The US Department of Veterans Affairs (VA) announced plans to expand preventive services, health care, and benefits for veterans with cancer.

Urethral cancers are set to be added to the list of > 300 conditions considered presumptive under the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics (PACT) Act of 2022. Veterans deployed to Iraq, Afghanistan, Somalia, Djibouti, Egypt, Jordan, Lebanon, Syria, Yemen, Uzbekistan, and the entire Southwest Asia theater will not need to prove their service caused their urethral cancer in order to receive treatment for it. Additionally, the VA plans to evaluate whether there is a relationship between urinary bladder and ureteral cancers and toxic exposures for these veterans, and determine whether these conditions are presumptive. The VA has already screened > 5 million veterans for toxic exposures under the PACT Act, as part of an ongoing mission to expand cancer care services.

The VA is also set to expand access to screening programs in 2024 by providing:

• genetic testing to every veteran who may need it;
• lung cancer screening programs to every VA medical center; and
• home tests for colorectal cancer to > 1 million veterans nationwide.

The VA continues to expand the reach of smoking cessation services, with ≥ 6 additional sites added to the Quit VET eReferral program by the end of 2024, and a new pilot program to integrate smoking cessation services into lung cancer screening. 

The VA has already taken steps to build on the Biden-Harris Administration Cancer Moonshot program, which has the goals of preventing ≥ 4 million cancer deaths by 2047 and to improve the experience of individuals with cancer. For instance, it has prioritized claims processing for veterans with cancer and expanded cancer risk assessments and mammograms to veterans aged < 40 years, regardless of age, symptoms, family history, or whether they are enrolled in VA health care. In September, the VA and the National Cancer Institute announced a data-sharing collaboration to better understand and treat cancer among veterans.

“VA is planting the seeds for the future of cancer care,” said VHA Under Secretary for Health Shereef Elnahal, MD. “By investing in screenings, expanding access, and embracing cutting-edge technologies, VA is revolutionizing cancer care delivery, providing the best care possible to our nation’s heroes.” 

The US Department of Veterans Affairs (VA) announced plans to expand preventive services, health care, and benefits for veterans with cancer.

Urethral cancers are set to be added to the list of > 300 conditions considered presumptive under the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics (PACT) Act of 2022. Veterans deployed to Iraq, Afghanistan, Somalia, Djibouti, Egypt, Jordan, Lebanon, Syria, Yemen, Uzbekistan, and the entire Southwest Asia theater will not need to prove their service caused their urethral cancer in order to receive treatment for it. Additionally, the VA plans to evaluate whether there is a relationship between urinary bladder and ureteral cancers and toxic exposures for these veterans, and determine whether these conditions are presumptive. The VA has already screened > 5 million veterans for toxic exposures under the PACT Act, as part of an ongoing mission to expand cancer care services.

The VA is also set to expand access to screening programs in 2024 by providing:

• genetic testing to every veteran who may need it;
• lung cancer screening programs to every VA medical center; and
• home tests for colorectal cancer to > 1 million veterans nationwide.

The VA continues to expand the reach of smoking cessation services, with ≥ 6 additional sites added to the Quit VET eReferral program by the end of 2024, and a new pilot program to integrate smoking cessation services into lung cancer screening. 

The VA has already taken steps to build on the Biden-Harris Administration Cancer Moonshot program, which has the goals of preventing ≥ 4 million cancer deaths by 2047 and to improve the experience of individuals with cancer. For instance, it has prioritized claims processing for veterans with cancer and expanded cancer risk assessments and mammograms to veterans aged < 40 years, regardless of age, symptoms, family history, or whether they are enrolled in VA health care. In September, the VA and the National Cancer Institute announced a data-sharing collaboration to better understand and treat cancer among veterans.

“VA is planting the seeds for the future of cancer care,” said VHA Under Secretary for Health Shereef Elnahal, MD. “By investing in screenings, expanding access, and embracing cutting-edge technologies, VA is revolutionizing cancer care delivery, providing the best care possible to our nation’s heroes.” 

The US Department of Veterans Affairs (VA) announced plans to expand preventive services, health care, and benefits for veterans with cancer.

Urethral cancers are set to be added to the list of > 300 conditions considered presumptive under the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics (PACT) Act of 2022. Veterans deployed to Iraq, Afghanistan, Somalia, Djibouti, Egypt, Jordan, Lebanon, Syria, Yemen, Uzbekistan, and the entire Southwest Asia theater will not need to prove their service caused their urethral cancer in order to receive treatment for it. Additionally, the VA plans to evaluate whether there is a relationship between urinary bladder and ureteral cancers and toxic exposures for these veterans, and determine whether these conditions are presumptive. The VA has already screened > 5 million veterans for toxic exposures under the PACT Act, as part of an ongoing mission to expand cancer care services.

The VA is also set to expand access to screening programs in 2024 by providing:

• genetic testing to every veteran who may need it;
• lung cancer screening programs to every VA medical center; and
• home tests for colorectal cancer to > 1 million veterans nationwide.

The VA continues to expand the reach of smoking cessation services, with ≥ 6 additional sites added to the Quit VET eReferral program by the end of 2024, and a new pilot program to integrate smoking cessation services into lung cancer screening. 

The VA has already taken steps to build on the Biden-Harris Administration Cancer Moonshot program, which has the goals of preventing ≥ 4 million cancer deaths by 2047 and to improve the experience of individuals with cancer. For instance, it has prioritized claims processing for veterans with cancer and expanded cancer risk assessments and mammograms to veterans aged < 40 years, regardless of age, symptoms, family history, or whether they are enrolled in VA health care. In September, the VA and the National Cancer Institute announced a data-sharing collaboration to better understand and treat cancer among veterans.

“VA is planting the seeds for the future of cancer care,” said VHA Under Secretary for Health Shereef Elnahal, MD. “By investing in screenings, expanding access, and embracing cutting-edge technologies, VA is revolutionizing cancer care delivery, providing the best care possible to our nation’s heroes.” 

An experimental therapeutic DNA vaccine against human papillomavirus type 16 (HPV16) was safe and well tolerated, and successfully cleared the virus in a majority of patients with HPV16-positive cervical intraepithelial neoplasia (CIN) 2 or 3 in a phase I trial.

The vaccine, pNGVL4a-CRTE6E7L2, also showed signs of efficacy in patients living with HIV, reported Kimberly Lynn Levinson, MD, MPH, associate professor of obstetrics and gynecology at Johns Hopkins Medicine in Baltimore.

“We demonstrated a 78% rate of clearance for both histologic regression and HPV16, with some clearance of other HPV types,” she said in an oral abstract presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer, held in San Diego.

Further evaluation of the vaccine in vulvar, vaginal, and other tissue types is required, and evaluation of immune response at the local and systemic is ongoing, Dr. Levinson said.

In contrast to HPV16 prophylactic vaccines, which form an antibody-specific response to HPV, therapeutic vaccines elicit a cell-mediated immunity, primarily focusing on the virus’ E6 and E7 proteins.

There are currently only three Food and Drug Administration–approved therapeutic vaccines for cancer, but none are as yet approved for treatment of gynecologic malignancies.

According to the US National Institutes of Health, there are multiple therapeutic HPV vaccines in development using either vector-based, peptide and protein-based, or nucleic-acid based approaches, or whole cell (dendritic cell) approaches.
 

Current Study

Dr. Levinson noted that “DNA vaccines are both well tolerated and simple to produce, and the addition of calreticulin enhances immune response.”

The investigational vaccine is delivered via an electoporation device (TriGrid delivery system) that stimulates muscle at the injection site to produce an enhanced immune response.

In preclinical studies the device was associated with an enhanced immune response compared with standard intramuscular injection. The enhance immune effect persisted despite CD4 T cell depletion.

The investigators conducted a phase 1 dose-escalation study, administering the vaccine to two separate cohorts: women without HIV who had HPV16-positive cervical dysplasia (CIN 2/3) and women living with HIV with HPV16-positive cervical or vulvovaginal dysplasia (CIN 2/3, VIN 2/3 or VAIN 2/3).

The vaccine was delivered at weeks 0, 4, and 8, at doses of 0.3 mg, 1.0 mg, or 3.0 mg. At week 12, all patients underwent site-specific biopsy to verify non-progression.

At 6 months, the patients then underwent definitive treatment with either loop electro excision or vulvar/vaginal excision. At 12 months, all patients had standard evaluations with biopsies.

Dr. Levinson reported results for the first 14 women enrolled, 10 of whom were HIV-negative and 4 of whom were HIV-positive.

Of nine women in the HIV-negative arm who had completed 6-month visits and were evaluable, two had HPV16 clearance by 2-month follow-up, and seven had clearance at 6 months. Other HPV subtypes cleared in two of five patients at 3 months and in three of five at 6 months.

In addition, seven of nine patients in this arm had histologic regression at 6 months.

In the HIV-positive arm, the two patients with CIN had no HPV16 clearance at 3 months, but both had clearance at 16 months. The vaccine did not clear other HPV subtypes in these patients, however.

Of the two women in this arm who had VIN, one had HPV16 clearance and histologic regression at 6 months. The other patient had neither viral clearance nor histologic regression.

All participants tolerated each vaccine well. Adverse events were all grade 1 in severity and resolved within 4 weeks. The most common event was tenderness at the injection site. There were also three cases of mild headache, two cases of drowsiness, and one of nausea.
 

What’s Next?

In the question-and-answer session following the presentation, Ronald D. Alvarez, MD, MBA, chairman and clinical service chief of obstetrics and gynecology at Vanderbilt University Medical Center in Nashville, Tennessee, asked Dr. Levinson how the vaccine development will proceed.

