. 1 ends out-of-pocket payments for all vaccines by Medicare patients – including RSV vaccines, if they are licensed for this group.

Before, “if you hadn’t met your deductible, it could be very expensive,” said Leonard Friedland, MD, vice president for scientific affairs and public health in GSK’s vaccines division, which also makes shingles and combination tetanus-diphtheria-whooping cough boosters covered by the new law. “It’s a tremendously important advance.”

Of course, high levels of vaccine hesitancy are likely to blunt uptake of the shots regardless of who pays, said Jennifer Reich, a sociologist at the University of Colorado who studies vaccination attitudes.

New types of shots, like the Sanofi-AstraZeneca antibodies, often alarm parents, and Pfizer’s shot for pregnant women is likely to push fear buttons as well, she said.

Public health officials “don’t seem very savvy about how to get ahead” of claims that vaccines undermine fertility or otherwise harm people, said Ms. Reich.

On the other hand, this winter’s RSV epidemic will be persuasive to many parents, said Heidi Larson, leader of the Vaccine Confidence Project and a professor of anthropology at the London School of Hygiene and Tropical Medicine.

“It’s a scary thing to have your kid hospitalized with RSV,” she said.

While unfortunate, “the high number of children who died or were admitted to the ICU in the past season with RSV – in some ways that’s helpful,” said Laura Riley, MD, chair of obstetrics and gynecology at Weill Cornell Medicine, New York.

Specialists in her field haven’t really started talking about how to communicate with women about the vaccine, said Dr. Riley, who chairs the immunization group at the American College of Obstetricians and Gynecologists.

“Everyone’s been waiting to see if it gets approved,” she said. “The education has to start soon, but it’s hard to roll out education before you roll out the shot.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

After more than 5 decades of trying, the drug industry is on the verge of providing effective immunizations against the respiratory syncytial virus (RSV), which has put an estimated 90,000 U.S. infants and small children in the hospital since the start of October.

But only one of the shots is designed to be given to babies, and a glitch in congressional language may make it difficult to allow children from low-income families to get it as readily as the well insured.

Since 1994, routine vaccination has been a childhood entitlement under the Vaccines for Children program, through which the federal government buys millions of vaccines and provides them free through pediatricians and clinics to children who are uninsured, underinsured, or on Medicaid – more than half of all American kids.

The 1993 law creating the program didn’t specifically include antibody shots, which were used only as rare emergency therapy at the time the bill was written.

But the first medication of its kind likely to be available to babies, called nirsevimab (it was approved in Europe in December, and Food and Drug Administration approval is expected in the summer of 2023), is not a vaccine but rather a monoclonal antibody that neutralizes RSV in the bloodstream.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is certain to recommend giving the antibody to infants, said Kelly Moore, MD, president of the advocacy group Immunize.org. The CDC is currently assessing whether nirsevimab would be eligible for the Vaccines for Children program, agency spokesperson Kristen Nordlund told KHN.

Failing to do so would “consign thousands upon thousands of infants to hospitalization and serious illness for semantic reasons despite existence of an immunization that functionally performs just like a seasonal vaccine,” Dr. Moore said.

Officials from Sanofi, which is producing the nirsevimab injection along with AstraZeneca, declined to state a price but said the range would be similar to that of a pediatric vaccine course. The CDC pays about $650 for the most expensive routine vaccine, the four shots against pneumococcal infection. In other words, FDA approval would make nirsevimab a blockbuster drug worth billions annually if it’s given to a large share of the 3.7 million or so children born in the U.S. each year.

Pfizer and GlaxoSmithKline are making traditional vaccines against RSV and expect FDA approval later in 2023. Pfizer’s shot initially would be given to pregnant women – to shield their babies from the disease – while GSK’s would be given to the elderly.

Vaccines designed for infants are in the pipeline, but some experts are still nervous about them. A 1966 RSV vaccine trial failed spectacularly, killing two toddlers, and immunologists aren’t totally in agreement over the cause, said Barney Graham, MD, PhD, the retired National Institutes of Health scientist whose studies of the episode contributed to successful COVID-19 and RSV vaccines.

After 2 years of COVID lockdowns and masking slowed its transmission, RSV exploded across the United States in 2023, swamping pediatric intensive care units.

Sanofi and AstraZeneca hope to have nirsevimab approved by the FDA, recommended by the CDC, and deployed nationwide by fall to prevent future RSV epidemics.

Their product is designed to be provided before a baby’s first winter RSV season. In clinical trials, the antibodies provided up to 5 months of protection. Most children wouldn’t need a second dose because the virus is not a mortal danger to healthy kids over a year old, said Jon Heinrichs, a senior member of Sanofi’s vaccines division.

If the antibody treatment is not accepted for the Vaccines for Children program, that will limit access to the shot for the uninsured and those on Medicaid, the majority of whom represent racial or ethnic minorities, Dr. Moore said. The drugmakers would have to negotiate with each state’s Medicaid program to get it on their formularies.

Excluding the shot from Vaccines for Children “would only worsen existing health disparities,” said Sean O’Leary, MD, a professor of pediatrics at the University of Colorado at Denver, Aurora, and chair of the infectious diseases committee of the American Academy of Pediatrics.

RSV affects babies of all social classes but tends to hit poor, crowded households hardest, said Dr. Graham. “Family history of asthma or allergy makes it worse,” he said, and premature babies are also at higher risk.

While 2%-3% of U.S. infants are hospitalized with RSV each year, only a few hundred don’t survive. But as many as 10,000 people 65 and older perish because of an infection every year, and a little-discussed legal change will make RSV and other vaccines more available to this group.

A section of the 2022 Inflation Reduction Act that went into effect Jan. 1 ends out-of-pocket payments for all vaccines by Medicare patients – including RSV vaccines, if they are licensed for this group.

Before, “if you hadn’t met your deductible, it could be very expensive,” said Leonard Friedland, MD, vice president for scientific affairs and public health in GSK’s vaccines division, which also makes shingles and combination tetanus-diphtheria-whooping cough boosters covered by the new law. “It’s a tremendously important advance.”

Of course, high levels of vaccine hesitancy are likely to blunt uptake of the shots regardless of who pays, said Jennifer Reich, a sociologist at the University of Colorado who studies vaccination attitudes.

New types of shots, like the Sanofi-AstraZeneca antibodies, often alarm parents, and Pfizer’s shot for pregnant women is likely to push fear buttons as well, she said.

Public health officials “don’t seem very savvy about how to get ahead” of claims that vaccines undermine fertility or otherwise harm people, said Ms. Reich.

On the other hand, this winter’s RSV epidemic will be persuasive to many parents, said Heidi Larson, leader of the Vaccine Confidence Project and a professor of anthropology at the London School of Hygiene and Tropical Medicine.

“It’s a scary thing to have your kid hospitalized with RSV,” she said.

While unfortunate, “the high number of children who died or were admitted to the ICU in the past season with RSV – in some ways that’s helpful,” said Laura Riley, MD, chair of obstetrics and gynecology at Weill Cornell Medicine, New York.

Specialists in her field haven’t really started talking about how to communicate with women about the vaccine, said Dr. Riley, who chairs the immunization group at the American College of Obstetricians and Gynecologists.

“Everyone’s been waiting to see if it gets approved,” she said. “The education has to start soon, but it’s hard to roll out education before you roll out the shot.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

A 27-gene immuno-oncology assay appears to provide useful information about whether patients with advanced non–small cell lung cancer (NSCLC) could benefit from immune checkpoint inhibitor (ICI) therapy despite their poor status, researchers reported.

Positive findings on the test, known as DetermaIO, were “associated with efficacy of response to ICI therapy in advanced NSCLC patients,” Matthew G. Varga, PhD, manager of scientific affairs at Oncocyte, said in an interview. “These data suggest that DetermaIO warrants further study in poor performance status patients as it has the potential to identify likely responders to ICI therapy.”

Oncocyte, which is developing the test, presented the findings in a poster at the annual meeting of the Society for Immunotherapy of Cancer.

According to Dr. Varga, “DetermaIO is an RT-qPCR test that can be applied to FFPE [formalin-fixed, paraffin-embedded] tissue specimens to quantify the relative gene expression of 27 genes and subsequently applies our proprietary algorithm to generate an IO score based on the gene expression profile. The DetermaIO score is a binary IO+ or IO– score, representing likely responder or nonresponder, respectively.”

The test was originally developed for triple negative breast cancer, Dr. Varga said, and it’s been validated in non–small cell lung cancer, metastatic urothelial carcinoma, and metastatic colorectal carcinoma.

For the study, the researchers retrospectively tracked associations between DetermaIO score and either progression-free survival (PFS) or overall survival (OS) in 147 patients in Canada with NSCLC who were treated with ICI monotherapy. All had programmed death-ligand 1 (PD-L1) ≥ 50%.

Overall, outcomes were poor: The median survival was 12.7 months, and median PFS was 7.0 months. These outcomes were even worse in those who underwent therapy as a second- line treatment: The median survival was 9.7 months, and median PFS was 4.4 months.

“DetermaIO was significantly associated with PFS at hazard ratio [HR] = 0.55, 95% [confidence interval] CI, 0.32-0.94, P = .028. In our analyses, a hazard ratio less than 1 suggests lower risk – i.e, that DetermaIO+ patients have lower risk of an event – death or progression – compared to a DetermaIO– patient,” Dr. Varga said. “The association for overall survival was not statistically significant, but it was suggestive of clinically meaningful benefit.”

He added that “we could identify likely responders from nonresponders, suggesting that the DetermaIO score adds both independent and incremental data to the existing gold standard biomarker. The objective response rate for all first-line patients – n = 78 – was 44.9%. Twenty-two DetermaIO– tumors had a 23% response rate (5 partial responses) whereas of the 56 DetermaIO+ patients, the response rate was 54% (2 complete response and 28 partial responses).”

A score on the test, he said, was not associated with OS or PFS in patients who received second-line or later treatment.

The study was not designed to evaluate the predictive power of the test. “For a biomarker to be defined as predictive requires a formal test of interaction between a treatment group (ICI monotherapy, for example) vs. a control group (chemo-only or other regimen),” Dr. Varga explained. “In our analysis, there was no group of patients who did not receive ICI monotherapy. Thus a test for interaction and a predictive claim cannot be made.”

The test is available for at no cost via an early access program, Dr. Varga said, and Oncocyte is getting ready to seek Medicare coverage. The ultimate cost of the test, he said, is unknown.

Oncocyte funded this study. Dr. Varga and several other study authors are Oncocyte employees, and another author is a paid consultant to the company.

A 27-gene immuno-oncology assay appears to provide useful information about whether patients with advanced non–small cell lung cancer (NSCLC) could benefit from immune checkpoint inhibitor (ICI) therapy despite their poor status, researchers reported.

Positive findings on the test, known as DetermaIO, were “associated with efficacy of response to ICI therapy in advanced NSCLC patients,” Matthew G. Varga, PhD, manager of scientific affairs at Oncocyte, said in an interview. “These data suggest that DetermaIO warrants further study in poor performance status patients as it has the potential to identify likely responders to ICI therapy.”

Oncocyte, which is developing the test, presented the findings in a poster at the annual meeting of the Society for Immunotherapy of Cancer.

According to Dr. Varga, “DetermaIO is an RT-qPCR test that can be applied to FFPE [formalin-fixed, paraffin-embedded] tissue specimens to quantify the relative gene expression of 27 genes and subsequently applies our proprietary algorithm to generate an IO score based on the gene expression profile. The DetermaIO score is a binary IO+ or IO– score, representing likely responder or nonresponder, respectively.”

The test was originally developed for triple negative breast cancer, Dr. Varga said, and it’s been validated in non–small cell lung cancer, metastatic urothelial carcinoma, and metastatic colorectal carcinoma.

For the study, the researchers retrospectively tracked associations between DetermaIO score and either progression-free survival (PFS) or overall survival (OS) in 147 patients in Canada with NSCLC who were treated with ICI monotherapy. All had programmed death-ligand 1 (PD-L1) ≥ 50%.

Overall, outcomes were poor: The median survival was 12.7 months, and median PFS was 7.0 months. These outcomes were even worse in those who underwent therapy as a second- line treatment: The median survival was 9.7 months, and median PFS was 4.4 months.

“DetermaIO was significantly associated with PFS at hazard ratio [HR] = 0.55, 95% [confidence interval] CI, 0.32-0.94, P = .028. In our analyses, a hazard ratio less than 1 suggests lower risk – i.e, that DetermaIO+ patients have lower risk of an event – death or progression – compared to a DetermaIO– patient,” Dr. Varga said. “The association for overall survival was not statistically significant, but it was suggestive of clinically meaningful benefit.”

He added that “we could identify likely responders from nonresponders, suggesting that the DetermaIO score adds both independent and incremental data to the existing gold standard biomarker. The objective response rate for all first-line patients – n = 78 – was 44.9%. Twenty-two DetermaIO– tumors had a 23% response rate (5 partial responses) whereas of the 56 DetermaIO+ patients, the response rate was 54% (2 complete response and 28 partial responses).”

A score on the test, he said, was not associated with OS or PFS in patients who received second-line or later treatment.

The study was not designed to evaluate the predictive power of the test. “For a biomarker to be defined as predictive requires a formal test of interaction between a treatment group (ICI monotherapy, for example) vs. a control group (chemo-only or other regimen),” Dr. Varga explained. “In our analysis, there was no group of patients who did not receive ICI monotherapy. Thus a test for interaction and a predictive claim cannot be made.”

The test is available for at no cost via an early access program, Dr. Varga said, and Oncocyte is getting ready to seek Medicare coverage. The ultimate cost of the test, he said, is unknown.

Oncocyte funded this study. Dr. Varga and several other study authors are Oncocyte employees, and another author is a paid consultant to the company.

A 27-gene immuno-oncology assay appears to provide useful information about whether patients with advanced non–small cell lung cancer (NSCLC) could benefit from immune checkpoint inhibitor (ICI) therapy despite their poor status, researchers reported.

Positive findings on the test, known as DetermaIO, were “associated with efficacy of response to ICI therapy in advanced NSCLC patients,” Matthew G. Varga, PhD, manager of scientific affairs at Oncocyte, said in an interview. “These data suggest that DetermaIO warrants further study in poor performance status patients as it has the potential to identify likely responders to ICI therapy.”

Oncocyte, which is developing the test, presented the findings in a poster at the annual meeting of the Society for Immunotherapy of Cancer.

According to Dr. Varga, “DetermaIO is an RT-qPCR test that can be applied to FFPE [formalin-fixed, paraffin-embedded] tissue specimens to quantify the relative gene expression of 27 genes and subsequently applies our proprietary algorithm to generate an IO score based on the gene expression profile. The DetermaIO score is a binary IO+ or IO– score, representing likely responder or nonresponder, respectively.”

The test was originally developed for triple negative breast cancer, Dr. Varga said, and it’s been validated in non–small cell lung cancer, metastatic urothelial carcinoma, and metastatic colorectal carcinoma.

For the study, the researchers retrospectively tracked associations between DetermaIO score and either progression-free survival (PFS) or overall survival (OS) in 147 patients in Canada with NSCLC who were treated with ICI monotherapy. All had programmed death-ligand 1 (PD-L1) ≥ 50%.

Overall, outcomes were poor: The median survival was 12.7 months, and median PFS was 7.0 months. These outcomes were even worse in those who underwent therapy as a second- line treatment: The median survival was 9.7 months, and median PFS was 4.4 months.

