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FDA approves oral form of ALS drug edaravone
Edaravone is a pyrazolone free-radical scavenger thought to lessen the effects of oxidative stress, which is a probable factor in ALS onset and progression. The drug was first approved in 2017 as an intravenous (IV) infusion to treat ALS.
Radicava ORS is self-administered and can be taken at home. After fasting overnight, Radicava ORS should be taken in the morning orally or through a feeding tube. The oral version has the same dosing regimen as the original IV version, with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period and subsequent treatment cycles consisting of daily dosing for 10 out of 14-day periods, followed by 14-day drug-free periods.
Compared with the IV formation of Radicava, Radicava ORS has been shown to generate comparable levels of active drug in the bloodstream, the FDA said.
The FDA determined that IV Radicava was effective based on a 6-month clinical trial in Japan involving 137 individuals who were randomly chosen to receive either the drug or a placebo. At 24 weeks, individuals receiving Radicava showed less decline on a clinical assessment of daily functioning, compared with those receiving placebo.
The most common side effects of Radicava are bruising, problems walking, and headache. Fatigue is also a possible side effect from Radicava ORS. Both formulations can have serious side effects associated with allergic reactions, including hives, rash, and shortness of breath.
Full prescribing information, including additional information on risks associated with Radicava ORS, is available online.
The FDA granted Radicava ORS orphan drug status, priority review, and Fast Track designations.
A version of this article first appeared on Medscape.com.
Edaravone is a pyrazolone free-radical scavenger thought to lessen the effects of oxidative stress, which is a probable factor in ALS onset and progression. The drug was first approved in 2017 as an intravenous (IV) infusion to treat ALS.
Radicava ORS is self-administered and can be taken at home. After fasting overnight, Radicava ORS should be taken in the morning orally or through a feeding tube. The oral version has the same dosing regimen as the original IV version, with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period and subsequent treatment cycles consisting of daily dosing for 10 out of 14-day periods, followed by 14-day drug-free periods.
Compared with the IV formation of Radicava, Radicava ORS has been shown to generate comparable levels of active drug in the bloodstream, the FDA said.
The FDA determined that IV Radicava was effective based on a 6-month clinical trial in Japan involving 137 individuals who were randomly chosen to receive either the drug or a placebo. At 24 weeks, individuals receiving Radicava showed less decline on a clinical assessment of daily functioning, compared with those receiving placebo.
The most common side effects of Radicava are bruising, problems walking, and headache. Fatigue is also a possible side effect from Radicava ORS. Both formulations can have serious side effects associated with allergic reactions, including hives, rash, and shortness of breath.
Full prescribing information, including additional information on risks associated with Radicava ORS, is available online.
The FDA granted Radicava ORS orphan drug status, priority review, and Fast Track designations.
A version of this article first appeared on Medscape.com.
Edaravone is a pyrazolone free-radical scavenger thought to lessen the effects of oxidative stress, which is a probable factor in ALS onset and progression. The drug was first approved in 2017 as an intravenous (IV) infusion to treat ALS.
Radicava ORS is self-administered and can be taken at home. After fasting overnight, Radicava ORS should be taken in the morning orally or through a feeding tube. The oral version has the same dosing regimen as the original IV version, with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period and subsequent treatment cycles consisting of daily dosing for 10 out of 14-day periods, followed by 14-day drug-free periods.
Compared with the IV formation of Radicava, Radicava ORS has been shown to generate comparable levels of active drug in the bloodstream, the FDA said.
The FDA determined that IV Radicava was effective based on a 6-month clinical trial in Japan involving 137 individuals who were randomly chosen to receive either the drug or a placebo. At 24 weeks, individuals receiving Radicava showed less decline on a clinical assessment of daily functioning, compared with those receiving placebo.
The most common side effects of Radicava are bruising, problems walking, and headache. Fatigue is also a possible side effect from Radicava ORS. Both formulations can have serious side effects associated with allergic reactions, including hives, rash, and shortness of breath.
Full prescribing information, including additional information on risks associated with Radicava ORS, is available online.
The FDA granted Radicava ORS orphan drug status, priority review, and Fast Track designations.
A version of this article first appeared on Medscape.com.
Mixing BP meds with NSAID may be ‘triple whammy’ for kidneys
The study also looked at risk factors associated with the effect of triple therapy with these agents, which has been called “triple whammy” AKI.
“It’s not that everyone who happens to take this combination of drugs is going to have problems,” Anita Layton, PhD, University of Waterloo, Ontario, said in a statement. “But the research shows it’s enough of a problem that you should exercise caution.”
The study was published online in Mathematical Biosciences.
In an earlier study, triple therapy with a diuretic, RAS inhibitor, and NSAID was associated with a 31% increased risk for AKI, relative to diuretic and RAS inhibitor therapy only.
However, the factors that predispose some patients to develop “triple whammy” AKI are unclear.
To better understand the mechanism by which triple therapy increases risk for AKI, Dr. Layton and colleagues used computational models to gauge interactions between concurrent use of a diuretic, a RAS inhibitor, and an NSAID.
They identified dehydration and high sensitivity to drug treatment as key contributing factors to the development of triple whammy AKI.
Their model simulations suggested that low water intake, the myogenic response (that is, the reflex response of arteries and arterioles to changes in blood pressure to maintain consistent blood flow), and drug sensitivity “may predispose patients with hypertension to develop triple whammy-induced AKI,” they wrote.
“We hypothesize that individuals with an impaired myogenic response may be particularly susceptible to triple whammy AKI. Additionally, increased drug sensitivity or low water intake can predispose patients to triple whammy AKI,” they added.
In the absence of additional risk factors, there was no indication of an elevated risk for AKI when an angiotensin-converting enzyme (ACE) inhibitor and NSAID are combined, the study team said.
In contrast, when an ACE inhibitor, diuretic, and NSAID are combined, critical blood pressure and glomerular filtration rate (GFR) regulatory mechanisms are simultaneously interrupted, they reported.
“Perhaps not unexpectedly, model simulations indicate that triple treatment reduces GFR more than single or double treatments in all individuals. However, under triple treatment, urine volume and GFR have not been predicted to fall sufficiently far to indicate AKI,” they wrote. “This result is consistent with the fact that only a fraction of individuals develop AKI following triple treatment.”
They expect, therefore, that hypertensive patients who are otherwise healthy will be able to withstand triple treatment, in the absence of these aggravating factors, the researchers concluded.
Nonetheless, it’s wise to “always be careful when mixing medications,” Dr. Layton told this news organization.
She noted that “triple whammy AKI is known among kidney researchers and nephrologists. To what extent nonspecialists are aware, it isn’t clear.
“More importantly,” Dr. Layton said, “NSAIDs can be obtained over the counter, and triple whammy AKI isn’t common knowledge outside of the medical community.”
This research was supported by the Canada 150 Research Chair program and by the Natural Sciences and Engineering Research Council of Canada. The authors have declared no conflicts of interest.
A version of this article first appeared on Medscape.com.
The study also looked at risk factors associated with the effect of triple therapy with these agents, which has been called “triple whammy” AKI.
“It’s not that everyone who happens to take this combination of drugs is going to have problems,” Anita Layton, PhD, University of Waterloo, Ontario, said in a statement. “But the research shows it’s enough of a problem that you should exercise caution.”
The study was published online in Mathematical Biosciences.
In an earlier study, triple therapy with a diuretic, RAS inhibitor, and NSAID was associated with a 31% increased risk for AKI, relative to diuretic and RAS inhibitor therapy only.
However, the factors that predispose some patients to develop “triple whammy” AKI are unclear.
To better understand the mechanism by which triple therapy increases risk for AKI, Dr. Layton and colleagues used computational models to gauge interactions between concurrent use of a diuretic, a RAS inhibitor, and an NSAID.
They identified dehydration and high sensitivity to drug treatment as key contributing factors to the development of triple whammy AKI.
Their model simulations suggested that low water intake, the myogenic response (that is, the reflex response of arteries and arterioles to changes in blood pressure to maintain consistent blood flow), and drug sensitivity “may predispose patients with hypertension to develop triple whammy-induced AKI,” they wrote.
“We hypothesize that individuals with an impaired myogenic response may be particularly susceptible to triple whammy AKI. Additionally, increased drug sensitivity or low water intake can predispose patients to triple whammy AKI,” they added.
In the absence of additional risk factors, there was no indication of an elevated risk for AKI when an angiotensin-converting enzyme (ACE) inhibitor and NSAID are combined, the study team said.
In contrast, when an ACE inhibitor, diuretic, and NSAID are combined, critical blood pressure and glomerular filtration rate (GFR) regulatory mechanisms are simultaneously interrupted, they reported.
“Perhaps not unexpectedly, model simulations indicate that triple treatment reduces GFR more than single or double treatments in all individuals. However, under triple treatment, urine volume and GFR have not been predicted to fall sufficiently far to indicate AKI,” they wrote. “This result is consistent with the fact that only a fraction of individuals develop AKI following triple treatment.”
They expect, therefore, that hypertensive patients who are otherwise healthy will be able to withstand triple treatment, in the absence of these aggravating factors, the researchers concluded.
Nonetheless, it’s wise to “always be careful when mixing medications,” Dr. Layton told this news organization.
She noted that “triple whammy AKI is known among kidney researchers and nephrologists. To what extent nonspecialists are aware, it isn’t clear.
“More importantly,” Dr. Layton said, “NSAIDs can be obtained over the counter, and triple whammy AKI isn’t common knowledge outside of the medical community.”
This research was supported by the Canada 150 Research Chair program and by the Natural Sciences and Engineering Research Council of Canada. The authors have declared no conflicts of interest.
A version of this article first appeared on Medscape.com.
The study also looked at risk factors associated with the effect of triple therapy with these agents, which has been called “triple whammy” AKI.
“It’s not that everyone who happens to take this combination of drugs is going to have problems,” Anita Layton, PhD, University of Waterloo, Ontario, said in a statement. “But the research shows it’s enough of a problem that you should exercise caution.”
The study was published online in Mathematical Biosciences.
In an earlier study, triple therapy with a diuretic, RAS inhibitor, and NSAID was associated with a 31% increased risk for AKI, relative to diuretic and RAS inhibitor therapy only.
However, the factors that predispose some patients to develop “triple whammy” AKI are unclear.
To better understand the mechanism by which triple therapy increases risk for AKI, Dr. Layton and colleagues used computational models to gauge interactions between concurrent use of a diuretic, a RAS inhibitor, and an NSAID.
They identified dehydration and high sensitivity to drug treatment as key contributing factors to the development of triple whammy AKI.
Their model simulations suggested that low water intake, the myogenic response (that is, the reflex response of arteries and arterioles to changes in blood pressure to maintain consistent blood flow), and drug sensitivity “may predispose patients with hypertension to develop triple whammy-induced AKI,” they wrote.
“We hypothesize that individuals with an impaired myogenic response may be particularly susceptible to triple whammy AKI. Additionally, increased drug sensitivity or low water intake can predispose patients to triple whammy AKI,” they added.
In the absence of additional risk factors, there was no indication of an elevated risk for AKI when an angiotensin-converting enzyme (ACE) inhibitor and NSAID are combined, the study team said.
In contrast, when an ACE inhibitor, diuretic, and NSAID are combined, critical blood pressure and glomerular filtration rate (GFR) regulatory mechanisms are simultaneously interrupted, they reported.
“Perhaps not unexpectedly, model simulations indicate that triple treatment reduces GFR more than single or double treatments in all individuals. However, under triple treatment, urine volume and GFR have not been predicted to fall sufficiently far to indicate AKI,” they wrote. “This result is consistent with the fact that only a fraction of individuals develop AKI following triple treatment.”
