Federal Practitioner

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.

The Centers for Disease Control and Prevention on Sept. 1 approved the use of vaccines designed to target both Omicron and the older variants of the coronavirus, a step that may aid a goal of a widespread immunization campaign before winter arrives in the United States.

The CDC’s Advisory Committee on Immunization Practices voted 13-1 on two separate questions. One sought the panel’s backing for the use of a single dose of a new version of the Pfizer COVID-19 vaccines for people aged 12 and older. The second question dealt with a single dose of the reworked Moderna vaccine for people aged 18 and older.

The federal government wants to speed use of revamped COVID-19 shots, which the Food and Drug Administration on Sept. 1 cleared for use in the United States. Hours later, CDC Director Rochelle Walensky, MD, agreed with the panel’s recommendation. 

“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” Dr. Walensky said in a statement. “They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it.”

The FDA vote on Aug. 31 expanded the emergency use authorization EUA for both Moderna and Pfizer’s original COVID-19 vaccines. The new products are also called “updated boosters.” Both contain two mRNA components of SARS-CoV-2 virus, one of the original strain  and another that is found in the BA.4 and BA.5 strains of the Omicron variant, the FDA said.

Basically, the FDA cleared the way for these new boosters after it relied heavily on results of certain blood tests that suggested an immune response boost from the new formulas, plus 18 months of mostly safe use of the original versions of the shots.

What neither the FDA nor the CDC has, however, is evidence from studies in humans on how well these new vaccines work or whether they are as safe as the originals. But the FDA did consider clinical evidence for the older shots and results from studies on the new boosters that were done in mice.

ACIP Committee member Pablo Sanchez, MD, of Ohio State University was the sole “no” vote on each question.  

“It’s a new vaccine, it’s a new platform. There’s a lot of hesitancy already. We need the human data,”  Dr. Sanchez said.

Dr. Sanchez did not doubt that the newer versions of the vaccine would prove safe.

“I personally am in the age group where I’m at high risk and I’m almost sure that I will receive it,” Dr. Sanchez said. “I just feel that this was a bit premature, and I wish that we had seen that data. Having said that, I am comfortable that the vaccine will likely be safe like the others.”

Dr. Sanchez was not alone in raising concerns about backing new COVID-19 shots for which there is not direct clinical evidence from human studies.

Committee member Sarah Long, MD, of Drexel University in Philadelphia, said during the discussion she would “reluctantly” vote in favor of the updated vaccines. She said she believes they will have the potential to reduce hospitalizations and even deaths, even with questions remaining about the data.

Dr. Long joined other committee members in pointing to the approach to updating flu vaccines as a model. In an attempt to keep ahead of influenza, companies seek to defeat new strains through tweaks to their FDA-approved vaccines. There is not much clinical information available about these revised products, Dr. Long said. She compared it to remodeling an existing home.

“It is the same scaffolding, part of the same roof, we’re just putting in some dormers and windows,” with the revisions to the flu vaccine, she said.

Earlier in the day, committee member Jamie Loehr, MD,  of Cayuga Family Medicine in Ithaca, N.Y., also used changes to the annual flu shots as the model for advancing COVID-19 shots.

“So after thinking about it, I am comfortable even though we don’t have human data,” he said.

There were several questions during the meeting about why the FDA had not convened a meeting of its Vaccines and Related Biological Products Advisory Committee (regarding these specific bivalent vaccines). Typically, the FDA committee of advisers considers new vaccines before the agency authorizes their use. In this case, however, the agency acted on its own.

The FDA said the committee considered the new, bivalent COVID-19 boosters in earlier meetings and that was enough outside feedback.

But holding a meeting of advisers on these specific products could have helped build public confidence in these medicines, Dorit Reiss, PhD, of the University of California Hastings College of Law, said during the public comment session of the CDC advisers’ meeting.

“We could wish the vaccines were more effective against infection, but they’re safe and they prevent hospitalization and death,” she said.

The Department of Health and Human Services anticipated the backing of ACIP. The Administration for Strategic Preparedness and Response  on Aug. 31 began distributing “millions of doses of the updated booster to tens of thousands of sites nationwide,” Jason Roos, PhD,  chief operating officer for HHS Coordination Operations and Response Element, wrote in a blog.

