Mixed Topics

Prompted by the “unprecedented” increase in the occurrence of infective endocarditis (IE) cases among people who inject drugs, the American Heart Association has issued a scientific statement devoted solely to this challenging patient population.

The statement provides a more in-depth focus on the management of IE among this unique population than what has been provided in prior AHA IE-related documents.

The statement stresses that managing IE in people who inject drugs is complex and requires a unique multidisciplinary approach that includes consultation with an addiction specialist.

The statement was published online in Circulation.
 

Poor long-term prognosis

In the United States from 2002 to 2016, the proportion of patients hospitalized with IE related to injection drug use doubled from 8% to about 16%.

The long-term prognosis for this population is “currently dismal for this relatively young group of individuals,” writing group Chair Daniel C. DeSimone, MD, with the Mayo Clinic in Rochester, Minn., notes in a news release.

To improve prognosis, the writing group advises a multidisciplinary team care approach that includes cardiologists, cardiac surgeons, and infectious diseases specialists as well as addiction medicine or addiction psychiatry specialists, pharmacists, social workers, and nurse specialists.

Nurse specialists can coordinate care from the initial IE hospitalization to outpatient and community care to support substance use disorder.

“Clinical teams must recognize that substance use disorder is a treatable chronic, relapsing medical illness and many people are able to enter sustained remission, particularly when they receive effective treatments,” the writing group emphasizes.

Although not all patients with injection drug–related IE have opioid addiction, for those who do, the “best practice” is to offer buprenorphine or methadone “as soon as possible” after the patient presents to the hospital, they advise.
 

Antimicrobial therapy

The writing group says it’s “reasonable” to offer people with injection drug–related IE standard treatment for IE, which is 6 weeks of intravenous antibiotics. They recognize, however, that this regimen is often not feasible in this patient population and say there is growing evidence that partial intravenous therapy followed by oral antibiotic treatment to complete a total of 6 weeks is a possible option.

They also highlight the “critical” importance of preventive measures in people who inject drugs who are successfully treated for an initial bout of IE because they remain at “extremely” high risk for subsequent bouts of IE, regardless of whether injection drug use is continued.

The writing group also stresses that people with IE who inject drugs should be considered for heart valve repair or replacement surgery regardless of current drug use if they have indications for valve surgery.

“There’s no evidence that indications for valve surgery are different for people who inject drugs compared to those who don’t, however, some treatment centers don’t offer surgery, especially if the patient currently injects drugs or has had a previous valve surgery,” Dr. DeSimone says in the release.

“Those who develop infective endocarditis require complex care delivered by professionals who look beyond stigma and bias to provide optimal and equitable care,” Dr. DeSimone adds.

The writing group acknowledges that while addiction medicine and addiction psychiatry expertise are critical to managing IE in injection drug users, these specific resources are currently not widely available.

They call on health care systems to attract individuals with addiction training and support addiction medicine consultative services, particularly in centers where drug use–related IE is common and expected to continue to increase.

This AHA scientific statement was prepared by the volunteer writing group on behalf of the AHA Rheumatic Fever, Endocarditis and Kawasaki Disease Committee of the Council on Lifelong Congenital Heart Disease and Heart Health in the Young; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiovascular and Stroke Nursing; the Council on Clinical Cardiology; and the Council on Peripheral Vascular Disease.

This research had no commercial funding. Dr. DeSimone has no relevant disclosures.

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

Prompted by the “unprecedented” increase in the occurrence of infective endocarditis (IE) cases among people who inject drugs, the American Heart Association has issued a scientific statement devoted solely to this challenging patient population.

The statement provides a more in-depth focus on the management of IE among this unique population than what has been provided in prior AHA IE-related documents.

The statement stresses that managing IE in people who inject drugs is complex and requires a unique multidisciplinary approach that includes consultation with an addiction specialist.

The statement was published online in Circulation.
 

Poor long-term prognosis

In the United States from 2002 to 2016, the proportion of patients hospitalized with IE related to injection drug use doubled from 8% to about 16%.

The long-term prognosis for this population is “currently dismal for this relatively young group of individuals,” writing group Chair Daniel C. DeSimone, MD, with the Mayo Clinic in Rochester, Minn., notes in a news release.

To improve prognosis, the writing group advises a multidisciplinary team care approach that includes cardiologists, cardiac surgeons, and infectious diseases specialists as well as addiction medicine or addiction psychiatry specialists, pharmacists, social workers, and nurse specialists.

Nurse specialists can coordinate care from the initial IE hospitalization to outpatient and community care to support substance use disorder.

“Clinical teams must recognize that substance use disorder is a treatable chronic, relapsing medical illness and many people are able to enter sustained remission, particularly when they receive effective treatments,” the writing group emphasizes.

Although not all patients with injection drug–related IE have opioid addiction, for those who do, the “best practice” is to offer buprenorphine or methadone “as soon as possible” after the patient presents to the hospital, they advise.
 

Antimicrobial therapy

The writing group says it’s “reasonable” to offer people with injection drug–related IE standard treatment for IE, which is 6 weeks of intravenous antibiotics. They recognize, however, that this regimen is often not feasible in this patient population and say there is growing evidence that partial intravenous therapy followed by oral antibiotic treatment to complete a total of 6 weeks is a possible option.

They also highlight the “critical” importance of preventive measures in people who inject drugs who are successfully treated for an initial bout of IE because they remain at “extremely” high risk for subsequent bouts of IE, regardless of whether injection drug use is continued.

The writing group also stresses that people with IE who inject drugs should be considered for heart valve repair or replacement surgery regardless of current drug use if they have indications for valve surgery.

“There’s no evidence that indications for valve surgery are different for people who inject drugs compared to those who don’t, however, some treatment centers don’t offer surgery, especially if the patient currently injects drugs or has had a previous valve surgery,” Dr. DeSimone says in the release.

“Those who develop infective endocarditis require complex care delivered by professionals who look beyond stigma and bias to provide optimal and equitable care,” Dr. DeSimone adds.

The writing group acknowledges that while addiction medicine and addiction psychiatry expertise are critical to managing IE in injection drug users, these specific resources are currently not widely available.

They call on health care systems to attract individuals with addiction training and support addiction medicine consultative services, particularly in centers where drug use–related IE is common and expected to continue to increase.

This AHA scientific statement was prepared by the volunteer writing group on behalf of the AHA Rheumatic Fever, Endocarditis and Kawasaki Disease Committee of the Council on Lifelong Congenital Heart Disease and Heart Health in the Young; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiovascular and Stroke Nursing; the Council on Clinical Cardiology; and the Council on Peripheral Vascular Disease.

This research had no commercial funding. Dr. DeSimone has no relevant disclosures.

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

Prompted by the “unprecedented” increase in the occurrence of infective endocarditis (IE) cases among people who inject drugs, the American Heart Association has issued a scientific statement devoted solely to this challenging patient population.

The statement provides a more in-depth focus on the management of IE among this unique population than what has been provided in prior AHA IE-related documents.

The statement stresses that managing IE in people who inject drugs is complex and requires a unique multidisciplinary approach that includes consultation with an addiction specialist.

The statement was published online in Circulation.
 

Poor long-term prognosis

In the United States from 2002 to 2016, the proportion of patients hospitalized with IE related to injection drug use doubled from 8% to about 16%.

The long-term prognosis for this population is “currently dismal for this relatively young group of individuals,” writing group Chair Daniel C. DeSimone, MD, with the Mayo Clinic in Rochester, Minn., notes in a news release.

To improve prognosis, the writing group advises a multidisciplinary team care approach that includes cardiologists, cardiac surgeons, and infectious diseases specialists as well as addiction medicine or addiction psychiatry specialists, pharmacists, social workers, and nurse specialists.

Nurse specialists can coordinate care from the initial IE hospitalization to outpatient and community care to support substance use disorder.

“Clinical teams must recognize that substance use disorder is a treatable chronic, relapsing medical illness and many people are able to enter sustained remission, particularly when they receive effective treatments,” the writing group emphasizes.

Although not all patients with injection drug–related IE have opioid addiction, for those who do, the “best practice” is to offer buprenorphine or methadone “as soon as possible” after the patient presents to the hospital, they advise.
 

Antimicrobial therapy

The writing group says it’s “reasonable” to offer people with injection drug–related IE standard treatment for IE, which is 6 weeks of intravenous antibiotics. They recognize, however, that this regimen is often not feasible in this patient population and say there is growing evidence that partial intravenous therapy followed by oral antibiotic treatment to complete a total of 6 weeks is a possible option.

They also highlight the “critical” importance of preventive measures in people who inject drugs who are successfully treated for an initial bout of IE because they remain at “extremely” high risk for subsequent bouts of IE, regardless of whether injection drug use is continued.

The writing group also stresses that people with IE who inject drugs should be considered for heart valve repair or replacement surgery regardless of current drug use if they have indications for valve surgery.

“There’s no evidence that indications for valve surgery are different for people who inject drugs compared to those who don’t, however, some treatment centers don’t offer surgery, especially if the patient currently injects drugs or has had a previous valve surgery,” Dr. DeSimone says in the release.

“Those who develop infective endocarditis require complex care delivered by professionals who look beyond stigma and bias to provide optimal and equitable care,” Dr. DeSimone adds.

The writing group acknowledges that while addiction medicine and addiction psychiatry expertise are critical to managing IE in injection drug users, these specific resources are currently not widely available.

They call on health care systems to attract individuals with addiction training and support addiction medicine consultative services, particularly in centers where drug use–related IE is common and expected to continue to increase.

This AHA scientific statement was prepared by the volunteer writing group on behalf of the AHA Rheumatic Fever, Endocarditis and Kawasaki Disease Committee of the Council on Lifelong Congenital Heart Disease and Heart Health in the Young; the Council on Cardiovascular Surgery and Anesthesia; the Council on Cardiovascular and Stroke Nursing; the Council on Clinical Cardiology; and the Council on Peripheral Vascular Disease.

This research had no commercial funding. Dr. DeSimone has no relevant disclosures.

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

Background

Increasing utilization of comprehensive genomic profiling (CGP) and a growing number of targeted agents (TAs) has led to substantial improvements in outcomes among patients with cancer with actionable mutations. We sought to evaluate real-world use and outcomes of off-label TA among patients who underwent CGP.