They expect, therefore, that hypertensive patients who are otherwise healthy will be able to withstand triple treatment, in the absence of these aggravating factors, the researchers concluded.
Nonetheless, it’s wise to “always be careful when mixing medications,” Dr. Layton told this news organization.
She noted that “triple whammy AKI is known among kidney researchers and nephrologists. To what extent nonspecialists are aware, it isn’t clear.
“More importantly,” Dr. Layton said, “NSAIDs can be obtained over the counter, and triple whammy AKI isn’t common knowledge outside of the medical community.”
This research was supported by the Canada 150 Research Chair program and by the Natural Sciences and Engineering Research Council of Canada. The authors have declared no conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM MATHEMATICAL BIOSCIENCES
DOJ complaint flags HCV drug denials for people with addiction
A complaint filed with the U.S. Department of Justice (DOJ) alleges that Alabama’s Medicaid program is illegally denying curative drug treatment for hepatitis C virus (HCV) infection to people with substance use disorder.
The complaint was filed May 9 by the Center for Health Law and Policy Innovation (CHLPI) of Harvard Law School, in partnership with AIDS Alabama.
It alleges that Alabama Medicaid has a policy of denying HCV treatment to people who have used illegal drugs or alcohol in the past 6 months.
CHLPI and AIDS Alabama argue that these restrictions violate the Americans With Disabilities Act, which protects people who are disabled because of substance use disorder.
“Forced sobriety policies don’t just unfairly prevent people with substance use disorder from accessing life-saving treatment; they also severely hamper public health efforts to stop the spread of the disease,” Kevin Costello, CHLPI’s litigation director, said in a statement.
“These policies are rooted in stigma, not science, and they violate antidiscrimination provisions of the Americans With Disabilities Act,” Mr. Costello said.
Filing an administrative complaint against Alabama is “an important milestone in fighting sobriety restrictions,” he added.
Morally wrong
Kathie Hiers, CEO of AIDS Alabama, noted that Alabama’s health outcomes are among the worst in the nation.
“Policies that prevent adequate medical care from being provided must end. HCV now has a cure, and withholding that cure from Alabamians based on a moral judgment is wrong and certainly doesn’t follow the science,” Ms. Hiers added.
Direct-acting antiviral (DAA) therapy can cure up to 99% of people living with HCV.
The complaint against Alabama Medicaid builds on CHLPI’s successful policy advocacy and litigation campaigns to expand access to DAA therapy in state Medicaid programs across the country.
Since 2017, 19 states have removed treatment restrictions that were based on drug or alcohol use. In other states, however, “severe, illegal sobriety restrictions remain,” according to CHLPI.
Alabama, Mississippi, Arkansas, South Carolina, and South Dakota still require Medicaid enrollees with HCV to prove they have not used drugs or alcohol for 6 months before they can receive treatment. Iowa, North Dakota, and West Virginia have a 3-month abstinence requirement.
The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America recommend DAA therapy for all patients with chronic HCV infection, regardless of drug or alcohol use.
CHLPI intends to expand this “enforcement campaign” to all states where sobriety restrictions persist.
A version of this article first appeared on Medscape.com.
A complaint filed with the U.S. Department of Justice (DOJ) alleges that Alabama’s Medicaid program is illegally denying curative drug treatment for hepatitis C virus (HCV) infection to people with substance use disorder.
The complaint was filed May 9 by the Center for Health Law and Policy Innovation (CHLPI) of Harvard Law School, in partnership with AIDS Alabama.
It alleges that Alabama Medicaid has a policy of denying HCV treatment to people who have used illegal drugs or alcohol in the past 6 months.
CHLPI and AIDS Alabama argue that these restrictions violate the Americans With Disabilities Act, which protects people who are disabled because of substance use disorder.
“Forced sobriety policies don’t just unfairly prevent people with substance use disorder from accessing life-saving treatment; they also severely hamper public health efforts to stop the spread of the disease,” Kevin Costello, CHLPI’s litigation director, said in a statement.
“These policies are rooted in stigma, not science, and they violate antidiscrimination provisions of the Americans With Disabilities Act,” Mr. Costello said.
Filing an administrative complaint against Alabama is “an important milestone in fighting sobriety restrictions,” he added.
Morally wrong
Kathie Hiers, CEO of AIDS Alabama, noted that Alabama’s health outcomes are among the worst in the nation.
“Policies that prevent adequate medical care from being provided must end. HCV now has a cure, and withholding that cure from Alabamians based on a moral judgment is wrong and certainly doesn’t follow the science,” Ms. Hiers added.
Direct-acting antiviral (DAA) therapy can cure up to 99% of people living with HCV.
The complaint against Alabama Medicaid builds on CHLPI’s successful policy advocacy and litigation campaigns to expand access to DAA therapy in state Medicaid programs across the country.
Since 2017, 19 states have removed treatment restrictions that were based on drug or alcohol use. In other states, however, “severe, illegal sobriety restrictions remain,” according to CHLPI.
Alabama, Mississippi, Arkansas, South Carolina, and South Dakota still require Medicaid enrollees with HCV to prove they have not used drugs or alcohol for 6 months before they can receive treatment. Iowa, North Dakota, and West Virginia have a 3-month abstinence requirement.
The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America recommend DAA therapy for all patients with chronic HCV infection, regardless of drug or alcohol use.
CHLPI intends to expand this “enforcement campaign” to all states where sobriety restrictions persist.
A version of this article first appeared on Medscape.com.
A complaint filed with the U.S. Department of Justice (DOJ) alleges that Alabama’s Medicaid program is illegally denying curative drug treatment for hepatitis C virus (HCV) infection to people with substance use disorder.
The complaint was filed May 9 by the Center for Health Law and Policy Innovation (CHLPI) of Harvard Law School, in partnership with AIDS Alabama.
It alleges that Alabama Medicaid has a policy of denying HCV treatment to people who have used illegal drugs or alcohol in the past 6 months.
CHLPI and AIDS Alabama argue that these restrictions violate the Americans With Disabilities Act, which protects people who are disabled because of substance use disorder.
“Forced sobriety policies don’t just unfairly prevent people with substance use disorder from accessing life-saving treatment; they also severely hamper public health efforts to stop the spread of the disease,” Kevin Costello, CHLPI’s litigation director, said in a statement.
“These policies are rooted in stigma, not science, and they violate antidiscrimination provisions of the Americans With Disabilities Act,” Mr. Costello said.
Filing an administrative complaint against Alabama is “an important milestone in fighting sobriety restrictions,” he added.
Morally wrong
Kathie Hiers, CEO of AIDS Alabama, noted that Alabama’s health outcomes are among the worst in the nation.
“Policies that prevent adequate medical care from being provided must end. HCV now has a cure, and withholding that cure from Alabamians based on a moral judgment is wrong and certainly doesn’t follow the science,” Ms. Hiers added.
Direct-acting antiviral (DAA) therapy can cure up to 99% of people living with HCV.
The complaint against Alabama Medicaid builds on CHLPI’s successful policy advocacy and litigation campaigns to expand access to DAA therapy in state Medicaid programs across the country.
Since 2017, 19 states have removed treatment restrictions that were based on drug or alcohol use. In other states, however, “severe, illegal sobriety restrictions remain,” according to CHLPI.
Alabama, Mississippi, Arkansas, South Carolina, and South Dakota still require Medicaid enrollees with HCV to prove they have not used drugs or alcohol for 6 months before they can receive treatment. Iowa, North Dakota, and West Virginia have a 3-month abstinence requirement.
The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America recommend DAA therapy for all patients with chronic HCV infection, regardless of drug or alcohol use.
CHLPI intends to expand this “enforcement campaign” to all states where sobriety restrictions persist.
A version of this article first appeared on Medscape.com.
Can fecal transplants help reverse aging?
Transplanting fecal microbiota from young mice into older mice can reverse signs of aging in the gut, brain, and eyes, a team of scientists from the United Kingdom has found. Conversely, transplanting microbiota from old mice to young mice has the opposite effect.
This research provides “tantalizing evidence for the direct involvement of gut microbes in aging and the functional decline of brain function and vision and offers a potential solution in the form of gut microbe replacement therapy,” Simon Carding, PhD, who heads the gut microbes and health research program at the Quadram Institute in Norwich, England, said in a news release.
The study was published online in the journal Microbiome.
The fountain of youth?
Age-related changes in diversity, composition, and function of the gut microbiota are associated with low-grade systemic inflammation, declining tissue function, and increased susceptibility to age-related chronic diseases.
Dr. Carding and colleagues at the Quadram Institute and the University of East Anglia used fecal microbiota transplant (FMT) to exchange the intestinal microbiota of young mice and aged mice.
Young mice who received aged microbiota showed increased intestinal barrier permeability (leaky gut) coupled with upregulated inflammation in the brain and retina, as well as loss of a key functional protein in the eye, they report.
Conversely, these detrimental effects were reversed when microbiota from young mice was transferred to aged mice. FMT with young microbiota also led to enrichment of beneficial taxa in aged mice.
“Our data support the suggestion that altered gut microbiota in old age contributes to intestinal and systemic inflammation, and so may contribute to driving inflammatory pathologies of aged organs,” the study team wrote.
“Targeting the gut-brain axis in aging, by modification of microbial composition to modulate immune and metabolic pathways, may therefore be a potential avenue for therapeutic approaches to age-associated inflammatory and functional decline,” they suggested.
In ongoing studies, the study team are working to understand how long the beneficial effects of young donor microbiota last, which will establish whether FMT can promote long-term health benefits in aged individuals and ameliorate age-associated neurodegeneration and retinal functional deterioration.
“Our results provide more evidence of the important links between microbes in the gut and healthy aging of tissues and organs around the body,” lead author Aimée Parker, PhD, from the Quadram Institute, said in the release.
“We hope that our findings will contribute ultimately to understanding how we can manipulate our diet and our gut bacteria to maximize good health in later life,” she added.
Support for this research was provided by the Biotechnology and Biological Sciences Research Council. The authors report no relevant financial relationships .
A version of this article first appeared on Medscape.com.
Transplanting fecal microbiota from young mice into older mice can reverse signs of aging in the gut, brain, and eyes, a team of scientists from the United Kingdom has found. Conversely, transplanting microbiota from old mice to young mice has the opposite effect.
This research provides “tantalizing evidence for the direct involvement of gut microbes in aging and the functional decline of brain function and vision and offers a potential solution in the form of gut microbe replacement therapy,” Simon Carding, PhD, who heads the gut microbes and health research program at the Quadram Institute in Norwich, England, said in a news release.
The study was published online in the journal Microbiome.
The fountain of youth?
Age-related changes in diversity, composition, and function of the gut microbiota are associated with low-grade systemic inflammation, declining tissue function, and increased susceptibility to age-related chronic diseases.
Dr. Carding and colleagues at the Quadram Institute and the University of East Anglia used fecal microbiota transplant (FMT) to exchange the intestinal microbiota of young mice and aged mice.
Young mice who received aged microbiota showed increased intestinal barrier permeability (leaky gut) coupled with upregulated inflammation in the brain and retina, as well as loss of a key functional protein in the eye, they report.
Conversely, these detrimental effects were reversed when microbiota from young mice was transferred to aged mice. FMT with young microbiota also led to enrichment of beneficial taxa in aged mice.
“Our data support the suggestion that altered gut microbiota in old age contributes to intestinal and systemic inflammation, and so may contribute to driving inflammatory pathologies of aged organs,” the study team wrote.
“Targeting the gut-brain axis in aging, by modification of microbial composition to modulate immune and metabolic pathways, may therefore be a potential avenue for therapeutic approaches to age-associated inflammatory and functional decline,” they suggested.