“DetermaIO was significantly associated with PFS at hazard ratio [HR] = 0.55, 95% [confidence interval] CI, 0.32-0.94, P = .028. In our analyses, a hazard ratio less than 1 suggests lower risk – i.e, that DetermaIO+ patients have lower risk of an event – death or progression – compared to a DetermaIO– patient,” Dr. Varga said. “The association for overall survival was not statistically significant, but it was suggestive of clinically meaningful benefit.”

He added that “we could identify likely responders from nonresponders, suggesting that the DetermaIO score adds both independent and incremental data to the existing gold standard biomarker. The objective response rate for all first-line patients – n = 78 – was 44.9%. Twenty-two DetermaIO– tumors had a 23% response rate (5 partial responses) whereas of the 56 DetermaIO+ patients, the response rate was 54% (2 complete response and 28 partial responses).”

A score on the test, he said, was not associated with OS or PFS in patients who received second-line or later treatment.

The study was not designed to evaluate the predictive power of the test. “For a biomarker to be defined as predictive requires a formal test of interaction between a treatment group (ICI monotherapy, for example) vs. a control group (chemo-only or other regimen),” Dr. Varga explained. “In our analysis, there was no group of patients who did not receive ICI monotherapy. Thus a test for interaction and a predictive claim cannot be made.”

The test is available for at no cost via an early access program, Dr. Varga said, and Oncocyte is getting ready to seek Medicare coverage. The ultimate cost of the test, he said, is unknown.

Oncocyte funded this study. Dr. Varga and several other study authors are Oncocyte employees, and another author is a paid consultant to the company.

A survey of physicians treating breast cancer patients finds that many use diagnostic mammograms for surveillance rather than screening mammograms, despite lack of evidence for a clinical difference.

Existing guidelines offer little help, according to Pavani Chalasani, MD, MPH, who presented the study at the San Antonio Breast Cancer Symposium. “They just say [do an] annual mammogram, but they don’t say, ‘Do we need to do screening? Do we need to do breast MRIs?’”

Her personal experience also reflected a general confusion. “I asked my colleagues and got different answers from seven colleagues,” said Dr. Chalasani, who is an oncologist at the University of Arizona Cancer Center, Tucson.

She noted that diagnostic mammograms are generally similar to screening mammograms, but the radiologist is viewing the images in real time and can take additional views as needed while the patient is still present. “That is the biggest difference,” said Dr. Chalasani. No studies have been conducted to determine which method produces better results.

To get a snapshot of current practice, she and her colleagues developed a survey, which the American Society of Clinical Oncology sent to 1,000 randomly selected members between Oct. 19 and Nov. 22, 2021. 244 individuals responded; 93.5% were physicians, and half identified as female. A total of 174 respondents were medical oncologists, 31 were radiation oncologists, and 20 were surgical oncologists. The imbalance among respondents is a limitation of the study. That “may or may not be reflective of our real-time practices (among surgeons), but we do think that since a lot of times patients are seen by medical oncologists, there could be overlap,” said Dr. Chalasani.

About 50% of respondents said that they use breast MRI in the diagnosis of 25% or fewer patients. Approximately 64% of respondents said they used diagnostic mammograms versus about 31% who used imaging mammograms at first imaging. About 53% said they ordered mammograms within the first 6 months after treatment.

38% of those who ordered diagnostic mammograms for surveillance used it for 3-5 years, while 29% continued it for 5 years or more. One-quarter employed additional imaging during follow-up, most commonly breast ultrasound. About 65% said they had no stop date for screening mammograms, as long as the patient remained healthy. The choice of screening or diagnostic mammography was about 50:50, though about 55% said they use screening mammography for patients 80 years of age or older.

Dr. Chalasani pointed out that both screening and diagnostic mammograms provide similar imaging quality. Screening mammograms are completely covered by insurance, while diagnostic mammograms typically require a copay. “We’re doing this [diagnostic mammography] with no guidelines, but there is this out of pocket cost, without knowing if it’s the right thing to do,” she said.

National Comprehensive Cancer Network guidelines indicate that diagnostic mammograms can be conducted for 5 years after a ductal carcinoma in situ diagnosis, but it doesn’t provide guidance for invasive cancers. Some past studies suggested that doing diagnostic mammograms for 3 years may increase diagnosis, but it isn’t clear if any such advantage would actually result in a clinical difference, according to Dr. Chalasani. “With the treatments we have, we still might cure [the cancer]. So what endpoints are we looking for? Are we changing care to add on toxicity to the patient, and stress to the patient and also for the health care system?”

She hopes that physicians will look at the results and understand that diagnostic mammograms, while they intuitively feel superior, are not supported by guidelines, and patients must incur an extra cost.

Her team also plans to conduct cost-effectiveness analysis of diagnostic mammograms.

Dr. Chalasani has no relevant financial disclosures.

A survey of physicians treating breast cancer patients finds that many use diagnostic mammograms for surveillance rather than screening mammograms, despite lack of evidence for a clinical difference.

Existing guidelines offer little help, according to Pavani Chalasani, MD, MPH, who presented the study at the San Antonio Breast Cancer Symposium. “They just say [do an] annual mammogram, but they don’t say, ‘Do we need to do screening? Do we need to do breast MRIs?’”

Her personal experience also reflected a general confusion. “I asked my colleagues and got different answers from seven colleagues,” said Dr. Chalasani, who is an oncologist at the University of Arizona Cancer Center, Tucson.

She noted that diagnostic mammograms are generally similar to screening mammograms, but the radiologist is viewing the images in real time and can take additional views as needed while the patient is still present. “That is the biggest difference,” said Dr. Chalasani. No studies have been conducted to determine which method produces better results.

To get a snapshot of current practice, she and her colleagues developed a survey, which the American Society of Clinical Oncology sent to 1,000 randomly selected members between Oct. 19 and Nov. 22, 2021. 244 individuals responded; 93.5% were physicians, and half identified as female. A total of 174 respondents were medical oncologists, 31 were radiation oncologists, and 20 were surgical oncologists. The imbalance among respondents is a limitation of the study. That “may or may not be reflective of our real-time practices (among surgeons), but we do think that since a lot of times patients are seen by medical oncologists, there could be overlap,” said Dr. Chalasani.

About 50% of respondents said that they use breast MRI in the diagnosis of 25% or fewer patients. Approximately 64% of respondents said they used diagnostic mammograms versus about 31% who used imaging mammograms at first imaging. About 53% said they ordered mammograms within the first 6 months after treatment.

38% of those who ordered diagnostic mammograms for surveillance used it for 3-5 years, while 29% continued it for 5 years or more. One-quarter employed additional imaging during follow-up, most commonly breast ultrasound. About 65% said they had no stop date for screening mammograms, as long as the patient remained healthy. The choice of screening or diagnostic mammography was about 50:50, though about 55% said they use screening mammography for patients 80 years of age or older.

Dr. Chalasani pointed out that both screening and diagnostic mammograms provide similar imaging quality. Screening mammograms are completely covered by insurance, while diagnostic mammograms typically require a copay. “We’re doing this [diagnostic mammography] with no guidelines, but there is this out of pocket cost, without knowing if it’s the right thing to do,” she said.

National Comprehensive Cancer Network guidelines indicate that diagnostic mammograms can be conducted for 5 years after a ductal carcinoma in situ diagnosis, but it doesn’t provide guidance for invasive cancers. Some past studies suggested that doing diagnostic mammograms for 3 years may increase diagnosis, but it isn’t clear if any such advantage would actually result in a clinical difference, according to Dr. Chalasani. “With the treatments we have, we still might cure [the cancer]. So what endpoints are we looking for? Are we changing care to add on toxicity to the patient, and stress to the patient and also for the health care system?”

She hopes that physicians will look at the results and understand that diagnostic mammograms, while they intuitively feel superior, are not supported by guidelines, and patients must incur an extra cost.

Her team also plans to conduct cost-effectiveness analysis of diagnostic mammograms.

Dr. Chalasani has no relevant financial disclosures.

A survey of physicians treating breast cancer patients finds that many use diagnostic mammograms for surveillance rather than screening mammograms, despite lack of evidence for a clinical difference.

Existing guidelines offer little help, according to Pavani Chalasani, MD, MPH, who presented the study at the San Antonio Breast Cancer Symposium. “They just say [do an] annual mammogram, but they don’t say, ‘Do we need to do screening? Do we need to do breast MRIs?’”

Her personal experience also reflected a general confusion. “I asked my colleagues and got different answers from seven colleagues,” said Dr. Chalasani, who is an oncologist at the University of Arizona Cancer Center, Tucson.

She noted that diagnostic mammograms are generally similar to screening mammograms, but the radiologist is viewing the images in real time and can take additional views as needed while the patient is still present. “That is the biggest difference,” said Dr. Chalasani. No studies have been conducted to determine which method produces better results.

To get a snapshot of current practice, she and her colleagues developed a survey, which the American Society of Clinical Oncology sent to 1,000 randomly selected members between Oct. 19 and Nov. 22, 2021. 244 individuals responded; 93.5% were physicians, and half identified as female. A total of 174 respondents were medical oncologists, 31 were radiation oncologists, and 20 were surgical oncologists. The imbalance among respondents is a limitation of the study. That “may or may not be reflective of our real-time practices (among surgeons), but we do think that since a lot of times patients are seen by medical oncologists, there could be overlap,” said Dr. Chalasani.

About 50% of respondents said that they use breast MRI in the diagnosis of 25% or fewer patients. Approximately 64% of respondents said they used diagnostic mammograms versus about 31% who used imaging mammograms at first imaging. About 53% said they ordered mammograms within the first 6 months after treatment.

38% of those who ordered diagnostic mammograms for surveillance used it for 3-5 years, while 29% continued it for 5 years or more. One-quarter employed additional imaging during follow-up, most commonly breast ultrasound. About 65% said they had no stop date for screening mammograms, as long as the patient remained healthy. The choice of screening or diagnostic mammography was about 50:50, though about 55% said they use screening mammography for patients 80 years of age or older.

Dr. Chalasani pointed out that both screening and diagnostic mammograms provide similar imaging quality. Screening mammograms are completely covered by insurance, while diagnostic mammograms typically require a copay. “We’re doing this [diagnostic mammography] with no guidelines, but there is this out of pocket cost, without knowing if it’s the right thing to do,” she said.

National Comprehensive Cancer Network guidelines indicate that diagnostic mammograms can be conducted for 5 years after a ductal carcinoma in situ diagnosis, but it doesn’t provide guidance for invasive cancers. Some past studies suggested that doing diagnostic mammograms for 3 years may increase diagnosis, but it isn’t clear if any such advantage would actually result in a clinical difference, according to Dr. Chalasani. “With the treatments we have, we still might cure [the cancer]. So what endpoints are we looking for? Are we changing care to add on toxicity to the patient, and stress to the patient and also for the health care system?”

She hopes that physicians will look at the results and understand that diagnostic mammograms, while they intuitively feel superior, are not supported by guidelines, and patients must incur an extra cost.

Her team also plans to conduct cost-effectiveness analysis of diagnostic mammograms.

Dr. Chalasani has no relevant financial disclosures.

Long-course radiation therapy for rectal cancer is more likely to spare organs than short-course therapy, including when chemotherapy is provided first as part of a total neoadjuvant therapy (TNT) strategy, shows new research presented at the ASCO Gastrointestinal Cancers Symposium 2023.

“When we looked at the 2-year organ preservation rates, they were numerically higher in the long-course group versus the short-course group,” said study author J. Joshua Smith, MD, PhD,FACS, a colorectal surgeon with Memorial Sloan Kettering Cancer Center, New York. “Our study will be the first, to our knowledge, that examines a significant proportion of patients treated with the induction total neoadjuvant therapy approach – chemo first.”

An ideal outcome in rectal cancer is no need for surgery, Dr. Smith said. “If you can avoid surgery altogether and preserve the organ [the rectum], that’s a big win for the patient as they are usually able to avoid having a permanent or temporary ostomy.”

Long-course and short-course radiation have similar outcomes in terms of patients going on to need surgery, but it’s not clear which is superior in terms of organ sparing, toxicity, and side effects, said Paul Romesser, MD, a radiation oncologist with Memorial Sloan Kettering Cancer Center, New York, who served as first author of the study.

During the early months of the COVID-19 pandemic, the cancer center embraced short-course radiation in rectal cancer, Dr. Romesser said. “Once we emerged from the cloud of COVID, we said: ‘Well, what do we do now? Where do we go? Do we go back to what we did before? Or, do we go stick with the same? And what does that mean for organ preservation?’ ”

The researchers retrospectively identified 563 consecutive patients treated with TNT from 2018 to 2021. They focused on 332 who didn’t have metastatic disease, synchronous/metachronous malignancies, or nonadenocarcinoma histology (long course = 256, short course = 76). The groups had similar high-risk features, and about 82% were clinical stage III).

Patients most commonly received induction chemotherapy followed by consolidative radiation (78% long course, 70% short course).

The 2-year survival rates were similar, but organ preservation was higher in the long-course group versus the short-course group (40%; 95% confidence interval, 35%-47% vs. 29%; 95% CI, 20%-42%). And the 2-year local regrowth rate was also better in the long-course group versus the short-course group (20%; 95% CI, 12%-27% vs. 36%; 95% CI, 16%-52%).

Why might long-course therapy be better? “It’s probably just coming down to the biologically equivalent dose,” which is likely lower in short-course radiation, Dr. Romesser said.

Going forward, Dr. Romesser said he’ll tell patients about the findings of this study and a previous report published in 2022 that determined that “organ preservation is achievable in half of the patients with rectal cancer treated with total neoadjuvant therapy, without an apparent detriment in survival, compared with historical controls treated with chemoradiotherapy, TME [total mesorectal excision], and postoperative chemotherapy.” Dr. Smith is a coauthor of that study.

“Generally, I’ll steer patients toward long course, assuming all else is equal, and it’s not an undue burden on them financially and socially to come in for 5-6 weeks of chemoradiation,” Dr. Romesser said. He added that, “generally, the insurance companies recognize [short-course and long-course radiation] as both acceptable and standard treatment options for patients. We haven’t found that insurances will approve one, but not the other.”

The study was funded by the National Institutes of Health. Dr. Romesser disclosed consulting/advisory roles (EMD Serono, Faeth, Natera), research funding (XRad), and travel/accommodations/expenses (Elekta). Dr. Smith disclosed consulting/advisory roles (Foundation Medicine, Guardant Health). The other study authors reported no conflicts of interest.

The Gastrointestinal Cancers Symposium is sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

Long-course radiation therapy for rectal cancer is more likely to spare organs than short-course therapy, including when chemotherapy is provided first as part of a total neoadjuvant therapy (TNT) strategy, shows new research presented at the ASCO Gastrointestinal Cancers Symposium 2023.

“When we looked at the 2-year organ preservation rates, they were numerically higher in the long-course group versus the short-course group,” said study author J. Joshua Smith, MD, PhD,FACS, a colorectal surgeon with Memorial Sloan Kettering Cancer Center, New York. “Our study will be the first, to our knowledge, that examines a significant proportion of patients treated with the induction total neoadjuvant therapy approach – chemo first.”

An ideal outcome in rectal cancer is no need for surgery, Dr. Smith said. “If you can avoid surgery altogether and preserve the organ [the rectum], that’s a big win for the patient as they are usually able to avoid having a permanent or temporary ostomy.”