“Obviously, you have more data to collect and analyze, but how are you going to move forward with what looks like equal efficacy between the 1 milligram and the 3 milligram doses? Are you just going to go with the maximum tolerated dose, or consider a lower dose if it shows equal efficacy in terms of histologic regression as well as HPV clearance?” he asked.

“This is something we’re very interested in, and we do plan for the dose-expansion phase to go with the higher dose,” Dr. Levinson replied. “We need to evaluate it further and we may need to do further randomization between the medium dose and the highest dose to determine if there are differences both with systemic and local responses.”

Robert DeBernardo, MD, section head of obstetrics and gynecology and the Women’s Health Institute at the Cleveland Clinic, asked whether Dr. Levinson and colleagues were considering evaluating the vaccine in transplant recipients, “because we have a lot of persistent HPV in that subgroup.”

Dr. Levinson said that one of the dose-expansion cohorts for further study is a population of patients scheduled for transplantation.

“What we’re interested in is looking at whether we can ‘cure’ HPV prior to transplantation, and we think that’s going to be the best way to show that this vaccine potentially eliminates the virus, because if we can eliminate the virus and then take a population that’s going to be immunodeficient, then that would show that there’s no reactivation of the virus,” she said.

The study is supported by the National Institutes of Health. Dr. Levinson, Dr. Alvarez, and Dr. DeBernardo had no conflicts of interest to report.

An experimental therapeutic DNA vaccine against human papillomavirus type 16 (HPV16) was safe and well tolerated, and successfully cleared the virus in a majority of patients with HPV16-positive cervical intraepithelial neoplasia (CIN) 2 or 3 in a phase I trial.

The vaccine, pNGVL4a-CRTE6E7L2, also showed signs of efficacy in patients living with HIV, reported Kimberly Lynn Levinson, MD, MPH, associate professor of obstetrics and gynecology at Johns Hopkins Medicine in Baltimore.

“We demonstrated a 78% rate of clearance for both histologic regression and HPV16, with some clearance of other HPV types,” she said in an oral abstract presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer, held in San Diego.

Further evaluation of the vaccine in vulvar, vaginal, and other tissue types is required, and evaluation of immune response at the local and systemic is ongoing, Dr. Levinson said.

In contrast to HPV16 prophylactic vaccines, which form an antibody-specific response to HPV, therapeutic vaccines elicit a cell-mediated immunity, primarily focusing on the virus’ E6 and E7 proteins.

There are currently only three Food and Drug Administration–approved therapeutic vaccines for cancer, but none are as yet approved for treatment of gynecologic malignancies.

According to the US National Institutes of Health, there are multiple therapeutic HPV vaccines in development using either vector-based, peptide and protein-based, or nucleic-acid based approaches, or whole cell (dendritic cell) approaches.
 

Current Study

Dr. Levinson noted that “DNA vaccines are both well tolerated and simple to produce, and the addition of calreticulin enhances immune response.”

The investigational vaccine is delivered via an electoporation device (TriGrid delivery system) that stimulates muscle at the injection site to produce an enhanced immune response.

In preclinical studies the device was associated with an enhanced immune response compared with standard intramuscular injection. The enhance immune effect persisted despite CD4 T cell depletion.

The investigators conducted a phase 1 dose-escalation study, administering the vaccine to two separate cohorts: women without HIV who had HPV16-positive cervical dysplasia (CIN 2/3) and women living with HIV with HPV16-positive cervical or vulvovaginal dysplasia (CIN 2/3, VIN 2/3 or VAIN 2/3).

The vaccine was delivered at weeks 0, 4, and 8, at doses of 0.3 mg, 1.0 mg, or 3.0 mg. At week 12, all patients underwent site-specific biopsy to verify non-progression.

At 6 months, the patients then underwent definitive treatment with either loop electro excision or vulvar/vaginal excision. At 12 months, all patients had standard evaluations with biopsies.

Dr. Levinson reported results for the first 14 women enrolled, 10 of whom were HIV-negative and 4 of whom were HIV-positive.

Of nine women in the HIV-negative arm who had completed 6-month visits and were evaluable, two had HPV16 clearance by 2-month follow-up, and seven had clearance at 6 months. Other HPV subtypes cleared in two of five patients at 3 months and in three of five at 6 months.

In addition, seven of nine patients in this arm had histologic regression at 6 months.

In the HIV-positive arm, the two patients with CIN had no HPV16 clearance at 3 months, but both had clearance at 16 months. The vaccine did not clear other HPV subtypes in these patients, however.

Of the two women in this arm who had VIN, one had HPV16 clearance and histologic regression at 6 months. The other patient had neither viral clearance nor histologic regression.

All participants tolerated each vaccine well. Adverse events were all grade 1 in severity and resolved within 4 weeks. The most common event was tenderness at the injection site. There were also three cases of mild headache, two cases of drowsiness, and one of nausea.
 

What’s Next?

In the question-and-answer session following the presentation, Ronald D. Alvarez, MD, MBA, chairman and clinical service chief of obstetrics and gynecology at Vanderbilt University Medical Center in Nashville, Tennessee, asked Dr. Levinson how the vaccine development will proceed.

“Obviously, you have more data to collect and analyze, but how are you going to move forward with what looks like equal efficacy between the 1 milligram and the 3 milligram doses? Are you just going to go with the maximum tolerated dose, or consider a lower dose if it shows equal efficacy in terms of histologic regression as well as HPV clearance?” he asked.

“This is something we’re very interested in, and we do plan for the dose-expansion phase to go with the higher dose,” Dr. Levinson replied. “We need to evaluate it further and we may need to do further randomization between the medium dose and the highest dose to determine if there are differences both with systemic and local responses.”

Robert DeBernardo, MD, section head of obstetrics and gynecology and the Women’s Health Institute at the Cleveland Clinic, asked whether Dr. Levinson and colleagues were considering evaluating the vaccine in transplant recipients, “because we have a lot of persistent HPV in that subgroup.”

Dr. Levinson said that one of the dose-expansion cohorts for further study is a population of patients scheduled for transplantation.

“What we’re interested in is looking at whether we can ‘cure’ HPV prior to transplantation, and we think that’s going to be the best way to show that this vaccine potentially eliminates the virus, because if we can eliminate the virus and then take a population that’s going to be immunodeficient, then that would show that there’s no reactivation of the virus,” she said.

The study is supported by the National Institutes of Health. Dr. Levinson, Dr. Alvarez, and Dr. DeBernardo had no conflicts of interest to report.

An experimental therapeutic DNA vaccine against human papillomavirus type 16 (HPV16) was safe and well tolerated, and successfully cleared the virus in a majority of patients with HPV16-positive cervical intraepithelial neoplasia (CIN) 2 or 3 in a phase I trial.

The vaccine, pNGVL4a-CRTE6E7L2, also showed signs of efficacy in patients living with HIV, reported Kimberly Lynn Levinson, MD, MPH, associate professor of obstetrics and gynecology at Johns Hopkins Medicine in Baltimore.

“We demonstrated a 78% rate of clearance for both histologic regression and HPV16, with some clearance of other HPV types,” she said in an oral abstract presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer, held in San Diego.

Further evaluation of the vaccine in vulvar, vaginal, and other tissue types is required, and evaluation of immune response at the local and systemic is ongoing, Dr. Levinson said.

In contrast to HPV16 prophylactic vaccines, which form an antibody-specific response to HPV, therapeutic vaccines elicit a cell-mediated immunity, primarily focusing on the virus’ E6 and E7 proteins.

There are currently only three Food and Drug Administration–approved therapeutic vaccines for cancer, but none are as yet approved for treatment of gynecologic malignancies.

According to the US National Institutes of Health, there are multiple therapeutic HPV vaccines in development using either vector-based, peptide and protein-based, or nucleic-acid based approaches, or whole cell (dendritic cell) approaches.
 

Current Study

Dr. Levinson noted that “DNA vaccines are both well tolerated and simple to produce, and the addition of calreticulin enhances immune response.”

The investigational vaccine is delivered via an electoporation device (TriGrid delivery system) that stimulates muscle at the injection site to produce an enhanced immune response.

In preclinical studies the device was associated with an enhanced immune response compared with standard intramuscular injection. The enhance immune effect persisted despite CD4 T cell depletion.

The investigators conducted a phase 1 dose-escalation study, administering the vaccine to two separate cohorts: women without HIV who had HPV16-positive cervical dysplasia (CIN 2/3) and women living with HIV with HPV16-positive cervical or vulvovaginal dysplasia (CIN 2/3, VIN 2/3 or VAIN 2/3).

The vaccine was delivered at weeks 0, 4, and 8, at doses of 0.3 mg, 1.0 mg, or 3.0 mg. At week 12, all patients underwent site-specific biopsy to verify non-progression.

At 6 months, the patients then underwent definitive treatment with either loop electro excision or vulvar/vaginal excision. At 12 months, all patients had standard evaluations with biopsies.

Dr. Levinson reported results for the first 14 women enrolled, 10 of whom were HIV-negative and 4 of whom were HIV-positive.

Of nine women in the HIV-negative arm who had completed 6-month visits and were evaluable, two had HPV16 clearance by 2-month follow-up, and seven had clearance at 6 months. Other HPV subtypes cleared in two of five patients at 3 months and in three of five at 6 months.

In addition, seven of nine patients in this arm had histologic regression at 6 months.

In the HIV-positive arm, the two patients with CIN had no HPV16 clearance at 3 months, but both had clearance at 16 months. The vaccine did not clear other HPV subtypes in these patients, however.

Of the two women in this arm who had VIN, one had HPV16 clearance and histologic regression at 6 months. The other patient had neither viral clearance nor histologic regression.