“These boosters will be available at tens of thousands of vaccination sites ... including local pharmacies, their physicians’ offices, and vaccine centers operated by state and local health officials,”Dr. Roos wrote.

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

The Centers for Disease Control and Prevention on Sept. 1 approved the use of vaccines designed to target both Omicron and the older variants of the coronavirus, a step that may aid a goal of a widespread immunization campaign before winter arrives in the United States.

The CDC’s Advisory Committee on Immunization Practices voted 13-1 on two separate questions. One sought the panel’s backing for the use of a single dose of a new version of the Pfizer COVID-19 vaccines for people aged 12 and older. The second question dealt with a single dose of the reworked Moderna vaccine for people aged 18 and older.

The federal government wants to speed use of revamped COVID-19 shots, which the Food and Drug Administration on Sept. 1 cleared for use in the United States. Hours later, CDC Director Rochelle Walensky, MD, agreed with the panel’s recommendation. 

“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” Dr. Walensky said in a statement. “They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it.”

The FDA vote on Aug. 31 expanded the emergency use authorization EUA for both Moderna and Pfizer’s original COVID-19 vaccines. The new products are also called “updated boosters.” Both contain two mRNA components of SARS-CoV-2 virus, one of the original strain  and another that is found in the BA.4 and BA.5 strains of the Omicron variant, the FDA said.

Basically, the FDA cleared the way for these new boosters after it relied heavily on results of certain blood tests that suggested an immune response boost from the new formulas, plus 18 months of mostly safe use of the original versions of the shots.

What neither the FDA nor the CDC has, however, is evidence from studies in humans on how well these new vaccines work or whether they are as safe as the originals. But the FDA did consider clinical evidence for the older shots and results from studies on the new boosters that were done in mice.

ACIP Committee member Pablo Sanchez, MD, of Ohio State University was the sole “no” vote on each question.  

“It’s a new vaccine, it’s a new platform. There’s a lot of hesitancy already. We need the human data,”  Dr. Sanchez said.

Dr. Sanchez did not doubt that the newer versions of the vaccine would prove safe.

“I personally am in the age group where I’m at high risk and I’m almost sure that I will receive it,” Dr. Sanchez said. “I just feel that this was a bit premature, and I wish that we had seen that data. Having said that, I am comfortable that the vaccine will likely be safe like the others.”

Dr. Sanchez was not alone in raising concerns about backing new COVID-19 shots for which there is not direct clinical evidence from human studies.

Committee member Sarah Long, MD, of Drexel University in Philadelphia, said during the discussion she would “reluctantly” vote in favor of the updated vaccines. She said she believes they will have the potential to reduce hospitalizations and even deaths, even with questions remaining about the data.

Dr. Long joined other committee members in pointing to the approach to updating flu vaccines as a model. In an attempt to keep ahead of influenza, companies seek to defeat new strains through tweaks to their FDA-approved vaccines. There is not much clinical information available about these revised products, Dr. Long said. She compared it to remodeling an existing home.

“It is the same scaffolding, part of the same roof, we’re just putting in some dormers and windows,” with the revisions to the flu vaccine, she said.

Earlier in the day, committee member Jamie Loehr, MD,  of Cayuga Family Medicine in Ithaca, N.Y., also used changes to the annual flu shots as the model for advancing COVID-19 shots.

“So after thinking about it, I am comfortable even though we don’t have human data,” he said.

There were several questions during the meeting about why the FDA had not convened a meeting of its Vaccines and Related Biological Products Advisory Committee (regarding these specific bivalent vaccines). Typically, the FDA committee of advisers considers new vaccines before the agency authorizes their use. In this case, however, the agency acted on its own.

The FDA said the committee considered the new, bivalent COVID-19 boosters in earlier meetings and that was enough outside feedback.

But holding a meeting of advisers on these specific products could have helped build public confidence in these medicines, Dorit Reiss, PhD, of the University of California Hastings College of Law, said during the public comment session of the CDC advisers’ meeting.

“We could wish the vaccines were more effective against infection, but they’re safe and they prevent hospitalization and death,” she said.

The Department of Health and Human Services anticipated the backing of ACIP. The Administration for Strategic Preparedness and Response  on Aug. 31 began distributing “millions of doses of the updated booster to tens of thousands of sites nationwide,” Jason Roos, PhD,  chief operating officer for HHS Coordination Operations and Response Element, wrote in a blog.