In ongoing studies, the study team are working to understand how long the beneficial effects of young donor microbiota last, which will establish whether FMT can promote long-term health benefits in aged individuals and ameliorate age-associated neurodegeneration and retinal functional deterioration.
“Our results provide more evidence of the important links between microbes in the gut and healthy aging of tissues and organs around the body,” lead author Aimée Parker, PhD, from the Quadram Institute, said in the release.
“We hope that our findings will contribute ultimately to understanding how we can manipulate our diet and our gut bacteria to maximize good health in later life,” she added.
Support for this research was provided by the Biotechnology and Biological Sciences Research Council. The authors report no relevant financial relationships .
A version of this article first appeared on Medscape.com.
Transplanting fecal microbiota from young mice into older mice can reverse signs of aging in the gut, brain, and eyes, a team of scientists from the United Kingdom has found. Conversely, transplanting microbiota from old mice to young mice has the opposite effect.
This research provides “tantalizing evidence for the direct involvement of gut microbes in aging and the functional decline of brain function and vision and offers a potential solution in the form of gut microbe replacement therapy,” Simon Carding, PhD, who heads the gut microbes and health research program at the Quadram Institute in Norwich, England, said in a news release.
The study was published online in the journal Microbiome.
The fountain of youth?
Age-related changes in diversity, composition, and function of the gut microbiota are associated with low-grade systemic inflammation, declining tissue function, and increased susceptibility to age-related chronic diseases.
Dr. Carding and colleagues at the Quadram Institute and the University of East Anglia used fecal microbiota transplant (FMT) to exchange the intestinal microbiota of young mice and aged mice.
Young mice who received aged microbiota showed increased intestinal barrier permeability (leaky gut) coupled with upregulated inflammation in the brain and retina, as well as loss of a key functional protein in the eye, they report.
Conversely, these detrimental effects were reversed when microbiota from young mice was transferred to aged mice. FMT with young microbiota also led to enrichment of beneficial taxa in aged mice.
“Our data support the suggestion that altered gut microbiota in old age contributes to intestinal and systemic inflammation, and so may contribute to driving inflammatory pathologies of aged organs,” the study team wrote.
“Targeting the gut-brain axis in aging, by modification of microbial composition to modulate immune and metabolic pathways, may therefore be a potential avenue for therapeutic approaches to age-associated inflammatory and functional decline,” they suggested.
In ongoing studies, the study team are working to understand how long the beneficial effects of young donor microbiota last, which will establish whether FMT can promote long-term health benefits in aged individuals and ameliorate age-associated neurodegeneration and retinal functional deterioration.
“Our results provide more evidence of the important links between microbes in the gut and healthy aging of tissues and organs around the body,” lead author Aimée Parker, PhD, from the Quadram Institute, said in the release.
“We hope that our findings will contribute ultimately to understanding how we can manipulate our diet and our gut bacteria to maximize good health in later life,” she added.
Support for this research was provided by the Biotechnology and Biological Sciences Research Council. The authors report no relevant financial relationships .
A version of this article first appeared on Medscape.com.
Do psychotropic meds raise or lower COVID risk in psych patients?
Investigators found that second-generation antipsychotics were associated with a 48% lower risk of COVID-19, while valproic acid was associated with a 39% increased risk of the disease.
“Exposures to several psychotropic medications were associated with risk of COVID-19 infection among inpatients with serious mental illness; decreased risk was observed with the use of second generation antipsychotics, with paliperidone use associated with the largest effect size. Valproic acid use was associated with an increased risk of infection,” the investigators, led by Katlyn Nemani, MD, at NYU Langone Medical Center, New York, write.
The study was published online in JAMA Network Open.
Vulnerable population
Patients with serious mental illness are particularly vulnerable to COVID-19. Several psychotropic medications have been identified as potential therapeutic agents to prevent or treat COVID-19, but they have not been systematically studied in this patient population.
The researchers analyzed data from 1,958 adults who were continuously hospitalized with serious mental illness from March 8 to July 1, 2020. The mean age was 51.4 years, and 1,442 (74%) were men.
A total of 969 patients (49.5%) had laboratory-confirmed COVID-19 while hospitalized, and 38 (3.9%) died – a mortality rate four times higher than estimates from the general population in New York during the same time frame, the researchers note.
“This finding is consistent with prior studies that have found increased rates of infection in congregate settings and increased mortality after infection among patients with serious mental illness,” the investigators write.
The use of second-generation antipsychotic medications, as a class, was associated with a lower likelihood of COVID-19 (odds ratio, 0.62; 95% confidence interval, 0.45-0.86), while the use of mood stabilizers was associated with increased likelihood of infection (OR, 1.23; 95% CI, 1.03-1.47).
In a multivariable model of individual medications, use of the long-acting atypical antipsychotic paliperidone was associated with a lower odds of infection (OR, 0.59; 95% CI, 0.41-0.84), and use of valproic acid was associated with increased odds of infection (OR, 1.39; 95% CI, 1.10-1.76).
Valproic acid downregulates angiotensin-converting enzyme 2 in endothelial cells, which may impair immune function and contribute to poor outcomes for patients with COVID-19, the researchers say.
The use of clozapine was associated with reduced odds of COVID-related death (unadjusted OR, 0.25; 95% CI, 0.10-0.62; fully adjusted OR, 0.43; 95% CI, 0.17-1.12).
“Although there have been concerns about clozapine use during the pandemic as a risk factor for pneumonia and potential toxic effects during acute infection, clozapine use was not associated with an increased risk of COVID-19 infection or death in the present study. In fact, unadjusted estimates suggested a significant protective association,” the investigators write.
However, they note, data on clozapine and COVID-19 have been mixed.
Two prior studies of health record data showed an increased risk of COVID-19 associated with clozapine treatment, while a study that was limited to inpatients found a lower risk of infection and a lower risk of symptomatic disease in association with clozapine use.
The researchers also found a lower mortality risk in patients taking antidepressants; there were no COVID-related deaths among patients taking escitalopram, venlafaxine, bupropion, or fluvoxamine.
Although the association was not statistically significant, this observation is in line with larger studies that showed reduced risk of adverse outcomes associated with antidepressant use, the researchers note.
A matter of debate
In an accompanying commentary, Benedetta Vai, PhD, and Mario Gennaro Mazza, MD, with IRCCS San Raffaele Scientific Institute, Milan, point out that the link between psychopharmacologic compounds, in particular antipsychotics, and severe COVID-19 outcomes remains “a matter of debate, with inconsistent findings between studies.”
They note further research is needed to determine whether the protective role of second-generation antipsychotics on risk of COVID-19 is mediated by an immune effect or by the direct antiviral properties of these molecules.
The study had no specific funding. Dr. Nemani, Dr. Vai, and Dr. Mazza have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Investigators found that second-generation antipsychotics were associated with a 48% lower risk of COVID-19, while valproic acid was associated with a 39% increased risk of the disease.
“Exposures to several psychotropic medications were associated with risk of COVID-19 infection among inpatients with serious mental illness; decreased risk was observed with the use of second generation antipsychotics, with paliperidone use associated with the largest effect size. Valproic acid use was associated with an increased risk of infection,” the investigators, led by Katlyn Nemani, MD, at NYU Langone Medical Center, New York, write.
The study was published online in JAMA Network Open.
Vulnerable population
Patients with serious mental illness are particularly vulnerable to COVID-19. Several psychotropic medications have been identified as potential therapeutic agents to prevent or treat COVID-19, but they have not been systematically studied in this patient population.
The researchers analyzed data from 1,958 adults who were continuously hospitalized with serious mental illness from March 8 to July 1, 2020. The mean age was 51.4 years, and 1,442 (74%) were men.
A total of 969 patients (49.5%) had laboratory-confirmed COVID-19 while hospitalized, and 38 (3.9%) died – a mortality rate four times higher than estimates from the general population in New York during the same time frame, the researchers note.
“This finding is consistent with prior studies that have found increased rates of infection in congregate settings and increased mortality after infection among patients with serious mental illness,” the investigators write.
The use of second-generation antipsychotic medications, as a class, was associated with a lower likelihood of COVID-19 (odds ratio, 0.62; 95% confidence interval, 0.45-0.86), while the use of mood stabilizers was associated with increased likelihood of infection (OR, 1.23; 95% CI, 1.03-1.47).
In a multivariable model of individual medications, use of the long-acting atypical antipsychotic paliperidone was associated with a lower odds of infection (OR, 0.59; 95% CI, 0.41-0.84), and use of valproic acid was associated with increased odds of infection (OR, 1.39; 95% CI, 1.10-1.76).
Valproic acid downregulates angiotensin-converting enzyme 2 in endothelial cells, which may impair immune function and contribute to poor outcomes for patients with COVID-19, the researchers say.
The use of clozapine was associated with reduced odds of COVID-related death (unadjusted OR, 0.25; 95% CI, 0.10-0.62; fully adjusted OR, 0.43; 95% CI, 0.17-1.12).
“Although there have been concerns about clozapine use during the pandemic as a risk factor for pneumonia and potential toxic effects during acute infection, clozapine use was not associated with an increased risk of COVID-19 infection or death in the present study. In fact, unadjusted estimates suggested a significant protective association,” the investigators write.
However, they note, data on clozapine and COVID-19 have been mixed.
Two prior studies of health record data showed an increased risk of COVID-19 associated with clozapine treatment, while a study that was limited to inpatients found a lower risk of infection and a lower risk of symptomatic disease in association with clozapine use.
The researchers also found a lower mortality risk in patients taking antidepressants; there were no COVID-related deaths among patients taking escitalopram, venlafaxine, bupropion, or fluvoxamine.
Although the association was not statistically significant, this observation is in line with larger studies that showed reduced risk of adverse outcomes associated with antidepressant use, the researchers note.
A matter of debate
In an accompanying commentary, Benedetta Vai, PhD, and Mario Gennaro Mazza, MD, with IRCCS San Raffaele Scientific Institute, Milan, point out that the link between psychopharmacologic compounds, in particular antipsychotics, and severe COVID-19 outcomes remains “a matter of debate, with inconsistent findings between studies.”
They note further research is needed to determine whether the protective role of second-generation antipsychotics on risk of COVID-19 is mediated by an immune effect or by the direct antiviral properties of these molecules.
The study had no specific funding. Dr. Nemani, Dr. Vai, and Dr. Mazza have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Investigators found that second-generation antipsychotics were associated with a 48% lower risk of COVID-19, while valproic acid was associated with a 39% increased risk of the disease.
“Exposures to several psychotropic medications were associated with risk of COVID-19 infection among inpatients with serious mental illness; decreased risk was observed with the use of second generation antipsychotics, with paliperidone use associated with the largest effect size. Valproic acid use was associated with an increased risk of infection,” the investigators, led by Katlyn Nemani, MD, at NYU Langone Medical Center, New York, write.
The study was published online in JAMA Network Open.
Vulnerable population
Patients with serious mental illness are particularly vulnerable to COVID-19. Several psychotropic medications have been identified as potential therapeutic agents to prevent or treat COVID-19, but they have not been systematically studied in this patient population.
The researchers analyzed data from 1,958 adults who were continuously hospitalized with serious mental illness from March 8 to July 1, 2020. The mean age was 51.4 years, and 1,442 (74%) were men.
A total of 969 patients (49.5%) had laboratory-confirmed COVID-19 while hospitalized, and 38 (3.9%) died – a mortality rate four times higher than estimates from the general population in New York during the same time frame, the researchers note.
“This finding is consistent with prior studies that have found increased rates of infection in congregate settings and increased mortality after infection among patients with serious mental illness,” the investigators write.