Long-course and short-course radiation have similar outcomes in terms of patients going on to need surgery, but it’s not clear which is superior in terms of organ sparing, toxicity, and side effects, said Paul Romesser, MD, a radiation oncologist with Memorial Sloan Kettering Cancer Center, New York, who served as first author of the study.

During the early months of the COVID-19 pandemic, the cancer center embraced short-course radiation in rectal cancer, Dr. Romesser said. “Once we emerged from the cloud of COVID, we said: ‘Well, what do we do now? Where do we go? Do we go back to what we did before? Or, do we go stick with the same? And what does that mean for organ preservation?’ ”

The researchers retrospectively identified 563 consecutive patients treated with TNT from 2018 to 2021. They focused on 332 who didn’t have metastatic disease, synchronous/metachronous malignancies, or nonadenocarcinoma histology (long course = 256, short course = 76). The groups had similar high-risk features, and about 82% were clinical stage III).

Patients most commonly received induction chemotherapy followed by consolidative radiation (78% long course, 70% short course).

The 2-year survival rates were similar, but organ preservation was higher in the long-course group versus the short-course group (40%; 95% confidence interval, 35%-47% vs. 29%; 95% CI, 20%-42%). And the 2-year local regrowth rate was also better in the long-course group versus the short-course group (20%; 95% CI, 12%-27% vs. 36%; 95% CI, 16%-52%).

Why might long-course therapy be better? “It’s probably just coming down to the biologically equivalent dose,” which is likely lower in short-course radiation, Dr. Romesser said.

Going forward, Dr. Romesser said he’ll tell patients about the findings of this study and a previous report published in 2022 that determined that “organ preservation is achievable in half of the patients with rectal cancer treated with total neoadjuvant therapy, without an apparent detriment in survival, compared with historical controls treated with chemoradiotherapy, TME [total mesorectal excision], and postoperative chemotherapy.” Dr. Smith is a coauthor of that study.

“Generally, I’ll steer patients toward long course, assuming all else is equal, and it’s not an undue burden on them financially and socially to come in for 5-6 weeks of chemoradiation,” Dr. Romesser said. He added that, “generally, the insurance companies recognize [short-course and long-course radiation] as both acceptable and standard treatment options for patients. We haven’t found that insurances will approve one, but not the other.”

The study was funded by the National Institutes of Health. Dr. Romesser disclosed consulting/advisory roles (EMD Serono, Faeth, Natera), research funding (XRad), and travel/accommodations/expenses (Elekta). Dr. Smith disclosed consulting/advisory roles (Foundation Medicine, Guardant Health). The other study authors reported no conflicts of interest.

The Gastrointestinal Cancers Symposium is sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

Long-course radiation therapy for rectal cancer is more likely to spare organs than short-course therapy, including when chemotherapy is provided first as part of a total neoadjuvant therapy (TNT) strategy, shows new research presented at the ASCO Gastrointestinal Cancers Symposium 2023.

“When we looked at the 2-year organ preservation rates, they were numerically higher in the long-course group versus the short-course group,” said study author J. Joshua Smith, MD, PhD,FACS, a colorectal surgeon with Memorial Sloan Kettering Cancer Center, New York. “Our study will be the first, to our knowledge, that examines a significant proportion of patients treated with the induction total neoadjuvant therapy approach – chemo first.”

An ideal outcome in rectal cancer is no need for surgery, Dr. Smith said. “If you can avoid surgery altogether and preserve the organ [the rectum], that’s a big win for the patient as they are usually able to avoid having a permanent or temporary ostomy.”

Long-course and short-course radiation have similar outcomes in terms of patients going on to need surgery, but it’s not clear which is superior in terms of organ sparing, toxicity, and side effects, said Paul Romesser, MD, a radiation oncologist with Memorial Sloan Kettering Cancer Center, New York, who served as first author of the study.

During the early months of the COVID-19 pandemic, the cancer center embraced short-course radiation in rectal cancer, Dr. Romesser said. “Once we emerged from the cloud of COVID, we said: ‘Well, what do we do now? Where do we go? Do we go back to what we did before? Or, do we go stick with the same? And what does that mean for organ preservation?’ ”

The researchers retrospectively identified 563 consecutive patients treated with TNT from 2018 to 2021. They focused on 332 who didn’t have metastatic disease, synchronous/metachronous malignancies, or nonadenocarcinoma histology (long course = 256, short course = 76). The groups had similar high-risk features, and about 82% were clinical stage III).

Patients most commonly received induction chemotherapy followed by consolidative radiation (78% long course, 70% short course).

The 2-year survival rates were similar, but organ preservation was higher in the long-course group versus the short-course group (40%; 95% confidence interval, 35%-47% vs. 29%; 95% CI, 20%-42%). And the 2-year local regrowth rate was also better in the long-course group versus the short-course group (20%; 95% CI, 12%-27% vs. 36%; 95% CI, 16%-52%).

Why might long-course therapy be better? “It’s probably just coming down to the biologically equivalent dose,” which is likely lower in short-course radiation, Dr. Romesser said.

Going forward, Dr. Romesser said he’ll tell patients about the findings of this study and a previous report published in 2022 that determined that “organ preservation is achievable in half of the patients with rectal cancer treated with total neoadjuvant therapy, without an apparent detriment in survival, compared with historical controls treated with chemoradiotherapy, TME [total mesorectal excision], and postoperative chemotherapy.” Dr. Smith is a coauthor of that study.

“Generally, I’ll steer patients toward long course, assuming all else is equal, and it’s not an undue burden on them financially and socially to come in for 5-6 weeks of chemoradiation,” Dr. Romesser said. He added that, “generally, the insurance companies recognize [short-course and long-course radiation] as both acceptable and standard treatment options for patients. We haven’t found that insurances will approve one, but not the other.”

The study was funded by the National Institutes of Health. Dr. Romesser disclosed consulting/advisory roles (EMD Serono, Faeth, Natera), research funding (XRad), and travel/accommodations/expenses (Elekta). Dr. Smith disclosed consulting/advisory roles (Foundation Medicine, Guardant Health). The other study authors reported no conflicts of interest.

The Gastrointestinal Cancers Symposium is sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

Is the ketogenic diet the only way to lose weight? Of course not! Keep track of calories in vs. calories out and almost anyone can lose weight. The problem is keeping it off. To understand that, we need to look at metabolic adaptation and the biology of obesity.

Our bodies have a “set point” that is epigenetically latched onto the environment the brain senses, just as the fetal environment responds to the maternal environment.

Thomas R. Collins/MDedge News

If food is plentiful, our hormones force us to eat until our bodies feel that there are enough fat stores to survive. Because of environmental influences such as highly processed food, preservatives, climate change, and regulation of temperature, our brains have decided that we need more adipose tissue than we did 50-100 years ago. It could be that an element in food has caused a dysfunction of the pathways that regulate our body weight, and most of us “defend” a higher body weight in this environment.

How to counteract that? Not easily. The ketogenic diet works temporarily just like any other diet where calorie intake is lower than usual. It seems to be agreeable to many people because they say they feel full after eating protein, fat, and perhaps some vegetables. Protein and fat are certainly more satiating than simple carbohydrates.

If strictly followed, a ketogenic diet will force the body to burn fat and go into ketosis. Without a source for glucose, the brain will burn ketones from fat stores. Owen and colleagues discovered this in 1969 when they did their now-famous studies of fasting in inpatients at Brigham and Women’s hospital, using IV amino acids to protect muscle mass.
 

Keto for life?

Is the ketogenic diet a healthy diet for the long term? That is a different question.

Of course not – we need high-fiber carbohydrate sources such as whole grains, fruits, and vegetables to keep the colon healthy and obtain the vitamins and minerals needed to make the Krebs cycle, or citric acid cycle, work at its best.

Why, then, are we promoting ketogenic diets for those with obesity and type 2 diabetes? Ketogenic or low-carbohydrate diets are easy to teach and can rapidly help patients lose weight and return their blood glucose, blood pressure, and other metabolic parameters to normal.

The patient will be instructed to avoid all highly processed foods. Studies have shown that highly processed foods, created to maximize flavor, “coerce” people to eat more calories than when presented with the same number of calories in unprocessed foods, a way to fool the brain.
 

Why are we fooling the brain?

We circumvent the natural satiety mechanisms that start with the gut. When we eat, our gastric fundus and intestinal stretch receptors start the process that informs the hypothalamus about food intake. Highly processed foods are usually devoid of fiber and volume, and pack in the calories in small volumes so that the stretch receptors are not activated until more calories are ingested. The study mentioned above developed two ad lib diets with the same number of calories, sugar, fat, and carbohydrate content – one ultraprocessed and the other unprocessed.

That explanation is just the tip of the iceberg, because a lot more than primitive stretch receptors is informing the brain. There are gut hormones that are secreted before and after meals, such as ghrelin, glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), and cholecystokinin (CCK), among a slew of others. These peptide hormones are all secreted from gut cells into the blood or vagus nerve, or both, and alert the brain that there is or is not enough food to maintain body weight at its set point.

It’s a highly regulated and precise system that regulates body weight for survival of the species in this environment. However, the environment has changed over the past 100 years but our genetic makeup for survival of the fittest has not. The mechanism of action for defense of a higher body weight set point in this new environment has not been elucidated as yet. Most likely, there are many players or instigators involved, such as food-supply changes, sedentary lifestyle, ambient temperature, fetal programming, air quality, and global warming and climate change, to name a few.

The goal of obesity researchers is to investigate the underlying mechanisms of the increased prevalence of obesity over the past 100 years. The goal of obesity medicine specialists is to treat obesity in adults and children, and to prevent obesity as much as possible with lifestyle change and medications that have been shown to help “reverse” the metabolic adaptation to this environment. Our newest GLP-1/GIP receptor agonists have been shown in animal models to hit several pathways that lead to obesity. They are not just appetite suppressants. Yes, they do modulate appetite and satiety, but they also affect energy expenditure. The body’s normal reaction to a lack of calorie intake is to reduce resting energy expenditure until body weight increases back to “set point levels.” These agonists prevent that metabolic adaptation. That is why they are true agents that can treat obesity – the disease.

Back to the ketogenic diet. The ketogenic diet can fool the brain temporarily by using protein and fat to elicit satiety with less food intake in calories. After a while, however, gut hormones and other factors begin to counteract the weight loss with a reduction in resting energy and total energy expenditure, and other metabolic measures, to get the body back to a certain body weight set point.

The ketogenic diet also can help dieters avoid ultra- and highly processed foods. In the end, any type of diet that lowers caloric intake will work for weight loss, but it’s the maintenance of that weight loss that makes a long-term difference, and that involves closing the metabolic gap that the body generates to defend fat mass. Understanding this pathophysiology will allow obesity medicine specialists to assist patients with obesity to lose weight and keep it off.

Dr. Apovian is in the department of medicine, division of endocrinology, diabetes, and hypertension, and codirector, Center for Weight Management and Wellness, Harvard Medical School, Boston. She disclosed ties with Altimmune, Cowen and Company, Currax Pharmaceuticals, EPG Communication Holdings, Gelesis Srl, L-Nutra, NeuroBo Pharmaceuticals, National Institutes of Health, Patient-Centered Outcomes Research Institute, GI Dynamics, and Novo Nordisk. A version of this article first appeared on Medscape.com.

Is the ketogenic diet the only way to lose weight? Of course not! Keep track of calories in vs. calories out and almost anyone can lose weight. The problem is keeping it off. To understand that, we need to look at metabolic adaptation and the biology of obesity.

Our bodies have a “set point” that is epigenetically latched onto the environment the brain senses, just as the fetal environment responds to the maternal environment.

Thomas R. Collins/MDedge News

If food is plentiful, our hormones force us to eat until our bodies feel that there are enough fat stores to survive. Because of environmental influences such as highly processed food, preservatives, climate change, and regulation of temperature, our brains have decided that we need more adipose tissue than we did 50-100 years ago. It could be that an element in food has caused a dysfunction of the pathways that regulate our body weight, and most of us “defend” a higher body weight in this environment.

How to counteract that? Not easily. The ketogenic diet works temporarily just like any other diet where calorie intake is lower than usual. It seems to be agreeable to many people because they say they feel full after eating protein, fat, and perhaps some vegetables. Protein and fat are certainly more satiating than simple carbohydrates.

If strictly followed, a ketogenic diet will force the body to burn fat and go into ketosis. Without a source for glucose, the brain will burn ketones from fat stores. Owen and colleagues discovered this in 1969 when they did their now-famous studies of fasting in inpatients at Brigham and Women’s hospital, using IV amino acids to protect muscle mass.
 

Keto for life?

Is the ketogenic diet a healthy diet for the long term? That is a different question.

Of course not – we need high-fiber carbohydrate sources such as whole grains, fruits, and vegetables to keep the colon healthy and obtain the vitamins and minerals needed to make the Krebs cycle, or citric acid cycle, work at its best.

Why, then, are we promoting ketogenic diets for those with obesity and type 2 diabetes? Ketogenic or low-carbohydrate diets are easy to teach and can rapidly help patients lose weight and return their blood glucose, blood pressure, and other metabolic parameters to normal.

The patient will be instructed to avoid all highly processed foods. Studies have shown that highly processed foods, created to maximize flavor, “coerce” people to eat more calories than when presented with the same number of calories in unprocessed foods, a way to fool the brain.
 

Why are we fooling the brain?

We circumvent the natural satiety mechanisms that start with the gut. When we eat, our gastric fundus and intestinal stretch receptors start the process that informs the hypothalamus about food intake. Highly processed foods are usually devoid of fiber and volume, and pack in the calories in small volumes so that the stretch receptors are not activated until more calories are ingested. The study mentioned above developed two ad lib diets with the same number of calories, sugar, fat, and carbohydrate content – one ultraprocessed and the other unprocessed.

That explanation is just the tip of the iceberg, because a lot more than primitive stretch receptors is informing the brain. There are gut hormones that are secreted before and after meals, such as ghrelin, glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), and cholecystokinin (CCK), among a slew of others. These peptide hormones are all secreted from gut cells into the blood or vagus nerve, or both, and alert the brain that there is or is not enough food to maintain body weight at its set point.

It’s a highly regulated and precise system that regulates body weight for survival of the species in this environment. However, the environment has changed over the past 100 years but our genetic makeup for survival of the fittest has not. The mechanism of action for defense of a higher body weight set point in this new environment has not been elucidated as yet. Most likely, there are many players or instigators involved, such as food-supply changes, sedentary lifestyle, ambient temperature, fetal programming, air quality, and global warming and climate change, to name a few.

The goal of obesity researchers is to investigate the underlying mechanisms of the increased prevalence of obesity over the past 100 years. The goal of obesity medicine specialists is to treat obesity in adults and children, and to prevent obesity as much as possible with lifestyle change and medications that have been shown to help “reverse” the metabolic adaptation to this environment. Our newest GLP-1/GIP receptor agonists have been shown in animal models to hit several pathways that lead to obesity. They are not just appetite suppressants. Yes, they do modulate appetite and satiety, but they also affect energy expenditure. The body’s normal reaction to a lack of calorie intake is to reduce resting energy expenditure until body weight increases back to “set point levels.” These agonists prevent that metabolic adaptation. That is why they are true agents that can treat obesity – the disease.