All participants tolerated each vaccine well. Adverse events were all grade 1 in severity and resolved within 4 weeks. The most common event was tenderness at the injection site. There were also three cases of mild headache, two cases of drowsiness, and one of nausea.
 

What’s Next?

In the question-and-answer session following the presentation, Ronald D. Alvarez, MD, MBA, chairman and clinical service chief of obstetrics and gynecology at Vanderbilt University Medical Center in Nashville, Tennessee, asked Dr. Levinson how the vaccine development will proceed.

“Obviously, you have more data to collect and analyze, but how are you going to move forward with what looks like equal efficacy between the 1 milligram and the 3 milligram doses? Are you just going to go with the maximum tolerated dose, or consider a lower dose if it shows equal efficacy in terms of histologic regression as well as HPV clearance?” he asked.

“This is something we’re very interested in, and we do plan for the dose-expansion phase to go with the higher dose,” Dr. Levinson replied. “We need to evaluate it further and we may need to do further randomization between the medium dose and the highest dose to determine if there are differences both with systemic and local responses.”

Robert DeBernardo, MD, section head of obstetrics and gynecology and the Women’s Health Institute at the Cleveland Clinic, asked whether Dr. Levinson and colleagues were considering evaluating the vaccine in transplant recipients, “because we have a lot of persistent HPV in that subgroup.”

Dr. Levinson said that one of the dose-expansion cohorts for further study is a population of patients scheduled for transplantation.

“What we’re interested in is looking at whether we can ‘cure’ HPV prior to transplantation, and we think that’s going to be the best way to show that this vaccine potentially eliminates the virus, because if we can eliminate the virus and then take a population that’s going to be immunodeficient, then that would show that there’s no reactivation of the virus,” she said.

The study is supported by the National Institutes of Health. Dr. Levinson, Dr. Alvarez, and Dr. DeBernardo had no conflicts of interest to report.

Living in a disadvantaged neighborhood is associated with accelerated brain aging and a higher risk for early dementia, regardless of income level or education, new research suggested.

Analysis of two datasets revealed that people living in the most disadvantaged neighborhoods had a more than 20% higher risk for dementia than those in other areas and measurably poorer brain health as early as age 45, regardless of their own personal income and education.

“If you want to prevent dementia and you’re not asking someone about their neighborhood, you’re missing information that’s important to know,” lead author Aaron Reuben, PhD, postdoctoral scholar in neuropsychology and environmental health at Duke University, Durham, North Carolina, said in a news release.

The study was published online in Alzheimer’s & Dementia.

Higher Risk in Men

Few interventions exist to halt or delay the progression of Alzheimer’s disease and related dementias (ADRD), which has increasingly led to a focus on primary prevention.

Although previous research pointed to a link between socioeconomically disadvantaged neighborhoods and a greater risk for cognitive deficits, mild cognitive impairment, dementia, and poor brain health, the timeline for the emergence of that risk is unknown.

To fill in the gaps, investigators studied data on all 1.4 million New Zealand residents, dividing neighborhoods into quintiles based on level of disadvantage (assessed by the New Zealand Index of Deprivation) to see whether dementia diagnoses followed neighborhood socioeconomic gradients.

After adjusting for covariates, they found that overall, those living in disadvantaged areas were slightly more likely to develop dementia across the 20-year study period (adjusted hazard ratio [HR], 1.09; 95% CI, 1.08-1.10).

The more disadvantaged the neighborhood, the higher the dementia risk, with a 43% higher risk for ADRD among those in the highest quintile than among those in the lowest quintile (HR, 1.43; 95% CI, 1.36-1.49).

The effect was larger in men than in women and in younger vs older individuals, with the youngest age group showing 21% greater risk in women and 26% greater risk in men vs the oldest age group.

Dementia Prevention Starts Early

Researchers then turned to the Dunedin Study, a cohort of 938 New Zealanders (50% female) followed from birth to age 45 to track their psychological, social, and physiological health with brain scans, memory tests, and cognitive self-assessments.

The analysis suggested that by age 45, those living in more disadvantaged neighborhoods across adulthood had accumulated a significantly greater number of midlife risk factors for later ADRD.

They also had worse structural brain integrity, with each standard deviation increase in neighborhood disadvantage resulting in a thinner cortex, greater white matter hyperintensities volume, and older brain age.

Those living in poorer areas had lower cognitive test scores, reported more issues with everyday cognitive function, and showed a greater reduction in IQ from childhood to midlife. Analysis of brain scans also revealed mean brain ages 2.98 years older than those living in the least disadvantaged areas (P = .001).

Limitations included the study’s observational design, which could not establish causation, and the fact that the researchers did not have access to individual-level socioeconomic information for the entire population. Additionally, brain-integrity measures in the Dunedin Study were largely cross-sectional.

“If you want to truly prevent dementia, you’ve got to start early because 20 years before anyone will get a diagnosis, we’re seeing dementia’s emergence,” Dr. Reuben said. “And it could be even earlier.”

Funding for the study was provided by the National Institutes for Health; UK Medical Research Council; Health Research Council of New Zealand; Brain Research New Zealand; New Zealand Ministry of Business, Innovation, & Employment; and the Duke University and the University of North Carolina Alzheimer’s Disease Research Center. The authors declared no relevant financial relationships.

A version of this article appeared on Medscape.com.

Living in a disadvantaged neighborhood is associated with accelerated brain aging and a higher risk for early dementia, regardless of income level or education, new research suggested.

Analysis of two datasets revealed that people living in the most disadvantaged neighborhoods had a more than 20% higher risk for dementia than those in other areas and measurably poorer brain health as early as age 45, regardless of their own personal income and education.

“If you want to prevent dementia and you’re not asking someone about their neighborhood, you’re missing information that’s important to know,” lead author Aaron Reuben, PhD, postdoctoral scholar in neuropsychology and environmental health at Duke University, Durham, North Carolina, said in a news release.

The study was published online in Alzheimer’s & Dementia.

Higher Risk in Men

Few interventions exist to halt or delay the progression of Alzheimer’s disease and related dementias (ADRD), which has increasingly led to a focus on primary prevention.

Although previous research pointed to a link between socioeconomically disadvantaged neighborhoods and a greater risk for cognitive deficits, mild cognitive impairment, dementia, and poor brain health, the timeline for the emergence of that risk is unknown.

To fill in the gaps, investigators studied data on all 1.4 million New Zealand residents, dividing neighborhoods into quintiles based on level of disadvantage (assessed by the New Zealand Index of Deprivation) to see whether dementia diagnoses followed neighborhood socioeconomic gradients.

After adjusting for covariates, they found that overall, those living in disadvantaged areas were slightly more likely to develop dementia across the 20-year study period (adjusted hazard ratio [HR], 1.09; 95% CI, 1.08-1.10).

The more disadvantaged the neighborhood, the higher the dementia risk, with a 43% higher risk for ADRD among those in the highest quintile than among those in the lowest quintile (HR, 1.43; 95% CI, 1.36-1.49).

The effect was larger in men than in women and in younger vs older individuals, with the youngest age group showing 21% greater risk in women and 26% greater risk in men vs the oldest age group.

Dementia Prevention Starts Early

Researchers then turned to the Dunedin Study, a cohort of 938 New Zealanders (50% female) followed from birth to age 45 to track their psychological, social, and physiological health with brain scans, memory tests, and cognitive self-assessments.

The analysis suggested that by age 45, those living in more disadvantaged neighborhoods across adulthood had accumulated a significantly greater number of midlife risk factors for later ADRD.

They also had worse structural brain integrity, with each standard deviation increase in neighborhood disadvantage resulting in a thinner cortex, greater white matter hyperintensities volume, and older brain age.

Those living in poorer areas had lower cognitive test scores, reported more issues with everyday cognitive function, and showed a greater reduction in IQ from childhood to midlife. Analysis of brain scans also revealed mean brain ages 2.98 years older than those living in the least disadvantaged areas (P = .001).

Limitations included the study’s observational design, which could not establish causation, and the fact that the researchers did not have access to individual-level socioeconomic information for the entire population. Additionally, brain-integrity measures in the Dunedin Study were largely cross-sectional.

“If you want to truly prevent dementia, you’ve got to start early because 20 years before anyone will get a diagnosis, we’re seeing dementia’s emergence,” Dr. Reuben said. “And it could be even earlier.”

Funding for the study was provided by the National Institutes for Health; UK Medical Research Council; Health Research Council of New Zealand; Brain Research New Zealand; New Zealand Ministry of Business, Innovation, & Employment; and the Duke University and the University of North Carolina Alzheimer’s Disease Research Center. The authors declared no relevant financial relationships.

A version of this article appeared on Medscape.com.

Living in a disadvantaged neighborhood is associated with accelerated brain aging and a higher risk for early dementia, regardless of income level or education, new research suggested.

Analysis of two datasets revealed that people living in the most disadvantaged neighborhoods had a more than 20% higher risk for dementia than those in other areas and measurably poorer brain health as early as age 45, regardless of their own personal income and education.

“If you want to prevent dementia and you’re not asking someone about their neighborhood, you’re missing information that’s important to know,” lead author Aaron Reuben, PhD, postdoctoral scholar in neuropsychology and environmental health at Duke University, Durham, North Carolina, said in a news release.

The study was published online in Alzheimer’s & Dementia.

Higher Risk in Men

Few interventions exist to halt or delay the progression of Alzheimer’s disease and related dementias (ADRD), which has increasingly led to a focus on primary prevention.

Although previous research pointed to a link between socioeconomically disadvantaged neighborhoods and a greater risk for cognitive deficits, mild cognitive impairment, dementia, and poor brain health, the timeline for the emergence of that risk is unknown.

To fill in the gaps, investigators studied data on all 1.4 million New Zealand residents, dividing neighborhoods into quintiles based on level of disadvantage (assessed by the New Zealand Index of Deprivation) to see whether dementia diagnoses followed neighborhood socioeconomic gradients.