The use of second-generation antipsychotic medications, as a class, was associated with a lower likelihood of COVID-19 (odds ratio, 0.62; 95% confidence interval, 0.45-0.86), while the use of mood stabilizers was associated with increased likelihood of infection (OR, 1.23; 95% CI, 1.03-1.47).
In a multivariable model of individual medications, use of the long-acting atypical antipsychotic paliperidone was associated with a lower odds of infection (OR, 0.59; 95% CI, 0.41-0.84), and use of valproic acid was associated with increased odds of infection (OR, 1.39; 95% CI, 1.10-1.76).
Valproic acid downregulates angiotensin-converting enzyme 2 in endothelial cells, which may impair immune function and contribute to poor outcomes for patients with COVID-19, the researchers say.
The use of clozapine was associated with reduced odds of COVID-related death (unadjusted OR, 0.25; 95% CI, 0.10-0.62; fully adjusted OR, 0.43; 95% CI, 0.17-1.12).
“Although there have been concerns about clozapine use during the pandemic as a risk factor for pneumonia and potential toxic effects during acute infection, clozapine use was not associated with an increased risk of COVID-19 infection or death in the present study. In fact, unadjusted estimates suggested a significant protective association,” the investigators write.
However, they note, data on clozapine and COVID-19 have been mixed.
Two prior studies of health record data showed an increased risk of COVID-19 associated with clozapine treatment, while a study that was limited to inpatients found a lower risk of infection and a lower risk of symptomatic disease in association with clozapine use.
The researchers also found a lower mortality risk in patients taking antidepressants; there were no COVID-related deaths among patients taking escitalopram, venlafaxine, bupropion, or fluvoxamine.
Although the association was not statistically significant, this observation is in line with larger studies that showed reduced risk of adverse outcomes associated with antidepressant use, the researchers note.
A matter of debate
In an accompanying commentary, Benedetta Vai, PhD, and Mario Gennaro Mazza, MD, with IRCCS San Raffaele Scientific Institute, Milan, point out that the link between psychopharmacologic compounds, in particular antipsychotics, and severe COVID-19 outcomes remains “a matter of debate, with inconsistent findings between studies.”
They note further research is needed to determine whether the protective role of second-generation antipsychotics on risk of COVID-19 is mediated by an immune effect or by the direct antiviral properties of these molecules.
The study had no specific funding. Dr. Nemani, Dr. Vai, and Dr. Mazza have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Cold forceps on par with cold snare polypectomy for tiny polyps
For nonpedunculated polyps measuring 3 mm or less, cold forceps polypectomy is noninferior to cold snare polypectomy and takes significantly less time, according to the results of the TINYPOLYP trial.
“In our trial, which is the largest to date evaluating complete resection of polyps ≤ 3 mm using cold forceps versus cold snare, we demonstrate that it is acceptable to remove ≤ 3 mm polyps with either cold snare or cold forceps,” lead author Mike Wei, MD, a gastroenterology and hepatology fellow at Stanford University, California, told this news organization.
“Cold forceps can oftentimes be the more efficient way to remove polyps compared to cold snare, and, as such, it was important to provide validation for this practice,” Dr. Wei said.
The study was published online in The American Journal of Gastroenterology.
Evaluating two techniques
Both the U.S. Multi-Society Task Force on Colorectal Cancer and the European Society of Gastrointestinal Endoscopy recommend that diminutive (< 5 mm) and small (6-9 mm) polyps be removed by cold snare polypectomy (CSP).
But whether CSP has a significant advantage over cold forceps polypectomy (CFP) for polyps ≤ 3 mm was unclear.
The TINYPOLYP trial enrolled 179 adults aged 18 years and older who underwent colonoscopy for any indication; colonoscopy was performed by four board-certified endoscopists who each had at least 4 years of experience after completing their fellowship.
A total of 279 nonpedunculated polyps ≤ 3 mm were identified; 138 were removed by CSP, and 141 were removed by CFP. Patient and procedure characteristics were similar in the two groups.
The polyps were similar in size in the CSP and CFP groups (2.5 and 2.6 mm, respectively), as was the distribution of polyps (33.3% and 26.2% in the ascending colon; 26.8% and 24.8% in the transverse colon). A higher proportion of tubular adenomas were removed by CSP than by CFP (79.7% vs. 66.0%).
CSP took significantly longer to perform than CFP (42.3 sec vs. 23.2 sec, P < .001). But with CFP, it was significantly more likely that polyps would need to be removed in more than one piece, compared with CSP (15.6% vs. 3.6%, P < .001).
Hemostatic clip was deployed for one polyp in the CFP group (0.7%); none were used in the CSP group, which was a nonsignificant difference.
There was also no significant difference in positive margins on biopsy (two cases in each group; 1.7%) or in the rate of complete resection (98.3% in both groups), demonstrating noninferiority of CFP, compared with CSP, the study team says.
There were no 30-day complications in either group, including perforation, postpolypectomy bleeding, and postpolypectomy syndrome, and no patient required management of postpolypectomy bleeding. No patient died within 30 days of colonoscopy.
On the basis of their results, Dr. Wei and colleagues say, “When an endoscopist encounters a diminutive polyp ≤ 3 mm, either a cold forceps or cold snare can be utilized during the procedure.”
Guidance for endoscopists
Reached for comment, Emre Gorgun, MD, in the department of colorectal surgery at the Cleveland Clinic, Ohio, said this is an “interesting” study that attempts to pinpoint the “best endoscopic management of tiny polyps.”
“From previously published, well-designed studies, we know that the cold snare technique works very well for polyps up to 10 mm. There have been more recent studies showing that the cold snare technique can be used even in larger polyps, 10-15 mm,” Dr. Gorgun said in an interview.
On the other hand, for polyps < 5 mm, “cold snare technique may take longer and may not provide any added benefits,” he noted. “It may be associated with higher cost due to utilizing more tools, as well as more procedure time and provider services.”
Dr. Gorgun said that the results of the TINYPOLYP study “can help endoscopists in decisionmaking when they come across polyps smaller than 5 mm.”
The study demonstrates that these tiny polyps can “certainly be destroyed/removed by the cold forceps approach,” he added.
The trial had no specific funding. Dr. Wei reports no relevant financial relationships. Dr. Gorgun is a consultant for Boston Scientific, Olympus, and Dilumen.
A version of this article first appeared on Medscape.com.
For nonpedunculated polyps measuring 3 mm or less, cold forceps polypectomy is noninferior to cold snare polypectomy and takes significantly less time, according to the results of the TINYPOLYP trial.
“In our trial, which is the largest to date evaluating complete resection of polyps ≤ 3 mm using cold forceps versus cold snare, we demonstrate that it is acceptable to remove ≤ 3 mm polyps with either cold snare or cold forceps,” lead author Mike Wei, MD, a gastroenterology and hepatology fellow at Stanford University, California, told this news organization.
“Cold forceps can oftentimes be the more efficient way to remove polyps compared to cold snare, and, as such, it was important to provide validation for this practice,” Dr. Wei said.
The study was published online in The American Journal of Gastroenterology.
Evaluating two techniques
Both the U.S. Multi-Society Task Force on Colorectal Cancer and the European Society of Gastrointestinal Endoscopy recommend that diminutive (< 5 mm) and small (6-9 mm) polyps be removed by cold snare polypectomy (CSP).
But whether CSP has a significant advantage over cold forceps polypectomy (CFP) for polyps ≤ 3 mm was unclear.
The TINYPOLYP trial enrolled 179 adults aged 18 years and older who underwent colonoscopy for any indication; colonoscopy was performed by four board-certified endoscopists who each had at least 4 years of experience after completing their fellowship.
A total of 279 nonpedunculated polyps ≤ 3 mm were identified; 138 were removed by CSP, and 141 were removed by CFP. Patient and procedure characteristics were similar in the two groups.
The polyps were similar in size in the CSP and CFP groups (2.5 and 2.6 mm, respectively), as was the distribution of polyps (33.3% and 26.2% in the ascending colon; 26.8% and 24.8% in the transverse colon). A higher proportion of tubular adenomas were removed by CSP than by CFP (79.7% vs. 66.0%).
CSP took significantly longer to perform than CFP (42.3 sec vs. 23.2 sec, P < .001). But with CFP, it was significantly more likely that polyps would need to be removed in more than one piece, compared with CSP (15.6% vs. 3.6%, P < .001).
Hemostatic clip was deployed for one polyp in the CFP group (0.7%); none were used in the CSP group, which was a nonsignificant difference.
There was also no significant difference in positive margins on biopsy (two cases in each group; 1.7%) or in the rate of complete resection (98.3% in both groups), demonstrating noninferiority of CFP, compared with CSP, the study team says.
There were no 30-day complications in either group, including perforation, postpolypectomy bleeding, and postpolypectomy syndrome, and no patient required management of postpolypectomy bleeding. No patient died within 30 days of colonoscopy.
On the basis of their results, Dr. Wei and colleagues say, “When an endoscopist encounters a diminutive polyp ≤ 3 mm, either a cold forceps or cold snare can be utilized during the procedure.”
Guidance for endoscopists
Reached for comment, Emre Gorgun, MD, in the department of colorectal surgery at the Cleveland Clinic, Ohio, said this is an “interesting” study that attempts to pinpoint the “best endoscopic management of tiny polyps.”
“From previously published, well-designed studies, we know that the cold snare technique works very well for polyps up to 10 mm. There have been more recent studies showing that the cold snare technique can be used even in larger polyps, 10-15 mm,” Dr. Gorgun said in an interview.
On the other hand, for polyps < 5 mm, “cold snare technique may take longer and may not provide any added benefits,” he noted. “It may be associated with higher cost due to utilizing more tools, as well as more procedure time and provider services.”
Dr. Gorgun said that the results of the TINYPOLYP study “can help endoscopists in decisionmaking when they come across polyps smaller than 5 mm.”
The study demonstrates that these tiny polyps can “certainly be destroyed/removed by the cold forceps approach,” he added.
The trial had no specific funding. Dr. Wei reports no relevant financial relationships. Dr. Gorgun is a consultant for Boston Scientific, Olympus, and Dilumen.
A version of this article first appeared on Medscape.com.
For nonpedunculated polyps measuring 3 mm or less, cold forceps polypectomy is noninferior to cold snare polypectomy and takes significantly less time, according to the results of the TINYPOLYP trial.
“In our trial, which is the largest to date evaluating complete resection of polyps ≤ 3 mm using cold forceps versus cold snare, we demonstrate that it is acceptable to remove ≤ 3 mm polyps with either cold snare or cold forceps,” lead author Mike Wei, MD, a gastroenterology and hepatology fellow at Stanford University, California, told this news organization.
“Cold forceps can oftentimes be the more efficient way to remove polyps compared to cold snare, and, as such, it was important to provide validation for this practice,” Dr. Wei said.
The study was published online in The American Journal of Gastroenterology.
Evaluating two techniques
Both the U.S. Multi-Society Task Force on Colorectal Cancer and the European Society of Gastrointestinal Endoscopy recommend that diminutive (< 5 mm) and small (6-9 mm) polyps be removed by cold snare polypectomy (CSP).
But whether CSP has a significant advantage over cold forceps polypectomy (CFP) for polyps ≤ 3 mm was unclear.
The TINYPOLYP trial enrolled 179 adults aged 18 years and older who underwent colonoscopy for any indication; colonoscopy was performed by four board-certified endoscopists who each had at least 4 years of experience after completing their fellowship.
A total of 279 nonpedunculated polyps ≤ 3 mm were identified; 138 were removed by CSP, and 141 were removed by CFP. Patient and procedure characteristics were similar in the two groups.