Back to the ketogenic diet. The ketogenic diet can fool the brain temporarily by using protein and fat to elicit satiety with less food intake in calories. After a while, however, gut hormones and other factors begin to counteract the weight loss with a reduction in resting energy and total energy expenditure, and other metabolic measures, to get the body back to a certain body weight set point.

The ketogenic diet also can help dieters avoid ultra- and highly processed foods. In the end, any type of diet that lowers caloric intake will work for weight loss, but it’s the maintenance of that weight loss that makes a long-term difference, and that involves closing the metabolic gap that the body generates to defend fat mass. Understanding this pathophysiology will allow obesity medicine specialists to assist patients with obesity to lose weight and keep it off.

Dr. Apovian is in the department of medicine, division of endocrinology, diabetes, and hypertension, and codirector, Center for Weight Management and Wellness, Harvard Medical School, Boston. She disclosed ties with Altimmune, Cowen and Company, Currax Pharmaceuticals, EPG Communication Holdings, Gelesis Srl, L-Nutra, NeuroBo Pharmaceuticals, National Institutes of Health, Patient-Centered Outcomes Research Institute, GI Dynamics, and Novo Nordisk. A version of this article first appeared on Medscape.com.

Is the ketogenic diet the only way to lose weight? Of course not! Keep track of calories in vs. calories out and almost anyone can lose weight. The problem is keeping it off. To understand that, we need to look at metabolic adaptation and the biology of obesity.

Our bodies have a “set point” that is epigenetically latched onto the environment the brain senses, just as the fetal environment responds to the maternal environment.

Thomas R. Collins/MDedge News

If food is plentiful, our hormones force us to eat until our bodies feel that there are enough fat stores to survive. Because of environmental influences such as highly processed food, preservatives, climate change, and regulation of temperature, our brains have decided that we need more adipose tissue than we did 50-100 years ago. It could be that an element in food has caused a dysfunction of the pathways that regulate our body weight, and most of us “defend” a higher body weight in this environment.

How to counteract that? Not easily. The ketogenic diet works temporarily just like any other diet where calorie intake is lower than usual. It seems to be agreeable to many people because they say they feel full after eating protein, fat, and perhaps some vegetables. Protein and fat are certainly more satiating than simple carbohydrates.

If strictly followed, a ketogenic diet will force the body to burn fat and go into ketosis. Without a source for glucose, the brain will burn ketones from fat stores. Owen and colleagues discovered this in 1969 when they did their now-famous studies of fasting in inpatients at Brigham and Women’s hospital, using IV amino acids to protect muscle mass.
 

Keto for life?

Is the ketogenic diet a healthy diet for the long term? That is a different question.

Of course not – we need high-fiber carbohydrate sources such as whole grains, fruits, and vegetables to keep the colon healthy and obtain the vitamins and minerals needed to make the Krebs cycle, or citric acid cycle, work at its best.

Why, then, are we promoting ketogenic diets for those with obesity and type 2 diabetes? Ketogenic or low-carbohydrate diets are easy to teach and can rapidly help patients lose weight and return their blood glucose, blood pressure, and other metabolic parameters to normal.

The patient will be instructed to avoid all highly processed foods. Studies have shown that highly processed foods, created to maximize flavor, “coerce” people to eat more calories than when presented with the same number of calories in unprocessed foods, a way to fool the brain.
 

Why are we fooling the brain?

We circumvent the natural satiety mechanisms that start with the gut. When we eat, our gastric fundus and intestinal stretch receptors start the process that informs the hypothalamus about food intake. Highly processed foods are usually devoid of fiber and volume, and pack in the calories in small volumes so that the stretch receptors are not activated until more calories are ingested. The study mentioned above developed two ad lib diets with the same number of calories, sugar, fat, and carbohydrate content – one ultraprocessed and the other unprocessed.

That explanation is just the tip of the iceberg, because a lot more than primitive stretch receptors is informing the brain. There are gut hormones that are secreted before and after meals, such as ghrelin, glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), and cholecystokinin (CCK), among a slew of others. These peptide hormones are all secreted from gut cells into the blood or vagus nerve, or both, and alert the brain that there is or is not enough food to maintain body weight at its set point.

It’s a highly regulated and precise system that regulates body weight for survival of the species in this environment. However, the environment has changed over the past 100 years but our genetic makeup for survival of the fittest has not. The mechanism of action for defense of a higher body weight set point in this new environment has not been elucidated as yet. Most likely, there are many players or instigators involved, such as food-supply changes, sedentary lifestyle, ambient temperature, fetal programming, air quality, and global warming and climate change, to name a few.

The goal of obesity researchers is to investigate the underlying mechanisms of the increased prevalence of obesity over the past 100 years. The goal of obesity medicine specialists is to treat obesity in adults and children, and to prevent obesity as much as possible with lifestyle change and medications that have been shown to help “reverse” the metabolic adaptation to this environment. Our newest GLP-1/GIP receptor agonists have been shown in animal models to hit several pathways that lead to obesity. They are not just appetite suppressants. Yes, they do modulate appetite and satiety, but they also affect energy expenditure. The body’s normal reaction to a lack of calorie intake is to reduce resting energy expenditure until body weight increases back to “set point levels.” These agonists prevent that metabolic adaptation. That is why they are true agents that can treat obesity – the disease.

Back to the ketogenic diet. The ketogenic diet can fool the brain temporarily by using protein and fat to elicit satiety with less food intake in calories. After a while, however, gut hormones and other factors begin to counteract the weight loss with a reduction in resting energy and total energy expenditure, and other metabolic measures, to get the body back to a certain body weight set point.

The ketogenic diet also can help dieters avoid ultra- and highly processed foods. In the end, any type of diet that lowers caloric intake will work for weight loss, but it’s the maintenance of that weight loss that makes a long-term difference, and that involves closing the metabolic gap that the body generates to defend fat mass. Understanding this pathophysiology will allow obesity medicine specialists to assist patients with obesity to lose weight and keep it off.

Dr. Apovian is in the department of medicine, division of endocrinology, diabetes, and hypertension, and codirector, Center for Weight Management and Wellness, Harvard Medical School, Boston. She disclosed ties with Altimmune, Cowen and Company, Currax Pharmaceuticals, EPG Communication Holdings, Gelesis Srl, L-Nutra, NeuroBo Pharmaceuticals, National Institutes of Health, Patient-Centered Outcomes Research Institute, GI Dynamics, and Novo Nordisk. A version of this article first appeared on Medscape.com.

Adults with mainly type 2 diabetes had gaps in the use of medications for managing blood glucose, hypertension, and lipids, in an analysis of nationally representative U.S. survey data.

A mean of 19.5%, 17.1%, and 43.3% of survey participants had inconsistent use of glucose-, BP-, or lipid-lowering medications, respectively, over 2 years in a series of successive 2-year surveys in 2005-2019.

A new group of participants was enrolled for each successive 2-year survey.

“We found persistent and sometimes increasing gaps in continuity of use of these [glycemia, hypertension, and lipid] treatments at the national level,” the researchers wrote.

Moreover, “this outcome was found despite long-lasting guidelines that generally recommend medications as an ongoing part of therapy for adults with type 2 diabetes to reduce macrovascular and microvascular disease risk,” they stressed.

The data did not distinguish between type 1 and type 2 diabetes, but more than 90% of diabetes diagnoses in the United States are type 2 diabetes, the researchers noted.

Therefore, it is “correct, our findings primarily reflect type 2 diabetes,” lead author Puneet Kaur Chehal, PhD, assistant professor, Emory University, Atlanta, clarified in an email.

“The clinical guidelines for treatment of type 1 diabetes are distinct,” she added, so “it is difficult to draw any conclusions from our study for this population.”

“To observe national trends in continuous use decrease at the same time that diabetes complications are increasing and physicians are guided to shift away from treat-to-target and towards individual patient needs certainly caught our attention,” she said.

“Our findings highlight the need for additional research to understand what is going on here,” according to Dr. Chehal.

“We did not observe levels of glucose (or blood pressure and lipids) to explore if the decrease in glucose-lowering drugs was warranted,” she added. “Our evidence of differences in continuity in use across subgroups (by race/ethnicity, payer, and age) does warrant further analysis of whether the decreasing trends we observe are lapses in access or deliberate changes in treatment.”

The study was published online in JAMA Network Open.
 

Investigating trends in medication adherence

Type 2 diabetes is a chronic condition and medications to control blood glucose, BP, and lipids lower the risk of diabetes-associated complications, Dr. Chehal and colleagues wrote.  

After years of improvement, these cardiometabolic parameters plateaued and even decreased in 2013-2021, in parallel with increasing rates of diabetes complications, especially in younger adults, certain ethnic minority groups, and people with increased risks.

Suboptimal medication adherence among people with type 2 diabetes is associated with preventable complications and onset of heart disease, kidney disease, or diabetic neuropathy, which can lead to amputation.

However, previous studies of medication adherence were typically limited to patients covered by Medicare or commercial insurance, or studies only had 1-year follow-up.

Therefore, the researchers performed a cross-sectional analysis of a series of 2-year data from the Medical Expenditure Panel Survey (MEPS), in which participants reply to five interviews in 2 years and new participants are selected each year.

The researchers analyzed data from 15,237 adults aged 18 and older with type 2 diabetes who participated in 1 of 14 2-year MEPS survey panels in 2005-2019.

About half of participants (47.4%) were age 45-64 and about half (54.2%) were women. They were also racially diverse (43% non-Latino White, 25% Latino, and 24% non-Latino Black).

Participants were classified as having “inconsistent use” of glucose-lowering medication, for example, if they did not fill at least one prescription for a glucose-lowering drug in each of the 2 years.

“As long as [the medication] was some type of glucose-, blood pressure–, or lipid-lowering medication and was filled, it counted as continued use for that category,” Dr. Chehal explained.

They are preparing another paper that explores changes in medication regimens.

The current study showed continued use of glucose-lowering medication in both years decreased from 84.5% in 2005-2006 to 77.4% in 2018-2019, no use of glucose-lowering medication in either of the 2 years increased from 8.1% in 2005-2006 to 12.9% in 2018-2019, inconsistent use of glucose-lowering medication increased from 3.3% in 2005-2006 to 7.1% in 2018-2019, and new use of glucose-lowering medications in year 2 fluctuated between 2% and 4% across panels.

It also showed inconsistent use of BP-lowering medication increased from 3.9% in 2005-2006 to 9.0% in 2016-2017 and inconsistent use of lipid-lowering medication increased to a high of 9.9% in 2017-2018.

Younger and Black participants were less likely to consistently use glucose-lowering medication, Latino patients were less likely to consistently use BP-lowering medications, and Black and Latino patients were less likely to continuously use lipid-lowering medications. Uninsured adults were more likely to use no medications or use medications inconsistently.

“Changes and inconsistencies in payer formularies and out-of-pocket cost burden, especially among adults with no or insufficient insurance (i.e., Medicare Part D), remain prominent issues,” according to Dr. Chehal and colleagues.

“Decreases in continuity in use of glucose-lowering medications in recent panels may explain worsening diabetes complications,” they wrote.

This may be partly caused by recommended decreases in sulfonylurea and thiazolidinedione use and increased prescribing of new and more cost-prohibitive medications, they suggested.

Or this may be caused by the shift away from treating aggressively until a target is achieved toward individualizing treatment based on a patient’s age, phenotype, or comorbidities (for example, kidney disease).

The study was supported by a grant from MSD, a subsidiary of Merck, to Emory University. Some of the researchers received grants from Merck for the submitted work or were partially supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health to the Georgia Center for Diabetes Translation Research. Dr. Chehal reported no relevant financial relationships.

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

Adults with mainly type 2 diabetes had gaps in the use of medications for managing blood glucose, hypertension, and lipids, in an analysis of nationally representative U.S. survey data.

A mean of 19.5%, 17.1%, and 43.3% of survey participants had inconsistent use of glucose-, BP-, or lipid-lowering medications, respectively, over 2 years in a series of successive 2-year surveys in 2005-2019.

A new group of participants was enrolled for each successive 2-year survey.

“We found persistent and sometimes increasing gaps in continuity of use of these [glycemia, hypertension, and lipid] treatments at the national level,” the researchers wrote.

Moreover, “this outcome was found despite long-lasting guidelines that generally recommend medications as an ongoing part of therapy for adults with type 2 diabetes to reduce macrovascular and microvascular disease risk,” they stressed.

The data did not distinguish between type 1 and type 2 diabetes, but more than 90% of diabetes diagnoses in the United States are type 2 diabetes, the researchers noted.

Therefore, it is “correct, our findings primarily reflect type 2 diabetes,” lead author Puneet Kaur Chehal, PhD, assistant professor, Emory University, Atlanta, clarified in an email.

“The clinical guidelines for treatment of type 1 diabetes are distinct,” she added, so “it is difficult to draw any conclusions from our study for this population.”

“To observe national trends in continuous use decrease at the same time that diabetes complications are increasing and physicians are guided to shift away from treat-to-target and towards individual patient needs certainly caught our attention,” she said.

“Our findings highlight the need for additional research to understand what is going on here,” according to Dr. Chehal.

“We did not observe levels of glucose (or blood pressure and lipids) to explore if the decrease in glucose-lowering drugs was warranted,” she added. “Our evidence of differences in continuity in use across subgroups (by race/ethnicity, payer, and age) does warrant further analysis of whether the decreasing trends we observe are lapses in access or deliberate changes in treatment.”

The study was published online in JAMA Network Open.
 

Investigating trends in medication adherence

Type 2 diabetes is a chronic condition and medications to control blood glucose, BP, and lipids lower the risk of diabetes-associated complications, Dr. Chehal and colleagues wrote.  

After years of improvement, these cardiometabolic parameters plateaued and even decreased in 2013-2021, in parallel with increasing rates of diabetes complications, especially in younger adults, certain ethnic minority groups, and people with increased risks.

Suboptimal medication adherence among people with type 2 diabetes is associated with preventable complications and onset of heart disease, kidney disease, or diabetic neuropathy, which can lead to amputation.

However, previous studies of medication adherence were typically limited to patients covered by Medicare or commercial insurance, or studies only had 1-year follow-up.

Therefore, the researchers performed a cross-sectional analysis of a series of 2-year data from the Medical Expenditure Panel Survey (MEPS), in which participants reply to five interviews in 2 years and new participants are selected each year.

The researchers analyzed data from 15,237 adults aged 18 and older with type 2 diabetes who participated in 1 of 14 2-year MEPS survey panels in 2005-2019.

About half of participants (47.4%) were age 45-64 and about half (54.2%) were women. They were also racially diverse (43% non-Latino White, 25% Latino, and 24% non-Latino Black).

Participants were classified as having “inconsistent use” of glucose-lowering medication, for example, if they did not fill at least one prescription for a glucose-lowering drug in each of the 2 years.

“As long as [the medication] was some type of glucose-, blood pressure–, or lipid-lowering medication and was filled, it counted as continued use for that category,” Dr. Chehal explained.

They are preparing another paper that explores changes in medication regimens.

The current study showed continued use of glucose-lowering medication in both years decreased from 84.5% in 2005-2006 to 77.4% in 2018-2019, no use of glucose-lowering medication in either of the 2 years increased from 8.1% in 2005-2006 to 12.9% in 2018-2019, inconsistent use of glucose-lowering medication increased from 3.3% in 2005-2006 to 7.1% in 2018-2019, and new use of glucose-lowering medications in year 2 fluctuated between 2% and 4% across panels.