After adjusting for covariates, they found that overall, those living in disadvantaged areas were slightly more likely to develop dementia across the 20-year study period (adjusted hazard ratio [HR], 1.09; 95% CI, 1.08-1.10).

The more disadvantaged the neighborhood, the higher the dementia risk, with a 43% higher risk for ADRD among those in the highest quintile than among those in the lowest quintile (HR, 1.43; 95% CI, 1.36-1.49).

The effect was larger in men than in women and in younger vs older individuals, with the youngest age group showing 21% greater risk in women and 26% greater risk in men vs the oldest age group.

Dementia Prevention Starts Early

Researchers then turned to the Dunedin Study, a cohort of 938 New Zealanders (50% female) followed from birth to age 45 to track their psychological, social, and physiological health with brain scans, memory tests, and cognitive self-assessments.

The analysis suggested that by age 45, those living in more disadvantaged neighborhoods across adulthood had accumulated a significantly greater number of midlife risk factors for later ADRD.

They also had worse structural brain integrity, with each standard deviation increase in neighborhood disadvantage resulting in a thinner cortex, greater white matter hyperintensities volume, and older brain age.

Those living in poorer areas had lower cognitive test scores, reported more issues with everyday cognitive function, and showed a greater reduction in IQ from childhood to midlife. Analysis of brain scans also revealed mean brain ages 2.98 years older than those living in the least disadvantaged areas (P = .001).

Limitations included the study’s observational design, which could not establish causation, and the fact that the researchers did not have access to individual-level socioeconomic information for the entire population. Additionally, brain-integrity measures in the Dunedin Study were largely cross-sectional.

“If you want to truly prevent dementia, you’ve got to start early because 20 years before anyone will get a diagnosis, we’re seeing dementia’s emergence,” Dr. Reuben said. “And it could be even earlier.”

Funding for the study was provided by the National Institutes for Health; UK Medical Research Council; Health Research Council of New Zealand; Brain Research New Zealand; New Zealand Ministry of Business, Innovation, & Employment; and the Duke University and the University of North Carolina Alzheimer’s Disease Research Center. The authors declared no relevant financial relationships.

A version of this article appeared on Medscape.com.

Adding low-dose radiation to the current standard first-line treatment, durvalumab plus etoposide-platinum chemotherapy, appears to improve survival outcomes in patients with extensive-stage small cell lung cancer (SCLC), suggested new findings from a small, single-arm study.

The analysis, presented at the 2024 European Lung Cancer Congress, revealed that low-dose radiation improved patients’ median progression-free and overall survival compared with standard first-line treatment, reported in a 2019 trial, lead author Yan Zhang, MD, reported.

The standard first-line treatment results came from the 2019 CASPIAN trial, which found that patients receiving the first-line regimen had a median progression-free survival of 5 months and a median overall survival of 13 months, with 54% of patient alive at 1 year.

The latest data, which included a small cohort of 30 patients, revealed that adding low-dose radiation to the standard first-line therapy led to a higher median progression-free survival of 8.3 months and extended median overall survival beyond the study follow-up period of 17.3 months. Overall, 66% of patients were alive at 1 year.

These are “promising” improvements over CASPIAN, Dr. Zhang, a lung cancer medical oncologist at Sichuan University, Chengdu, China, said at the Congress, which was organized by the European Society for Medical Oncology.

Study discussant Gerry Hanna, PhD, MBBS, a radiation oncologist at Belfast City Hospital, Belfast, Northern Ireland, agreed. Although there were just 30 patients, “you cannot deny these are [strong] results in terms of extensive-stage small cell cancer,” Dr. Hanna said.

Although standard first-line treatment of extensive-stage SCLC is durvalumab plus etoposide-platinum chemotherapy, the benefits aren’t durable for many patients.

This problem led Dr. Zhang and his colleagues to look for ways to improve outcomes. Because the CASPIAN trial did not include radiation to the primary tumor, it seemed a logical strategy to explore.

In the current single-arm study, Dr. Zhang and his team added 15 Gy radiation in five fractions to the primary lung tumors of 30 patients during the first cycle of durvalumab plus etoposide-platinum.

Subjects received 1500 mg of durvalumab plus etoposide-platinum every 3 weeks for four cycles. Low-dose radiation to the primary tumor was delivered over 5 days at the start of treatment. Patients then continued with durvalumab maintenance every 4 weeks until progression or intolerable toxicity.

Six patients (20%) had liver metastases at the baseline, and three (10%) had brain metastases. Over half had prophylactic cranial radiation. Performance scores were 0-1, and all but one of the participants were men.

Six- and 12-month progression-free survival rates were 57% and 40%, respectively. Overall survival was 90% at 6 months and 66% at 12 months. Median overall survival was 13 months in the CASPIAN trial but not reached in Dr. Zhang’s trial after a median follow-up of 17.3 months, with the earliest deaths occurring at 10.8 months.

Grade 3 treatment-related adverse events occurred in 80% of patients, most frequently hematologic toxicities. Five patients (16.7%) had severe adverse reactions to radiation. Although the overall dose of radiation was low, at 3 Gy each, the fractions were on the large side.

Hanna wanted more information on the radiotoxicity issue, but even so, he said that adding low-dose radiation to our durvalumab-chemotherapy doublet warrants further investigation.

Both Dr. Hanna and Dr. Zhang thought that instead of killing cancer cells directly, the greatest benefit of upfront radiation, and the peritumoral inflammation it causes, is to augment durvalumab’s effect.

Overall, Dr. Hanna stressed that we haven’t had results like these before in a SCLC study, particularly for novel agents, let alone radiation.

The study was funded by AstraZeneca, maker of durvalumab. Dr. Zhang and Dr. Hanna didn’t have any relevant disclosures.

A version of this article appeared on Medscape.com.

Adding low-dose radiation to the current standard first-line treatment, durvalumab plus etoposide-platinum chemotherapy, appears to improve survival outcomes in patients with extensive-stage small cell lung cancer (SCLC), suggested new findings from a small, single-arm study.

The analysis, presented at the 2024 European Lung Cancer Congress, revealed that low-dose radiation improved patients’ median progression-free and overall survival compared with standard first-line treatment, reported in a 2019 trial, lead author Yan Zhang, MD, reported.

The standard first-line treatment results came from the 2019 CASPIAN trial, which found that patients receiving the first-line regimen had a median progression-free survival of 5 months and a median overall survival of 13 months, with 54% of patient alive at 1 year.

The latest data, which included a small cohort of 30 patients, revealed that adding low-dose radiation to the standard first-line therapy led to a higher median progression-free survival of 8.3 months and extended median overall survival beyond the study follow-up period of 17.3 months. Overall, 66% of patients were alive at 1 year.

These are “promising” improvements over CASPIAN, Dr. Zhang, a lung cancer medical oncologist at Sichuan University, Chengdu, China, said at the Congress, which was organized by the European Society for Medical Oncology.

Study discussant Gerry Hanna, PhD, MBBS, a radiation oncologist at Belfast City Hospital, Belfast, Northern Ireland, agreed. Although there were just 30 patients, “you cannot deny these are [strong] results in terms of extensive-stage small cell cancer,” Dr. Hanna said.

Although standard first-line treatment of extensive-stage SCLC is durvalumab plus etoposide-platinum chemotherapy, the benefits aren’t durable for many patients.

This problem led Dr. Zhang and his colleagues to look for ways to improve outcomes. Because the CASPIAN trial did not include radiation to the primary tumor, it seemed a logical strategy to explore.

In the current single-arm study, Dr. Zhang and his team added 15 Gy radiation in five fractions to the primary lung tumors of 30 patients during the first cycle of durvalumab plus etoposide-platinum.

Subjects received 1500 mg of durvalumab plus etoposide-platinum every 3 weeks for four cycles. Low-dose radiation to the primary tumor was delivered over 5 days at the start of treatment. Patients then continued with durvalumab maintenance every 4 weeks until progression or intolerable toxicity.

Six patients (20%) had liver metastases at the baseline, and three (10%) had brain metastases. Over half had prophylactic cranial radiation. Performance scores were 0-1, and all but one of the participants were men.

Six- and 12-month progression-free survival rates were 57% and 40%, respectively. Overall survival was 90% at 6 months and 66% at 12 months. Median overall survival was 13 months in the CASPIAN trial but not reached in Dr. Zhang’s trial after a median follow-up of 17.3 months, with the earliest deaths occurring at 10.8 months.

Grade 3 treatment-related adverse events occurred in 80% of patients, most frequently hematologic toxicities. Five patients (16.7%) had severe adverse reactions to radiation. Although the overall dose of radiation was low, at 3 Gy each, the fractions were on the large side.

Hanna wanted more information on the radiotoxicity issue, but even so, he said that adding low-dose radiation to our durvalumab-chemotherapy doublet warrants further investigation.

Both Dr. Hanna and Dr. Zhang thought that instead of killing cancer cells directly, the greatest benefit of upfront radiation, and the peritumoral inflammation it causes, is to augment durvalumab’s effect.

Overall, Dr. Hanna stressed that we haven’t had results like these before in a SCLC study, particularly for novel agents, let alone radiation.

The study was funded by AstraZeneca, maker of durvalumab. Dr. Zhang and Dr. Hanna didn’t have any relevant disclosures.

A version of this article appeared on Medscape.com.

Adding low-dose radiation to the current standard first-line treatment, durvalumab plus etoposide-platinum chemotherapy, appears to improve survival outcomes in patients with extensive-stage small cell lung cancer (SCLC), suggested new findings from a small, single-arm study.