The polyps were similar in size in the CSP and CFP groups (2.5 and 2.6 mm, respectively), as was the distribution of polyps (33.3% and 26.2% in the ascending colon; 26.8% and 24.8% in the transverse colon). A higher proportion of tubular adenomas were removed by CSP than by CFP (79.7% vs. 66.0%).
CSP took significantly longer to perform than CFP (42.3 sec vs. 23.2 sec, P < .001). But with CFP, it was significantly more likely that polyps would need to be removed in more than one piece, compared with CSP (15.6% vs. 3.6%, P < .001).
Hemostatic clip was deployed for one polyp in the CFP group (0.7%); none were used in the CSP group, which was a nonsignificant difference.
There was also no significant difference in positive margins on biopsy (two cases in each group; 1.7%) or in the rate of complete resection (98.3% in both groups), demonstrating noninferiority of CFP, compared with CSP, the study team says.
There were no 30-day complications in either group, including perforation, postpolypectomy bleeding, and postpolypectomy syndrome, and no patient required management of postpolypectomy bleeding. No patient died within 30 days of colonoscopy.
On the basis of their results, Dr. Wei and colleagues say, “When an endoscopist encounters a diminutive polyp ≤ 3 mm, either a cold forceps or cold snare can be utilized during the procedure.”
Guidance for endoscopists
Reached for comment, Emre Gorgun, MD, in the department of colorectal surgery at the Cleveland Clinic, Ohio, said this is an “interesting” study that attempts to pinpoint the “best endoscopic management of tiny polyps.”
“From previously published, well-designed studies, we know that the cold snare technique works very well for polyps up to 10 mm. There have been more recent studies showing that the cold snare technique can be used even in larger polyps, 10-15 mm,” Dr. Gorgun said in an interview.
On the other hand, for polyps < 5 mm, “cold snare technique may take longer and may not provide any added benefits,” he noted. “It may be associated with higher cost due to utilizing more tools, as well as more procedure time and provider services.”
Dr. Gorgun said that the results of the TINYPOLYP study “can help endoscopists in decisionmaking when they come across polyps smaller than 5 mm.”
The study demonstrates that these tiny polyps can “certainly be destroyed/removed by the cold forceps approach,” he added.
The trial had no specific funding. Dr. Wei reports no relevant financial relationships. Dr. Gorgun is a consultant for Boston Scientific, Olympus, and Dilumen.
A version of this article first appeared on Medscape.com.
FROM THE AMERICAN JOURNAL OF GASTROENTEROLOGY
How social determinants of health impact disparities in IBD care, outcomes
The incidence of inflammatory bowel disease (IBD) is on the rise among racial and ethnic minority groups in the United States, and social determinants of health (SDOH) contribute to disparities in IBD care and outcome, say the authors of a new paper on the topic.
It’s an “overdue priority to acknowledge the weight and influence of the SDOH on health disparities in IBD care,” write Adjoa Anyane-Yeboa, MD, PhD, with Massachusetts General Hospital, Boston, and co-authors.
“Only after this acknowledgement can we begin to develop alternative systems that work to rectify the deleterious effects of our current policies in a more longitudinal and effective manner,” they say.
Their paper was published online in Clinical Gastroenterology and Hepatology.
Upstream factors propagate downstream outcomes
The authors found multiple examples in the literature of how upstream SDOH (for example, racism, poverty, neighborhood violence, and under-insurance) lead to midstream SDOH (for example, lack of social support, lack of access to specialized IBD care, poor housing conditions, and food insecurity) that result in poor downstream outcomes in IBD (for example, delayed diagnosis, increased disease activity, IBD flares, and suboptimal medical management).
The IBD literature shows that Black/African American adults with IBD often have worse outcomes across the IBD care continuum than White peers, with higher hospitalization rates, longer stays, increased hospitalization costs, higher readmission rates, and more complications after IBD surgery.
Unequal access to specialized IBD care is a factor, with Black/African American patients less likely to undergo annual visits to a gastroenterologist or IBD specialist, twice as likely than White patients to visit the emergency department over a 12-month period, and less likely to receive treatment with infliximab.
As has been shown for other chronic digestive diseases and cancers, disparities in outcomes related to IBD exist across race, ethnicity, differential insurance status and coverage, and socioeconomic status, the authors note.
Yet, they point out that, interestingly, a 2021 study of patients with Medicaid insurance from four states revealed no disparities in the use of IBD-specific medications between Black/African American and White patients, suggesting that when access to care is equal, disparities diminish.
Target multiple stakeholders to achieve IBD health equity
Achieving health equity in IBD will require strategies targeting medical trainees, providers, practices, and health systems, as well as community and industry leaders and policymakers, Dr. Anyane-Yeboa and colleagues say.
At the medical trainee level, racism and bias should be addressed early in medical student, resident, and fellow training and education. Curricula should move away from race-based training, where race is considered an independent risk factor for disease and often used to guide differential diagnoses and treatment, they suggest.
At the provider level, they say self-reflection around one’s own beliefs, biases, perceptions, and interactions with diverse and vulnerable patient groups is “paramount.” Individual self-reflection should be coupled with mandatory and effective implicit bias and anti-racism training.
At the practice or hospital system level, screening for SDOH at the point of care, addressing barriers to needed treatment, and connecting patients to appropriate resources are all important, they write.
The researchers also call for policy-level changes to increase funding for health equity research, which is historically undervalued and underfunded.
“Focusing on SDOH as the root cause of health inequity in IBD is essential to improve outcomes for marginalized patients,” they write.
Given that research describing specific interventions to address SDOH in IBD is currently nonexistent, “our paper serves as a call to action for more work to be done in this area,” they say.
“As medical providers and health care organizations, we all have a responsibility to address the SDOH when caring for our patients in order to provide each patient with IBD the opportunity to achieve the best health possible,” they conclude.
This research had no specific funding. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The incidence of inflammatory bowel disease (IBD) is on the rise among racial and ethnic minority groups in the United States, and social determinants of health (SDOH) contribute to disparities in IBD care and outcome, say the authors of a new paper on the topic.
It’s an “overdue priority to acknowledge the weight and influence of the SDOH on health disparities in IBD care,” write Adjoa Anyane-Yeboa, MD, PhD, with Massachusetts General Hospital, Boston, and co-authors.
“Only after this acknowledgement can we begin to develop alternative systems that work to rectify the deleterious effects of our current policies in a more longitudinal and effective manner,” they say.
Their paper was published online in Clinical Gastroenterology and Hepatology.
Upstream factors propagate downstream outcomes
The authors found multiple examples in the literature of how upstream SDOH (for example, racism, poverty, neighborhood violence, and under-insurance) lead to midstream SDOH (for example, lack of social support, lack of access to specialized IBD care, poor housing conditions, and food insecurity) that result in poor downstream outcomes in IBD (for example, delayed diagnosis, increased disease activity, IBD flares, and suboptimal medical management).
The IBD literature shows that Black/African American adults with IBD often have worse outcomes across the IBD care continuum than White peers, with higher hospitalization rates, longer stays, increased hospitalization costs, higher readmission rates, and more complications after IBD surgery.
Unequal access to specialized IBD care is a factor, with Black/African American patients less likely to undergo annual visits to a gastroenterologist or IBD specialist, twice as likely than White patients to visit the emergency department over a 12-month period, and less likely to receive treatment with infliximab.
As has been shown for other chronic digestive diseases and cancers, disparities in outcomes related to IBD exist across race, ethnicity, differential insurance status and coverage, and socioeconomic status, the authors note.
Yet, they point out that, interestingly, a 2021 study of patients with Medicaid insurance from four states revealed no disparities in the use of IBD-specific medications between Black/African American and White patients, suggesting that when access to care is equal, disparities diminish.
Target multiple stakeholders to achieve IBD health equity
Achieving health equity in IBD will require strategies targeting medical trainees, providers, practices, and health systems, as well as community and industry leaders and policymakers, Dr. Anyane-Yeboa and colleagues say.
At the medical trainee level, racism and bias should be addressed early in medical student, resident, and fellow training and education. Curricula should move away from race-based training, where race is considered an independent risk factor for disease and often used to guide differential diagnoses and treatment, they suggest.
At the provider level, they say self-reflection around one’s own beliefs, biases, perceptions, and interactions with diverse and vulnerable patient groups is “paramount.” Individual self-reflection should be coupled with mandatory and effective implicit bias and anti-racism training.
At the practice or hospital system level, screening for SDOH at the point of care, addressing barriers to needed treatment, and connecting patients to appropriate resources are all important, they write.
The researchers also call for policy-level changes to increase funding for health equity research, which is historically undervalued and underfunded.
“Focusing on SDOH as the root cause of health inequity in IBD is essential to improve outcomes for marginalized patients,” they write.
Given that research describing specific interventions to address SDOH in IBD is currently nonexistent, “our paper serves as a call to action for more work to be done in this area,” they say.
“As medical providers and health care organizations, we all have a responsibility to address the SDOH when caring for our patients in order to provide each patient with IBD the opportunity to achieve the best health possible,” they conclude.
This research had no specific funding. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The incidence of inflammatory bowel disease (IBD) is on the rise among racial and ethnic minority groups in the United States, and social determinants of health (SDOH) contribute to disparities in IBD care and outcome, say the authors of a new paper on the topic.
It’s an “overdue priority to acknowledge the weight and influence of the SDOH on health disparities in IBD care,” write Adjoa Anyane-Yeboa, MD, PhD, with Massachusetts General Hospital, Boston, and co-authors.
“Only after this acknowledgement can we begin to develop alternative systems that work to rectify the deleterious effects of our current policies in a more longitudinal and effective manner,” they say.
Their paper was published online in Clinical Gastroenterology and Hepatology.
Upstream factors propagate downstream outcomes
The authors found multiple examples in the literature of how upstream SDOH (for example, racism, poverty, neighborhood violence, and under-insurance) lead to midstream SDOH (for example, lack of social support, lack of access to specialized IBD care, poor housing conditions, and food insecurity) that result in poor downstream outcomes in IBD (for example, delayed diagnosis, increased disease activity, IBD flares, and suboptimal medical management).
The IBD literature shows that Black/African American adults with IBD often have worse outcomes across the IBD care continuum than White peers, with higher hospitalization rates, longer stays, increased hospitalization costs, higher readmission rates, and more complications after IBD surgery.
Unequal access to specialized IBD care is a factor, with Black/African American patients less likely to undergo annual visits to a gastroenterologist or IBD specialist, twice as likely than White patients to visit the emergency department over a 12-month period, and less likely to receive treatment with infliximab.
As has been shown for other chronic digestive diseases and cancers, disparities in outcomes related to IBD exist across race, ethnicity, differential insurance status and coverage, and socioeconomic status, the authors note.
Yet, they point out that, interestingly, a 2021 study of patients with Medicaid insurance from four states revealed no disparities in the use of IBD-specific medications between Black/African American and White patients, suggesting that when access to care is equal, disparities diminish.
Target multiple stakeholders to achieve IBD health equity
Achieving health equity in IBD will require strategies targeting medical trainees, providers, practices, and health systems, as well as community and industry leaders and policymakers, Dr. Anyane-Yeboa and colleagues say.
At the medical trainee level, racism and bias should be addressed early in medical student, resident, and fellow training and education. Curricula should move away from race-based training, where race is considered an independent risk factor for disease and often used to guide differential diagnoses and treatment, they suggest.
At the provider level, they say self-reflection around one’s own beliefs, biases, perceptions, and interactions with diverse and vulnerable patient groups is “paramount.” Individual self-reflection should be coupled with mandatory and effective implicit bias and anti-racism training.
At the practice or hospital system level, screening for SDOH at the point of care, addressing barriers to needed treatment, and connecting patients to appropriate resources are all important, they write.