Methods

The National Precision Oncology Program database and VA Corporate Data Warehouse were queried to identify patients who underwent CGP between Feb 2019 and Dec 2021 and were prescribed 1 of 73 TAs for malignancy. OncoKB (accessed March 2022) annotations were used to select patients who received offlabel TAs based upon CGP results. Chart abstraction was performed in April 2022 to review response to offlabel TAs, toxicities, and treatment duration.

Results

Of 18,686 patients who underwent CGP, 2,107 (11%) were prescribed a TA and 170 (0.9%) were prescribed a total of 185 off-label TA regimens. Median age was 68 years, 88% were male, and 82% had prior systemic therapy, with 28% receiving 3 or more prior lines. Frequency of off-label TA prescriptions was highest for patients with unknown primary (CUP) (9%), thyroid (8%), and breast (6%) cancers. Most frequently targeted alterations involved ERBB2 (22%), BRAF (22%), and BRCA1/BRCA2/ATM (20%). Among the 161 regimens prescribed > 4 weeks, 44 (27%) led to complete or partial response, and 63 (39%) were administered for 6 months or longer or are continuing. Median progression free (PFS) and overall survival (OS) were 5.3 (95% CI, 4.3–6.5) and 9.9 (95% CI, 8.3–12.4) months, respectively. Patients with OncoKb level 2/3A/3B annotations had improved PFS (HR 0.45; 95% CI, 0.24-0.82; P = .01) and OS (HR 0.27; 95% CI, 0.15-0.48; P < .005) compared to level 4 treatments. Across all 185 regimens prescribed, 30 (16.2%) were discontinued due to toxicity, and further systemic treatment was prescribed subsequently in 58 (31.3%).

Conclusions

While the overall use of off-label TAs is low, nearly 10% of CUP and thyroid cancer patients who undergo CGP are prescribed TAs for off-label indications. More than one-quarter of off-label TA regimens lead to treatment response. Treatments associated with level 4 annotations lead to worse outcomes than TAs bearing superior levels of evidence.

Background

Increasing utilization of comprehensive genomic profiling (CGP) and a growing number of targeted agents (TAs) has led to substantial improvements in outcomes among patients with cancer with actionable mutations. We sought to evaluate real-world use and outcomes of off-label TA among patients who underwent CGP.

Methods

The National Precision Oncology Program database and VA Corporate Data Warehouse were queried to identify patients who underwent CGP between Feb 2019 and Dec 2021 and were prescribed 1 of 73 TAs for malignancy. OncoKB (accessed March 2022) annotations were used to select patients who received offlabel TAs based upon CGP results. Chart abstraction was performed in April 2022 to review response to offlabel TAs, toxicities, and treatment duration.

Results

Of 18,686 patients who underwent CGP, 2,107 (11%) were prescribed a TA and 170 (0.9%) were prescribed a total of 185 off-label TA regimens. Median age was 68 years, 88% were male, and 82% had prior systemic therapy, with 28% receiving 3 or more prior lines. Frequency of off-label TA prescriptions was highest for patients with unknown primary (CUP) (9%), thyroid (8%), and breast (6%) cancers. Most frequently targeted alterations involved ERBB2 (22%), BRAF (22%), and BRCA1/BRCA2/ATM (20%). Among the 161 regimens prescribed > 4 weeks, 44 (27%) led to complete or partial response, and 63 (39%) were administered for 6 months or longer or are continuing. Median progression free (PFS) and overall survival (OS) were 5.3 (95% CI, 4.3–6.5) and 9.9 (95% CI, 8.3–12.4) months, respectively. Patients with OncoKb level 2/3A/3B annotations had improved PFS (HR 0.45; 95% CI, 0.24-0.82; P = .01) and OS (HR 0.27; 95% CI, 0.15-0.48; P < .005) compared to level 4 treatments. Across all 185 regimens prescribed, 30 (16.2%) were discontinued due to toxicity, and further systemic treatment was prescribed subsequently in 58 (31.3%).

Conclusions

While the overall use of off-label TAs is low, nearly 10% of CUP and thyroid cancer patients who undergo CGP are prescribed TAs for off-label indications. More than one-quarter of off-label TA regimens lead to treatment response. Treatments associated with level 4 annotations lead to worse outcomes than TAs bearing superior levels of evidence.

Background

Increasing utilization of comprehensive genomic profiling (CGP) and a growing number of targeted agents (TAs) has led to substantial improvements in outcomes among patients with cancer with actionable mutations. We sought to evaluate real-world use and outcomes of off-label TA among patients who underwent CGP.

Methods

The National Precision Oncology Program database and VA Corporate Data Warehouse were queried to identify patients who underwent CGP between Feb 2019 and Dec 2021 and were prescribed 1 of 73 TAs for malignancy. OncoKB (accessed March 2022) annotations were used to select patients who received offlabel TAs based upon CGP results. Chart abstraction was performed in April 2022 to review response to offlabel TAs, toxicities, and treatment duration.

Results

Of 18,686 patients who underwent CGP, 2,107 (11%) were prescribed a TA and 170 (0.9%) were prescribed a total of 185 off-label TA regimens. Median age was 68 years, 88% were male, and 82% had prior systemic therapy, with 28% receiving 3 or more prior lines. Frequency of off-label TA prescriptions was highest for patients with unknown primary (CUP) (9%), thyroid (8%), and breast (6%) cancers. Most frequently targeted alterations involved ERBB2 (22%), BRAF (22%), and BRCA1/BRCA2/ATM (20%). Among the 161 regimens prescribed > 4 weeks, 44 (27%) led to complete or partial response, and 63 (39%) were administered for 6 months or longer or are continuing. Median progression free (PFS) and overall survival (OS) were 5.3 (95% CI, 4.3–6.5) and 9.9 (95% CI, 8.3–12.4) months, respectively. Patients with OncoKb level 2/3A/3B annotations had improved PFS (HR 0.45; 95% CI, 0.24-0.82; P = .01) and OS (HR 0.27; 95% CI, 0.15-0.48; P < .005) compared to level 4 treatments. Across all 185 regimens prescribed, 30 (16.2%) were discontinued due to toxicity, and further systemic treatment was prescribed subsequently in 58 (31.3%).

Conclusions

While the overall use of off-label TAs is low, nearly 10% of CUP and thyroid cancer patients who undergo CGP are prescribed TAs for off-label indications. More than one-quarter of off-label TA regimens lead to treatment response. Treatments associated with level 4 annotations lead to worse outcomes than TAs bearing superior levels of evidence.

Both yoga and cognitive-behavioral therapy (CBT) provide meaningful improvements in worry, anxiety, and insomnia in older adults that last even 6 months after discontinuing treatment, new research suggests.

The study is the first to compare the long-term effects from the two interventions; and the results offer clinicians and patients two effective choices for reducing worry and anxiety, researchers noted.

“Anxiety can be a really big problem for older adults,” lead investigator Suzanne Danhauer, PhD, professor of social sciences and health policy at Wake Forest University, Winston-Salem, N.C., said in an interview.

“So to find something they can do that lasts ... and has some enduring impact on their quality of life and their mental health, and they’re both nonpharmacologic treatments, I think for a lot of older people that’s really attractive,” Dr. Danhauer said.

The findings are published in the September issue of the American Journal of Geriatric Psychiatry.
 

Long-term benefits

The two-stage randomized preference trial included 500 community-dwelling individuals over age 60 who scored 26 or above on the Penn State Worry Questionnaire–Abbreviated (PSWQ-A), indicating heightened anxiety and worry.

Half the group took part in a randomized, controlled trial comparing CBT (n = 125) with yoga (n = 125). The other half participated in a preference trial where they were allowed to choose between CBT (n = 120) and yoga (n = 130).

Participants completed 20 yoga sessions over 10 weeks or 10 weekly CBT calls between May 2017 and November 2018.

Measures used included the PSWQ-A, the Insomnia Severity Index (ISI), the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 – Anxiety 8a, and the PROMIS-29 to assess depression, fatigue, physical function, social participation, and pain.

In 2020, the researchers published results at 11 weeks showing improvements from baseline in all areas. The scores for anxiety and worry were similar between the CBT and yoga groups, but CBT yielded significantly higher improvement in insomnia.

At 37 weeks, about 6 months after the interventions had ended, the investigators found even greater improvements from baseline in all areas measured – except physical function.

However, at that point, there were no significant differences between the two interventions in either the randomized controlled trial or the preference trial. There were also no differences in the results between the two trial designs.

“There were some little differences, but by and large we found both interventions to be efficacious,” Dr. Danhauer said. “This gives clinicians [the] choice to be able to say, ‘you can try either one of these and they’re probably going to help.’ ”
 

Beyond statistically significant

The researchers also found the improvements were not just statistically significant, but were also clinically meaningful for worry, anxiety, and insomnia.

Meaningful changes were defined as a decrease of at least 5.5 points on the PSWQ-A for worry, a decrease of at least 3 points on the PROMIS Anxiety scale for anxiety, and a decrease of at least 6 points in the ISI for insomnia.

At long-term follow-up, the majority of participants in both the CBT and yoga arms of the randomized, controlled trial demonstrated meaningful change in worry (85.7% and 77.6%, respectively), anxiety (82.1% and 80.8%), and insomnia (52.8% and 44.3%).

The majority of participants also reported meaningful improvements in generalized anxiety symptoms, depressive symptoms, and fatigue, but not for physical function, pain interference, or pain intensity.

“That’s the part to me that’s particularly notable. The improvements weren’t just statistically significant, they were clinically meaningful as well,” Dr. Danhauer said.

“When it comes right down to people’s lives, they want differences they can feel and see and not just what a P value looks like,” she added.
 

Real-world impact

In an accompanying editorial, Carmen Andreescu, MD, associate professor of psychiatry at the University of Pittsburgh, agreed that the results have “real-world impact.”

“Clinicians can direct their patients toward interventions that may be beneficial, consolidate the results over time and avoid fueling the well-trained worry cognitive loop with concerns related to potential side effects,” Dr. Andreescu wrote.

She adds that interventions such as these “may increase accessibility and provide relief for the immediate suffering of our patients.”

The study was funded by the Patient-Centered Outcomes Research Institute Program. Dr. Danhauer and Dr. Andreescu reported no relevant financial relationships.

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

Both yoga and cognitive-behavioral therapy (CBT) provide meaningful improvements in worry, anxiety, and insomnia in older adults that last even 6 months after discontinuing treatment, new research suggests.

The study is the first to compare the long-term effects from the two interventions; and the results offer clinicians and patients two effective choices for reducing worry and anxiety, researchers noted.