The analysis, presented at the 2024 European Lung Cancer Congress, revealed that low-dose radiation improved patients’ median progression-free and overall survival compared with standard first-line treatment, reported in a 2019 trial, lead author Yan Zhang, MD, reported.

The standard first-line treatment results came from the 2019 CASPIAN trial, which found that patients receiving the first-line regimen had a median progression-free survival of 5 months and a median overall survival of 13 months, with 54% of patient alive at 1 year.

The latest data, which included a small cohort of 30 patients, revealed that adding low-dose radiation to the standard first-line therapy led to a higher median progression-free survival of 8.3 months and extended median overall survival beyond the study follow-up period of 17.3 months. Overall, 66% of patients were alive at 1 year.

These are “promising” improvements over CASPIAN, Dr. Zhang, a lung cancer medical oncologist at Sichuan University, Chengdu, China, said at the Congress, which was organized by the European Society for Medical Oncology.

Study discussant Gerry Hanna, PhD, MBBS, a radiation oncologist at Belfast City Hospital, Belfast, Northern Ireland, agreed. Although there were just 30 patients, “you cannot deny these are [strong] results in terms of extensive-stage small cell cancer,” Dr. Hanna said.

Although standard first-line treatment of extensive-stage SCLC is durvalumab plus etoposide-platinum chemotherapy, the benefits aren’t durable for many patients.

This problem led Dr. Zhang and his colleagues to look for ways to improve outcomes. Because the CASPIAN trial did not include radiation to the primary tumor, it seemed a logical strategy to explore.

In the current single-arm study, Dr. Zhang and his team added 15 Gy radiation in five fractions to the primary lung tumors of 30 patients during the first cycle of durvalumab plus etoposide-platinum.

Subjects received 1500 mg of durvalumab plus etoposide-platinum every 3 weeks for four cycles. Low-dose radiation to the primary tumor was delivered over 5 days at the start of treatment. Patients then continued with durvalumab maintenance every 4 weeks until progression or intolerable toxicity.

Six patients (20%) had liver metastases at the baseline, and three (10%) had brain metastases. Over half had prophylactic cranial radiation. Performance scores were 0-1, and all but one of the participants were men.

Six- and 12-month progression-free survival rates were 57% and 40%, respectively. Overall survival was 90% at 6 months and 66% at 12 months. Median overall survival was 13 months in the CASPIAN trial but not reached in Dr. Zhang’s trial after a median follow-up of 17.3 months, with the earliest deaths occurring at 10.8 months.

Grade 3 treatment-related adverse events occurred in 80% of patients, most frequently hematologic toxicities. Five patients (16.7%) had severe adverse reactions to radiation. Although the overall dose of radiation was low, at 3 Gy each, the fractions were on the large side.

Hanna wanted more information on the radiotoxicity issue, but even so, he said that adding low-dose radiation to our durvalumab-chemotherapy doublet warrants further investigation.

Both Dr. Hanna and Dr. Zhang thought that instead of killing cancer cells directly, the greatest benefit of upfront radiation, and the peritumoral inflammation it causes, is to augment durvalumab’s effect.

Overall, Dr. Hanna stressed that we haven’t had results like these before in a SCLC study, particularly for novel agents, let alone radiation.

The study was funded by AstraZeneca, maker of durvalumab. Dr. Zhang and Dr. Hanna didn’t have any relevant disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Vitamin D deficiency is independently linked to the risk for diabetic peripheral neuropathy (DPN) by potentially affecting large nerve fibers in older patients with type 2 diabetes (T2D).

METHODOLOGY:

• Although previous research has shown that vitamin D deficiency is common in patients with diabetes and may increase the risk for peripheral neuropathy, its effects on large and small nerve fiber lesions have not been well explored yet.
• Researchers conducted a cross-sectional study to understand the association between vitamin D deficiency and DPN development in 230 older patients (mean age, 67 years) with T2D for about 15 years who were recruited from Beijing Hospital between 2020 and 2023.
• All patients were evaluated for DPN based on poor blood sugar control or symptoms such as pain and sensory abnormalities, of which 175 patients diagnosed with DPN were propensity-matched with 55 patients without DPN.
• Vitamin D deficiency, defined as serum 25-hydroxyvitamin D circulating levels below 20 ng/mL, was reported in 169 patients.
• Large nerve fiber lesions were evaluated using electromyography, and small nerve fiber lesions were assessed by measuring skin conductance.

TAKEAWAY:

• Vitamin D deficiency was more likely to affect large fiber lesions, suggested by longer median sensory nerve latency, minimum latency of the F-wave, and median nerve motor evoked potential latency than those in the vitamin D–sufficient group.
• Furthermore, vitamin D deficiency was linked to large fiber neuropathy with increased odds of prolongation of motor nerve latency (odds ratio, 1.362; P = .038).
• The electrochemical skin conductance, which indicates damage to small nerve fibers, was comparable between patients with and without vitamin D deficiency.

IN PRACTICE:

This study is too preliminary to have practice application.

SOURCE:

This study was led by Sijia Fei, Department of Endocrinology, Beijing Hospital, Beijing, People’s Republic of China, and was published online in Diabetes Research and Clinical Practice.

LIMITATIONS:

Skin biopsy, the “gold-standard” for quantifying intraepidermal nerve fiber density, was not used to assess small nerve fiber lesions. Additionally, a causal link between vitamin D deficiency and diabetic nerve damage was not established owing to the cross-sectional nature of the study. Some patients with T2D may have been receiving insulin therapy, which may have affected vitamin D levels.

DISCLOSURES:

The study was supported by grants from the National Natural Science Foundation of China and China National Key R&D Program. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Vitamin D deficiency is independently linked to the risk for diabetic peripheral neuropathy (DPN) by potentially affecting large nerve fibers in older patients with type 2 diabetes (T2D).

METHODOLOGY:

• Although previous research has shown that vitamin D deficiency is common in patients with diabetes and may increase the risk for peripheral neuropathy, its effects on large and small nerve fiber lesions have not been well explored yet.
• Researchers conducted a cross-sectional study to understand the association between vitamin D deficiency and DPN development in 230 older patients (mean age, 67 years) with T2D for about 15 years who were recruited from Beijing Hospital between 2020 and 2023.
• All patients were evaluated for DPN based on poor blood sugar control or symptoms such as pain and sensory abnormalities, of which 175 patients diagnosed with DPN were propensity-matched with 55 patients without DPN.
• Vitamin D deficiency, defined as serum 25-hydroxyvitamin D circulating levels below 20 ng/mL, was reported in 169 patients.
• Large nerve fiber lesions were evaluated using electromyography, and small nerve fiber lesions were assessed by measuring skin conductance.

TAKEAWAY:

• Vitamin D deficiency was more likely to affect large fiber lesions, suggested by longer median sensory nerve latency, minimum latency of the F-wave, and median nerve motor evoked potential latency than those in the vitamin D–sufficient group.
• Furthermore, vitamin D deficiency was linked to large fiber neuropathy with increased odds of prolongation of motor nerve latency (odds ratio, 1.362; P = .038).
• The electrochemical skin conductance, which indicates damage to small nerve fibers, was comparable between patients with and without vitamin D deficiency.

IN PRACTICE:

This study is too preliminary to have practice application.

SOURCE:

This study was led by Sijia Fei, Department of Endocrinology, Beijing Hospital, Beijing, People’s Republic of China, and was published online in Diabetes Research and Clinical Practice.

LIMITATIONS:

Skin biopsy, the “gold-standard” for quantifying intraepidermal nerve fiber density, was not used to assess small nerve fiber lesions. Additionally, a causal link between vitamin D deficiency and diabetic nerve damage was not established owing to the cross-sectional nature of the study. Some patients with T2D may have been receiving insulin therapy, which may have affected vitamin D levels.

DISCLOSURES:

The study was supported by grants from the National Natural Science Foundation of China and China National Key R&D Program. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Vitamin D deficiency is independently linked to the risk for diabetic peripheral neuropathy (DPN) by potentially affecting large nerve fibers in older patients with type 2 diabetes (T2D).

METHODOLOGY:

• Although previous research has shown that vitamin D deficiency is common in patients with diabetes and may increase the risk for peripheral neuropathy, its effects on large and small nerve fiber lesions have not been well explored yet.
• Researchers conducted a cross-sectional study to understand the association between vitamin D deficiency and DPN development in 230 older patients (mean age, 67 years) with T2D for about 15 years who were recruited from Beijing Hospital between 2020 and 2023.
• All patients were evaluated for DPN based on poor blood sugar control or symptoms such as pain and sensory abnormalities, of which 175 patients diagnosed with DPN were propensity-matched with 55 patients without DPN.
• Vitamin D deficiency, defined as serum 25-hydroxyvitamin D circulating levels below 20 ng/mL, was reported in 169 patients.
• Large nerve fiber lesions were evaluated using electromyography, and small nerve fiber lesions were assessed by measuring skin conductance.

TAKEAWAY:

• Vitamin D deficiency was more likely to affect large fiber lesions, suggested by longer median sensory nerve latency, minimum latency of the F-wave, and median nerve motor evoked potential latency than those in the vitamin D–sufficient group.
• Furthermore, vitamin D deficiency was linked to large fiber neuropathy with increased odds of prolongation of motor nerve latency (odds ratio, 1.362; P = .038).
• The electrochemical skin conductance, which indicates damage to small nerve fibers, was comparable between patients with and without vitamin D deficiency.

IN PRACTICE:

This study is too preliminary to have practice application.

SOURCE:

This study was led by Sijia Fei, Department of Endocrinology, Beijing Hospital, Beijing, People’s Republic of China, and was published online in Diabetes Research and Clinical Practice.