The researchers also call for policy-level changes to increase funding for health equity research, which is historically undervalued and underfunded.
“Focusing on SDOH as the root cause of health inequity in IBD is essential to improve outcomes for marginalized patients,” they write.
Given that research describing specific interventions to address SDOH in IBD is currently nonexistent, “our paper serves as a call to action for more work to be done in this area,” they say.
“As medical providers and health care organizations, we all have a responsibility to address the SDOH when caring for our patients in order to provide each patient with IBD the opportunity to achieve the best health possible,” they conclude.
This research had no specific funding. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
‘Bane of my existence:’ The burden of Medicare Advantage denials
, a recent analysis suggests.
The report from the Office of Inspector General (OIG) of the U.S. Department of Health & Human Services found that 13% of prior authorization denials were for service requests, which included cancer care, that met Medicare coverage rules and 18% of payment denials were for claims that met Medicare coverage and MAO billing rules, delaying or halting payments for services that clinicians had provided.
MAO denials are the “bane of my existence,” said Michael Buckstein, MD, PhD, a radiation oncologist at Mount Sinai Hospital in New York.
“Working at a large hospital in a metropolitan city, we spend enormous and increasing amounts of time on prior approvals and we get denials quite frequently, which certainly can lead to delays in treatment,” said Dr. Buckstein, who reviewed the OIG report for this news organization.
According to Dr. Buckstein, once a claim is denied, staff must spend time filing and scheduling an appeal, and if the appeal is denied in a physician peer-to-peer review, staff could face secondary and tertiary appeals. “We have been living with this frustration for a long time,” Dr. Buckstein said.
Widespread and persistent problems
Medicare Advantage plans, which are approved by the Centers for Medicare & Medicaid Services but run by private companies, continue to grow in popularity.
In 2021, 26.4 million Medicare beneficiaries (42%) were enrolled in a Medicare Advantage plan, and by 2030, about 51% of all Medicare beneficiaries will be enrolled, according to estimates from the Kaiser Family Foundation.
“Although MAOs approve the vast majority of prior authorization requests and provider payment requests, MAOs also deny millions of requests each year,” the OIG wrote. “CMS’s annual audits of MAOs have highlighted widespread and persistent problems related to inappropriate denials of services and payment.”
In the current report, the OIG reviewed case files for 247 denials of prior authorization requests and 183 payment denials issued by 15 of the largest MAOs during 1 week in June of 2019.
The authors found that 13% of prior authorization denials occurred for service requests that met Medicare coverage rules, meaning these services would likely have been approved had the patient been enrolled in traditional Medicare.
The most prominent service types among these denials included imaging services, stays in postacute facilities, and injections.
In one case, for example, the MAO stated that a beneficiary would need to wait at least 1 year for a follow-up MRI because the size of the patient’s adrenal lesion (< 2 cm) was too small to warrant follow-up before 1 year. However, this restriction is not included in Medicare coverage rules. And an OIG physician panel found that the documentation in the original request demonstrated that the MRI was medically necessary to determine whether the lesion seen on an earlier CT scan was malignant.
Upon appeal, the MAO reversed its original denial.
Among the payment requests that MAOs denied, almost one in five were for claims that met Medicare coverage and billing rules, which delayed or prevented payments for services already delivered. Most payment denials were caused by human error during manual claims-processing reviews and system processing errors, the OIG report found.
In one case, for example, a MAO denied payment for radiation treatment for a patient with a tumor on the pancreas, incorrectly claiming that no prior authorization had been submitted for the service. However, the physician subsequently provided a screenshot demonstrating that the MAO had granted prior authorization for the billed claim, and the MAO reversed the denial.
Most of these prior authorization denial reversals occurred because of an appeal filed by the beneficiary or the provider, which can take weeks.
In one case, an MAO denied a request for a CT scan of the chest and pelvis for a beneficiary with endometrial cancer. It took 5 weeks for the provider to get the denial reversed. The OIG panel determined that the original request included sufficient documentation to demonstrate the CT was needed to assess the stage of the cancer and determine the appropriate course of treatment.
These denials and reversals not only waste time but may also cause harm. In a 2021 American Medical Association survey, 34% of physicians reported that prior authorization led to a serious adverse event for a patient in their care, including hospitalization, medical intervention to prevent permanent impairment, and even disability or death.
Almost 90% of the physicians surveyed described the burden associated with prior authorizations as ‘high’ or ‘extremely high.’ More specifically, physicians and their staff spend nearly 2 days a week on prior authorizations and 40% of physicians have staff who work exclusively on prior authorizations.
“It’s just not the way medicine should be practiced, especially for cancer patients who are very vulnerable and want rapid care,” Dr. Buckstein said.
Time for action
Weighing in on the OIG report, Robert E. Wailes, MD, president of the California Medical Association, noted that “it has become common practice for health insurance companies to create obstacles for patients in hopes of not having to pay for essential healthcare.”
The reason for these obstacles is simple, he said: “Fewer procedures performed translates to larger insurance company profits.”
America’s Health Insurance Plans (AHIP) defended prior authorization, saying it is “an important patient safety, cost-saving, and waste-prevention tool.”
The group also called out the OIG review for its “extraordinarily small” sample of 247 prior authorization requests over 1 week.
“Drawing far-reaching conclusions based on a very small sample of data and misleading headlines is not a productive way to improve our healthcare system for patients,” the AHIP statement reads.
But, according to Anna Schwamlein Howard, who works on policy development at the American Cancer Society Cancer Action Network, the recent OIG report is in line with previous OIG reports.
And, Ms. Howard emphasized, the current report and others like it “highlight the need for CMS to utilize its audit authority and ensure that beneficiaries have access to medically necessary treatments, particularly cancer treatments.”
Along those lines, the OIG report recommends that the CMS should issue new guidance on the appropriate use of MAO clinical criteria in medical necessity reviews, update its audit protocols to address issues identified in the report, and direct MAOs to take additional steps to identify and address vulnerabilities that can lead to manual review and system errors.
In a statement, the CMS said it is committed to oversight and enforcement of the requirements of the Medicare Advantage program and agreed with the OIG recommendations.
“Lawmakers must act now to place patient needs before corporate profits and simplify by streamlining prior authorization processes,” Dr. Wailes said.
The ACS recently released a paper on this topic entitled, “The Medicare Appeals Process: Reforms Needed to Ensure Beneficiary Access.”
A version of this article first appeared on Medscape.com.
, a recent analysis suggests.
The report from the Office of Inspector General (OIG) of the U.S. Department of Health & Human Services found that 13% of prior authorization denials were for service requests, which included cancer care, that met Medicare coverage rules and 18% of payment denials were for claims that met Medicare coverage and MAO billing rules, delaying or halting payments for services that clinicians had provided.
MAO denials are the “bane of my existence,” said Michael Buckstein, MD, PhD, a radiation oncologist at Mount Sinai Hospital in New York.
“Working at a large hospital in a metropolitan city, we spend enormous and increasing amounts of time on prior approvals and we get denials quite frequently, which certainly can lead to delays in treatment,” said Dr. Buckstein, who reviewed the OIG report for this news organization.
According to Dr. Buckstein, once a claim is denied, staff must spend time filing and scheduling an appeal, and if the appeal is denied in a physician peer-to-peer review, staff could face secondary and tertiary appeals. “We have been living with this frustration for a long time,” Dr. Buckstein said.
Widespread and persistent problems
Medicare Advantage plans, which are approved by the Centers for Medicare & Medicaid Services but run by private companies, continue to grow in popularity.
In 2021, 26.4 million Medicare beneficiaries (42%) were enrolled in a Medicare Advantage plan, and by 2030, about 51% of all Medicare beneficiaries will be enrolled, according to estimates from the Kaiser Family Foundation.
“Although MAOs approve the vast majority of prior authorization requests and provider payment requests, MAOs also deny millions of requests each year,” the OIG wrote. “CMS’s annual audits of MAOs have highlighted widespread and persistent problems related to inappropriate denials of services and payment.”
In the current report, the OIG reviewed case files for 247 denials of prior authorization requests and 183 payment denials issued by 15 of the largest MAOs during 1 week in June of 2019.
The authors found that 13% of prior authorization denials occurred for service requests that met Medicare coverage rules, meaning these services would likely have been approved had the patient been enrolled in traditional Medicare.
The most prominent service types among these denials included imaging services, stays in postacute facilities, and injections.
In one case, for example, the MAO stated that a beneficiary would need to wait at least 1 year for a follow-up MRI because the size of the patient’s adrenal lesion (< 2 cm) was too small to warrant follow-up before 1 year. However, this restriction is not included in Medicare coverage rules. And an OIG physician panel found that the documentation in the original request demonstrated that the MRI was medically necessary to determine whether the lesion seen on an earlier CT scan was malignant.
Upon appeal, the MAO reversed its original denial.
Among the payment requests that MAOs denied, almost one in five were for claims that met Medicare coverage and billing rules, which delayed or prevented payments for services already delivered. Most payment denials were caused by human error during manual claims-processing reviews and system processing errors, the OIG report found.
In one case, for example, a MAO denied payment for radiation treatment for a patient with a tumor on the pancreas, incorrectly claiming that no prior authorization had been submitted for the service. However, the physician subsequently provided a screenshot demonstrating that the MAO had granted prior authorization for the billed claim, and the MAO reversed the denial.
Most of these prior authorization denial reversals occurred because of an appeal filed by the beneficiary or the provider, which can take weeks.
In one case, an MAO denied a request for a CT scan of the chest and pelvis for a beneficiary with endometrial cancer. It took 5 weeks for the provider to get the denial reversed. The OIG panel determined that the original request included sufficient documentation to demonstrate the CT was needed to assess the stage of the cancer and determine the appropriate course of treatment.
These denials and reversals not only waste time but may also cause harm. In a 2021 American Medical Association survey, 34% of physicians reported that prior authorization led to a serious adverse event for a patient in their care, including hospitalization, medical intervention to prevent permanent impairment, and even disability or death.
Almost 90% of the physicians surveyed described the burden associated with prior authorizations as ‘high’ or ‘extremely high.’ More specifically, physicians and their staff spend nearly 2 days a week on prior authorizations and 40% of physicians have staff who work exclusively on prior authorizations.
“It’s just not the way medicine should be practiced, especially for cancer patients who are very vulnerable and want rapid care,” Dr. Buckstein said.
Time for action
Weighing in on the OIG report, Robert E. Wailes, MD, president of the California Medical Association, noted that “it has become common practice for health insurance companies to create obstacles for patients in hopes of not having to pay for essential healthcare.”
The reason for these obstacles is simple, he said: “Fewer procedures performed translates to larger insurance company profits.”
America’s Health Insurance Plans (AHIP) defended prior authorization, saying it is “an important patient safety, cost-saving, and waste-prevention tool.”
The group also called out the OIG review for its “extraordinarily small” sample of 247 prior authorization requests over 1 week.
“Drawing far-reaching conclusions based on a very small sample of data and misleading headlines is not a productive way to improve our healthcare system for patients,” the AHIP statement reads.
But, according to Anna Schwamlein Howard, who works on policy development at the American Cancer Society Cancer Action Network, the recent OIG report is in line with previous OIG reports.
And, Ms. Howard emphasized, the current report and others like it “highlight the need for CMS to utilize its audit authority and ensure that beneficiaries have access to medically necessary treatments, particularly cancer treatments.”
Along those lines, the OIG report recommends that the CMS should issue new guidance on the appropriate use of MAO clinical criteria in medical necessity reviews, update its audit protocols to address issues identified in the report, and direct MAOs to take additional steps to identify and address vulnerabilities that can lead to manual review and system errors.
In a statement, the CMS said it is committed to oversight and enforcement of the requirements of the Medicare Advantage program and agreed with the OIG recommendations.