“Anxiety can be a really big problem for older adults,” lead investigator Suzanne Danhauer, PhD, professor of social sciences and health policy at Wake Forest University, Winston-Salem, N.C., said in an interview.

“So to find something they can do that lasts ... and has some enduring impact on their quality of life and their mental health, and they’re both nonpharmacologic treatments, I think for a lot of older people that’s really attractive,” Dr. Danhauer said.

The findings are published in the September issue of the American Journal of Geriatric Psychiatry.
 

Long-term benefits

The two-stage randomized preference trial included 500 community-dwelling individuals over age 60 who scored 26 or above on the Penn State Worry Questionnaire–Abbreviated (PSWQ-A), indicating heightened anxiety and worry.

Half the group took part in a randomized, controlled trial comparing CBT (n = 125) with yoga (n = 125). The other half participated in a preference trial where they were allowed to choose between CBT (n = 120) and yoga (n = 130).

Participants completed 20 yoga sessions over 10 weeks or 10 weekly CBT calls between May 2017 and November 2018.

Measures used included the PSWQ-A, the Insomnia Severity Index (ISI), the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 – Anxiety 8a, and the PROMIS-29 to assess depression, fatigue, physical function, social participation, and pain.

In 2020, the researchers published results at 11 weeks showing improvements from baseline in all areas. The scores for anxiety and worry were similar between the CBT and yoga groups, but CBT yielded significantly higher improvement in insomnia.

At 37 weeks, about 6 months after the interventions had ended, the investigators found even greater improvements from baseline in all areas measured – except physical function.

However, at that point, there were no significant differences between the two interventions in either the randomized controlled trial or the preference trial. There were also no differences in the results between the two trial designs.

“There were some little differences, but by and large we found both interventions to be efficacious,” Dr. Danhauer said. “This gives clinicians [the] choice to be able to say, ‘you can try either one of these and they’re probably going to help.’ ”
 

Beyond statistically significant

The researchers also found the improvements were not just statistically significant, but were also clinically meaningful for worry, anxiety, and insomnia.

Meaningful changes were defined as a decrease of at least 5.5 points on the PSWQ-A for worry, a decrease of at least 3 points on the PROMIS Anxiety scale for anxiety, and a decrease of at least 6 points in the ISI for insomnia.

At long-term follow-up, the majority of participants in both the CBT and yoga arms of the randomized, controlled trial demonstrated meaningful change in worry (85.7% and 77.6%, respectively), anxiety (82.1% and 80.8%), and insomnia (52.8% and 44.3%).

The majority of participants also reported meaningful improvements in generalized anxiety symptoms, depressive symptoms, and fatigue, but not for physical function, pain interference, or pain intensity.

“That’s the part to me that’s particularly notable. The improvements weren’t just statistically significant, they were clinically meaningful as well,” Dr. Danhauer said.

“When it comes right down to people’s lives, they want differences they can feel and see and not just what a P value looks like,” she added.
 

Real-world impact

In an accompanying editorial, Carmen Andreescu, MD, associate professor of psychiatry at the University of Pittsburgh, agreed that the results have “real-world impact.”

“Clinicians can direct their patients toward interventions that may be beneficial, consolidate the results over time and avoid fueling the well-trained worry cognitive loop with concerns related to potential side effects,” Dr. Andreescu wrote.

She adds that interventions such as these “may increase accessibility and provide relief for the immediate suffering of our patients.”

The study was funded by the Patient-Centered Outcomes Research Institute Program. Dr. Danhauer and Dr. Andreescu reported no relevant financial relationships.

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

Both yoga and cognitive-behavioral therapy (CBT) provide meaningful improvements in worry, anxiety, and insomnia in older adults that last even 6 months after discontinuing treatment, new research suggests.

The study is the first to compare the long-term effects from the two interventions; and the results offer clinicians and patients two effective choices for reducing worry and anxiety, researchers noted.

“Anxiety can be a really big problem for older adults,” lead investigator Suzanne Danhauer, PhD, professor of social sciences and health policy at Wake Forest University, Winston-Salem, N.C., said in an interview.

“So to find something they can do that lasts ... and has some enduring impact on their quality of life and their mental health, and they’re both nonpharmacologic treatments, I think for a lot of older people that’s really attractive,” Dr. Danhauer said.

The findings are published in the September issue of the American Journal of Geriatric Psychiatry.
 

Long-term benefits

The two-stage randomized preference trial included 500 community-dwelling individuals over age 60 who scored 26 or above on the Penn State Worry Questionnaire–Abbreviated (PSWQ-A), indicating heightened anxiety and worry.

Half the group took part in a randomized, controlled trial comparing CBT (n = 125) with yoga (n = 125). The other half participated in a preference trial where they were allowed to choose between CBT (n = 120) and yoga (n = 130).

Participants completed 20 yoga sessions over 10 weeks or 10 weekly CBT calls between May 2017 and November 2018.

Measures used included the PSWQ-A, the Insomnia Severity Index (ISI), the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 – Anxiety 8a, and the PROMIS-29 to assess depression, fatigue, physical function, social participation, and pain.

In 2020, the researchers published results at 11 weeks showing improvements from baseline in all areas. The scores for anxiety and worry were similar between the CBT and yoga groups, but CBT yielded significantly higher improvement in insomnia.

At 37 weeks, about 6 months after the interventions had ended, the investigators found even greater improvements from baseline in all areas measured – except physical function.

However, at that point, there were no significant differences between the two interventions in either the randomized controlled trial or the preference trial. There were also no differences in the results between the two trial designs.

“There were some little differences, but by and large we found both interventions to be efficacious,” Dr. Danhauer said. “This gives clinicians [the] choice to be able to say, ‘you can try either one of these and they’re probably going to help.’ ”
 

Beyond statistically significant

The researchers also found the improvements were not just statistically significant, but were also clinically meaningful for worry, anxiety, and insomnia.

Meaningful changes were defined as a decrease of at least 5.5 points on the PSWQ-A for worry, a decrease of at least 3 points on the PROMIS Anxiety scale for anxiety, and a decrease of at least 6 points in the ISI for insomnia.

At long-term follow-up, the majority of participants in both the CBT and yoga arms of the randomized, controlled trial demonstrated meaningful change in worry (85.7% and 77.6%, respectively), anxiety (82.1% and 80.8%), and insomnia (52.8% and 44.3%).

The majority of participants also reported meaningful improvements in generalized anxiety symptoms, depressive symptoms, and fatigue, but not for physical function, pain interference, or pain intensity.

“That’s the part to me that’s particularly notable. The improvements weren’t just statistically significant, they were clinically meaningful as well,” Dr. Danhauer said.

“When it comes right down to people’s lives, they want differences they can feel and see and not just what a P value looks like,” she added.
 

Real-world impact

In an accompanying editorial, Carmen Andreescu, MD, associate professor of psychiatry at the University of Pittsburgh, agreed that the results have “real-world impact.”

“Clinicians can direct their patients toward interventions that may be beneficial, consolidate the results over time and avoid fueling the well-trained worry cognitive loop with concerns related to potential side effects,” Dr. Andreescu wrote.

She adds that interventions such as these “may increase accessibility and provide relief for the immediate suffering of our patients.”

The study was funded by the Patient-Centered Outcomes Research Institute Program. Dr. Danhauer and Dr. Andreescu reported no relevant financial relationships.

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

Purpose

To evaluate the impact that a pharmacistmanaged oral anticancer clinic has on patient adherence to oral anticancer therapy in regard to medication adherence and adherence to lab monitoring.

Background

Oral anticancer therapy is typically preconceived to be safer than intravenous. However, these medications have a narrow therapeutic window and significant toxicities, requiring close monitoring to ensure patient safety. Previous studies have shown that pharmacist-led oral anticancer clinics have improved adherence and decreased toxicity.

Methods

A retrospective chart review was completed for patients prescribed abiraterone, enzalutamide, or ibrutinib. The primary outcome assessed medication adherence by comparing the medication possession ratio (MPR) before (phase 1) and after (phase 2) the initiation of the pharmacist-led oral anticancer therapy clinic. The secondary outcome assessed lab monitoring adherence by patients and providers in phase 1 vs. phase 2. This study also examined descriptive outcomes in phase 2.

Data Analysis

Independent sample t tests were used to analyze primary and secondary endpoints. For descriptive endpoints, standard deviations and range of scores were assessed for continuous variables.

Results

A statistically significant increase in the mean MPR ratio was shown between phase 1 vs phase 2 (0.98 vs 1.05; P = .027). For patient adherence to lab monitoring, there was a statistically significant improvement for patients on abiraterone (21.9% vs. 67%; P < .001) and enzalutamide (35.7% vs 90.5%; P = .006). There was a decline in lab monitoring adherence for patient on ibrutinib but this effect was not statistically significant (56.2% vs. 51%; P = .283). Similar results were shown for provider adherence to lab monitoring. Descriptive outcomes showed that the pharmacist had on average 6.7 encounters per patient.

Conclusions/Implications

A pharmacist-led oral anticancer clinic can improve MPR ratios and patient adherence to oral anticancer regimens. Patient and provider lab monitoring adherence was improved for abiraterone and enzalutamide. Improvement in patient/ provider lab monitoring adherence for ibrutinib was not shown, possibly due to the impact of the COVID-19 pandemic, small sample size, and retrospective nature of this study. The results of this study supports that overall, a pharmacist-led oral anticancer clinic can significantly improve patient outcomes, which aligns with previous smaller studies.

Purpose

To evaluate the impact that a pharmacistmanaged oral anticancer clinic has on patient adherence to oral anticancer therapy in regard to medication adherence and adherence to lab monitoring.

Background

Oral anticancer therapy is typically preconceived to be safer than intravenous. However, these medications have a narrow therapeutic window and significant toxicities, requiring close monitoring to ensure patient safety. Previous studies have shown that pharmacist-led oral anticancer clinics have improved adherence and decreased toxicity.

Methods

A retrospective chart review was completed for patients prescribed abiraterone, enzalutamide, or ibrutinib. The primary outcome assessed medication adherence by comparing the medication possession ratio (MPR) before (phase 1) and after (phase 2) the initiation of the pharmacist-led oral anticancer therapy clinic. The secondary outcome assessed lab monitoring adherence by patients and providers in phase 1 vs. phase 2. This study also examined descriptive outcomes in phase 2.

Data Analysis

Independent sample t tests were used to analyze primary and secondary endpoints. For descriptive endpoints, standard deviations and range of scores were assessed for continuous variables.