“These boosters will be available at tens of thousands of vaccination sites ... including local pharmacies, their physicians’ offices, and vaccine centers operated by state and local health officials,”Dr. Roos wrote.

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

The Centers for Disease Control and Prevention on Sept. 1 approved the use of vaccines designed to target both Omicron and the older variants of the coronavirus, a step that may aid a goal of a widespread immunization campaign before winter arrives in the United States.

The CDC’s Advisory Committee on Immunization Practices voted 13-1 on two separate questions. One sought the panel’s backing for the use of a single dose of a new version of the Pfizer COVID-19 vaccines for people aged 12 and older. The second question dealt with a single dose of the reworked Moderna vaccine for people aged 18 and older.

The federal government wants to speed use of revamped COVID-19 shots, which the Food and Drug Administration on Sept. 1 cleared for use in the United States. Hours later, CDC Director Rochelle Walensky, MD, agreed with the panel’s recommendation. 

“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” Dr. Walensky said in a statement. “They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it.”

The FDA vote on Aug. 31 expanded the emergency use authorization EUA for both Moderna and Pfizer’s original COVID-19 vaccines. The new products are also called “updated boosters.” Both contain two mRNA components of SARS-CoV-2 virus, one of the original strain  and another that is found in the BA.4 and BA.5 strains of the Omicron variant, the FDA said.

Basically, the FDA cleared the way for these new boosters after it relied heavily on results of certain blood tests that suggested an immune response boost from the new formulas, plus 18 months of mostly safe use of the original versions of the shots.

What neither the FDA nor the CDC has, however, is evidence from studies in humans on how well these new vaccines work or whether they are as safe as the originals. But the FDA did consider clinical evidence for the older shots and results from studies on the new boosters that were done in mice.

ACIP Committee member Pablo Sanchez, MD, of Ohio State University was the sole “no” vote on each question.  

“It’s a new vaccine, it’s a new platform. There’s a lot of hesitancy already. We need the human data,”  Dr. Sanchez said.

Dr. Sanchez did not doubt that the newer versions of the vaccine would prove safe.

“I personally am in the age group where I’m at high risk and I’m almost sure that I will receive it,” Dr. Sanchez said. “I just feel that this was a bit premature, and I wish that we had seen that data. Having said that, I am comfortable that the vaccine will likely be safe like the others.”

Dr. Sanchez was not alone in raising concerns about backing new COVID-19 shots for which there is not direct clinical evidence from human studies.

Committee member Sarah Long, MD, of Drexel University in Philadelphia, said during the discussion she would “reluctantly” vote in favor of the updated vaccines. She said she believes they will have the potential to reduce hospitalizations and even deaths, even with questions remaining about the data.

Dr. Long joined other committee members in pointing to the approach to updating flu vaccines as a model. In an attempt to keep ahead of influenza, companies seek to defeat new strains through tweaks to their FDA-approved vaccines. There is not much clinical information available about these revised products, Dr. Long said. She compared it to remodeling an existing home.

“It is the same scaffolding, part of the same roof, we’re just putting in some dormers and windows,” with the revisions to the flu vaccine, she said.

Earlier in the day, committee member Jamie Loehr, MD,  of Cayuga Family Medicine in Ithaca, N.Y., also used changes to the annual flu shots as the model for advancing COVID-19 shots.

“So after thinking about it, I am comfortable even though we don’t have human data,” he said.

There were several questions during the meeting about why the FDA had not convened a meeting of its Vaccines and Related Biological Products Advisory Committee (regarding these specific bivalent vaccines). Typically, the FDA committee of advisers considers new vaccines before the agency authorizes their use. In this case, however, the agency acted on its own.

The FDA said the committee considered the new, bivalent COVID-19 boosters in earlier meetings and that was enough outside feedback.

But holding a meeting of advisers on these specific products could have helped build public confidence in these medicines, Dorit Reiss, PhD, of the University of California Hastings College of Law, said during the public comment session of the CDC advisers’ meeting.

“We could wish the vaccines were more effective against infection, but they’re safe and they prevent hospitalization and death,” she said.