LIMITATIONS:

Skin biopsy, the “gold-standard” for quantifying intraepidermal nerve fiber density, was not used to assess small nerve fiber lesions. Additionally, a causal link between vitamin D deficiency and diabetic nerve damage was not established owing to the cross-sectional nature of the study. Some patients with T2D may have been receiving insulin therapy, which may have affected vitamin D levels.

DISCLOSURES:

The study was supported by grants from the National Natural Science Foundation of China and China National Key R&D Program. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

Just over 2 months into 2024, measles cases in the United States aren’t looking great. 

The recent rise in cases across the U.S. is linked to unvaccinated travelers, lower than ideal vaccination rates, and misinformation, experts said. 

The Centers for Disease Control and Prevention has identified 45 cases of measles in 17 jurisdictions across the U.S. As of March 7, the federal health agency reported measles cases in Arizona, California, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York City, Ohio, Pennsylvania, Virginia, and Washington.

As for the 45 cases, “that’s almost as many as we had for the entire calendar year of 2023,” said Sarah Lim, MD, a medical specialist at the Minnesota Department of Health. “So we’re really not off to a great start.” (For context, there were 58 officially reported measles cases last year.) 

Chicago is having a measles outbreak — with eight cases reported so far. All but one case has been linked to a migrant child at a city shelter. Given the potential for rapid spread — measles is relatively rare here but potentially very serious — the CDC sent a team of experts to investigate and to help keep this outbreak from growing further.


 

Sometimes Deadly

About 30% of children have measles symptoms and about 25% end up hospitalized. Complications include diarrhea, a whole-body rash, ear infections that can lead to permanent deafness, and pneumonia. Pneumonia with measles can be so serious that 1 in 20 affected children die. Measles can also cause inflammation of the brain called encephalitis in about 1 in 1,000 children, sometimes causing epilepsy or permanent brain damage.

As with long COVID, some effects can last beyond the early infection. For example, measles “can wipe out immune memory that protects you against other bacterial and viral pathogens,” Dr. Lim said at a media briefing sponsored by the Infectious Diseases Society of America. This vulnerability to other infections can last up to 3 years after the early infection, she noted. 

Overall, measles kills between 1 and 3 people infected per thousand, mostly children.
 

Vaccine Misinformation Playing a Role

Vaccine misinformation is partly behind the uptick, and while many cases are mild, “this can be a devastating disease,” said Joshua Barocas, MD, associate professor of medicine in the divisions of General Internal Medicine and Infectious Diseases at the University of Colorado School of Medicine.

“I’m a parent myself. Parents are flooded with tons of information, some of that time being misinformation,” he said at the media briefing. “If you are a parent who’s been on the fence [about vaccination], now is the time, given the outbreak potential and the outbreaks that we’re seeing.” 

Vaccine misinformation “is about as old as vaccines themselves,” Dr. Lim said. Concerns about the MMR vaccine, which includes measles protection, are not new.

“It does seem to change periodically — new things bubble up, new ideas bubble up, and the problem is that it is like the old saying that ‘a lie can get halfway around the world before the truth can get its boots on.’ ” Social media helps to amplify vaccine misinformation, she said. 

“You don’t want to scare people unnecessarily — but reminding people what these childhood diseases really look like and what they do is incredibly important,” Dr. Lim said. “It’s so much easier to see stories about potential side effects of vaccines than it is to see stories about parents whose children were in intensive care for 2 weeks with pneumonia because of a severe case of measles.”

Dr. Barocas said misinformation is sometimes deliberate, sometimes not. Regardless, “our job as infectious disease physicians and public health professionals is not necessarily to put the counternarrative out there, but to continue to advocate for what we know works based on the best science and the best evidence.”

“And there is no reason to believe that vaccines are anything but helpful when it comes to preventing measles,” he noted. 
 

Lifelong Protection in Most Cases

The MMR vaccine, typically given as two doses in childhood, offers 93% and then 97% protection against the highly contagious virus. During the 2022-to-2023 school year, the measles vaccination rate among kindergarten children nationwide was 92%. That sounds like a high rate, Dr. Lim said, “but because measles is so contagious, vaccination rates need to be 95% or higher to contain transmission.”

One person with measles can infect anywhere from 12 to 18 other people, she said. When an infected person coughs or sneezes, tiny droplets spread through the air. “And if someone is unvaccinated and exposed, 9 times out of 10, that person will go on to develop the disease.” She said given the high transmission rate, measles often spreads within families to infect multiple children. 

If you know you’re not vaccinated but exposed, the advice is to get the measles shot as quickly as possible. “There is a recommendation to receive the MMR vaccine within 72 hours as post-exposure prophylaxis,” Dr. Lim said. “That’s a tight time window, but if you can do that, it reduces the risk of developing measles significantly.”

If you’re unsure or do not remember getting vaccinated against measles as a young child, your health care provider may be able to search state registries for an answer. If that doesn’t work, getting revaccinated with the MMR vaccine as an adult is an option. “There is no shame in getting caught up now,” Dr. Barocas said.

Dr. Lim agreed. “There is really no downside to getting additional doses.”
 

A version of this article appeared on WebMD.com.

Just over 2 months into 2024, measles cases in the United States aren’t looking great. 

The recent rise in cases across the U.S. is linked to unvaccinated travelers, lower than ideal vaccination rates, and misinformation, experts said. 

The Centers for Disease Control and Prevention has identified 45 cases of measles in 17 jurisdictions across the U.S. As of March 7, the federal health agency reported measles cases in Arizona, California, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York City, Ohio, Pennsylvania, Virginia, and Washington.

As for the 45 cases, “that’s almost as many as we had for the entire calendar year of 2023,” said Sarah Lim, MD, a medical specialist at the Minnesota Department of Health. “So we’re really not off to a great start.” (For context, there were 58 officially reported measles cases last year.) 

Chicago is having a measles outbreak — with eight cases reported so far. All but one case has been linked to a migrant child at a city shelter. Given the potential for rapid spread — measles is relatively rare here but potentially very serious — the CDC sent a team of experts to investigate and to help keep this outbreak from growing further.


 

Sometimes Deadly

About 30% of children have measles symptoms and about 25% end up hospitalized. Complications include diarrhea, a whole-body rash, ear infections that can lead to permanent deafness, and pneumonia. Pneumonia with measles can be so serious that 1 in 20 affected children die. Measles can also cause inflammation of the brain called encephalitis in about 1 in 1,000 children, sometimes causing epilepsy or permanent brain damage.

As with long COVID, some effects can last beyond the early infection. For example, measles “can wipe out immune memory that protects you against other bacterial and viral pathogens,” Dr. Lim said at a media briefing sponsored by the Infectious Diseases Society of America. This vulnerability to other infections can last up to 3 years after the early infection, she noted. 

Overall, measles kills between 1 and 3 people infected per thousand, mostly children.
 

Vaccine Misinformation Playing a Role

Vaccine misinformation is partly behind the uptick, and while many cases are mild, “this can be a devastating disease,” said Joshua Barocas, MD, associate professor of medicine in the divisions of General Internal Medicine and Infectious Diseases at the University of Colorado School of Medicine.

“I’m a parent myself. Parents are flooded with tons of information, some of that time being misinformation,” he said at the media briefing. “If you are a parent who’s been on the fence [about vaccination], now is the time, given the outbreak potential and the outbreaks that we’re seeing.” 

Vaccine misinformation “is about as old as vaccines themselves,” Dr. Lim said. Concerns about the MMR vaccine, which includes measles protection, are not new.

“It does seem to change periodically — new things bubble up, new ideas bubble up, and the problem is that it is like the old saying that ‘a lie can get halfway around the world before the truth can get its boots on.’ ” Social media helps to amplify vaccine misinformation, she said. 

“You don’t want to scare people unnecessarily — but reminding people what these childhood diseases really look like and what they do is incredibly important,” Dr. Lim said. “It’s so much easier to see stories about potential side effects of vaccines than it is to see stories about parents whose children were in intensive care for 2 weeks with pneumonia because of a severe case of measles.”

Dr. Barocas said misinformation is sometimes deliberate, sometimes not. Regardless, “our job as infectious disease physicians and public health professionals is not necessarily to put the counternarrative out there, but to continue to advocate for what we know works based on the best science and the best evidence.”

“And there is no reason to believe that vaccines are anything but helpful when it comes to preventing measles,” he noted. 
 

Lifelong Protection in Most Cases

The MMR vaccine, typically given as two doses in childhood, offers 93% and then 97% protection against the highly contagious virus. During the 2022-to-2023 school year, the measles vaccination rate among kindergarten children nationwide was 92%. That sounds like a high rate, Dr. Lim said, “but because measles is so contagious, vaccination rates need to be 95% or higher to contain transmission.”

One person with measles can infect anywhere from 12 to 18 other people, she said. When an infected person coughs or sneezes, tiny droplets spread through the air. “And if someone is unvaccinated and exposed, 9 times out of 10, that person will go on to develop the disease.” She said given the high transmission rate, measles often spreads within families to infect multiple children. 

If you know you’re not vaccinated but exposed, the advice is to get the measles shot as quickly as possible. “There is a recommendation to receive the MMR vaccine within 72 hours as post-exposure prophylaxis,” Dr. Lim said. “That’s a tight time window, but if you can do that, it reduces the risk of developing measles significantly.”

If you’re unsure or do not remember getting vaccinated against measles as a young child, your health care provider may be able to search state registries for an answer. If that doesn’t work, getting revaccinated with the MMR vaccine as an adult is an option. “There is no shame in getting caught up now,” Dr. Barocas said.

Dr. Lim agreed. “There is really no downside to getting additional doses.”
 

A version of this article appeared on WebMD.com.

Just over 2 months into 2024, measles cases in the United States aren’t looking great. 