It also showed inconsistent use of BP-lowering medication increased from 3.9% in 2005-2006 to 9.0% in 2016-2017 and inconsistent use of lipid-lowering medication increased to a high of 9.9% in 2017-2018.

Younger and Black participants were less likely to consistently use glucose-lowering medication, Latino patients were less likely to consistently use BP-lowering medications, and Black and Latino patients were less likely to continuously use lipid-lowering medications. Uninsured adults were more likely to use no medications or use medications inconsistently.

“Changes and inconsistencies in payer formularies and out-of-pocket cost burden, especially among adults with no or insufficient insurance (i.e., Medicare Part D), remain prominent issues,” according to Dr. Chehal and colleagues.

“Decreases in continuity in use of glucose-lowering medications in recent panels may explain worsening diabetes complications,” they wrote.

This may be partly caused by recommended decreases in sulfonylurea and thiazolidinedione use and increased prescribing of new and more cost-prohibitive medications, they suggested.

Or this may be caused by the shift away from treating aggressively until a target is achieved toward individualizing treatment based on a patient’s age, phenotype, or comorbidities (for example, kidney disease).

The study was supported by a grant from MSD, a subsidiary of Merck, to Emory University. Some of the researchers received grants from Merck for the submitted work or were partially supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health to the Georgia Center for Diabetes Translation Research. Dr. Chehal reported no relevant financial relationships.

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

Adults with mainly type 2 diabetes had gaps in the use of medications for managing blood glucose, hypertension, and lipids, in an analysis of nationally representative U.S. survey data.

A mean of 19.5%, 17.1%, and 43.3% of survey participants had inconsistent use of glucose-, BP-, or lipid-lowering medications, respectively, over 2 years in a series of successive 2-year surveys in 2005-2019.

A new group of participants was enrolled for each successive 2-year survey.

“We found persistent and sometimes increasing gaps in continuity of use of these [glycemia, hypertension, and lipid] treatments at the national level,” the researchers wrote.

Moreover, “this outcome was found despite long-lasting guidelines that generally recommend medications as an ongoing part of therapy for adults with type 2 diabetes to reduce macrovascular and microvascular disease risk,” they stressed.

The data did not distinguish between type 1 and type 2 diabetes, but more than 90% of diabetes diagnoses in the United States are type 2 diabetes, the researchers noted.

Therefore, it is “correct, our findings primarily reflect type 2 diabetes,” lead author Puneet Kaur Chehal, PhD, assistant professor, Emory University, Atlanta, clarified in an email.

“The clinical guidelines for treatment of type 1 diabetes are distinct,” she added, so “it is difficult to draw any conclusions from our study for this population.”

“To observe national trends in continuous use decrease at the same time that diabetes complications are increasing and physicians are guided to shift away from treat-to-target and towards individual patient needs certainly caught our attention,” she said.

“Our findings highlight the need for additional research to understand what is going on here,” according to Dr. Chehal.

“We did not observe levels of glucose (or blood pressure and lipids) to explore if the decrease in glucose-lowering drugs was warranted,” she added. “Our evidence of differences in continuity in use across subgroups (by race/ethnicity, payer, and age) does warrant further analysis of whether the decreasing trends we observe are lapses in access or deliberate changes in treatment.”

The study was published online in JAMA Network Open.
 

Investigating trends in medication adherence

Type 2 diabetes is a chronic condition and medications to control blood glucose, BP, and lipids lower the risk of diabetes-associated complications, Dr. Chehal and colleagues wrote.  

After years of improvement, these cardiometabolic parameters plateaued and even decreased in 2013-2021, in parallel with increasing rates of diabetes complications, especially in younger adults, certain ethnic minority groups, and people with increased risks.

Suboptimal medication adherence among people with type 2 diabetes is associated with preventable complications and onset of heart disease, kidney disease, or diabetic neuropathy, which can lead to amputation.

However, previous studies of medication adherence were typically limited to patients covered by Medicare or commercial insurance, or studies only had 1-year follow-up.

Therefore, the researchers performed a cross-sectional analysis of a series of 2-year data from the Medical Expenditure Panel Survey (MEPS), in which participants reply to five interviews in 2 years and new participants are selected each year.

The researchers analyzed data from 15,237 adults aged 18 and older with type 2 diabetes who participated in 1 of 14 2-year MEPS survey panels in 2005-2019.

About half of participants (47.4%) were age 45-64 and about half (54.2%) were women. They were also racially diverse (43% non-Latino White, 25% Latino, and 24% non-Latino Black).

Participants were classified as having “inconsistent use” of glucose-lowering medication, for example, if they did not fill at least one prescription for a glucose-lowering drug in each of the 2 years.

“As long as [the medication] was some type of glucose-, blood pressure–, or lipid-lowering medication and was filled, it counted as continued use for that category,” Dr. Chehal explained.

They are preparing another paper that explores changes in medication regimens.

The current study showed continued use of glucose-lowering medication in both years decreased from 84.5% in 2005-2006 to 77.4% in 2018-2019, no use of glucose-lowering medication in either of the 2 years increased from 8.1% in 2005-2006 to 12.9% in 2018-2019, inconsistent use of glucose-lowering medication increased from 3.3% in 2005-2006 to 7.1% in 2018-2019, and new use of glucose-lowering medications in year 2 fluctuated between 2% and 4% across panels.

It also showed inconsistent use of BP-lowering medication increased from 3.9% in 2005-2006 to 9.0% in 2016-2017 and inconsistent use of lipid-lowering medication increased to a high of 9.9% in 2017-2018.

Younger and Black participants were less likely to consistently use glucose-lowering medication, Latino patients were less likely to consistently use BP-lowering medications, and Black and Latino patients were less likely to continuously use lipid-lowering medications. Uninsured adults were more likely to use no medications or use medications inconsistently.

“Changes and inconsistencies in payer formularies and out-of-pocket cost burden, especially among adults with no or insufficient insurance (i.e., Medicare Part D), remain prominent issues,” according to Dr. Chehal and colleagues.

“Decreases in continuity in use of glucose-lowering medications in recent panels may explain worsening diabetes complications,” they wrote.

This may be partly caused by recommended decreases in sulfonylurea and thiazolidinedione use and increased prescribing of new and more cost-prohibitive medications, they suggested.

Or this may be caused by the shift away from treating aggressively until a target is achieved toward individualizing treatment based on a patient’s age, phenotype, or comorbidities (for example, kidney disease).

The study was supported by a grant from MSD, a subsidiary of Merck, to Emory University. Some of the researchers received grants from Merck for the submitted work or were partially supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health to the Georgia Center for Diabetes Translation Research. Dr. Chehal reported no relevant financial relationships.

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

When the Affordable Care Act was signed in 2010, patients became eligible for coverage of screening examinations, which was good news for gastroenterologists and their patients in the fight to prevent colorectal cancer.

But there was a problem: While noninvasive stool tests – measuring microscopic amounts of blood or key DNA mutations, both tip-offs to increased colorectal cancer risk – were considered a screen, the necessary follow-up colonoscopy was not, leaving patients with expensive copays or other payment responsibility.

That interpretation prompted a years-long effort to have the federal agencies who oversee the health insurance sector reinterpret their policy, which finally changed in May 2022. Medicare, which is not covered by the ACA and is administered by a different agency, announced a change to its policy in July 2022, and the change went into effect in January 2023.

“It’s a major victory for patients, and I couldn’t be more delighted,” said David Lieberman, MD, AGAF, professor of medicine in gastroenterology at Oregon Health & Science University, Portland, and former American Gastroenterological Association president, who participated in the effort.

AGA Regulatory Affairs Director Leslie Narramore said AGA Vice President of Public Policy and Advocacy Kathleen Teixeira worked for 10 years, alongside other GI societies and patient advocacy groups, to close the “colonoscopy loophole.” In 2022, the AGA, Fight Colorectal Cancer, and the American Cancer Society–Cancer Action Network met with White House officials and senior officials with the Department of Health & Human Services about expanding the coverage. They also lobbied to eliminate cost-sharing, another way in which preventive colonoscopy is discouraged.

“The COVID-19 public health emergency highlighted health disparities and barriers to access to care,” said Ms. Narramore, who gave input about the effort along with Ms. Teixeira and AGA Director of Government Affairs Sarah Ankney. “The temporary suspension of elective procedures, including screening colonoscopies, exacerbated the existing low colorectal screening rates and created momentum and willingness in agency officials to create positive change.”

Without coverage of the colonoscopy, patients have needed to cover at least part of the cost of the procedure, which could be $1,000 or more with private insurance, or $100 or more with Medicare, Dr. Lieberman said. So, he noted, unsuspecting patients might receive a positive result on a noninvasive test and have a colonoscopy, only to get a “surprise bill.” Or they would know about the lack of coverage and not get the colonoscopy.

“Prior to the policy change, gastroenterologists and their staff had to explain to patients that their insurer would not fully pay for a colonoscopy following a positive noninvasive stool test, and field questions from upset patients who weren’t aware of their insurance plan’s cost-sharing requirements for a cancer screening procedure they thought was free,” Ms. Narramore said.

There’s little doubt the change will help save lives and improve quality of life, Dr. Lieberman said.

“We don’t know the full impact of this new ruling, but we know that financial barriers are important for some patients,” he said. “And so by removing these barriers we hope that we’re going to see improved adherence to follow-up with colonoscopy after a positive stool test, and that would result in reductions in incidence, mortality, and increased life-years gained.”

Ms. Narramore said the changes show the importance of pushing for policy change.

“Our physician advocates were effective in educating policy makers on the need for coverage of the full colorectal cancer screening continuum, and how colorectal cancer needs to be viewed as a program given the various steps necessary for a complete screening,” she said. “These successful efforts demonstrate to our members that advocacy works and that they can be a voice for their patients in improving their access to care.”






 

When the Affordable Care Act was signed in 2010, patients became eligible for coverage of screening examinations, which was good news for gastroenterologists and their patients in the fight to prevent colorectal cancer.

But there was a problem: While noninvasive stool tests – measuring microscopic amounts of blood or key DNA mutations, both tip-offs to increased colorectal cancer risk – were considered a screen, the necessary follow-up colonoscopy was not, leaving patients with expensive copays or other payment responsibility.

That interpretation prompted a years-long effort to have the federal agencies who oversee the health insurance sector reinterpret their policy, which finally changed in May 2022. Medicare, which is not covered by the ACA and is administered by a different agency, announced a change to its policy in July 2022, and the change went into effect in January 2023.

“It’s a major victory for patients, and I couldn’t be more delighted,” said David Lieberman, MD, AGAF, professor of medicine in gastroenterology at Oregon Health & Science University, Portland, and former American Gastroenterological Association president, who participated in the effort.

AGA Regulatory Affairs Director Leslie Narramore said AGA Vice President of Public Policy and Advocacy Kathleen Teixeira worked for 10 years, alongside other GI societies and patient advocacy groups, to close the “colonoscopy loophole.” In 2022, the AGA, Fight Colorectal Cancer, and the American Cancer Society–Cancer Action Network met with White House officials and senior officials with the Department of Health & Human Services about expanding the coverage. They also lobbied to eliminate cost-sharing, another way in which preventive colonoscopy is discouraged.

“The COVID-19 public health emergency highlighted health disparities and barriers to access to care,” said Ms. Narramore, who gave input about the effort along with Ms. Teixeira and AGA Director of Government Affairs Sarah Ankney. “The temporary suspension of elective procedures, including screening colonoscopies, exacerbated the existing low colorectal screening rates and created momentum and willingness in agency officials to create positive change.”

Without coverage of the colonoscopy, patients have needed to cover at least part of the cost of the procedure, which could be $1,000 or more with private insurance, or $100 or more with Medicare, Dr. Lieberman said. So, he noted, unsuspecting patients might receive a positive result on a noninvasive test and have a colonoscopy, only to get a “surprise bill.” Or they would know about the lack of coverage and not get the colonoscopy.

“Prior to the policy change, gastroenterologists and their staff had to explain to patients that their insurer would not fully pay for a colonoscopy following a positive noninvasive stool test, and field questions from upset patients who weren’t aware of their insurance plan’s cost-sharing requirements for a cancer screening procedure they thought was free,” Ms. Narramore said.

There’s little doubt the change will help save lives and improve quality of life, Dr. Lieberman said.

“We don’t know the full impact of this new ruling, but we know that financial barriers are important for some patients,” he said. “And so by removing these barriers we hope that we’re going to see improved adherence to follow-up with colonoscopy after a positive stool test, and that would result in reductions in incidence, mortality, and increased life-years gained.”

Ms. Narramore said the changes show the importance of pushing for policy change.

“Our physician advocates were effective in educating policy makers on the need for coverage of the full colorectal cancer screening continuum, and how colorectal cancer needs to be viewed as a program given the various steps necessary for a complete screening,” she said. “These successful efforts demonstrate to our members that advocacy works and that they can be a voice for their patients in improving their access to care.”






 

When the Affordable Care Act was signed in 2010, patients became eligible for coverage of screening examinations, which was good news for gastroenterologists and their patients in the fight to prevent colorectal cancer.

But there was a problem: While noninvasive stool tests – measuring microscopic amounts of blood or key DNA mutations, both tip-offs to increased colorectal cancer risk – were considered a screen, the necessary follow-up colonoscopy was not, leaving patients with expensive copays or other payment responsibility.

That interpretation prompted a years-long effort to have the federal agencies who oversee the health insurance sector reinterpret their policy, which finally changed in May 2022. Medicare, which is not covered by the ACA and is administered by a different agency, announced a change to its policy in July 2022, and the change went into effect in January 2023.

“It’s a major victory for patients, and I couldn’t be more delighted,” said David Lieberman, MD, AGAF, professor of medicine in gastroenterology at Oregon Health & Science University, Portland, and former American Gastroenterological Association president, who participated in the effort.

AGA Regulatory Affairs Director Leslie Narramore said AGA Vice President of Public Policy and Advocacy Kathleen Teixeira worked for 10 years, alongside other GI societies and patient advocacy groups, to close the “colonoscopy loophole.” In 2022, the AGA, Fight Colorectal Cancer, and the American Cancer Society–Cancer Action Network met with White House officials and senior officials with the Department of Health & Human Services about expanding the coverage. They also lobbied to eliminate cost-sharing, another way in which preventive colonoscopy is discouraged.

“The COVID-19 public health emergency highlighted health disparities and barriers to access to care,” said Ms. Narramore, who gave input about the effort along with Ms. Teixeira and AGA Director of Government Affairs Sarah Ankney. “The temporary suspension of elective procedures, including screening colonoscopies, exacerbated the existing low colorectal screening rates and created momentum and willingness in agency officials to create positive change.”

Without coverage of the colonoscopy, patients have needed to cover at least part of the cost of the procedure, which could be $1,000 or more with private insurance, or $100 or more with Medicare, Dr. Lieberman said. So, he noted, unsuspecting patients might receive a positive result on a noninvasive test and have a colonoscopy, only to get a “surprise bill.” Or they would know about the lack of coverage and not get the colonoscopy.

“Prior to the policy change, gastroenterologists and their staff had to explain to patients that their insurer would not fully pay for a colonoscopy following a positive noninvasive stool test, and field questions from upset patients who weren’t aware of their insurance plan’s cost-sharing requirements for a cancer screening procedure they thought was free,” Ms. Narramore said.