The Department of Health and Human Services anticipated the backing of ACIP. The Administration for Strategic Preparedness and Response  on Aug. 31 began distributing “millions of doses of the updated booster to tens of thousands of sites nationwide,” Jason Roos, PhD,  chief operating officer for HHS Coordination Operations and Response Element, wrote in a blog.

“These boosters will be available at tens of thousands of vaccination sites ... including local pharmacies, their physicians’ offices, and vaccine centers operated by state and local health officials,”Dr. Roos wrote.

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

BARCELONA – Two noninvasive imaging methods for assessing coronary artery disease – cardiac magnetic resonance (CMR) and positron emission tomography using rubidium stress (RbPET) – had nearly identical accuracy for ruling-in or ruling-out coronary disease, making them for at least the time being equally appropriate to use when assessing low- or intermediate-risk patients with symptoms suggestive of possible coronary disease in a prospective, multicenter study with 372 patients.

RbPET and CMR using a 3 Tesla device showed “absolutely similar performance,” in a head-to-head comparison that used fractional flow reserve assessment via invasive coronary angiography in each patient in the study as the arbiter of the true extent of coronary disease, reported Morten Bøttcher, MD, PhD, at the annual congress of the European Society of Cardiology.

Mitchel L. Zoler/MDedge

This result is good news for practice because clinicians can feel free to use whichever of the two assessment methods is most feasible for each patient, said Dr. Bøttcher, a researcher at Aarhus (Denmark) University Hospital. But the study was limited by its size, and he hopes to run a future study with many more patients to try to more definitively compare RbPET and CMR.

‘The techniques are probably interchangeable’

“There is a very clear result from the data: The performance of the two modalities is similar in the population studied,” commented Colin Berry, MBChB, PhD, professor of cardiology and imaging at the University of Glasgow (Scotland), and designated discussant for the report. “The techniques are probably interchangeable,” he said.

Mitchel L. Zoler/MDedge

Dr. Bøttcher and his associates designed the Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease 2 (Dan-NICAD 2) to address a knowledge gap highlighted in the 2019 guidelines of the European Society of Cardiology for the management of patients with chronic coronary syndromes, specifically low- or intermediate-risk patients who present with symptoms of possible coronary disease who have been identified as having possibly stenotic coronary lesions using coronary CT angiography. The guidelines cite using noninvasive imaging at this point prior to invasive angiography, but note that the relative performance of the various imaging options available for this step in unknown, said Dr. Bøttcher.

The researchers enrolled 372 patients at any of four hospitals in Denmark who agreed to participate and had a positive result on a coronary CT examination performed to assess their symptoms of coronary disease. (These 372 patients came from an initial pool of people that was fourfold larger, but three-quarters had negative findings on their coronary CT examination.) Clinicians had referred all of these patients to invasive angiography with fractional flow reserve assessment, and prior to that procedure they each underwent both a RbPET and a CMR examination for the purpose of this study. The researchers used each patient’s eventual invasive angiography result as the definitive determinant of their coronary disease. These patients averaged 64 years old, and 71% were men.

This analysis showed that for all 372 patients RbPET had 63% sensitivity and 87% specificity for identifying hemodynamically obstructive coronary disease, with rates of 60% and 85%, respectively, for CMR. In the subgroup of 71 patients (19%) who had obstructive coronary disease when examined by invasive angiography the sensitivity and specificity of the RbPET examination was 90% and 78%, and for CMR the sensitivity and specificity was 83% and 76%, Dr. Bøttcher reported.

Negative imaging, positive FFR

He also noted that it remains unclear how to best manage patients who show no signs of ischemia when examined by RbPET or CMR, but have an apparently hemodynamically meaningful coronary lesion when assessed by invasive angiography and fractional flow reserve. “We don’t know whether we should be guided by the negative scan or by the positive FFR result,” Dr. Bøttcher said. “There is a challenge when you get different results.”

In addition, the two compared imaging methods both have logistical limitations. RbPET involved radiation exposure, and CMR performed with a 3-tesla device may not be as widely available and requires more expensive equipment.

Dr. Berry also noted that imaging methods continue to advance. For example, the CMR examinations used in the study involved qualitative assessments, but quantitative CMR is now becoming more widely available and may provide enhanced diagnostic capabilities. Dr. Berry added that patients with symptoms of coronary disease but without an identifiable coronary obstruction may have microvascular coronary disease, a disorder that he has been at the forefront of describing.