“Lawmakers must act now to place patient needs before corporate profits and simplify by streamlining prior authorization processes,” Dr. Wailes said.
The ACS recently released a paper on this topic entitled, “The Medicare Appeals Process: Reforms Needed to Ensure Beneficiary Access.”
A version of this article first appeared on Medscape.com.
, a recent analysis suggests.
The report from the Office of Inspector General (OIG) of the U.S. Department of Health & Human Services found that 13% of prior authorization denials were for service requests, which included cancer care, that met Medicare coverage rules and 18% of payment denials were for claims that met Medicare coverage and MAO billing rules, delaying or halting payments for services that clinicians had provided.
MAO denials are the “bane of my existence,” said Michael Buckstein, MD, PhD, a radiation oncologist at Mount Sinai Hospital in New York.
“Working at a large hospital in a metropolitan city, we spend enormous and increasing amounts of time on prior approvals and we get denials quite frequently, which certainly can lead to delays in treatment,” said Dr. Buckstein, who reviewed the OIG report for this news organization.
According to Dr. Buckstein, once a claim is denied, staff must spend time filing and scheduling an appeal, and if the appeal is denied in a physician peer-to-peer review, staff could face secondary and tertiary appeals. “We have been living with this frustration for a long time,” Dr. Buckstein said.
Widespread and persistent problems
Medicare Advantage plans, which are approved by the Centers for Medicare & Medicaid Services but run by private companies, continue to grow in popularity.
In 2021, 26.4 million Medicare beneficiaries (42%) were enrolled in a Medicare Advantage plan, and by 2030, about 51% of all Medicare beneficiaries will be enrolled, according to estimates from the Kaiser Family Foundation.
“Although MAOs approve the vast majority of prior authorization requests and provider payment requests, MAOs also deny millions of requests each year,” the OIG wrote. “CMS’s annual audits of MAOs have highlighted widespread and persistent problems related to inappropriate denials of services and payment.”
In the current report, the OIG reviewed case files for 247 denials of prior authorization requests and 183 payment denials issued by 15 of the largest MAOs during 1 week in June of 2019.
The authors found that 13% of prior authorization denials occurred for service requests that met Medicare coverage rules, meaning these services would likely have been approved had the patient been enrolled in traditional Medicare.
The most prominent service types among these denials included imaging services, stays in postacute facilities, and injections.
In one case, for example, the MAO stated that a beneficiary would need to wait at least 1 year for a follow-up MRI because the size of the patient’s adrenal lesion (< 2 cm) was too small to warrant follow-up before 1 year. However, this restriction is not included in Medicare coverage rules. And an OIG physician panel found that the documentation in the original request demonstrated that the MRI was medically necessary to determine whether the lesion seen on an earlier CT scan was malignant.
Upon appeal, the MAO reversed its original denial.
Among the payment requests that MAOs denied, almost one in five were for claims that met Medicare coverage and billing rules, which delayed or prevented payments for services already delivered. Most payment denials were caused by human error during manual claims-processing reviews and system processing errors, the OIG report found.
In one case, for example, a MAO denied payment for radiation treatment for a patient with a tumor on the pancreas, incorrectly claiming that no prior authorization had been submitted for the service. However, the physician subsequently provided a screenshot demonstrating that the MAO had granted prior authorization for the billed claim, and the MAO reversed the denial.
Most of these prior authorization denial reversals occurred because of an appeal filed by the beneficiary or the provider, which can take weeks.
In one case, an MAO denied a request for a CT scan of the chest and pelvis for a beneficiary with endometrial cancer. It took 5 weeks for the provider to get the denial reversed. The OIG panel determined that the original request included sufficient documentation to demonstrate the CT was needed to assess the stage of the cancer and determine the appropriate course of treatment.
These denials and reversals not only waste time but may also cause harm. In a 2021 American Medical Association survey, 34% of physicians reported that prior authorization led to a serious adverse event for a patient in their care, including hospitalization, medical intervention to prevent permanent impairment, and even disability or death.
Almost 90% of the physicians surveyed described the burden associated with prior authorizations as ‘high’ or ‘extremely high.’ More specifically, physicians and their staff spend nearly 2 days a week on prior authorizations and 40% of physicians have staff who work exclusively on prior authorizations.
“It’s just not the way medicine should be practiced, especially for cancer patients who are very vulnerable and want rapid care,” Dr. Buckstein said.
Time for action
Weighing in on the OIG report, Robert E. Wailes, MD, president of the California Medical Association, noted that “it has become common practice for health insurance companies to create obstacles for patients in hopes of not having to pay for essential healthcare.”
The reason for these obstacles is simple, he said: “Fewer procedures performed translates to larger insurance company profits.”
America’s Health Insurance Plans (AHIP) defended prior authorization, saying it is “an important patient safety, cost-saving, and waste-prevention tool.”
The group also called out the OIG review for its “extraordinarily small” sample of 247 prior authorization requests over 1 week.
“Drawing far-reaching conclusions based on a very small sample of data and misleading headlines is not a productive way to improve our healthcare system for patients,” the AHIP statement reads.
But, according to Anna Schwamlein Howard, who works on policy development at the American Cancer Society Cancer Action Network, the recent OIG report is in line with previous OIG reports.
And, Ms. Howard emphasized, the current report and others like it “highlight the need for CMS to utilize its audit authority and ensure that beneficiaries have access to medically necessary treatments, particularly cancer treatments.”
Along those lines, the OIG report recommends that the CMS should issue new guidance on the appropriate use of MAO clinical criteria in medical necessity reviews, update its audit protocols to address issues identified in the report, and direct MAOs to take additional steps to identify and address vulnerabilities that can lead to manual review and system errors.
In a statement, the CMS said it is committed to oversight and enforcement of the requirements of the Medicare Advantage program and agreed with the OIG recommendations.
“Lawmakers must act now to place patient needs before corporate profits and simplify by streamlining prior authorization processes,” Dr. Wailes said.
The ACS recently released a paper on this topic entitled, “The Medicare Appeals Process: Reforms Needed to Ensure Beneficiary Access.”
A version of this article first appeared on Medscape.com.
COVID booster mounts ‘brisk’ response in patients with cancer
New data shed light on the durability of antibody responses to SARS-CoV-2 vaccines and the impact of booster doses for patients with cancer undergoing systemic therapy or who have received a stem cell transplant (SCT).
In a cross-sectional study of 453 such patients, anti–SARS-CoV-2 spike protein receptor binding domain (anti-RBD) antibodies peaked 1 month after the second dose of an mRNA vaccine and remained stable over the next 6 months.
Notably, compared with the primary vaccine course, patients experienced a 20-fold increase in anti-RBD antibodies after the third vaccine dose, “indicative of a brisk anamnestic response from memory B cells,” Qamar Khan, MD, a medical oncologist at the University of Kansas Medical Center, Kansas City, and colleagues report.
The study appeared online in JAMA Oncology.
Given the risk of poor outcomes among patients with cancer and recipients of SCTs who get COVID, Dr. Khan and colleagues wanted to understand the durability of the antibody response to COVID vaccines in this population.
Among the 453 patients enrolled in the study, 70% had solid tumors and 30% had hematologic malignancies. Just over 40% were receiving chemotherapy, 16% were receiving immunotherapy, 14% were receiving a targeted oral agent, 5% were receiving chemoimmunotherapy, and 25% had received an SCT.
Regarding vaccine type, 61% received the Pfizer-BioNTech mRNA vaccine, 36% received the Moderna mRNA vaccine, and 4% got the Janssen/Johnson & Johnson vaccine. The mean age of the cohort was 60.4 years; 56% were women.
Prior to vaccination, the geometric mean titer (GMT) of anti-RBD antibodies for all patients was 1.7; it increased to 18.65 2 weeks after the first dose.
At 1 month after the second mRNA dose (or 2 months after the Johnson & Johnson vaccine), GMTs of anti-RBD antibodies reached 470.38 and then decreased to 425.8 at 3 months after the second dose (or 4 months after the Johnson & Johnson vaccine). Patients who were male, older than 65 years, and who had been diagnosed with a hematologic malignant tumor were more likely to have lower anti-RBD GMT 3 months after the second vaccine dose.
GMTs subsequently increased to 447.23 6 months after the second dose (7 months for Johnson & Johnson).
One month after the third dose, GMTs of anti-RBD antibodies rose to 9,224.85 – more than 20 times the previous GMT value.
According to the investigators, roughly 80% of these patients remained above the threshold of an anti-RBD level of 100 U/mL or higher at 6 months.
“While still an arbitrary cutoff, an anti-RBD level of 100 U/mL or higher has been associated with protection and has been used to evaluate the effectiveness of a third dose of an mRNA vaccine in a randomized clinical trial of patients who received a solid organ transplant,” Dr. Khan and colleagues write.
“Although more data are needed to confirm this level as protective, if established, anti-RBD can potentially be used to prioritize additional vaccine doses, especially in regions of the world with limited vaccine resources,” the authors conclude.
The study was supported in part by the University of Kansas Cancer Center and the Investigator Initiated Steering Committee, by a grant from the National Institute of General Medical Sciences, and a University of Kansas Cancer Center Support Grant from the National Cancer Institute. Dr. Khan reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New data shed light on the durability of antibody responses to SARS-CoV-2 vaccines and the impact of booster doses for patients with cancer undergoing systemic therapy or who have received a stem cell transplant (SCT).
In a cross-sectional study of 453 such patients, anti–SARS-CoV-2 spike protein receptor binding domain (anti-RBD) antibodies peaked 1 month after the second dose of an mRNA vaccine and remained stable over the next 6 months.
Notably, compared with the primary vaccine course, patients experienced a 20-fold increase in anti-RBD antibodies after the third vaccine dose, “indicative of a brisk anamnestic response from memory B cells,” Qamar Khan, MD, a medical oncologist at the University of Kansas Medical Center, Kansas City, and colleagues report.
The study appeared online in JAMA Oncology.
Given the risk of poor outcomes among patients with cancer and recipients of SCTs who get COVID, Dr. Khan and colleagues wanted to understand the durability of the antibody response to COVID vaccines in this population.
Among the 453 patients enrolled in the study, 70% had solid tumors and 30% had hematologic malignancies. Just over 40% were receiving chemotherapy, 16% were receiving immunotherapy, 14% were receiving a targeted oral agent, 5% were receiving chemoimmunotherapy, and 25% had received an SCT.
Regarding vaccine type, 61% received the Pfizer-BioNTech mRNA vaccine, 36% received the Moderna mRNA vaccine, and 4% got the Janssen/Johnson & Johnson vaccine. The mean age of the cohort was 60.4 years; 56% were women.
Prior to vaccination, the geometric mean titer (GMT) of anti-RBD antibodies for all patients was 1.7; it increased to 18.65 2 weeks after the first dose.
At 1 month after the second mRNA dose (or 2 months after the Johnson & Johnson vaccine), GMTs of anti-RBD antibodies reached 470.38 and then decreased to 425.8 at 3 months after the second dose (or 4 months after the Johnson & Johnson vaccine). Patients who were male, older than 65 years, and who had been diagnosed with a hematologic malignant tumor were more likely to have lower anti-RBD GMT 3 months after the second vaccine dose.
GMTs subsequently increased to 447.23 6 months after the second dose (7 months for Johnson & Johnson).
One month after the third dose, GMTs of anti-RBD antibodies rose to 9,224.85 – more than 20 times the previous GMT value.
According to the investigators, roughly 80% of these patients remained above the threshold of an anti-RBD level of 100 U/mL or higher at 6 months.