There’s little doubt the change will help save lives and improve quality of life, Dr. Lieberman said.

“We don’t know the full impact of this new ruling, but we know that financial barriers are important for some patients,” he said. “And so by removing these barriers we hope that we’re going to see improved adherence to follow-up with colonoscopy after a positive stool test, and that would result in reductions in incidence, mortality, and increased life-years gained.”

Ms. Narramore said the changes show the importance of pushing for policy change.

“Our physician advocates were effective in educating policy makers on the need for coverage of the full colorectal cancer screening continuum, and how colorectal cancer needs to be viewed as a program given the various steps necessary for a complete screening,” she said. “These successful efforts demonstrate to our members that advocacy works and that they can be a voice for their patients in improving their access to care.”






 

In adults with prediabetes, vitamin D helped decrease the risk that these individuals would develop diabetes, suggests a meta-analysis of three trials.

Results of the analysis, led by Anastassios G. Pittas, MD, MS, with the division of endocrinology, diabetes, and metabolism at Tufts Medical Center, in Boston, were published online in Annals of Internal Medicine (2023 Feb 7. doi: 10.7326/M22-3018).

All three eligible trials included in the analysis were randomized, double blinded, and placebo controlled. The three eligible trials tested three oral formulations of Vitamin D: cholecalciferol, 20,000 IU (500 mcg) weekly; cholecalciferol, 4,000 IU (100 mcg) daily; or eldecalcitol, 0.75 mcg daily, against placebos.

The authors of the new paper found that vitamin D reduced the risk for diabetes in people with prediabetes by a statistically significant 15% in adjusted analyses. The 3-year absolute risk reduction was 3.3%.

They found no difference in the rate ratios for adverse events (kidney stones, 1.17, 95% confidence interval, 0.69-1.99; hypercalcemia, 2.34; 95% CI, 0.83-6.66]; hypercalciuria, 1.65; 95% CI, 0.83-3.28]; death, 0.85; 95% CI, 0.31-2.36]) when study participants got vitamin D instead of placebo.

Differences from previous analyses

The relationship between vitamin D levels and risk for type 2 diabetes has been studied in previous trials and results have been mixed.

The authors note that two previous meta-analyses included trials “that had relatively short durations for assessment of diabetes risk (for example, ≤ 1 year), had high risk of bias (for example, open-label trials), or were not specifically designed and conducted for primary prevention of type 2 diabetes, potentially undermining the validity of the results.”

Each of the trials in this meta-analysis had a low risk of bias as determined by the Cochrane risk-of-bias tool, Dr. Pittas and colleagues said.

“The present study does not reach an opposite conclusion from the D2d study,” said Dr. Pittas, who coauthored that paper as well. “Rather, it confirms the results of the D2d study. In D2d and two other similar vitamin D and diabetes prevention trials (one in Norway and one in Japan), vitamin D reduced the rate of progression to diabetes in adults with prediabetes, but the observed differences were not statistically significant because the reported relative risk reductions (10%-13%) were smaller than each trial was powered to detect (25%-36%).”

“Individual participant data meta-analyses increase the statistical power to detect an effect. After combining data, we found that vitamin D reduced the risk of progression from prediabetes to diabetes by 15% and this result was statistically significant. So, the conclusion of the meta-analysis is essentially the same conclusion as in D2d and the other two trials. The difference is that the result is now statistically significant,” Dr. Pittas added.

Small reduction but large population

The authors acknowledged that the absolute risk reduction number is small, especially when compared with the risk reduction seen with intensive lifestyle changes (58%) and metformin (31%), as reported in an article published in the New England of Journal of Medicine (2002 Feb 7;346:393-403). But “extrapolating to the more than 374 million adults worldwide who have prediabetes suggests that inexpensive vitamin D supplementation could delay the development of diabetes in more than 10 million people,” they said.

As for how high vitamin D levels need to be, the authors write that their research indicates that the optimal level of vitamin D in the blood needed to reduce diabetes risk may be higher than an Institute of Medicine committee recommendation in 2011.

“The blood 25-hydroxy vitamin D level needed to optimally reduce diabetes risk may be near and possibly above the range of 125-150 nmol/L (50-60 ng/mL) that the 2011 Institute of Medicine Committee to Review Dietary Reference Intakes for Calcium and Vitamin D provided as the range corresponding to the tolerable upper intake level (UL) of 4,000 IU/d for vitamin D,” the authors of the new paper said.

Editorialists urge caution

In an accompanying editorial also published in the Annals of Internal Medicine, Malachi J. McKenna, MD, with the department of clinical chemistry, at St. Vincent’s University Hospital, and Mary A.T. Flynn, PhD, RD, with the Food Safety Authority of Ireland in Dublin, urge caution regarding vitamin D dosing.

They write that there are important distinctions between vitamin D supplements and vitamin D therapy, and the potential harms of high-dose vitamin D are still unclear.

“Vitamin D supplementation of 10 to 20 mcg (400 to 800 IU) daily can be applied safely at the population level to prevent skeletal and possibly nonskeletal disease. Very-high-dose vitamin D therapy might prevent type 2 diabetes in some patients but may also cause harm,” they note.

Dr. Pittas said in an interview that there have been some studies with high-dose vitamin D (up to 500,000 IU a year in one study) that reported an increased fall risk in older adults who had high fall risk. “However, these findings are not generalizable to other populations that are younger and at low or average fall risk, such as the prediabetes population to which the results of this meta-analysis apply,” he noted.

“The benefit-to-risk ratio for vitamin D depends on the target population and medical condition,” Dr. Pittas said. “The editorial refers to the NAM (National Academy of Medicine) vitamin D guidelines for the general, healthy population to promote bone health. The guidelines should not be extrapolated to specific populations, for example [patients with] prediabetes,” where the vitamin D benefit-to-risk ratio would be different from that in the general population.

Dr. Pittas and colleagues caution that the people studied in this meta-analysis were at high risk for type 2 diabetes, so these results do not apply to the general healthy population. The results also should not be extrapolated to people at average risk for any type of diabetes, they add.

Several physicians either declined to comment or did not respond to requests for comment on this research.

Dr. Pittas reports the National Institutes of Health and the American Diabetes Association made payments to his institution to conduct Vitamin D-related research. He is an unpaid cochair of the Endocrine Society’s Evaluation, Treatment and Prevention of Vitamin D Deficiency Clinical Practice Guideline team.

Coauthor Dr. Jorde reports grants from Novo Nordisk Foundation, North Norwegian Regional Health Authorities, and the Research Council of Norway.

Dr. Dawson-Hughes reports she is on the DSMB for AgNovos Healthcare. AgNovos is developing a bone implant to reduce hip fracture risk and she gets a stipend from the company. She reports Helsinn Therapeutics provided anamorelin and matching placebo for an NIH-funded clinical trial.

Dr. Trikalinos was supported by the D2d study. He is a technical methodological consultant to Latham and Watkins, who is retained by Pacira Pharmaceuticals.

Dr. Angellotti has been employed by Takeda and owns stock in the company.

The editorialists report no relevant financial relationships.

In adults with prediabetes, vitamin D helped decrease the risk that these individuals would develop diabetes, suggests a meta-analysis of three trials.

Results of the analysis, led by Anastassios G. Pittas, MD, MS, with the division of endocrinology, diabetes, and metabolism at Tufts Medical Center, in Boston, were published online in Annals of Internal Medicine (2023 Feb 7. doi: 10.7326/M22-3018).

All three eligible trials included in the analysis were randomized, double blinded, and placebo controlled. The three eligible trials tested three oral formulations of Vitamin D: cholecalciferol, 20,000 IU (500 mcg) weekly; cholecalciferol, 4,000 IU (100 mcg) daily; or eldecalcitol, 0.75 mcg daily, against placebos.

The authors of the new paper found that vitamin D reduced the risk for diabetes in people with prediabetes by a statistically significant 15% in adjusted analyses. The 3-year absolute risk reduction was 3.3%.

They found no difference in the rate ratios for adverse events (kidney stones, 1.17, 95% confidence interval, 0.69-1.99; hypercalcemia, 2.34; 95% CI, 0.83-6.66]; hypercalciuria, 1.65; 95% CI, 0.83-3.28]; death, 0.85; 95% CI, 0.31-2.36]) when study participants got vitamin D instead of placebo.

Differences from previous analyses

The relationship between vitamin D levels and risk for type 2 diabetes has been studied in previous trials and results have been mixed.

The authors note that two previous meta-analyses included trials “that had relatively short durations for assessment of diabetes risk (for example, ≤ 1 year), had high risk of bias (for example, open-label trials), or were not specifically designed and conducted for primary prevention of type 2 diabetes, potentially undermining the validity of the results.”

Each of the trials in this meta-analysis had a low risk of bias as determined by the Cochrane risk-of-bias tool, Dr. Pittas and colleagues said.

“The present study does not reach an opposite conclusion from the D2d study,” said Dr. Pittas, who coauthored that paper as well. “Rather, it confirms the results of the D2d study. In D2d and two other similar vitamin D and diabetes prevention trials (one in Norway and one in Japan), vitamin D reduced the rate of progression to diabetes in adults with prediabetes, but the observed differences were not statistically significant because the reported relative risk reductions (10%-13%) were smaller than each trial was powered to detect (25%-36%).”

“Individual participant data meta-analyses increase the statistical power to detect an effect. After combining data, we found that vitamin D reduced the risk of progression from prediabetes to diabetes by 15% and this result was statistically significant. So, the conclusion of the meta-analysis is essentially the same conclusion as in D2d and the other two trials. The difference is that the result is now statistically significant,” Dr. Pittas added.

Small reduction but large population

The authors acknowledged that the absolute risk reduction number is small, especially when compared with the risk reduction seen with intensive lifestyle changes (58%) and metformin (31%), as reported in an article published in the New England of Journal of Medicine (2002 Feb 7;346:393-403). But “extrapolating to the more than 374 million adults worldwide who have prediabetes suggests that inexpensive vitamin D supplementation could delay the development of diabetes in more than 10 million people,” they said.

As for how high vitamin D levels need to be, the authors write that their research indicates that the optimal level of vitamin D in the blood needed to reduce diabetes risk may be higher than an Institute of Medicine committee recommendation in 2011.

“The blood 25-hydroxy vitamin D level needed to optimally reduce diabetes risk may be near and possibly above the range of 125-150 nmol/L (50-60 ng/mL) that the 2011 Institute of Medicine Committee to Review Dietary Reference Intakes for Calcium and Vitamin D provided as the range corresponding to the tolerable upper intake level (UL) of 4,000 IU/d for vitamin D,” the authors of the new paper said.

Editorialists urge caution

In an accompanying editorial also published in the Annals of Internal Medicine, Malachi J. McKenna, MD, with the department of clinical chemistry, at St. Vincent’s University Hospital, and Mary A.T. Flynn, PhD, RD, with the Food Safety Authority of Ireland in Dublin, urge caution regarding vitamin D dosing.

They write that there are important distinctions between vitamin D supplements and vitamin D therapy, and the potential harms of high-dose vitamin D are still unclear.

“Vitamin D supplementation of 10 to 20 mcg (400 to 800 IU) daily can be applied safely at the population level to prevent skeletal and possibly nonskeletal disease. Very-high-dose vitamin D therapy might prevent type 2 diabetes in some patients but may also cause harm,” they note.

Dr. Pittas said in an interview that there have been some studies with high-dose vitamin D (up to 500,000 IU a year in one study) that reported an increased fall risk in older adults who had high fall risk. “However, these findings are not generalizable to other populations that are younger and at low or average fall risk, such as the prediabetes population to which the results of this meta-analysis apply,” he noted.

“The benefit-to-risk ratio for vitamin D depends on the target population and medical condition,” Dr. Pittas said. “The editorial refers to the NAM (National Academy of Medicine) vitamin D guidelines for the general, healthy population to promote bone health. The guidelines should not be extrapolated to specific populations, for example [patients with] prediabetes,” where the vitamin D benefit-to-risk ratio would be different from that in the general population.

Dr. Pittas and colleagues caution that the people studied in this meta-analysis were at high risk for type 2 diabetes, so these results do not apply to the general healthy population. The results also should not be extrapolated to people at average risk for any type of diabetes, they add.

Several physicians either declined to comment or did not respond to requests for comment on this research.

Dr. Pittas reports the National Institutes of Health and the American Diabetes Association made payments to his institution to conduct Vitamin D-related research. He is an unpaid cochair of the Endocrine Society’s Evaluation, Treatment and Prevention of Vitamin D Deficiency Clinical Practice Guideline team.

Coauthor Dr. Jorde reports grants from Novo Nordisk Foundation, North Norwegian Regional Health Authorities, and the Research Council of Norway.

Dr. Dawson-Hughes reports she is on the DSMB for AgNovos Healthcare. AgNovos is developing a bone implant to reduce hip fracture risk and she gets a stipend from the company. She reports Helsinn Therapeutics provided anamorelin and matching placebo for an NIH-funded clinical trial.

Dr. Trikalinos was supported by the D2d study. He is a technical methodological consultant to Latham and Watkins, who is retained by Pacira Pharmaceuticals.

Dr. Angellotti has been employed by Takeda and owns stock in the company.

The editorialists report no relevant financial relationships.

In adults with prediabetes, vitamin D helped decrease the risk that these individuals would develop diabetes, suggests a meta-analysis of three trials.

Results of the analysis, led by Anastassios G. Pittas, MD, MS, with the division of endocrinology, diabetes, and metabolism at Tufts Medical Center, in Boston, were published online in Annals of Internal Medicine (2023 Feb 7. doi: 10.7326/M22-3018).

All three eligible trials included in the analysis were randomized, double blinded, and placebo controlled. The three eligible trials tested three oral formulations of Vitamin D: cholecalciferol, 20,000 IU (500 mcg) weekly; cholecalciferol, 4,000 IU (100 mcg) daily; or eldecalcitol, 0.75 mcg daily, against placebos.

The authors of the new paper found that vitamin D reduced the risk for diabetes in people with prediabetes by a statistically significant 15% in adjusted analyses. The 3-year absolute risk reduction was 3.3%.

They found no difference in the rate ratios for adverse events (kidney stones, 1.17, 95% confidence interval, 0.69-1.99; hypercalcemia, 2.34; 95% CI, 0.83-6.66]; hypercalciuria, 1.65; 95% CI, 0.83-3.28]; death, 0.85; 95% CI, 0.31-2.36]) when study participants got vitamin D instead of placebo.

Differences from previous analyses

The relationship between vitamin D levels and risk for type 2 diabetes has been studied in previous trials and results have been mixed.

The authors note that two previous meta-analyses included trials “that had relatively short durations for assessment of diabetes risk (for example, ≤ 1 year), had high risk of bias (for example, open-label trials), or were not specifically designed and conducted for primary prevention of type 2 diabetes, potentially undermining the validity of the results.”

Each of the trials in this meta-analysis had a low risk of bias as determined by the Cochrane risk-of-bias tool, Dr. Pittas and colleagues said.

“The present study does not reach an opposite conclusion from the D2d study,” said Dr. Pittas, who coauthored that paper as well. “Rather, it confirms the results of the D2d study. In D2d and two other similar vitamin D and diabetes prevention trials (one in Norway and one in Japan), vitamin D reduced the rate of progression to diabetes in adults with prediabetes, but the observed differences were not statistically significant because the reported relative risk reductions (10%-13%) were smaller than each trial was powered to detect (25%-36%).”