Results

A statistically significant increase in the mean MPR ratio was shown between phase 1 vs phase 2 (0.98 vs 1.05; P = .027). For patient adherence to lab monitoring, there was a statistically significant improvement for patients on abiraterone (21.9% vs. 67%; P < .001) and enzalutamide (35.7% vs 90.5%; P = .006). There was a decline in lab monitoring adherence for patient on ibrutinib but this effect was not statistically significant (56.2% vs. 51%; P = .283). Similar results were shown for provider adherence to lab monitoring. Descriptive outcomes showed that the pharmacist had on average 6.7 encounters per patient.

Conclusions/Implications

A pharmacist-led oral anticancer clinic can improve MPR ratios and patient adherence to oral anticancer regimens. Patient and provider lab monitoring adherence was improved for abiraterone and enzalutamide. Improvement in patient/ provider lab monitoring adherence for ibrutinib was not shown, possibly due to the impact of the COVID-19 pandemic, small sample size, and retrospective nature of this study. The results of this study supports that overall, a pharmacist-led oral anticancer clinic can significantly improve patient outcomes, which aligns with previous smaller studies.

Purpose

To evaluate the impact that a pharmacistmanaged oral anticancer clinic has on patient adherence to oral anticancer therapy in regard to medication adherence and adherence to lab monitoring.

Background

Oral anticancer therapy is typically preconceived to be safer than intravenous. However, these medications have a narrow therapeutic window and significant toxicities, requiring close monitoring to ensure patient safety. Previous studies have shown that pharmacist-led oral anticancer clinics have improved adherence and decreased toxicity.

Methods

A retrospective chart review was completed for patients prescribed abiraterone, enzalutamide, or ibrutinib. The primary outcome assessed medication adherence by comparing the medication possession ratio (MPR) before (phase 1) and after (phase 2) the initiation of the pharmacist-led oral anticancer therapy clinic. The secondary outcome assessed lab monitoring adherence by patients and providers in phase 1 vs. phase 2. This study also examined descriptive outcomes in phase 2.

Data Analysis

Independent sample t tests were used to analyze primary and secondary endpoints. For descriptive endpoints, standard deviations and range of scores were assessed for continuous variables.

Results

A statistically significant increase in the mean MPR ratio was shown between phase 1 vs phase 2 (0.98 vs 1.05; P = .027). For patient adherence to lab monitoring, there was a statistically significant improvement for patients on abiraterone (21.9% vs. 67%; P < .001) and enzalutamide (35.7% vs 90.5%; P = .006). There was a decline in lab monitoring adherence for patient on ibrutinib but this effect was not statistically significant (56.2% vs. 51%; P = .283). Similar results were shown for provider adherence to lab monitoring. Descriptive outcomes showed that the pharmacist had on average 6.7 encounters per patient.

Conclusions/Implications

A pharmacist-led oral anticancer clinic can improve MPR ratios and patient adherence to oral anticancer regimens. Patient and provider lab monitoring adherence was improved for abiraterone and enzalutamide. Improvement in patient/ provider lab monitoring adherence for ibrutinib was not shown, possibly due to the impact of the COVID-19 pandemic, small sample size, and retrospective nature of this study. The results of this study supports that overall, a pharmacist-led oral anticancer clinic can significantly improve patient outcomes, which aligns with previous smaller studies.

Background

The VA Outpatient Chemotherapy Clinic sees approximately 870 veterans each year. Of these, 5% receive home-infusion chemotherapy. COVID-19 created staffing challenges for the contracted homeinfusion company utilized by the VA for home-infusion chemotherapy. The VA developed a self-contained home-infusion program for 5-FU to ensure needed care could be delivered to veterans without delay.

Methods

After researching private sector and VA models of providing home-infusion chemotherapy services, analyzing literature, internal VA patient safety data, and financial implications of different home-infusion pump options, including both CADD pumps and elastomeric pumps, CADD pumps were determined to be the best financial option and safest option for providing home-infusion 5-FU through the VA. Patient education documents were created from CADD pump user manuals and literature. 

Results

A home-infusion program for 5-FU chemotherapy was implemented at the VA Outpatient Chemotherapy Clinic in March 2022. Veterans receive a home-infusion pump, 5-FU, education, and access to a 24-hour telephone support line staffed by an oncology registered nurse through the VA. Patient education consists of home-infusion pump training, implanted port de-accessing, chemotherapy spill management, and hazardous waste disposal.

Conclusion

Ten veterans have started their home-infusion portion of therapy through the VA, amounting to 34 completed cycles, between March 2022 and June 2022. This program is completely self-contained within the VA Outpatient Chemotherapy Clinic. It has allowed for initiation and continuation of needed chemotherapy regimens in an environment of staffing instability at the contracted home-infusion company. The home-infusion program required the acquisition of home-infusion pumps and supplies. The home-infusion pumps can be reused by another patient after completion of treatment making this program sustainable. Existing VA medical oncology staffing was utilized with the additional need for oncology nurses to take calls to provide 24-hour telephone support for any pumprelated issues that may arise during home-infusion therapy. A VA home-infusion program allows for veterans to receive seamless cancer care through one entity. This program is replicable at other VAs and can be expanded to include other forms of home-infusion therapy, such as antibiotics.

Background

The VA Outpatient Chemotherapy Clinic sees approximately 870 veterans each year. Of these, 5% receive home-infusion chemotherapy. COVID-19 created staffing challenges for the contracted homeinfusion company utilized by the VA for home-infusion chemotherapy. The VA developed a self-contained home-infusion program for 5-FU to ensure needed care could be delivered to veterans without delay.

Methods

After researching private sector and VA models of providing home-infusion chemotherapy services, analyzing literature, internal VA patient safety data, and financial implications of different home-infusion pump options, including both CADD pumps and elastomeric pumps, CADD pumps were determined to be the best financial option and safest option for providing home-infusion 5-FU through the VA. Patient education documents were created from CADD pump user manuals and literature. 

Results

A home-infusion program for 5-FU chemotherapy was implemented at the VA Outpatient Chemotherapy Clinic in March 2022. Veterans receive a home-infusion pump, 5-FU, education, and access to a 24-hour telephone support line staffed by an oncology registered nurse through the VA. Patient education consists of home-infusion pump training, implanted port de-accessing, chemotherapy spill management, and hazardous waste disposal.

Conclusion

Ten veterans have started their home-infusion portion of therapy through the VA, amounting to 34 completed cycles, between March 2022 and June 2022. This program is completely self-contained within the VA Outpatient Chemotherapy Clinic. It has allowed for initiation and continuation of needed chemotherapy regimens in an environment of staffing instability at the contracted home-infusion company. The home-infusion program required the acquisition of home-infusion pumps and supplies. The home-infusion pumps can be reused by another patient after completion of treatment making this program sustainable. Existing VA medical oncology staffing was utilized with the additional need for oncology nurses to take calls to provide 24-hour telephone support for any pumprelated issues that may arise during home-infusion therapy. A VA home-infusion program allows for veterans to receive seamless cancer care through one entity. This program is replicable at other VAs and can be expanded to include other forms of home-infusion therapy, such as antibiotics.

Background

The VA Outpatient Chemotherapy Clinic sees approximately 870 veterans each year. Of these, 5% receive home-infusion chemotherapy. COVID-19 created staffing challenges for the contracted homeinfusion company utilized by the VA for home-infusion chemotherapy. The VA developed a self-contained home-infusion program for 5-FU to ensure needed care could be delivered to veterans without delay.

Methods

After researching private sector and VA models of providing home-infusion chemotherapy services, analyzing literature, internal VA patient safety data, and financial implications of different home-infusion pump options, including both CADD pumps and elastomeric pumps, CADD pumps were determined to be the best financial option and safest option for providing home-infusion 5-FU through the VA. Patient education documents were created from CADD pump user manuals and literature. 

Results

A home-infusion program for 5-FU chemotherapy was implemented at the VA Outpatient Chemotherapy Clinic in March 2022. Veterans receive a home-infusion pump, 5-FU, education, and access to a 24-hour telephone support line staffed by an oncology registered nurse through the VA. Patient education consists of home-infusion pump training, implanted port de-accessing, chemotherapy spill management, and hazardous waste disposal.

Conclusion

Ten veterans have started their home-infusion portion of therapy through the VA, amounting to 34 completed cycles, between March 2022 and June 2022. This program is completely self-contained within the VA Outpatient Chemotherapy Clinic. It has allowed for initiation and continuation of needed chemotherapy regimens in an environment of staffing instability at the contracted home-infusion company. The home-infusion program required the acquisition of home-infusion pumps and supplies. The home-infusion pumps can be reused by another patient after completion of treatment making this program sustainable. Existing VA medical oncology staffing was utilized with the additional need for oncology nurses to take calls to provide 24-hour telephone support for any pumprelated issues that may arise during home-infusion therapy. A VA home-infusion program allows for veterans to receive seamless cancer care through one entity. This program is replicable at other VAs and can be expanded to include other forms of home-infusion therapy, such as antibiotics.

Background

Currently, within the Veterans Affairs Healthcare System, anticancer therapy infusions and injections are primarily offered at VA medical centers (VAMCs) in urban areas. The time and out-of-pocket expenses related to travel present a barrier to care, often leading veterans to seek cancer care in the community. The Minneapolis VA developed a “Remote Infusion” program that deploys a chemotherapy certified RN to administer anticancer and supportive therapies at surrounding Community Based Outpatient Clinics (CBOCs). The program expanded in October 2021, and since, they have provided 259 infusions and injections to 145 veterans at 16 CBOCs. These efforts have saved at least 20,000 miles of travel for veterans in the Minneapolis/ St. Cloud catchment area. Building off the success of this program, the National Oncology Program Integrated Project Team has developed the “Close to Me” CBOC Infusion Program.

Methods

The “Close to Me” CBOC Infusion Program utilizes VAMCs to compound treatments. Then a chemotherapy certified RN is deployed to the surrounding CBOCs to administer treatments. Veterans eligible for this program must have received and tolerated their first dose of treatment at a VAMC. Medications included in this program have low risk of reaction, short infusion time, and at least 8 hours of drug stability. Treatments include immune check point inhibitors, leuprolide, octreotide, IV fluids, and iron infusions. Additional treatments continue to be evaluated and added. Telehealth modalities are utilized for patient visits with their oncology provider for treatment clearance. An implementation toolkit, including a library of standard operating procedures, note templates, and staffing models, has been developed for VAMCs interested in replicating this program.