Dan-NICAD 2 received no commercial funding. Dr. Bøttcher has been an adviser to Acarix, Amgen, AstraZeneca, Bayer, and Novo Nordisk. Dr. Berry had no disclosures.

BARCELONA – Two noninvasive imaging methods for assessing coronary artery disease – cardiac magnetic resonance (CMR) and positron emission tomography using rubidium stress (RbPET) – had nearly identical accuracy for ruling-in or ruling-out coronary disease, making them for at least the time being equally appropriate to use when assessing low- or intermediate-risk patients with symptoms suggestive of possible coronary disease in a prospective, multicenter study with 372 patients.

RbPET and CMR using a 3 Tesla device showed “absolutely similar performance,” in a head-to-head comparison that used fractional flow reserve assessment via invasive coronary angiography in each patient in the study as the arbiter of the true extent of coronary disease, reported Morten Bøttcher, MD, PhD, at the annual congress of the European Society of Cardiology.

Mitchel L. Zoler/MDedge

This result is good news for practice because clinicians can feel free to use whichever of the two assessment methods is most feasible for each patient, said Dr. Bøttcher, a researcher at Aarhus (Denmark) University Hospital. But the study was limited by its size, and he hopes to run a future study with many more patients to try to more definitively compare RbPET and CMR.

‘The techniques are probably interchangeable’

“There is a very clear result from the data: The performance of the two modalities is similar in the population studied,” commented Colin Berry, MBChB, PhD, professor of cardiology and imaging at the University of Glasgow (Scotland), and designated discussant for the report. “The techniques are probably interchangeable,” he said.

Mitchel L. Zoler/MDedge

Dr. Bøttcher and his associates designed the Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease 2 (Dan-NICAD 2) to address a knowledge gap highlighted in the 2019 guidelines of the European Society of Cardiology for the management of patients with chronic coronary syndromes, specifically low- or intermediate-risk patients who present with symptoms of possible coronary disease who have been identified as having possibly stenotic coronary lesions using coronary CT angiography. The guidelines cite using noninvasive imaging at this point prior to invasive angiography, but note that the relative performance of the various imaging options available for this step in unknown, said Dr. Bøttcher.

The researchers enrolled 372 patients at any of four hospitals in Denmark who agreed to participate and had a positive result on a coronary CT examination performed to assess their symptoms of coronary disease. (These 372 patients came from an initial pool of people that was fourfold larger, but three-quarters had negative findings on their coronary CT examination.) Clinicians had referred all of these patients to invasive angiography with fractional flow reserve assessment, and prior to that procedure they each underwent both a RbPET and a CMR examination for the purpose of this study. The researchers used each patient’s eventual invasive angiography result as the definitive determinant of their coronary disease. These patients averaged 64 years old, and 71% were men.

This analysis showed that for all 372 patients RbPET had 63% sensitivity and 87% specificity for identifying hemodynamically obstructive coronary disease, with rates of 60% and 85%, respectively, for CMR. In the subgroup of 71 patients (19%) who had obstructive coronary disease when examined by invasive angiography the sensitivity and specificity of the RbPET examination was 90% and 78%, and for CMR the sensitivity and specificity was 83% and 76%, Dr. Bøttcher reported.

Negative imaging, positive FFR

He also noted that it remains unclear how to best manage patients who show no signs of ischemia when examined by RbPET or CMR, but have an apparently hemodynamically meaningful coronary lesion when assessed by invasive angiography and fractional flow reserve. “We don’t know whether we should be guided by the negative scan or by the positive FFR result,” Dr. Bøttcher said. “There is a challenge when you get different results.”

In addition, the two compared imaging methods both have logistical limitations. RbPET involved radiation exposure, and CMR performed with a 3-tesla device may not be as widely available and requires more expensive equipment.

Dr. Berry also noted that imaging methods continue to advance. For example, the CMR examinations used in the study involved qualitative assessments, but quantitative CMR is now becoming more widely available and may provide enhanced diagnostic capabilities. Dr. Berry added that patients with symptoms of coronary disease but without an identifiable coronary obstruction may have microvascular coronary disease, a disorder that he has been at the forefront of describing.