The recent rise in cases across the U.S. is linked to unvaccinated travelers, lower than ideal vaccination rates, and misinformation, experts said. 

The Centers for Disease Control and Prevention has identified 45 cases of measles in 17 jurisdictions across the U.S. As of March 7, the federal health agency reported measles cases in Arizona, California, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York City, Ohio, Pennsylvania, Virginia, and Washington.

As for the 45 cases, “that’s almost as many as we had for the entire calendar year of 2023,” said Sarah Lim, MD, a medical specialist at the Minnesota Department of Health. “So we’re really not off to a great start.” (For context, there were 58 officially reported measles cases last year.) 

Chicago is having a measles outbreak — with eight cases reported so far. All but one case has been linked to a migrant child at a city shelter. Given the potential for rapid spread — measles is relatively rare here but potentially very serious — the CDC sent a team of experts to investigate and to help keep this outbreak from growing further.


 

Sometimes Deadly

About 30% of children have measles symptoms and about 25% end up hospitalized. Complications include diarrhea, a whole-body rash, ear infections that can lead to permanent deafness, and pneumonia. Pneumonia with measles can be so serious that 1 in 20 affected children die. Measles can also cause inflammation of the brain called encephalitis in about 1 in 1,000 children, sometimes causing epilepsy or permanent brain damage.

As with long COVID, some effects can last beyond the early infection. For example, measles “can wipe out immune memory that protects you against other bacterial and viral pathogens,” Dr. Lim said at a media briefing sponsored by the Infectious Diseases Society of America. This vulnerability to other infections can last up to 3 years after the early infection, she noted. 

Overall, measles kills between 1 and 3 people infected per thousand, mostly children.
 

Vaccine Misinformation Playing a Role

Vaccine misinformation is partly behind the uptick, and while many cases are mild, “this can be a devastating disease,” said Joshua Barocas, MD, associate professor of medicine in the divisions of General Internal Medicine and Infectious Diseases at the University of Colorado School of Medicine.

“I’m a parent myself. Parents are flooded with tons of information, some of that time being misinformation,” he said at the media briefing. “If you are a parent who’s been on the fence [about vaccination], now is the time, given the outbreak potential and the outbreaks that we’re seeing.” 

Vaccine misinformation “is about as old as vaccines themselves,” Dr. Lim said. Concerns about the MMR vaccine, which includes measles protection, are not new.

“It does seem to change periodically — new things bubble up, new ideas bubble up, and the problem is that it is like the old saying that ‘a lie can get halfway around the world before the truth can get its boots on.’ ” Social media helps to amplify vaccine misinformation, she said. 

“You don’t want to scare people unnecessarily — but reminding people what these childhood diseases really look like and what they do is incredibly important,” Dr. Lim said. “It’s so much easier to see stories about potential side effects of vaccines than it is to see stories about parents whose children were in intensive care for 2 weeks with pneumonia because of a severe case of measles.”

Dr. Barocas said misinformation is sometimes deliberate, sometimes not. Regardless, “our job as infectious disease physicians and public health professionals is not necessarily to put the counternarrative out there, but to continue to advocate for what we know works based on the best science and the best evidence.”

“And there is no reason to believe that vaccines are anything but helpful when it comes to preventing measles,” he noted. 
 

Lifelong Protection in Most Cases

The MMR vaccine, typically given as two doses in childhood, offers 93% and then 97% protection against the highly contagious virus. During the 2022-to-2023 school year, the measles vaccination rate among kindergarten children nationwide was 92%. That sounds like a high rate, Dr. Lim said, “but because measles is so contagious, vaccination rates need to be 95% or higher to contain transmission.”

One person with measles can infect anywhere from 12 to 18 other people, she said. When an infected person coughs or sneezes, tiny droplets spread through the air. “And if someone is unvaccinated and exposed, 9 times out of 10, that person will go on to develop the disease.” She said given the high transmission rate, measles often spreads within families to infect multiple children. 

If you know you’re not vaccinated but exposed, the advice is to get the measles shot as quickly as possible. “There is a recommendation to receive the MMR vaccine within 72 hours as post-exposure prophylaxis,” Dr. Lim said. “That’s a tight time window, but if you can do that, it reduces the risk of developing measles significantly.”

If you’re unsure or do not remember getting vaccinated against measles as a young child, your health care provider may be able to search state registries for an answer. If that doesn’t work, getting revaccinated with the MMR vaccine as an adult is an option. “There is no shame in getting caught up now,” Dr. Barocas said.

Dr. Lim agreed. “There is really no downside to getting additional doses.”
 

A version of this article appeared on WebMD.com.

Nine days after the independent laboratory Valisure petitioned the Food and Drug Administration (FDA) to recall acne products with benzoyl peroxide (BP) because of the lab’s findings of extremely high levels of the carcinogen benzene, it published another report in Environmental Health Perspectives (EHP), on March 14, also warning about BP acne products.

The bottom line was the same: The laboratory, based in New Haven, Connecticut, said its analyses raise substantial concerns about the safety of BP-containing acne products currently on the market.

The lab’s results showed that the products can form over 800 times the conditionally restricted FDA concentration limit of 2 parts per million (ppm) of benzene, with both prescription and over-the-counter products affected.

“This is a problem of degradation, not contamination,” David Light, CEO and founder of Valisure, said in a telephone interview. BP can decompose into benzene, and exposure to benzene has been linked with a higher risk for leukemia and other blood cancers, according to the American Cancer Society.

In the wake of the findings, however, debate has erupted over the method and approach used by Valisure to test these products, with critics and companies contending that more “real-world” use data are needed. And the US Pharmacopeia (USP) is asking for full transparency about the testing methods.

In a March 8 statement, USP said the petition indicated that modified USP methods were used in the study, noting that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

However, Valisure contended that drug products need to demonstrate stability over the entire life cycle, from shipment to continued use, emphasizing that constitutes the best “real-world” approach. It also defended the methodology it used.

The reports have led to a state of uncertainty about the use of BP products.

“Right now, we have more unknowns than anything else,” John Barbieri, MD, MBA, assistant professor of dermatology at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, said in a video posted on X and YouTube, summarizing the findings released by Valisure on March 6 and 14. He was not involved in the Valisure research.

Brigham and Women&#039;s Hospital

In a telephone interview, Dr. Barbieri said the report “needs to be taken seriously,” but he also believed the Valisure report is lacking information about testing under “real-world” conditions. He is calling for more information and more transparency about the data. What’s clear, Dr. Barbieri told this news organization, is that the findings about high benzene levels are not a manufacturing error. “It’s something to do with the molecule itself.”
 

Valisure’s Analyses

Valisure performed an initial analysis, using a method called gas chromatography-mass spectrometry, which is the FDA-preferred method for detecting benzene, Mr. Light said. It tested 175 acne products, 99 containing BP and 76 with other ingredients, such as salicylic acid. All the products without BP had no detectable benzene or values below 2 ppm, the FDA concentration limit for benzene.

Of the 99 BP products, 94 contained benzene without any elevated temperature incubation, according to Valisure. Using 50 °C (122 °F, the accepted pharmaceutical stability testing temperature) on 66 products, Valisure detected over 1500 ppm of benzene in two products, over 100 ppm in 17 products, and over 10 ppm in 42 products over an 18-day period.

The analysis confirmed, Valisure said in a press release and the petition, that a substantial amount of benzene can form in a BP product and leak outside the packaging into surrounding air.

The EHP paper, which includes authors from Valisure, reported that researchers took single lots of seven branded BP products, namely, Equate Beauty 2.5% BP cleansers, Neutrogena 10% BP cleanser, CVS Health 10% BP face wash, Walgreens 10% BP cream, Clean & Clear 10% cleanser, Equate Beauty 10% BP acne wash, and Proactiv 2.5% BP cleanser.

Using testing that involved gas chromatography-mass spectrometry, benzene was detected in all the BP products samples tested, and levels increased during incubation at body and shelf-life performance temperatures to more than 2 ppm. The authors concluded that the study “raises substantial concerns” about the safety of BP products currently on the market.
 

Methodology Debates

Two days after Valisure released its analysis on March 6, the USP reviewed the citizen’s petition filed by Valisure and called for more transparency around the testing methods.

“The petition referenced USP and indicated that modified USP methods and procedures were used in the study. The presence of unsafe levels of benzene should be taken seriously,” the statement said. The USP statement also noted that the Valisure analysis used modified USP methods and said that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

In its statement, USP took issue with a practice known as accelerated thermal degradation, which it said Valisure used. USP said the approach involves raising the storage temperature of a product to higher than the temperature indicated on the label for the purpose of simulating degradation over a longer period. While the approach may be acceptable, USP said, the temperatures chosen may not be what is expected to happen to the products.

In response, Mr. Light of Valisure referenced guidance issued in August, 2020, from the FDA, stating that the method it used in the BP analysis can be used to detect impurities in hand sanitizers, including benzene. (In 2021, Valisure detected high levels of benzene in some hand sanitizers and asked the FDA to take action.)
 

Company Response

Among the companies that took issue with the report was Reckitt, which makes Clearasil, which contains BP. In a statement, the company said, in part: “The products and their ingredients are stable over the storage conditions described on their packaging which represent all reasonable and foreseeable conditions.” It said the findings presented by Valisure reflect “unrealistic scenarios rather than real-world conditions.”

The Personal Care Products Council, a national trade association that represents cosmetic and personal care product manufacturers, also took issue with the findings and the approach used to evaluate the products.
 

FDA and the Citizen’s Petition

The FDA accepted the petition, Mr. Light said, and gave it a docket number. “We’ll hopefully hear more soon” because the FDA is required to respond to a citizen’s petition within 180 days, he said.