Results

The Pittsburgh VAMC launched the first “Close to Me” CBOC Infusion Program June 8, 2022.

Conclusions

 The “Close to Me” CBOC infusion program optimizes current VA infrastructure and processes to expand access to the world class oncology care VA provides by reducing travel burden for the veterans. Additional areas of novel solutions under development to provide expanded access points to anticancer therapies include mobile infusion units, mobile compounding units, and home administration.

Background

Currently, within the Veterans Affairs Healthcare System, anticancer therapy infusions and injections are primarily offered at VA medical centers (VAMCs) in urban areas. The time and out-of-pocket expenses related to travel present a barrier to care, often leading veterans to seek cancer care in the community. The Minneapolis VA developed a “Remote Infusion” program that deploys a chemotherapy certified RN to administer anticancer and supportive therapies at surrounding Community Based Outpatient Clinics (CBOCs). The program expanded in October 2021, and since, they have provided 259 infusions and injections to 145 veterans at 16 CBOCs. These efforts have saved at least 20,000 miles of travel for veterans in the Minneapolis/ St. Cloud catchment area. Building off the success of this program, the National Oncology Program Integrated Project Team has developed the “Close to Me” CBOC Infusion Program.

Methods

The “Close to Me” CBOC Infusion Program utilizes VAMCs to compound treatments. Then a chemotherapy certified RN is deployed to the surrounding CBOCs to administer treatments. Veterans eligible for this program must have received and tolerated their first dose of treatment at a VAMC. Medications included in this program have low risk of reaction, short infusion time, and at least 8 hours of drug stability. Treatments include immune check point inhibitors, leuprolide, octreotide, IV fluids, and iron infusions. Additional treatments continue to be evaluated and added. Telehealth modalities are utilized for patient visits with their oncology provider for treatment clearance. An implementation toolkit, including a library of standard operating procedures, note templates, and staffing models, has been developed for VAMCs interested in replicating this program.

Results

The Pittsburgh VAMC launched the first “Close to Me” CBOC Infusion Program June 8, 2022.

Conclusions

 The “Close to Me” CBOC infusion program optimizes current VA infrastructure and processes to expand access to the world class oncology care VA provides by reducing travel burden for the veterans. Additional areas of novel solutions under development to provide expanded access points to anticancer therapies include mobile infusion units, mobile compounding units, and home administration.

Background

Currently, within the Veterans Affairs Healthcare System, anticancer therapy infusions and injections are primarily offered at VA medical centers (VAMCs) in urban areas. The time and out-of-pocket expenses related to travel present a barrier to care, often leading veterans to seek cancer care in the community. The Minneapolis VA developed a “Remote Infusion” program that deploys a chemotherapy certified RN to administer anticancer and supportive therapies at surrounding Community Based Outpatient Clinics (CBOCs). The program expanded in October 2021, and since, they have provided 259 infusions and injections to 145 veterans at 16 CBOCs. These efforts have saved at least 20,000 miles of travel for veterans in the Minneapolis/ St. Cloud catchment area. Building off the success of this program, the National Oncology Program Integrated Project Team has developed the “Close to Me” CBOC Infusion Program.

Methods

The “Close to Me” CBOC Infusion Program utilizes VAMCs to compound treatments. Then a chemotherapy certified RN is deployed to the surrounding CBOCs to administer treatments. Veterans eligible for this program must have received and tolerated their first dose of treatment at a VAMC. Medications included in this program have low risk of reaction, short infusion time, and at least 8 hours of drug stability. Treatments include immune check point inhibitors, leuprolide, octreotide, IV fluids, and iron infusions. Additional treatments continue to be evaluated and added. Telehealth modalities are utilized for patient visits with their oncology provider for treatment clearance. An implementation toolkit, including a library of standard operating procedures, note templates, and staffing models, has been developed for VAMCs interested in replicating this program.

Results

The Pittsburgh VAMC launched the first “Close to Me” CBOC Infusion Program June 8, 2022.

Conclusions

 The “Close to Me” CBOC infusion program optimizes current VA infrastructure and processes to expand access to the world class oncology care VA provides by reducing travel burden for the veterans. Additional areas of novel solutions under development to provide expanded access points to anticancer therapies include mobile infusion units, mobile compounding units, and home administration.

Warning labels on alcoholic products need to be updated to spell out details of potential harm in order to make them more effective, two U.S. researchers have said.

The current labeling, which has not changed for 30 years, focuses on risks during pregnancy and with operating machinery and includes a vague statement that alcohol “may cause health problems.”

This is “so understated that it borders on being misleading,” the two researchers argued.

The science related to the use of alcohol has moved on, and there is now firm evidence of harm. Alcohol has been classified by the International Agency for Research on Cancer (IARC)  as a group 1 carcinogen and has been linked to an increased risk of many types of cancer. Drinking alcohol has also been linked to a wide range of other diseases, from liver disease to pancreatitis to some types of heart disease, the authors noted.

Yet the general public is mostly unaware of the most serious health risks that are associated with alcohol consumption, they pointed out.

“We believe Americans deserve the opportunity to make well-informed decisions about their alcohol consumption,” said Anna H. Grummon, PhD, of the Harvard T. H. Chan School of Public Health, Boston, and Marissa G. Hall, PhD, of the University of North Carolina at Chapel Hill.

“Designing and adopting new alcohol warning labels should therefore be a research and policy priority,” they added.

The two researchers set out their arguments in a perspective article published in The New England Journal of Medicine.

“Alcohol consumption and its associated harms are reaching a crisis point in the United States,” they pointed out.

It now accounts for more than 140,000 deaths per year in the United States, according to the latest data from the Centers for Disease Control and Prevention. The COVID-19 pandemic has made the problem even worse – there was a 25% increase in alcohol-related deaths during 2020.

New, well-designed warning labels on alcohol is a common sense strategy for providing consumers with information and reducing the burden of alcohol-related harm, the authors suggested.
 

Warning Labels Prominently Displayed

Warning labels are most effective when they are prominently displayed, when they include pictures of some type, and when the messages alternate so as to avoid any one message from becoming “stale,” the authors noted. This approach has worked well with cigarette packs. This type of warning has increased smoking quit rates in comparison with smaller, side-of-pack, text-only warning labels.

There is some evidence that this type of labeling can be effective for alcohol. When large, pictorial warnings about cancer risk were temporarily added to the front of alcohol containers in some stores in Yukon, Canada, alcohol sales declined by 6%-10%, they pointed out.

However, pressure from the alcohol industry led to changes in the Yukon project, and while a general health warning remains, the label about increased cancer risk was removed.

The alcohol industry has tried to suppress efforts to educate the public, and this has created problems in conveying health information to consumers, the authors noted. The industry spends more than $1 billion each year to market its products in the United States.

The authors caution that without government intervention, the alcohol industry has little incentive to communicate the risks.

Some companies even link their products to health campaigns, such as selling pink ribbon–themed alcoholic drinks during October to promote their efforts to raise funds for breast cancer research, despite compelling evidence linking alcohol to an increased risk of breast cancer.
 

Petition at Congress calling for new labels

This is not the first call for a change in the warning labels on alcohol.

Last year, a number of medical groups petitioned Congress for a new cancer-specific warning label to be displayed on all alcoholic beverages.

The petition was signed by the American Society of Clinical Oncology (ASCO), the American Institute for Cancer Research (AICR), and Breast Cancer Prevention Partners, in collaboration with the American Public Health Association, the Consumer Federation of America, the Center for Science in the Public Interest, Alcohol Justice, and the U.S. Alcohol Policy Alliance.

They are advocating for a label that would say: “WARNING: According to the Surgeon General, consumption of alcoholic beverages can cause cancer, including breast and colon cancers.”

That petition is still pending, Melissa Maitin-Shepard, MPP, policy expert at the AICR, said in an interview.

In addition, the AICR is “working to advocate for the addition of a cancer warning label to alcoholic beverages through multiple channels,” she said. “Given the strong evidence linking alcohol use with at least six types of cancer – and low awareness of the alcohol and cancer connection – there is a tremendous need to educate the public about alcohol and cancer risk.”

Noelle K. LoConte, MD, associate professor of medicine at the University of Wisconsin, Madison, who is the lead author of ASCO’s statement on alcohol and cancer risk, emphasized that there is no doubt that alcohol is a carcinogen, that it causes about 5% of cancers globally, and that its use has increased during the pandemic.

“Initiatives that raise awareness around this issue could help generate more public support for policies that limit alcohol access and thereby decrease the number of alcohol-associated cancers,” she said. “In ASCO’s statement on alcohol and cancer, we recommend several key strategies to reduce high-risk alcohol consumption, including limiting youth access to alcohol, giving municipalities more control over alcohol outlet density and points of sale, and increasing taxes on alcohol.”

However, she also had a small criticism of one point in the NEJM article. It shows a sample infographic that lists gastric cancer as being caused by alcohol. “But as of today, gastric cancer is not on the IARC list of alcohol-associated cancers,” she said. “I think this brings to mind one critical point, that these warning labels have to contain scientifically established facts.”

Dr. Grummon and Dr. Hall have disclosed no relevant financial relationships.

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

Warning labels on alcoholic products need to be updated to spell out details of potential harm in order to make them more effective, two U.S. researchers have said.

The current labeling, which has not changed for 30 years, focuses on risks during pregnancy and with operating machinery and includes a vague statement that alcohol “may cause health problems.”

This is “so understated that it borders on being misleading,” the two researchers argued.

The science related to the use of alcohol has moved on, and there is now firm evidence of harm. Alcohol has been classified by the International Agency for Research on Cancer (IARC)  as a group 1 carcinogen and has been linked to an increased risk of many types of cancer. Drinking alcohol has also been linked to a wide range of other diseases, from liver disease to pancreatitis to some types of heart disease, the authors noted.

Yet the general public is mostly unaware of the most serious health risks that are associated with alcohol consumption, they pointed out.

“We believe Americans deserve the opportunity to make well-informed decisions about their alcohol consumption,” said Anna H. Grummon, PhD, of the Harvard T. H. Chan School of Public Health, Boston, and Marissa G. Hall, PhD, of the University of North Carolina at Chapel Hill.

“Designing and adopting new alcohol warning labels should therefore be a research and policy priority,” they added.

The two researchers set out their arguments in a perspective article published in The New England Journal of Medicine.

“Alcohol consumption and its associated harms are reaching a crisis point in the United States,” they pointed out.