“While still an arbitrary cutoff, an anti-RBD level of 100 U/mL or higher has been associated with protection and has been used to evaluate the effectiveness of a third dose of an mRNA vaccine in a randomized clinical trial of patients who received a solid organ transplant,” Dr. Khan and colleagues write.
“Although more data are needed to confirm this level as protective, if established, anti-RBD can potentially be used to prioritize additional vaccine doses, especially in regions of the world with limited vaccine resources,” the authors conclude.
The study was supported in part by the University of Kansas Cancer Center and the Investigator Initiated Steering Committee, by a grant from the National Institute of General Medical Sciences, and a University of Kansas Cancer Center Support Grant from the National Cancer Institute. Dr. Khan reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New data shed light on the durability of antibody responses to SARS-CoV-2 vaccines and the impact of booster doses for patients with cancer undergoing systemic therapy or who have received a stem cell transplant (SCT).
In a cross-sectional study of 453 such patients, anti–SARS-CoV-2 spike protein receptor binding domain (anti-RBD) antibodies peaked 1 month after the second dose of an mRNA vaccine and remained stable over the next 6 months.
Notably, compared with the primary vaccine course, patients experienced a 20-fold increase in anti-RBD antibodies after the third vaccine dose, “indicative of a brisk anamnestic response from memory B cells,” Qamar Khan, MD, a medical oncologist at the University of Kansas Medical Center, Kansas City, and colleagues report.
The study appeared online in JAMA Oncology.
Given the risk of poor outcomes among patients with cancer and recipients of SCTs who get COVID, Dr. Khan and colleagues wanted to understand the durability of the antibody response to COVID vaccines in this population.
Among the 453 patients enrolled in the study, 70% had solid tumors and 30% had hematologic malignancies. Just over 40% were receiving chemotherapy, 16% were receiving immunotherapy, 14% were receiving a targeted oral agent, 5% were receiving chemoimmunotherapy, and 25% had received an SCT.
Regarding vaccine type, 61% received the Pfizer-BioNTech mRNA vaccine, 36% received the Moderna mRNA vaccine, and 4% got the Janssen/Johnson & Johnson vaccine. The mean age of the cohort was 60.4 years; 56% were women.
Prior to vaccination, the geometric mean titer (GMT) of anti-RBD antibodies for all patients was 1.7; it increased to 18.65 2 weeks after the first dose.
At 1 month after the second mRNA dose (or 2 months after the Johnson & Johnson vaccine), GMTs of anti-RBD antibodies reached 470.38 and then decreased to 425.8 at 3 months after the second dose (or 4 months after the Johnson & Johnson vaccine). Patients who were male, older than 65 years, and who had been diagnosed with a hematologic malignant tumor were more likely to have lower anti-RBD GMT 3 months after the second vaccine dose.
GMTs subsequently increased to 447.23 6 months after the second dose (7 months for Johnson & Johnson).
One month after the third dose, GMTs of anti-RBD antibodies rose to 9,224.85 – more than 20 times the previous GMT value.
According to the investigators, roughly 80% of these patients remained above the threshold of an anti-RBD level of 100 U/mL or higher at 6 months.
“While still an arbitrary cutoff, an anti-RBD level of 100 U/mL or higher has been associated with protection and has been used to evaluate the effectiveness of a third dose of an mRNA vaccine in a randomized clinical trial of patients who received a solid organ transplant,” Dr. Khan and colleagues write.
“Although more data are needed to confirm this level as protective, if established, anti-RBD can potentially be used to prioritize additional vaccine doses, especially in regions of the world with limited vaccine resources,” the authors conclude.
The study was supported in part by the University of Kansas Cancer Center and the Investigator Initiated Steering Committee, by a grant from the National Institute of General Medical Sciences, and a University of Kansas Cancer Center Support Grant from the National Cancer Institute. Dr. Khan reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA ONCOLOGY
FDA approves two vonoprazan therapies for H. pylori eradication
: Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin), both from Phathom Pharmaceuticals.
Vonoprazan is an oral potassium-competitive acid blocker and “the first innovative acid suppressant from a new drug class approved in the United States in over 30 years,” the company said in a news release announcing the approval.
“The approval of Voquezna treatment regimens offers physicians and patients two therapeutic options that showed superior eradication rates compared to proton pump inhibitor-based (PPI) lansoprazole triple therapy in the overall patient population in a pivotal trial,” Terrie Curran, president and CEO of Phathom Pharmaceuticals, said in the release.
“H. pylori eradication rates continue to decline in part due to antibiotic resistance, inadequate acid suppression, and complex treatment regimens, resulting in treatment failures and complications for patients,” Ms. Curran noted.
“New therapies that have the potential to address the limitations of current treatments are needed, and we look forward to bringing these innovative vonoprazan-based treatment options to the millions of H pylori sufferers in the United States,” Ms. Curran said.
FDA approval of vonoprazan triple and dual therapy was based on safety and efficacy data from the phase 3 PHALCON-HP trial involving 1,046 patients.
As earlier reported, both treatment regimens were noninferior to PPI-based triple therapy (lansoprazole with amoxicillin and clarithromycin) in patients with H. pylori strains that were not resistant to clarithromycin or amoxicillin at baseline.
In this analysis, the eradication rate was 78.8% with PPI-based triple therapy, compared with 84.7% with vonoprazan triple therapy and 78.5% with vonoprazan dual therapy.
Vonoprazan triple and dual therapy were both superior to PPI-based triple therapy among all patients, including patients with clarithromycin-resistant H. pylori.
Among patients with clarithromycin-resistant H. pylori, 31.9% achieved eradication with PPI triple therapy, compared with 65.8% with vonoprazan triple therapy and 69.6% with vonoprazan dual therapy.
Among all patients, 68.5% achieved eradication with PPI triple therapy, 80.8% with vonoprazan triple therapy and 77.2% with vonoprazan dual therapy.
Adverse event rates for the vonoprazan-based regimens were comparable to lansoprazole triple therapy. Full prescribing information is available online.
“As a practicing physician, I am excited about the potential of two novel, first-line H. pylori treatment options,” William D. Chey, MD, chief of gastroenterology & hepatology at the University of Michigan, Ann Arbor, said in the news release.
“I believe the added flexibility of having two additional effective therapies, including a dual therapy option that does not contain clarithromycin, offers the potential to improve clinical outcomes in patients with H. pylori infection,” Dr. Chey added.
The company expects to launch both products in the third quarter of 2022. Both treatment regimens will be supplied in convenient blister packs to help promote compliance.
A version of this article first appeared on Medscape.com.
: Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin), both from Phathom Pharmaceuticals.
Vonoprazan is an oral potassium-competitive acid blocker and “the first innovative acid suppressant from a new drug class approved in the United States in over 30 years,” the company said in a news release announcing the approval.
“The approval of Voquezna treatment regimens offers physicians and patients two therapeutic options that showed superior eradication rates compared to proton pump inhibitor-based (PPI) lansoprazole triple therapy in the overall patient population in a pivotal trial,” Terrie Curran, president and CEO of Phathom Pharmaceuticals, said in the release.
“H. pylori eradication rates continue to decline in part due to antibiotic resistance, inadequate acid suppression, and complex treatment regimens, resulting in treatment failures and complications for patients,” Ms. Curran noted.
“New therapies that have the potential to address the limitations of current treatments are needed, and we look forward to bringing these innovative vonoprazan-based treatment options to the millions of H pylori sufferers in the United States,” Ms. Curran said.
FDA approval of vonoprazan triple and dual therapy was based on safety and efficacy data from the phase 3 PHALCON-HP trial involving 1,046 patients.
As earlier reported, both treatment regimens were noninferior to PPI-based triple therapy (lansoprazole with amoxicillin and clarithromycin) in patients with H. pylori strains that were not resistant to clarithromycin or amoxicillin at baseline.
In this analysis, the eradication rate was 78.8% with PPI-based triple therapy, compared with 84.7% with vonoprazan triple therapy and 78.5% with vonoprazan dual therapy.
Vonoprazan triple and dual therapy were both superior to PPI-based triple therapy among all patients, including patients with clarithromycin-resistant H. pylori.
Among patients with clarithromycin-resistant H. pylori, 31.9% achieved eradication with PPI triple therapy, compared with 65.8% with vonoprazan triple therapy and 69.6% with vonoprazan dual therapy.
Among all patients, 68.5% achieved eradication with PPI triple therapy, 80.8% with vonoprazan triple therapy and 77.2% with vonoprazan dual therapy.
Adverse event rates for the vonoprazan-based regimens were comparable to lansoprazole triple therapy. Full prescribing information is available online.
“As a practicing physician, I am excited about the potential of two novel, first-line H. pylori treatment options,” William D. Chey, MD, chief of gastroenterology & hepatology at the University of Michigan, Ann Arbor, said in the news release.
“I believe the added flexibility of having two additional effective therapies, including a dual therapy option that does not contain clarithromycin, offers the potential to improve clinical outcomes in patients with H. pylori infection,” Dr. Chey added.
The company expects to launch both products in the third quarter of 2022. Both treatment regimens will be supplied in convenient blister packs to help promote compliance.
A version of this article first appeared on Medscape.com.
: Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin), both from Phathom Pharmaceuticals.
Vonoprazan is an oral potassium-competitive acid blocker and “the first innovative acid suppressant from a new drug class approved in the United States in over 30 years,” the company said in a news release announcing the approval.
“The approval of Voquezna treatment regimens offers physicians and patients two therapeutic options that showed superior eradication rates compared to proton pump inhibitor-based (PPI) lansoprazole triple therapy in the overall patient population in a pivotal trial,” Terrie Curran, president and CEO of Phathom Pharmaceuticals, said in the release.
“H. pylori eradication rates continue to decline in part due to antibiotic resistance, inadequate acid suppression, and complex treatment regimens, resulting in treatment failures and complications for patients,” Ms. Curran noted.
“New therapies that have the potential to address the limitations of current treatments are needed, and we look forward to bringing these innovative vonoprazan-based treatment options to the millions of H pylori sufferers in the United States,” Ms. Curran said.
FDA approval of vonoprazan triple and dual therapy was based on safety and efficacy data from the phase 3 PHALCON-HP trial involving 1,046 patients.
As earlier reported, both treatment regimens were noninferior to PPI-based triple therapy (lansoprazole with amoxicillin and clarithromycin) in patients with H. pylori strains that were not resistant to clarithromycin or amoxicillin at baseline.
In this analysis, the eradication rate was 78.8% with PPI-based triple therapy, compared with 84.7% with vonoprazan triple therapy and 78.5% with vonoprazan dual therapy.
Vonoprazan triple and dual therapy were both superior to PPI-based triple therapy among all patients, including patients with clarithromycin-resistant H. pylori.
Among patients with clarithromycin-resistant H. pylori, 31.9% achieved eradication with PPI triple therapy, compared with 65.8% with vonoprazan triple therapy and 69.6% with vonoprazan dual therapy.
Among all patients, 68.5% achieved eradication with PPI triple therapy, 80.8% with vonoprazan triple therapy and 77.2% with vonoprazan dual therapy.
Adverse event rates for the vonoprazan-based regimens were comparable to lansoprazole triple therapy. Full prescribing information is available online.
“As a practicing physician, I am excited about the potential of two novel, first-line H. pylori treatment options,” William D. Chey, MD, chief of gastroenterology & hepatology at the University of Michigan, Ann Arbor, said in the news release.
“I believe the added flexibility of having two additional effective therapies, including a dual therapy option that does not contain clarithromycin, offers the potential to improve clinical outcomes in patients with H. pylori infection,” Dr. Chey added.
The company expects to launch both products in the third quarter of 2022. Both treatment regimens will be supplied in convenient blister packs to help promote compliance.
A version of this article first appeared on Medscape.com.