“Individual participant data meta-analyses increase the statistical power to detect an effect. After combining data, we found that vitamin D reduced the risk of progression from prediabetes to diabetes by 15% and this result was statistically significant. So, the conclusion of the meta-analysis is essentially the same conclusion as in D2d and the other two trials. The difference is that the result is now statistically significant,” Dr. Pittas added.

Small reduction but large population

The authors acknowledged that the absolute risk reduction number is small, especially when compared with the risk reduction seen with intensive lifestyle changes (58%) and metformin (31%), as reported in an article published in the New England of Journal of Medicine (2002 Feb 7;346:393-403). But “extrapolating to the more than 374 million adults worldwide who have prediabetes suggests that inexpensive vitamin D supplementation could delay the development of diabetes in more than 10 million people,” they said.

As for how high vitamin D levels need to be, the authors write that their research indicates that the optimal level of vitamin D in the blood needed to reduce diabetes risk may be higher than an Institute of Medicine committee recommendation in 2011.

“The blood 25-hydroxy vitamin D level needed to optimally reduce diabetes risk may be near and possibly above the range of 125-150 nmol/L (50-60 ng/mL) that the 2011 Institute of Medicine Committee to Review Dietary Reference Intakes for Calcium and Vitamin D provided as the range corresponding to the tolerable upper intake level (UL) of 4,000 IU/d for vitamin D,” the authors of the new paper said.

Editorialists urge caution

In an accompanying editorial also published in the Annals of Internal Medicine, Malachi J. McKenna, MD, with the department of clinical chemistry, at St. Vincent’s University Hospital, and Mary A.T. Flynn, PhD, RD, with the Food Safety Authority of Ireland in Dublin, urge caution regarding vitamin D dosing.

They write that there are important distinctions between vitamin D supplements and vitamin D therapy, and the potential harms of high-dose vitamin D are still unclear.

“Vitamin D supplementation of 10 to 20 mcg (400 to 800 IU) daily can be applied safely at the population level to prevent skeletal and possibly nonskeletal disease. Very-high-dose vitamin D therapy might prevent type 2 diabetes in some patients but may also cause harm,” they note.

Dr. Pittas said in an interview that there have been some studies with high-dose vitamin D (up to 500,000 IU a year in one study) that reported an increased fall risk in older adults who had high fall risk. “However, these findings are not generalizable to other populations that are younger and at low or average fall risk, such as the prediabetes population to which the results of this meta-analysis apply,” he noted.

“The benefit-to-risk ratio for vitamin D depends on the target population and medical condition,” Dr. Pittas said. “The editorial refers to the NAM (National Academy of Medicine) vitamin D guidelines for the general, healthy population to promote bone health. The guidelines should not be extrapolated to specific populations, for example [patients with] prediabetes,” where the vitamin D benefit-to-risk ratio would be different from that in the general population.

Dr. Pittas and colleagues caution that the people studied in this meta-analysis were at high risk for type 2 diabetes, so these results do not apply to the general healthy population. The results also should not be extrapolated to people at average risk for any type of diabetes, they add.

Several physicians either declined to comment or did not respond to requests for comment on this research.

Dr. Pittas reports the National Institutes of Health and the American Diabetes Association made payments to his institution to conduct Vitamin D-related research. He is an unpaid cochair of the Endocrine Society’s Evaluation, Treatment and Prevention of Vitamin D Deficiency Clinical Practice Guideline team.

Coauthor Dr. Jorde reports grants from Novo Nordisk Foundation, North Norwegian Regional Health Authorities, and the Research Council of Norway.

Dr. Dawson-Hughes reports she is on the DSMB for AgNovos Healthcare. AgNovos is developing a bone implant to reduce hip fracture risk and she gets a stipend from the company. She reports Helsinn Therapeutics provided anamorelin and matching placebo for an NIH-funded clinical trial.

Dr. Trikalinos was supported by the D2d study. He is a technical methodological consultant to Latham and Watkins, who is retained by Pacira Pharmaceuticals.

Dr. Angellotti has been employed by Takeda and owns stock in the company.

The editorialists report no relevant financial relationships.

Since before the COVID-19 pandemic, primary care providers (PCPs) have been addressing an increasing frequency of mental health concerns, particularly anxiety and stress-related diagnoses, based on a recent study.

These findings point to a sizable gap in psychiatric care that has likely been exacerbated by the pandemic, reported lead author Lisa S. Rotenstein, MD, MBA, assistant professor of medicine at Harvard Medical School and Medical Director of Population Health at Brigham and Women’s Hospital, both in Boston, and colleagues.

To ensure that PCPs can effectively manage this burden, innovative approaches are needed, such as value-based care models, billing codes for integrated behavioral health, and e-consultations with psychiatric colleagues, they added.

“Previous studies demonstrated that the rate of adult mental health outpatient visits increased between 1995 and 2010,” Dr. Rotenstein and colleagues wrote in Health Affairs. “However, more than a decade later, the extent to which the rate of primary care visits addressing mental health concerns has changed is unclear, with multiple health care delivery trends potentially influencing a further increase in prevalence.”

To address this knowledge gap, the investigators turned to the 2006-2018 National Ambulatory Medical Care Surveys, a nationally representative, serial, cross-sectional dataset. The present analysis included 109,898 visits representing 3,891,233,060 weighted visits.

Over the study period, the proportion of PCP visits that addressed mental health concerns rose from 10.7% to 15.9%.

This latter figure has probably increased since the onset of the pandemic, the investigators wrote, while availability of psychiatric care hasn’t kept pace, meaning PCPs are increasingly on the hook for managing mental illness.

“Even before the pandemic, one in five Americans lived with a mental health condition,” Dr. Rotenstein said in a written comment. “The COVID pandemic has only accelerated demand for mental health treatment. ... We know that there aren’t enough psychiatrists to meet this demand.”

Over the course of the study period, the rate of depression and affective disorders diagnoses slowed while anxiety and stress-related disorders were increasingly diagnosed.

“Particularly given the common co-occurrence of anxiety and depression, the trends we identified may represent physicians’ greater comfort over time with accurately diagnosing anxiety in the primary care setting, potentially for diagnoses that previously would have been classified as depression,” the investigators wrote, noting these findings align with a 2014 study by Olfson and colleagues.

Multiple factors associated with primary care mental health visits

Several variables were associated with significantly greater likelihood that a mental health concern would be addressed at a given visit, including female sex, younger age, payment via Medicare or Medicaid, and the physician being the patient’s regular physician.

“Our study demonstrated that mental health concerns were significantly more likely to be addressed in a visit with one’s usual primary care physician,” Dr. Rotenstein said. “This finding emphasizes the value of the longitudinal, supportive relationship developed in primary care for raising and addressing the full continuum of a patient’s needs, including mental health concerns.”

The investigators also observed significant associations between race/ethnicity and likelihood of addressing a mental health concern.

Compared with White patients, Black patients were 40% less likely to have a primary care visit with a mental health concern (odds ratio, 0.6; P less than .001). Similarly, Hispanic patients were 40% less likely than non-Hispanic patients to have a visit with a mental health concern (OR, 0.6; P less than .001).

“Unfortunately, our data don’t give us insight into why Black and Hispanic patients were less likely to have a mental health concern addressed in the context of a primary care visit,” Dr. Rotenstein said. “However, the data do suggest an urgent need to better understand and subsequently address the underlying causes of these disparities.”

She suggested several possible explanations, including differences in rates of screening, issues with access to care, insurance coverage disparities, and communication or cultural barriers.

Stuck in the reimbursement trap

Michael Klinkman, MD , professor of family medicine and learning health sciences at the University of Michigan Medical School, Ann Arbor, said the data align with his own clinical experience.

“The proportion of visits where depression was addresed went down, but the baseline is going up, so I don’t think we’re dealing with any less depression,” Dr. Klinkman said in an interview. “It’s just that there’s a lot more anxiety and stress that we’re finding and dealing with in primary care.”

While most family doctors are comfortable with best practices in managing these conditions, they may feel increasingly overburdened by the sheer number of patients with mental illness under their care alone, according to Dr. Klinkman.

“Primary care docs are increasingly feeling like they’re on their own in dealing with mental health problems,” he said.

While he agreed in theory with the interventions proposed by Dr. Rotenstein and colleagues, some solutions, like billing code changes, may ultimately worsen the burden on primary care providers.

“My fear in all of this, frankly, is that we’re going to create a better sense of the need for primary care practice in general to address mental health and social care issues, and we’re just going to create a lot more work and more widget-counting around doing that,” said Dr. Klinkman. 

Value-based care appears to be a better solution, he said, since “we’re trying to take care of a human being, not the 1,050 pieces of that human being’s care that we’re trying to bundle up with different codes.”

A flat-fee, per-patient model, however, is unlikely to gain traction in the United States.

Dr. Klinkman has been involved in health care system reform up to the federal level, where he has encountered politicians who understood the issues but were incapable of helping because of partisan gridlock, he said. “It’s just politically near impossible to make changes in this basic health care business model.”

Policymakers advised Dr. Klinkman and his colleagues to strive for incremental changes, leaving them to grapple with increasingly complex reimbursement rules.

“We’re kind of stuck in this trap of trying to create new codes for services that we think ought to be better reimbursed,” Dr. Klinkman said. “We’re missing the person in all of this – the human being we’re trying to serve.”

The investigators, Dr. Cain, and Dr. Klinkman disclosed no conflicts of interest.

*This article was updated on 2/27/2023.

Since before the COVID-19 pandemic, primary care providers (PCPs) have been addressing an increasing frequency of mental health concerns, particularly anxiety and stress-related diagnoses, based on a recent study.

These findings point to a sizable gap in psychiatric care that has likely been exacerbated by the pandemic, reported lead author Lisa S. Rotenstein, MD, MBA, assistant professor of medicine at Harvard Medical School and Medical Director of Population Health at Brigham and Women’s Hospital, both in Boston, and colleagues.

To ensure that PCPs can effectively manage this burden, innovative approaches are needed, such as value-based care models, billing codes for integrated behavioral health, and e-consultations with psychiatric colleagues, they added.

“Previous studies demonstrated that the rate of adult mental health outpatient visits increased between 1995 and 2010,” Dr. Rotenstein and colleagues wrote in Health Affairs. “However, more than a decade later, the extent to which the rate of primary care visits addressing mental health concerns has changed is unclear, with multiple health care delivery trends potentially influencing a further increase in prevalence.”

To address this knowledge gap, the investigators turned to the 2006-2018 National Ambulatory Medical Care Surveys, a nationally representative, serial, cross-sectional dataset. The present analysis included 109,898 visits representing 3,891,233,060 weighted visits.

Over the study period, the proportion of PCP visits that addressed mental health concerns rose from 10.7% to 15.9%.

This latter figure has probably increased since the onset of the pandemic, the investigators wrote, while availability of psychiatric care hasn’t kept pace, meaning PCPs are increasingly on the hook for managing mental illness.

“Even before the pandemic, one in five Americans lived with a mental health condition,” Dr. Rotenstein said in a written comment. “The COVID pandemic has only accelerated demand for mental health treatment. ... We know that there aren’t enough psychiatrists to meet this demand.”

Over the course of the study period, the rate of depression and affective disorders diagnoses slowed while anxiety and stress-related disorders were increasingly diagnosed.

“Particularly given the common co-occurrence of anxiety and depression, the trends we identified may represent physicians’ greater comfort over time with accurately diagnosing anxiety in the primary care setting, potentially for diagnoses that previously would have been classified as depression,” the investigators wrote, noting these findings align with a 2014 study by Olfson and colleagues.

Multiple factors associated with primary care mental health visits

Several variables were associated with significantly greater likelihood that a mental health concern would be addressed at a given visit, including female sex, younger age, payment via Medicare or Medicaid, and the physician being the patient’s regular physician.

“Our study demonstrated that mental health concerns were significantly more likely to be addressed in a visit with one’s usual primary care physician,” Dr. Rotenstein said. “This finding emphasizes the value of the longitudinal, supportive relationship developed in primary care for raising and addressing the full continuum of a patient’s needs, including mental health concerns.”

The investigators also observed significant associations between race/ethnicity and likelihood of addressing a mental health concern.

Compared with White patients, Black patients were 40% less likely to have a primary care visit with a mental health concern (odds ratio, 0.6; P less than .001). Similarly, Hispanic patients were 40% less likely than non-Hispanic patients to have a visit with a mental health concern (OR, 0.6; P less than .001).

“Unfortunately, our data don’t give us insight into why Black and Hispanic patients were less likely to have a mental health concern addressed in the context of a primary care visit,” Dr. Rotenstein said. “However, the data do suggest an urgent need to better understand and subsequently address the underlying causes of these disparities.”

She suggested several possible explanations, including differences in rates of screening, issues with access to care, insurance coverage disparities, and communication or cultural barriers.

Stuck in the reimbursement trap

Michael Klinkman, MD , professor of family medicine and learning health sciences at the University of Michigan Medical School, Ann Arbor, said the data align with his own clinical experience.

“The proportion of visits where depression was addresed went down, but the baseline is going up, so I don’t think we’re dealing with any less depression,” Dr. Klinkman said in an interview. “It’s just that there’s a lot more anxiety and stress that we’re finding and dealing with in primary care.”

While most family doctors are comfortable with best practices in managing these conditions, they may feel increasingly overburdened by the sheer number of patients with mental illness under their care alone, according to Dr. Klinkman.

“Primary care docs are increasingly feeling like they’re on their own in dealing with mental health problems,” he said.

While he agreed in theory with the interventions proposed by Dr. Rotenstein and colleagues, some solutions, like billing code changes, may ultimately worsen the burden on primary care providers.

“My fear in all of this, frankly, is that we’re going to create a better sense of the need for primary care practice in general to address mental health and social care issues, and we’re just going to create a lot more work and more widget-counting around doing that,” said Dr. Klinkman. 

Value-based care appears to be a better solution, he said, since “we’re trying to take care of a human being, not the 1,050 pieces of that human being’s care that we’re trying to bundle up with different codes.”

A flat-fee, per-patient model, however, is unlikely to gain traction in the United States.

Dr. Klinkman has been involved in health care system reform up to the federal level, where he has encountered politicians who understood the issues but were incapable of helping because of partisan gridlock, he said. “It’s just politically near impossible to make changes in this basic health care business model.”

Policymakers advised Dr. Klinkman and his colleagues to strive for incremental changes, leaving them to grapple with increasingly complex reimbursement rules.

“We’re kind of stuck in this trap of trying to create new codes for services that we think ought to be better reimbursed,” Dr. Klinkman said. “We’re missing the person in all of this – the human being we’re trying to serve.”

The investigators, Dr. Cain, and Dr. Klinkman disclosed no conflicts of interest.

*This article was updated on 2/27/2023.

Since before the COVID-19 pandemic, primary care providers (PCPs) have been addressing an increasing frequency of mental health concerns, particularly anxiety and stress-related diagnoses, based on a recent study.

These findings point to a sizable gap in psychiatric care that has likely been exacerbated by the pandemic, reported lead author Lisa S. Rotenstein, MD, MBA, assistant professor of medicine at Harvard Medical School and Medical Director of Population Health at Brigham and Women’s Hospital, both in Boston, and colleagues.

To ensure that PCPs can effectively manage this burden, innovative approaches are needed, such as value-based care models, billing codes for integrated behavioral health, and e-consultations with psychiatric colleagues, they added.