It now accounts for more than 140,000 deaths per year in the United States, according to the latest data from the Centers for Disease Control and Prevention. The COVID-19 pandemic has made the problem even worse – there was a 25% increase in alcohol-related deaths during 2020.

New, well-designed warning labels on alcohol is a common sense strategy for providing consumers with information and reducing the burden of alcohol-related harm, the authors suggested.
 

Warning Labels Prominently Displayed

Warning labels are most effective when they are prominently displayed, when they include pictures of some type, and when the messages alternate so as to avoid any one message from becoming “stale,” the authors noted. This approach has worked well with cigarette packs. This type of warning has increased smoking quit rates in comparison with smaller, side-of-pack, text-only warning labels.

There is some evidence that this type of labeling can be effective for alcohol. When large, pictorial warnings about cancer risk were temporarily added to the front of alcohol containers in some stores in Yukon, Canada, alcohol sales declined by 6%-10%, they pointed out.

However, pressure from the alcohol industry led to changes in the Yukon project, and while a general health warning remains, the label about increased cancer risk was removed.

The alcohol industry has tried to suppress efforts to educate the public, and this has created problems in conveying health information to consumers, the authors noted. The industry spends more than $1 billion each year to market its products in the United States.

The authors caution that without government intervention, the alcohol industry has little incentive to communicate the risks.

Some companies even link their products to health campaigns, such as selling pink ribbon–themed alcoholic drinks during October to promote their efforts to raise funds for breast cancer research, despite compelling evidence linking alcohol to an increased risk of breast cancer.
 

Petition at Congress calling for new labels

This is not the first call for a change in the warning labels on alcohol.

Last year, a number of medical groups petitioned Congress for a new cancer-specific warning label to be displayed on all alcoholic beverages.

The petition was signed by the American Society of Clinical Oncology (ASCO), the American Institute for Cancer Research (AICR), and Breast Cancer Prevention Partners, in collaboration with the American Public Health Association, the Consumer Federation of America, the Center for Science in the Public Interest, Alcohol Justice, and the U.S. Alcohol Policy Alliance.

They are advocating for a label that would say: “WARNING: According to the Surgeon General, consumption of alcoholic beverages can cause cancer, including breast and colon cancers.”

That petition is still pending, Melissa Maitin-Shepard, MPP, policy expert at the AICR, said in an interview.

In addition, the AICR is “working to advocate for the addition of a cancer warning label to alcoholic beverages through multiple channels,” she said. “Given the strong evidence linking alcohol use with at least six types of cancer – and low awareness of the alcohol and cancer connection – there is a tremendous need to educate the public about alcohol and cancer risk.”

Noelle K. LoConte, MD, associate professor of medicine at the University of Wisconsin, Madison, who is the lead author of ASCO’s statement on alcohol and cancer risk, emphasized that there is no doubt that alcohol is a carcinogen, that it causes about 5% of cancers globally, and that its use has increased during the pandemic.

“Initiatives that raise awareness around this issue could help generate more public support for policies that limit alcohol access and thereby decrease the number of alcohol-associated cancers,” she said. “In ASCO’s statement on alcohol and cancer, we recommend several key strategies to reduce high-risk alcohol consumption, including limiting youth access to alcohol, giving municipalities more control over alcohol outlet density and points of sale, and increasing taxes on alcohol.”

However, she also had a small criticism of one point in the NEJM article. It shows a sample infographic that lists gastric cancer as being caused by alcohol. “But as of today, gastric cancer is not on the IARC list of alcohol-associated cancers,” she said. “I think this brings to mind one critical point, that these warning labels have to contain scientifically established facts.”

Dr. Grummon and Dr. Hall have disclosed no relevant financial relationships.

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

Warning labels on alcoholic products need to be updated to spell out details of potential harm in order to make them more effective, two U.S. researchers have said.

The current labeling, which has not changed for 30 years, focuses on risks during pregnancy and with operating machinery and includes a vague statement that alcohol “may cause health problems.”

This is “so understated that it borders on being misleading,” the two researchers argued.

The science related to the use of alcohol has moved on, and there is now firm evidence of harm. Alcohol has been classified by the International Agency for Research on Cancer (IARC)  as a group 1 carcinogen and has been linked to an increased risk of many types of cancer. Drinking alcohol has also been linked to a wide range of other diseases, from liver disease to pancreatitis to some types of heart disease, the authors noted.

Yet the general public is mostly unaware of the most serious health risks that are associated with alcohol consumption, they pointed out.

“We believe Americans deserve the opportunity to make well-informed decisions about their alcohol consumption,” said Anna H. Grummon, PhD, of the Harvard T. H. Chan School of Public Health, Boston, and Marissa G. Hall, PhD, of the University of North Carolina at Chapel Hill.

“Designing and adopting new alcohol warning labels should therefore be a research and policy priority,” they added.

The two researchers set out their arguments in a perspective article published in The New England Journal of Medicine.

“Alcohol consumption and its associated harms are reaching a crisis point in the United States,” they pointed out.

It now accounts for more than 140,000 deaths per year in the United States, according to the latest data from the Centers for Disease Control and Prevention. The COVID-19 pandemic has made the problem even worse – there was a 25% increase in alcohol-related deaths during 2020.

New, well-designed warning labels on alcohol is a common sense strategy for providing consumers with information and reducing the burden of alcohol-related harm, the authors suggested.
 

Warning Labels Prominently Displayed

Warning labels are most effective when they are prominently displayed, when they include pictures of some type, and when the messages alternate so as to avoid any one message from becoming “stale,” the authors noted. This approach has worked well with cigarette packs. This type of warning has increased smoking quit rates in comparison with smaller, side-of-pack, text-only warning labels.

There is some evidence that this type of labeling can be effective for alcohol. When large, pictorial warnings about cancer risk were temporarily added to the front of alcohol containers in some stores in Yukon, Canada, alcohol sales declined by 6%-10%, they pointed out.

However, pressure from the alcohol industry led to changes in the Yukon project, and while a general health warning remains, the label about increased cancer risk was removed.

The alcohol industry has tried to suppress efforts to educate the public, and this has created problems in conveying health information to consumers, the authors noted. The industry spends more than $1 billion each year to market its products in the United States.

The authors caution that without government intervention, the alcohol industry has little incentive to communicate the risks.

Some companies even link their products to health campaigns, such as selling pink ribbon–themed alcoholic drinks during October to promote their efforts to raise funds for breast cancer research, despite compelling evidence linking alcohol to an increased risk of breast cancer.
 

Petition at Congress calling for new labels

This is not the first call for a change in the warning labels on alcohol.

Last year, a number of medical groups petitioned Congress for a new cancer-specific warning label to be displayed on all alcoholic beverages.

The petition was signed by the American Society of Clinical Oncology (ASCO), the American Institute for Cancer Research (AICR), and Breast Cancer Prevention Partners, in collaboration with the American Public Health Association, the Consumer Federation of America, the Center for Science in the Public Interest, Alcohol Justice, and the U.S. Alcohol Policy Alliance.

They are advocating for a label that would say: “WARNING: According to the Surgeon General, consumption of alcoholic beverages can cause cancer, including breast and colon cancers.”

That petition is still pending, Melissa Maitin-Shepard, MPP, policy expert at the AICR, said in an interview.

In addition, the AICR is “working to advocate for the addition of a cancer warning label to alcoholic beverages through multiple channels,” she said. “Given the strong evidence linking alcohol use with at least six types of cancer – and low awareness of the alcohol and cancer connection – there is a tremendous need to educate the public about alcohol and cancer risk.”

Noelle K. LoConte, MD, associate professor of medicine at the University of Wisconsin, Madison, who is the lead author of ASCO’s statement on alcohol and cancer risk, emphasized that there is no doubt that alcohol is a carcinogen, that it causes about 5% of cancers globally, and that its use has increased during the pandemic.

“Initiatives that raise awareness around this issue could help generate more public support for policies that limit alcohol access and thereby decrease the number of alcohol-associated cancers,” she said. “In ASCO’s statement on alcohol and cancer, we recommend several key strategies to reduce high-risk alcohol consumption, including limiting youth access to alcohol, giving municipalities more control over alcohol outlet density and points of sale, and increasing taxes on alcohol.”

However, she also had a small criticism of one point in the NEJM article. It shows a sample infographic that lists gastric cancer as being caused by alcohol. “But as of today, gastric cancer is not on the IARC list of alcohol-associated cancers,” she said. “I think this brings to mind one critical point, that these warning labels have to contain scientifically established facts.”

Dr. Grummon and Dr. Hall have disclosed no relevant financial relationships.

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

Two large observational studies published in The BMJ this week highlight the dangers of a diet rich in ultraprocessed foods (UPFs).

The first links the diet to an increased risk for colorectal cancer; the second shows a heightened risk of death from heart disease or any cause over a 14-year period.

UPFs are highly manipulated and packed with added ingredients, including sugar, fat, and salt, and are low in protein and fiber. They include soft drinks, chips, chocolate, candy, ice cream, sweetened breakfast cereals, packaged soups, chicken nuggets, hot dogs, french fries, and many more.

Over the past 30 years, there’s been a steady increase in consumption of UPFs worldwide, coupled with mounting evidence that diets rich in UPFs raise the risk for several chronic diseases, including heart disease and cancer. Few studies, however, have focused specifically on the risk for colorectal cancer (CRC).  
 

Novel data

To investigate, researchers analyzed data on 206,248 American adults (46,341 men, 159,907 women) from the Nurses’ Health Study, Nurses’ Health Study II, and the Health Professionals Follow-up Study. Dietary intake was assessed every 4 years using detailed food frequency questionnaires.

During up to 28 years of follow-up, 1,294 men and 1,922 women developed CRC.

In Cox proportional models adjusted for confounding factors, men with the highest UPF intake had a 29% higher risk for CRC than men with the lowest UPF consumption. This association was limited to distal colon cancer, with a 72% increased risk.

Among subgroups of UPFs, a higher intake of meat/poultry/seafood-based, ready-to-eat products, and sugary drinks were associated with increased risk for CRC among men.

“These products include some processed meats like sausages, bacon, ham, and fish cakes. This is consistent with our hypothesis,” lead author Lu Wang, PhD, with Tufts University, Boston, said in a news release.

There was no association between overall UPF intake and risk for CRC in women, and the reasons for this are unclear, the researchers say.

However, among the subgroups of UPFs, there was a positive association between ready-to-eat/heat mixed dishes and CRC risk and an inverse association between yogurt and dairy desserts and CRC risk among women.