Dan-NICAD 2 received no commercial funding. Dr. Bøttcher has been an adviser to Acarix, Amgen, AstraZeneca, Bayer, and Novo Nordisk. Dr. Berry had no disclosures.

BARCELONA – Two noninvasive imaging methods for assessing coronary artery disease – cardiac magnetic resonance (CMR) and positron emission tomography using rubidium stress (RbPET) – had nearly identical accuracy for ruling-in or ruling-out coronary disease, making them for at least the time being equally appropriate to use when assessing low- or intermediate-risk patients with symptoms suggestive of possible coronary disease in a prospective, multicenter study with 372 patients.

RbPET and CMR using a 3 Tesla device showed “absolutely similar performance,” in a head-to-head comparison that used fractional flow reserve assessment via invasive coronary angiography in each patient in the study as the arbiter of the true extent of coronary disease, reported Morten Bøttcher, MD, PhD, at the annual congress of the European Society of Cardiology.

Mitchel L. Zoler/MDedge

This result is good news for practice because clinicians can feel free to use whichever of the two assessment methods is most feasible for each patient, said Dr. Bøttcher, a researcher at Aarhus (Denmark) University Hospital. But the study was limited by its size, and he hopes to run a future study with many more patients to try to more definitively compare RbPET and CMR.

‘The techniques are probably interchangeable’

“There is a very clear result from the data: The performance of the two modalities is similar in the population studied,” commented Colin Berry, MBChB, PhD, professor of cardiology and imaging at the University of Glasgow (Scotland), and designated discussant for the report. “The techniques are probably interchangeable,” he said.

Mitchel L. Zoler/MDedge

Dr. Bøttcher and his associates designed the Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease 2 (Dan-NICAD 2) to address a knowledge gap highlighted in the 2019 guidelines of the European Society of Cardiology for the management of patients with chronic coronary syndromes, specifically low- or intermediate-risk patients who present with symptoms of possible coronary disease who have been identified as having possibly stenotic coronary lesions using coronary CT angiography. The guidelines cite using noninvasive imaging at this point prior to invasive angiography, but note that the relative performance of the various imaging options available for this step in unknown, said Dr. Bøttcher.

The researchers enrolled 372 patients at any of four hospitals in Denmark who agreed to participate and had a positive result on a coronary CT examination performed to assess their symptoms of coronary disease. (These 372 patients came from an initial pool of people that was fourfold larger, but three-quarters had negative findings on their coronary CT examination.) Clinicians had referred all of these patients to invasive angiography with fractional flow reserve assessment, and prior to that procedure they each underwent both a RbPET and a CMR examination for the purpose of this study. The researchers used each patient’s eventual invasive angiography result as the definitive determinant of their coronary disease. These patients averaged 64 years old, and 71% were men.

This analysis showed that for all 372 patients RbPET had 63% sensitivity and 87% specificity for identifying hemodynamically obstructive coronary disease, with rates of 60% and 85%, respectively, for CMR. In the subgroup of 71 patients (19%) who had obstructive coronary disease when examined by invasive angiography the sensitivity and specificity of the RbPET examination was 90% and 78%, and for CMR the sensitivity and specificity was 83% and 76%, Dr. Bøttcher reported.

Negative imaging, positive FFR

He also noted that it remains unclear how to best manage patients who show no signs of ischemia when examined by RbPET or CMR, but have an apparently hemodynamically meaningful coronary lesion when assessed by invasive angiography and fractional flow reserve. “We don’t know whether we should be guided by the negative scan or by the positive FFR result,” Dr. Bøttcher said. “There is a challenge when you get different results.”

In addition, the two compared imaging methods both have logistical limitations. RbPET involved radiation exposure, and CMR performed with a 3-tesla device may not be as widely available and requires more expensive equipment.

Dr. Berry also noted that imaging methods continue to advance. For example, the CMR examinations used in the study involved qualitative assessments, but quantitative CMR is now becoming more widely available and may provide enhanced diagnostic capabilities. Dr. Berry added that patients with symptoms of coronary disease but without an identifiable coronary obstruction may have microvascular coronary disease, a disorder that he has been at the forefront of describing.

Dan-NICAD 2 received no commercial funding. Dr. Bøttcher has been an adviser to Acarix, Amgen, AstraZeneca, Bayer, and Novo Nordisk. Dr. Berry had no disclosures.

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.