“Previous studies demonstrated that the rate of adult mental health outpatient visits increased between 1995 and 2010,” Dr. Rotenstein and colleagues wrote in Health Affairs. “However, more than a decade later, the extent to which the rate of primary care visits addressing mental health concerns has changed is unclear, with multiple health care delivery trends potentially influencing a further increase in prevalence.”

To address this knowledge gap, the investigators turned to the 2006-2018 National Ambulatory Medical Care Surveys, a nationally representative, serial, cross-sectional dataset. The present analysis included 109,898 visits representing 3,891,233,060 weighted visits.

Over the study period, the proportion of PCP visits that addressed mental health concerns rose from 10.7% to 15.9%.

This latter figure has probably increased since the onset of the pandemic, the investigators wrote, while availability of psychiatric care hasn’t kept pace, meaning PCPs are increasingly on the hook for managing mental illness.

“Even before the pandemic, one in five Americans lived with a mental health condition,” Dr. Rotenstein said in a written comment. “The COVID pandemic has only accelerated demand for mental health treatment. ... We know that there aren’t enough psychiatrists to meet this demand.”

Over the course of the study period, the rate of depression and affective disorders diagnoses slowed while anxiety and stress-related disorders were increasingly diagnosed.

“Particularly given the common co-occurrence of anxiety and depression, the trends we identified may represent physicians’ greater comfort over time with accurately diagnosing anxiety in the primary care setting, potentially for diagnoses that previously would have been classified as depression,” the investigators wrote, noting these findings align with a 2014 study by Olfson and colleagues.

Multiple factors associated with primary care mental health visits

Several variables were associated with significantly greater likelihood that a mental health concern would be addressed at a given visit, including female sex, younger age, payment via Medicare or Medicaid, and the physician being the patient’s regular physician.

“Our study demonstrated that mental health concerns were significantly more likely to be addressed in a visit with one’s usual primary care physician,” Dr. Rotenstein said. “This finding emphasizes the value of the longitudinal, supportive relationship developed in primary care for raising and addressing the full continuum of a patient’s needs, including mental health concerns.”

The investigators also observed significant associations between race/ethnicity and likelihood of addressing a mental health concern.

Compared with White patients, Black patients were 40% less likely to have a primary care visit with a mental health concern (odds ratio, 0.6; P less than .001). Similarly, Hispanic patients were 40% less likely than non-Hispanic patients to have a visit with a mental health concern (OR, 0.6; P less than .001).

“Unfortunately, our data don’t give us insight into why Black and Hispanic patients were less likely to have a mental health concern addressed in the context of a primary care visit,” Dr. Rotenstein said. “However, the data do suggest an urgent need to better understand and subsequently address the underlying causes of these disparities.”

She suggested several possible explanations, including differences in rates of screening, issues with access to care, insurance coverage disparities, and communication or cultural barriers.

Stuck in the reimbursement trap

Michael Klinkman, MD , professor of family medicine and learning health sciences at the University of Michigan Medical School, Ann Arbor, said the data align with his own clinical experience.

“The proportion of visits where depression was addresed went down, but the baseline is going up, so I don’t think we’re dealing with any less depression,” Dr. Klinkman said in an interview. “It’s just that there’s a lot more anxiety and stress that we’re finding and dealing with in primary care.”

While most family doctors are comfortable with best practices in managing these conditions, they may feel increasingly overburdened by the sheer number of patients with mental illness under their care alone, according to Dr. Klinkman.

“Primary care docs are increasingly feeling like they’re on their own in dealing with mental health problems,” he said.

While he agreed in theory with the interventions proposed by Dr. Rotenstein and colleagues, some solutions, like billing code changes, may ultimately worsen the burden on primary care providers.

“My fear in all of this, frankly, is that we’re going to create a better sense of the need for primary care practice in general to address mental health and social care issues, and we’re just going to create a lot more work and more widget-counting around doing that,” said Dr. Klinkman. 

Value-based care appears to be a better solution, he said, since “we’re trying to take care of a human being, not the 1,050 pieces of that human being’s care that we’re trying to bundle up with different codes.”

A flat-fee, per-patient model, however, is unlikely to gain traction in the United States.

Dr. Klinkman has been involved in health care system reform up to the federal level, where he has encountered politicians who understood the issues but were incapable of helping because of partisan gridlock, he said. “It’s just politically near impossible to make changes in this basic health care business model.”

Policymakers advised Dr. Klinkman and his colleagues to strive for incremental changes, leaving them to grapple with increasingly complex reimbursement rules.

“We’re kind of stuck in this trap of trying to create new codes for services that we think ought to be better reimbursed,” Dr. Klinkman said. “We’re missing the person in all of this – the human being we’re trying to serve.”

The investigators, Dr. Cain, and Dr. Klinkman disclosed no conflicts of interest.

*This article was updated on 2/27/2023.

AURORA, COLO. – Inflammatory bowel disease doesn’t respect international borders, and clinicians who help in diet planning for patients with IBD should take into account cultural differences regarding food and eating, a nutrition specialist recommends.

“Many patients are in an environment that they’re not used to, an environment where most people speak English and their customs and their language may differ from the individual providing care to them. They’re often told, in addition, to eat foods that they may not even have heard of. It can really be a scary situation for many of these patients,” said Neha D. Shah, MPH, RD, CNSC, a dietitian at University of California San Francisco Health.

“Put yourself in their shoes. [Consider] what would make you feel more comfortable in that environment, and then apply that perspective to the care of your patient,” she advised colleagues at the annual Crohn’s & Colitis Congress^®, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

Ms. Shah explained that by incorporating understanding of cultural differences and food culture into the care of persons with IBD, clinicians can help patients from different ethnic backgrounds accept diets that both contain familiar foods and also help to ameliorate their gastrointestinal symptoms.
 

Food culture and acculturation

As of 2016, the estimated prevalence of IBD among pediatric patients in the United States was 77 per 100,000, and the prevalence in adults was estimated at 478.4 per 100,000. In a 2021 study of the effects of race and ethnicity on the diagnosis and management of IBD, the authors estimated that the prevalence of IBD in the United States was about 3.1 million persons, or 1.3% of the population, with an increase in prevalence in non-White persons and ethnicities, she noted.

Some of the increasing prevalence among minority populations may be attributable to diet acculturation, when members of a particular group partially or completely adopt the eating patterns and/or food choices of the host country.
 

Culturally appropriate foods

The term “food culture” refers to “the sociocultural aspect of eating, and include[s] the beliefs, values, and attitudes a community may accept around food,” she said.

Ms. Shah provided examples of culturally appropriate foods that may be tolerated by patients with IBD, such as beans, tortillas, chicken with rice, guacamole, mangos, and tomatoes in persons from South America, or lentils, breads, rice, oats, spinach, and tea among patients from the Indian subcontinent.

By understanding and respecting cultural differences, learning how to best communicate with persons of other cultures, and by being aware of one’s own biases, clinicians can better help patients create diet plans that fit within their expectations and lifestyles, she said.

For example, patients can be encouraged to incorporate more culturally familiar plant-based foods such as legumes to manage active disease and maintain remissions.

Patients with active disease should have at least one-half cup of one form of culturally appropriate fiber at each meal. The dietitian should consider recommending blending fiber into other foods or serving it cooked, mashed, or minced, depending upon the patient’s level of tolerance.

During the transition phase, patients can reintroduce an additional half cup of fiber at one meal, then at two meals, and finally at three daily meals. Patients can see whether they can tolerate more raw or whole high-fiber foods at this stage.

During remissions, patients should be advised to add two to three foods containing culturally appropriate fiber at each meal, she said.
 

‘Eye-opening’ realization

“I think it’s really eye-opening for us to think about how we have to have culturally sensitive discussions with our patients,” commented Sandra Kim, MD, from the University of Pittsburgh Medical Center, who moderated the session.

Dr. Kim asked Ms. Shah what advice she’d give to pediatric gastroenterologists about engaging patients and their families.

The clinician should ask both patients and parents about what the child eats and what the challenges of eating under certain circumstances are, and have culturally appropriate resources on hand.

Ms. Shah did not report a funding source for her work. She disclosed compensation as editor of the Journal of Practical Gastroeneterology and as GI on Demand–consultant for a joint virtual platform from the American College of Gastroenterology and Gastro Girl. She also serves as treasurer and director of operations for the South Asian IBD Alliance.
 

AURORA, COLO. – Inflammatory bowel disease doesn’t respect international borders, and clinicians who help in diet planning for patients with IBD should take into account cultural differences regarding food and eating, a nutrition specialist recommends.

“Many patients are in an environment that they’re not used to, an environment where most people speak English and their customs and their language may differ from the individual providing care to them. They’re often told, in addition, to eat foods that they may not even have heard of. It can really be a scary situation for many of these patients,” said Neha D. Shah, MPH, RD, CNSC, a dietitian at University of California San Francisco Health.

“Put yourself in their shoes. [Consider] what would make you feel more comfortable in that environment, and then apply that perspective to the care of your patient,” she advised colleagues at the annual Crohn’s & Colitis Congress^®, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

Ms. Shah explained that by incorporating understanding of cultural differences and food culture into the care of persons with IBD, clinicians can help patients from different ethnic backgrounds accept diets that both contain familiar foods and also help to ameliorate their gastrointestinal symptoms.
 

Food culture and acculturation

As of 2016, the estimated prevalence of IBD among pediatric patients in the United States was 77 per 100,000, and the prevalence in adults was estimated at 478.4 per 100,000. In a 2021 study of the effects of race and ethnicity on the diagnosis and management of IBD, the authors estimated that the prevalence of IBD in the United States was about 3.1 million persons, or 1.3% of the population, with an increase in prevalence in non-White persons and ethnicities, she noted.

Some of the increasing prevalence among minority populations may be attributable to diet acculturation, when members of a particular group partially or completely adopt the eating patterns and/or food choices of the host country.
 

Culturally appropriate foods

The term “food culture” refers to “the sociocultural aspect of eating, and include[s] the beliefs, values, and attitudes a community may accept around food,” she said.

Ms. Shah provided examples of culturally appropriate foods that may be tolerated by patients with IBD, such as beans, tortillas, chicken with rice, guacamole, mangos, and tomatoes in persons from South America, or lentils, breads, rice, oats, spinach, and tea among patients from the Indian subcontinent.

By understanding and respecting cultural differences, learning how to best communicate with persons of other cultures, and by being aware of one’s own biases, clinicians can better help patients create diet plans that fit within their expectations and lifestyles, she said.

For example, patients can be encouraged to incorporate more culturally familiar plant-based foods such as legumes to manage active disease and maintain remissions.

Patients with active disease should have at least one-half cup of one form of culturally appropriate fiber at each meal. The dietitian should consider recommending blending fiber into other foods or serving it cooked, mashed, or minced, depending upon the patient’s level of tolerance.

During the transition phase, patients can reintroduce an additional half cup of fiber at one meal, then at two meals, and finally at three daily meals. Patients can see whether they can tolerate more raw or whole high-fiber foods at this stage.

During remissions, patients should be advised to add two to three foods containing culturally appropriate fiber at each meal, she said.
 

‘Eye-opening’ realization

“I think it’s really eye-opening for us to think about how we have to have culturally sensitive discussions with our patients,” commented Sandra Kim, MD, from the University of Pittsburgh Medical Center, who moderated the session.

Dr. Kim asked Ms. Shah what advice she’d give to pediatric gastroenterologists about engaging patients and their families.

The clinician should ask both patients and parents about what the child eats and what the challenges of eating under certain circumstances are, and have culturally appropriate resources on hand.

Ms. Shah did not report a funding source for her work. She disclosed compensation as editor of the Journal of Practical Gastroeneterology and as GI on Demand–consultant for a joint virtual platform from the American College of Gastroenterology and Gastro Girl. She also serves as treasurer and director of operations for the South Asian IBD Alliance.
 

AURORA, COLO. – Inflammatory bowel disease doesn’t respect international borders, and clinicians who help in diet planning for patients with IBD should take into account cultural differences regarding food and eating, a nutrition specialist recommends.

“Many patients are in an environment that they’re not used to, an environment where most people speak English and their customs and their language may differ from the individual providing care to them. They’re often told, in addition, to eat foods that they may not even have heard of. It can really be a scary situation for many of these patients,” said Neha D. Shah, MPH, RD, CNSC, a dietitian at University of California San Francisco Health.

“Put yourself in their shoes. [Consider] what would make you feel more comfortable in that environment, and then apply that perspective to the care of your patient,” she advised colleagues at the annual Crohn’s & Colitis Congress^®, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.

Ms. Shah explained that by incorporating understanding of cultural differences and food culture into the care of persons with IBD, clinicians can help patients from different ethnic backgrounds accept diets that both contain familiar foods and also help to ameliorate their gastrointestinal symptoms.
 

Food culture and acculturation

As of 2016, the estimated prevalence of IBD among pediatric patients in the United States was 77 per 100,000, and the prevalence in adults was estimated at 478.4 per 100,000. In a 2021 study of the effects of race and ethnicity on the diagnosis and management of IBD, the authors estimated that the prevalence of IBD in the United States was about 3.1 million persons, or 1.3% of the population, with an increase in prevalence in non-White persons and ethnicities, she noted.

Some of the increasing prevalence among minority populations may be attributable to diet acculturation, when members of a particular group partially or completely adopt the eating patterns and/or food choices of the host country.
 

Culturally appropriate foods

The term “food culture” refers to “the sociocultural aspect of eating, and include[s] the beliefs, values, and attitudes a community may accept around food,” she said.

Ms. Shah provided examples of culturally appropriate foods that may be tolerated by patients with IBD, such as beans, tortillas, chicken with rice, guacamole, mangos, and tomatoes in persons from South America, or lentils, breads, rice, oats, spinach, and tea among patients from the Indian subcontinent.

By understanding and respecting cultural differences, learning how to best communicate with persons of other cultures, and by being aware of one’s own biases, clinicians can better help patients create diet plans that fit within their expectations and lifestyles, she said.

For example, patients can be encouraged to incorporate more culturally familiar plant-based foods such as legumes to manage active disease and maintain remissions.

Patients with active disease should have at least one-half cup of one form of culturally appropriate fiber at each meal. The dietitian should consider recommending blending fiber into other foods or serving it cooked, mashed, or minced, depending upon the patient’s level of tolerance.

During the transition phase, patients can reintroduce an additional half cup of fiber at one meal, then at two meals, and finally at three daily meals. Patients can see whether they can tolerate more raw or whole high-fiber foods at this stage.

During remissions, patients should be advised to add two to three foods containing culturally appropriate fiber at each meal, she said.
 

‘Eye-opening’ realization

“I think it’s really eye-opening for us to think about how we have to have culturally sensitive discussions with our patients,” commented Sandra Kim, MD, from the University of Pittsburgh Medical Center, who moderated the session.

Dr. Kim asked Ms. Shah what advice she’d give to pediatric gastroenterologists about engaging patients and their families.

The clinician should ask both patients and parents about what the child eats and what the challenges of eating under certain circumstances are, and have culturally appropriate resources on hand.

Ms. Shah did not report a funding source for her work. She disclosed compensation as editor of the Journal of Practical Gastroeneterology and as GI on Demand–consultant for a joint virtual platform from the American College of Gastroenterology and Gastro Girl. She also serves as treasurer and director of operations for the South Asian IBD Alliance.