It’s possible that foods like yogurt help counteract the harmful impacts of other types of UPFs in women, the researchers say.  

“Further research will be needed to determine whether there is a true sex difference in the associations or if null findings in women in this study were merely due to chance or some uncontrolled confounding factors in women that mitigated the association,” co-senior author Mingyang Song, MD, with Harvard T.H. Chan School of Public Health, Boston, says in the news release.
 

Hard on the heart too

The related study in The BMJ shows a joint association between a low-quality diet and high intake of UPFs and increased risk for death from heart disease or any cause.

In this study of 22,895 Italian adults (mean age, 55 years; 48% men), those with the least healthy diets had a 19% higher risk of dying from any cause and a 32% higher risk for death from cardiovascular disease, over 14 years, compared with peers with the healthiest diets.

Adults with the highest share of UPFs had similarly elevated risks for all-cause and heart disease mortality (19% and 27% higher risk, respectively).

When the two food dimensions (nutrients and food processing) were analyzed jointly, the association of poor diet quality with mortality was significantly attenuated, but UPF intake remained highly associated with mortality, even after accounting for poor nutritional diet quality.

“These findings suggest that highly processed foods are associated with poor health outcomes independently of their low nutritional composition,” Marialaura Bonaccio, PhD, with IRCCS NEUROMED, Pozzilli, Italy, and colleagues note in their paper.

The new studies linking UPFs to CRC and heart disease join a recent study that found high UPF intake is harmful for the aging brain, as reported by this news organization.
 

A call to action

Putting it bluntly, “everybody needs food, but nobody needs ultra-processed foods,” Carlos Monteiro, MD, PhD, and Geoffrey Cannon, with University of Sao Paulo, Brazil, write in an editorial in The BMJ.

They point out that most UPFs are made, sold, and promoted by corporations that make them to be convenient, affordable, and hyper-palatable, thus liable to displace other foods and also to be overconsumed.

“The rational solution is official public policies, including guidelines and publicity advising avoidance, and actions, including statutes, designed to reduce production and consumption of ultraprocessed foods and to restrict or preferably prohibit their promotion,” Dr. Monteiro and Mr. Cannon suggest.

What’s also needed, they say, are “available, attractive, and affordable” supplies of fresh and minimally processed foods, as well as national initiatives to promote and support freshly prepared meals made with fresh and minimally processed foods, using small amounts of processed culinary ingredients and processed foods.

“Enacted, this will promote public health. It will also nourish families, society, economies, and the environment,” the editorialists conclude.

The U.S. study was supported by the National Institutes of Health and the Friedman School of Nutrition Science and Policy at Tufts University. The Italian study was supported by the Pfizer Foundation, Italian Ministry of University and Research, Instrumentation Laboratory, Milan, and the Italian Ministry of Health. Dr. Wang, Dr. Song, Dr. Bonaccio, Dr. Monteiro, and Mr. Cannon report no relevant financial relationships.

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

This article was updated 9/1/22.

Two large observational studies published in The BMJ this week highlight the dangers of a diet rich in ultraprocessed foods (UPFs).

The first links the diet to an increased risk for colorectal cancer; the second shows a heightened risk of death from heart disease or any cause over a 14-year period.

UPFs are highly manipulated and packed with added ingredients, including sugar, fat, and salt, and are low in protein and fiber. They include soft drinks, chips, chocolate, candy, ice cream, sweetened breakfast cereals, packaged soups, chicken nuggets, hot dogs, french fries, and many more.

Over the past 30 years, there’s been a steady increase in consumption of UPFs worldwide, coupled with mounting evidence that diets rich in UPFs raise the risk for several chronic diseases, including heart disease and cancer. Few studies, however, have focused specifically on the risk for colorectal cancer (CRC).  
 

Novel data

To investigate, researchers analyzed data on 206,248 American adults (46,341 men, 159,907 women) from the Nurses’ Health Study, Nurses’ Health Study II, and the Health Professionals Follow-up Study. Dietary intake was assessed every 4 years using detailed food frequency questionnaires.

During up to 28 years of follow-up, 1,294 men and 1,922 women developed CRC.

In Cox proportional models adjusted for confounding factors, men with the highest UPF intake had a 29% higher risk for CRC than men with the lowest UPF consumption. This association was limited to distal colon cancer, with a 72% increased risk.

Among subgroups of UPFs, a higher intake of meat/poultry/seafood-based, ready-to-eat products, and sugary drinks were associated with increased risk for CRC among men.

“These products include some processed meats like sausages, bacon, ham, and fish cakes. This is consistent with our hypothesis,” lead author Lu Wang, PhD, with Tufts University, Boston, said in a news release.

There was no association between overall UPF intake and risk for CRC in women, and the reasons for this are unclear, the researchers say.

However, among the subgroups of UPFs, there was a positive association between ready-to-eat/heat mixed dishes and CRC risk and an inverse association between yogurt and dairy desserts and CRC risk among women.

It’s possible that foods like yogurt help counteract the harmful impacts of other types of UPFs in women, the researchers say.  

“Further research will be needed to determine whether there is a true sex difference in the associations or if null findings in women in this study were merely due to chance or some uncontrolled confounding factors in women that mitigated the association,” co-senior author Mingyang Song, MD, with Harvard T.H. Chan School of Public Health, Boston, says in the news release.
 

Hard on the heart too

The related study in The BMJ shows a joint association between a low-quality diet and high intake of UPFs and increased risk for death from heart disease or any cause.

In this study of 22,895 Italian adults (mean age, 55 years; 48% men), those with the least healthy diets had a 19% higher risk of dying from any cause and a 32% higher risk for death from cardiovascular disease, over 14 years, compared with peers with the healthiest diets.

Adults with the highest share of UPFs had similarly elevated risks for all-cause and heart disease mortality (19% and 27% higher risk, respectively).

When the two food dimensions (nutrients and food processing) were analyzed jointly, the association of poor diet quality with mortality was significantly attenuated, but UPF intake remained highly associated with mortality, even after accounting for poor nutritional diet quality.

“These findings suggest that highly processed foods are associated with poor health outcomes independently of their low nutritional composition,” Marialaura Bonaccio, PhD, with IRCCS NEUROMED, Pozzilli, Italy, and colleagues note in their paper.

The new studies linking UPFs to CRC and heart disease join a recent study that found high UPF intake is harmful for the aging brain, as reported by this news organization.
 

A call to action

Putting it bluntly, “everybody needs food, but nobody needs ultra-processed foods,” Carlos Monteiro, MD, PhD, and Geoffrey Cannon, with University of Sao Paulo, Brazil, write in an editorial in The BMJ.

They point out that most UPFs are made, sold, and promoted by corporations that make them to be convenient, affordable, and hyper-palatable, thus liable to displace other foods and also to be overconsumed.

“The rational solution is official public policies, including guidelines and publicity advising avoidance, and actions, including statutes, designed to reduce production and consumption of ultraprocessed foods and to restrict or preferably prohibit their promotion,” Dr. Monteiro and Mr. Cannon suggest.

What’s also needed, they say, are “available, attractive, and affordable” supplies of fresh and minimally processed foods, as well as national initiatives to promote and support freshly prepared meals made with fresh and minimally processed foods, using small amounts of processed culinary ingredients and processed foods.

“Enacted, this will promote public health. It will also nourish families, society, economies, and the environment,” the editorialists conclude.

The U.S. study was supported by the National Institutes of Health and the Friedman School of Nutrition Science and Policy at Tufts University. The Italian study was supported by the Pfizer Foundation, Italian Ministry of University and Research, Instrumentation Laboratory, Milan, and the Italian Ministry of Health. Dr. Wang, Dr. Song, Dr. Bonaccio, Dr. Monteiro, and Mr. Cannon report no relevant financial relationships.

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

This article was updated 9/1/22.

Two large observational studies published in The BMJ this week highlight the dangers of a diet rich in ultraprocessed foods (UPFs).

The first links the diet to an increased risk for colorectal cancer; the second shows a heightened risk of death from heart disease or any cause over a 14-year period.

UPFs are highly manipulated and packed with added ingredients, including sugar, fat, and salt, and are low in protein and fiber. They include soft drinks, chips, chocolate, candy, ice cream, sweetened breakfast cereals, packaged soups, chicken nuggets, hot dogs, french fries, and many more.

Over the past 30 years, there’s been a steady increase in consumption of UPFs worldwide, coupled with mounting evidence that diets rich in UPFs raise the risk for several chronic diseases, including heart disease and cancer. Few studies, however, have focused specifically on the risk for colorectal cancer (CRC).  
 

Novel data

To investigate, researchers analyzed data on 206,248 American adults (46,341 men, 159,907 women) from the Nurses’ Health Study, Nurses’ Health Study II, and the Health Professionals Follow-up Study. Dietary intake was assessed every 4 years using detailed food frequency questionnaires.

During up to 28 years of follow-up, 1,294 men and 1,922 women developed CRC.

In Cox proportional models adjusted for confounding factors, men with the highest UPF intake had a 29% higher risk for CRC than men with the lowest UPF consumption. This association was limited to distal colon cancer, with a 72% increased risk.

Among subgroups of UPFs, a higher intake of meat/poultry/seafood-based, ready-to-eat products, and sugary drinks were associated with increased risk for CRC among men.

“These products include some processed meats like sausages, bacon, ham, and fish cakes. This is consistent with our hypothesis,” lead author Lu Wang, PhD, with Tufts University, Boston, said in a news release.

There was no association between overall UPF intake and risk for CRC in women, and the reasons for this are unclear, the researchers say.

However, among the subgroups of UPFs, there was a positive association between ready-to-eat/heat mixed dishes and CRC risk and an inverse association between yogurt and dairy desserts and CRC risk among women.

It’s possible that foods like yogurt help counteract the harmful impacts of other types of UPFs in women, the researchers say.  

“Further research will be needed to determine whether there is a true sex difference in the associations or if null findings in women in this study were merely due to chance or some uncontrolled confounding factors in women that mitigated the association,” co-senior author Mingyang Song, MD, with Harvard T.H. Chan School of Public Health, Boston, says in the news release.
 

Hard on the heart too

The related study in The BMJ shows a joint association between a low-quality diet and high intake of UPFs and increased risk for death from heart disease or any cause.

In this study of 22,895 Italian adults (mean age, 55 years; 48% men), those with the least healthy diets had a 19% higher risk of dying from any cause and a 32% higher risk for death from cardiovascular disease, over 14 years, compared with peers with the healthiest diets.

Adults with the highest share of UPFs had similarly elevated risks for all-cause and heart disease mortality (19% and 27% higher risk, respectively).

When the two food dimensions (nutrients and food processing) were analyzed jointly, the association of poor diet quality with mortality was significantly attenuated, but UPF intake remained highly associated with mortality, even after accounting for poor nutritional diet quality.

“These findings suggest that highly processed foods are associated with poor health outcomes independently of their low nutritional composition,” Marialaura Bonaccio, PhD, with IRCCS NEUROMED, Pozzilli, Italy, and colleagues note in their paper.

The new studies linking UPFs to CRC and heart disease join a recent study that found high UPF intake is harmful for the aging brain, as reported by this news organization.
 

A call to action

Putting it bluntly, “everybody needs food, but nobody needs ultra-processed foods,” Carlos Monteiro, MD, PhD, and Geoffrey Cannon, with University of Sao Paulo, Brazil, write in an editorial in The BMJ.

They point out that most UPFs are made, sold, and promoted by corporations that make them to be convenient, affordable, and hyper-palatable, thus liable to displace other foods and also to be overconsumed.

“The rational solution is official public policies, including guidelines and publicity advising avoidance, and actions, including statutes, designed to reduce production and consumption of ultraprocessed foods and to restrict or preferably prohibit their promotion,” Dr. Monteiro and Mr. Cannon suggest.

What’s also needed, they say, are “available, attractive, and affordable” supplies of fresh and minimally processed foods, as well as national initiatives to promote and support freshly prepared meals made with fresh and minimally processed foods, using small amounts of processed culinary ingredients and processed foods.

“Enacted, this will promote public health. It will also nourish families, society, economies, and the environment,” the editorialists conclude.

The U.S. study was supported by the National Institutes of Health and the Friedman School of Nutrition Science and Policy at Tufts University. The Italian study was supported by the Pfizer Foundation, Italian Ministry of University and Research, Instrumentation Laboratory, Milan, and the Italian Ministry of Health. Dr. Wang, Dr. Song, Dr. Bonaccio, Dr. Monteiro, and Mr. Cannon report no relevant financial relationships.

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

This article was updated 9/1/22.

Life expectancy in the United States declined again in 2021, after a historic drop in 2020, to reach the lowest point in decades, according to new CDC data.

In 2021, the average American could expect to live until age 76, which fell from 77 in 2020 and 79 in 2019. That marks the lowest age since 1996 and the largest 2-year decline since 1923.

“Even small declines in life expectancy of a tenth or two-tenths of a year mean that on a population level, a lot more people are dying prematurely,” Robert Anderson, PhD, chief of mortality statistics at the National Center for Health Statistics, which produced the report, told The New York Times.

“This signals a huge impact on the population in terms of increased mortality,” he said.

COVID-19 played a major role, with excess death from the coronavirus contributing to half of the decline during the past 2 years. Drug overdose deaths also reached a record high in 2021, rising to about 109,000 people. Unintentional injuries, with about half due to drug overdose, were a leading cause of the decline in life expectancy, along with deaths from heart disease, chronic liver disease, cirrhosis, and suicide.

The decrease has been particularly devastating among Native Americans and Alaska Natives. Average life expectancy dropped by 4 years in 2020 alone and more than 6.5 years since the beginning of the pandemic. Now their life expectancy is 65, which was the average for all Americans in 1944.

“When I saw that in the report, I just – my jaw dropped,” Dr. Anderson told CNN.

“It was hard enough to fathom a 2.7-year decline over 2 years overall,” he said. “But then to see a 6.6-year decline for the American Indian population, it just shows the substantial impact that the pandemic has had on that population.”

Longstanding health issues and systemic problems, such as poverty, discrimination, and poor access to health care, led to the major declines among Native Americans and Alaska Natives, CNN reported.

“A lot of the talk is going to be around the pandemic, but we need to think about what has driven the conditions that have allowed certain communities to be more vulnerable,” Ruben Cantu, an associate program director with Prevention Institute, a nonprofit focused on health equity, told CNN.

The gap in life expectancy between women and men also became wider in 2021, growing to 5.9 years and marking the largest gap since 1996. The life expectancy for men in 2021 was 73.2, as compared with 79.1 for women.

The decline in overall U.S. life expectancy would have been even greater if there weren’t “offsetting effects,” the researchers wrote, such as declines in death due to the flu, pneumonia, chronic lower respiratory diseases, and Alzheimer’s disease.

The drop in U.S. life expectancy is “historic,” Steven Woolf, MD, retired director of the Center on Society and Health and Virginia Commonwealth University, told the Times.

Other high-income countries also saw a drop in life expectancy in 2020 due to the pandemic, but most began to recover last year due to major vaccine campaigns and behavior changes such as wearing masks, he said.

“None of them experienced a continuing fall in life expectancy like the U.S. did, and a good number of them saw life expectancy start inching back to normal,” he said. “The U.S. is clearly an outlier.”

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

Life expectancy in the United States declined again in 2021, after a historic drop in 2020, to reach the lowest point in decades, according to new CDC data.

In 2021, the average American could expect to live until age 76, which fell from 77 in 2020 and 79 in 2019. That marks the lowest age since 1996 and the largest 2-year decline since 1923.

“Even small declines in life expectancy of a tenth or two-tenths of a year mean that on a population level, a lot more people are dying prematurely,” Robert Anderson, PhD, chief of mortality statistics at the National Center for Health Statistics, which produced the report, told The New York Times.

“This signals a huge impact on the population in terms of increased mortality,” he said.

COVID-19 played a major role, with excess death from the coronavirus contributing to half of the decline during the past 2 years. Drug overdose deaths also reached a record high in 2021, rising to about 109,000 people. Unintentional injuries, with about half due to drug overdose, were a leading cause of the decline in life expectancy, along with deaths from heart disease, chronic liver disease, cirrhosis, and suicide.

The decrease has been particularly devastating among Native Americans and Alaska Natives. Average life expectancy dropped by 4 years in 2020 alone and more than 6.5 years since the beginning of the pandemic. Now their life expectancy is 65, which was the average for all Americans in 1944.

“When I saw that in the report, I just – my jaw dropped,” Dr. Anderson told CNN.

“It was hard enough to fathom a 2.7-year decline over 2 years overall,” he said. “But then to see a 6.6-year decline for the American Indian population, it just shows the substantial impact that the pandemic has had on that population.”

Longstanding health issues and systemic problems, such as poverty, discrimination, and poor access to health care, led to the major declines among Native Americans and Alaska Natives, CNN reported.

“A lot of the talk is going to be around the pandemic, but we need to think about what has driven the conditions that have allowed certain communities to be more vulnerable,” Ruben Cantu, an associate program director with Prevention Institute, a nonprofit focused on health equity, told CNN.

The gap in life expectancy between women and men also became wider in 2021, growing to 5.9 years and marking the largest gap since 1996. The life expectancy for men in 2021 was 73.2, as compared with 79.1 for women.

The decline in overall U.S. life expectancy would have been even greater if there weren’t “offsetting effects,” the researchers wrote, such as declines in death due to the flu, pneumonia, chronic lower respiratory diseases, and Alzheimer’s disease.

The drop in U.S. life expectancy is “historic,” Steven Woolf, MD, retired director of the Center on Society and Health and Virginia Commonwealth University, told the Times.

Other high-income countries also saw a drop in life expectancy in 2020 due to the pandemic, but most began to recover last year due to major vaccine campaigns and behavior changes such as wearing masks, he said.

“None of them experienced a continuing fall in life expectancy like the U.S. did, and a good number of them saw life expectancy start inching back to normal,” he said. “The U.S. is clearly an outlier.”

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

Life expectancy in the United States declined again in 2021, after a historic drop in 2020, to reach the lowest point in decades, according to new CDC data.

In 2021, the average American could expect to live until age 76, which fell from 77 in 2020 and 79 in 2019. That marks the lowest age since 1996 and the largest 2-year decline since 1923.

“Even small declines in life expectancy of a tenth or two-tenths of a year mean that on a population level, a lot more people are dying prematurely,” Robert Anderson, PhD, chief of mortality statistics at the National Center for Health Statistics, which produced the report, told The New York Times.

“This signals a huge impact on the population in terms of increased mortality,” he said.

COVID-19 played a major role, with excess death from the coronavirus contributing to half of the decline during the past 2 years. Drug overdose deaths also reached a record high in 2021, rising to about 109,000 people. Unintentional injuries, with about half due to drug overdose, were a leading cause of the decline in life expectancy, along with deaths from heart disease, chronic liver disease, cirrhosis, and suicide.

The decrease has been particularly devastating among Native Americans and Alaska Natives. Average life expectancy dropped by 4 years in 2020 alone and more than 6.5 years since the beginning of the pandemic. Now their life expectancy is 65, which was the average for all Americans in 1944.

“When I saw that in the report, I just – my jaw dropped,” Dr. Anderson told CNN.

“It was hard enough to fathom a 2.7-year decline over 2 years overall,” he said. “But then to see a 6.6-year decline for the American Indian population, it just shows the substantial impact that the pandemic has had on that population.”

Longstanding health issues and systemic problems, such as poverty, discrimination, and poor access to health care, led to the major declines among Native Americans and Alaska Natives, CNN reported.

“A lot of the talk is going to be around the pandemic, but we need to think about what has driven the conditions that have allowed certain communities to be more vulnerable,” Ruben Cantu, an associate program director with Prevention Institute, a nonprofit focused on health equity, told CNN.

The gap in life expectancy between women and men also became wider in 2021, growing to 5.9 years and marking the largest gap since 1996. The life expectancy for men in 2021 was 73.2, as compared with 79.1 for women.

The decline in overall U.S. life expectancy would have been even greater if there weren’t “offsetting effects,” the researchers wrote, such as declines in death due to the flu, pneumonia, chronic lower respiratory diseases, and Alzheimer’s disease.

The drop in U.S. life expectancy is “historic,” Steven Woolf, MD, retired director of the Center on Society and Health and Virginia Commonwealth University, told the Times.

Other high-income countries also saw a drop in life expectancy in 2020 due to the pandemic, but most began to recover last year due to major vaccine campaigns and behavior changes such as wearing masks, he said.

“None of them experienced a continuing fall in life expectancy like the U.S. did, and a good number of them saw life expectancy start inching back to normal,” he said. “The U.S. is clearly an outlier.”

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