“We generally don’t comment on pending citizens’ petitions,” an FDA spokesperson said in an email. “When we respond, we will respond directly to the petitioner and post the response in the designated agency public docket.”
 

Valisure’s Patent Application

Mr. Light and others have applied for a patent on methods of producing shelf-stable formulations to prevent degradation of BP to benzene.

“We saw the problem long before we had any sort of application,” Mr. Light said. The issue has been “known for decades.”
 

Role of BP Products for Acne

In the midst of uncertainty, “the first discussion is, do we want to use it?” Dr. Barbieri said in the interview. Some patients may want to avoid it altogether, until more data are available, including more verification of the findings, while others may be comfortable accepting the potential risk, he said.

“Benzoyl peroxide is one of our foundational acne treatments,” Dr. Barbieri said. In the American Academy of Dermatology updated guidelines on acne, published in January, 2024, strong recommendations were made for BP products, as well as topical retinoids, topical antibiotics, and oral doxycycline.

“When you take away BP, there’s no substitute for it,” Dr. Barbieri said. And if patients don’t get improvement with topicals, oral medications might be needed, and “these all have their own risks.”
 

In the Interim

Until more information is available, Dr. Barbieri is advising patients not to store the products at high temperatures or for a long time. Don’t keep the products past their expiration date, and perhaps keep products for a shorter time, “something like a month,” he said.

Those living in a hot climate might consider storing the products in the refrigerator, he said.

“We need more data from Valisure, from other groups that confirm their findings, and we need to hear from the FDA,” Dr. Barbieri said. “There’s a lot of uncertainty right now. But it’s important not to overreact.”

Dr. Barbieri had no relevant disclosures.


 

A version of this article appeared on Medscape.com.

Nine days after the independent laboratory Valisure petitioned the Food and Drug Administration (FDA) to recall acne products with benzoyl peroxide (BP) because of the lab’s findings of extremely high levels of the carcinogen benzene, it published another report in Environmental Health Perspectives (EHP), on March 14, also warning about BP acne products.

The bottom line was the same: The laboratory, based in New Haven, Connecticut, said its analyses raise substantial concerns about the safety of BP-containing acne products currently on the market.

The lab’s results showed that the products can form over 800 times the conditionally restricted FDA concentration limit of 2 parts per million (ppm) of benzene, with both prescription and over-the-counter products affected.

“This is a problem of degradation, not contamination,” David Light, CEO and founder of Valisure, said in a telephone interview. BP can decompose into benzene, and exposure to benzene has been linked with a higher risk for leukemia and other blood cancers, according to the American Cancer Society.

In the wake of the findings, however, debate has erupted over the method and approach used by Valisure to test these products, with critics and companies contending that more “real-world” use data are needed. And the US Pharmacopeia (USP) is asking for full transparency about the testing methods.

In a March 8 statement, USP said the petition indicated that modified USP methods were used in the study, noting that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

However, Valisure contended that drug products need to demonstrate stability over the entire life cycle, from shipment to continued use, emphasizing that constitutes the best “real-world” approach. It also defended the methodology it used.

The reports have led to a state of uncertainty about the use of BP products.

“Right now, we have more unknowns than anything else,” John Barbieri, MD, MBA, assistant professor of dermatology at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, said in a video posted on X and YouTube, summarizing the findings released by Valisure on March 6 and 14. He was not involved in the Valisure research.

Brigham and Women&#039;s Hospital

In a telephone interview, Dr. Barbieri said the report “needs to be taken seriously,” but he also believed the Valisure report is lacking information about testing under “real-world” conditions. He is calling for more information and more transparency about the data. What’s clear, Dr. Barbieri told this news organization, is that the findings about high benzene levels are not a manufacturing error. “It’s something to do with the molecule itself.”
 

Valisure’s Analyses

Valisure performed an initial analysis, using a method called gas chromatography-mass spectrometry, which is the FDA-preferred method for detecting benzene, Mr. Light said. It tested 175 acne products, 99 containing BP and 76 with other ingredients, such as salicylic acid. All the products without BP had no detectable benzene or values below 2 ppm, the FDA concentration limit for benzene.

Of the 99 BP products, 94 contained benzene without any elevated temperature incubation, according to Valisure. Using 50 °C (122 °F, the accepted pharmaceutical stability testing temperature) on 66 products, Valisure detected over 1500 ppm of benzene in two products, over 100 ppm in 17 products, and over 10 ppm in 42 products over an 18-day period.

The analysis confirmed, Valisure said in a press release and the petition, that a substantial amount of benzene can form in a BP product and leak outside the packaging into surrounding air.

The EHP paper, which includes authors from Valisure, reported that researchers took single lots of seven branded BP products, namely, Equate Beauty 2.5% BP cleansers, Neutrogena 10% BP cleanser, CVS Health 10% BP face wash, Walgreens 10% BP cream, Clean & Clear 10% cleanser, Equate Beauty 10% BP acne wash, and Proactiv 2.5% BP cleanser.

Using testing that involved gas chromatography-mass spectrometry, benzene was detected in all the BP products samples tested, and levels increased during incubation at body and shelf-life performance temperatures to more than 2 ppm. The authors concluded that the study “raises substantial concerns” about the safety of BP products currently on the market.
 

Methodology Debates

Two days after Valisure released its analysis on March 6, the USP reviewed the citizen’s petition filed by Valisure and called for more transparency around the testing methods.

“The petition referenced USP and indicated that modified USP methods and procedures were used in the study. The presence of unsafe levels of benzene should be taken seriously,” the statement said. The USP statement also noted that the Valisure analysis used modified USP methods and said that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

In its statement, USP took issue with a practice known as accelerated thermal degradation, which it said Valisure used. USP said the approach involves raising the storage temperature of a product to higher than the temperature indicated on the label for the purpose of simulating degradation over a longer period. While the approach may be acceptable, USP said, the temperatures chosen may not be what is expected to happen to the products.

In response, Mr. Light of Valisure referenced guidance issued in August, 2020, from the FDA, stating that the method it used in the BP analysis can be used to detect impurities in hand sanitizers, including benzene. (In 2021, Valisure detected high levels of benzene in some hand sanitizers and asked the FDA to take action.)
 

Company Response

Among the companies that took issue with the report was Reckitt, which makes Clearasil, which contains BP. In a statement, the company said, in part: “The products and their ingredients are stable over the storage conditions described on their packaging which represent all reasonable and foreseeable conditions.” It said the findings presented by Valisure reflect “unrealistic scenarios rather than real-world conditions.”

The Personal Care Products Council, a national trade association that represents cosmetic and personal care product manufacturers, also took issue with the findings and the approach used to evaluate the products.
 

FDA and the Citizen’s Petition

The FDA accepted the petition, Mr. Light said, and gave it a docket number. “We’ll hopefully hear more soon” because the FDA is required to respond to a citizen’s petition within 180 days, he said.

“We generally don’t comment on pending citizens’ petitions,” an FDA spokesperson said in an email. “When we respond, we will respond directly to the petitioner and post the response in the designated agency public docket.”
 

Valisure’s Patent Application

Mr. Light and others have applied for a patent on methods of producing shelf-stable formulations to prevent degradation of BP to benzene.

“We saw the problem long before we had any sort of application,” Mr. Light said. The issue has been “known for decades.”
 

Role of BP Products for Acne

In the midst of uncertainty, “the first discussion is, do we want to use it?” Dr. Barbieri said in the interview. Some patients may want to avoid it altogether, until more data are available, including more verification of the findings, while others may be comfortable accepting the potential risk, he said.

“Benzoyl peroxide is one of our foundational acne treatments,” Dr. Barbieri said. In the American Academy of Dermatology updated guidelines on acne, published in January, 2024, strong recommendations were made for BP products, as well as topical retinoids, topical antibiotics, and oral doxycycline.

“When you take away BP, there’s no substitute for it,” Dr. Barbieri said. And if patients don’t get improvement with topicals, oral medications might be needed, and “these all have their own risks.”
 

In the Interim

Until more information is available, Dr. Barbieri is advising patients not to store the products at high temperatures or for a long time. Don’t keep the products past their expiration date, and perhaps keep products for a shorter time, “something like a month,” he said.

Those living in a hot climate might consider storing the products in the refrigerator, he said.

“We need more data from Valisure, from other groups that confirm their findings, and we need to hear from the FDA,” Dr. Barbieri said. “There’s a lot of uncertainty right now. But it’s important not to overreact.”

Dr. Barbieri had no relevant disclosures.


 

A version of this article appeared on Medscape.com.

Nine days after the independent laboratory Valisure petitioned the Food and Drug Administration (FDA) to recall acne products with benzoyl peroxide (BP) because of the lab’s findings of extremely high levels of the carcinogen benzene, it published another report in Environmental Health Perspectives (EHP), on March 14, also warning about BP acne products.

The bottom line was the same: The laboratory, based in New Haven, Connecticut, said its analyses raise substantial concerns about the safety of BP-containing acne products currently on the market.

The lab’s results showed that the products can form over 800 times the conditionally restricted FDA concentration limit of 2 parts per million (ppm) of benzene, with both prescription and over-the-counter products affected.

“This is a problem of degradation, not contamination,” David Light, CEO and founder of Valisure, said in a telephone interview. BP can decompose into benzene, and exposure to benzene has been linked with a higher risk for leukemia and other blood cancers, according to the American Cancer Society.

In the wake of the findings, however, debate has erupted over the method and approach used by Valisure to test these products, with critics and companies contending that more “real-world” use data are needed. And the US Pharmacopeia (USP) is asking for full transparency about the testing methods.

In a March 8 statement, USP said the petition indicated that modified USP methods were used in the study, noting that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

However, Valisure contended that drug products need to demonstrate stability over the entire life cycle, from shipment to continued use, emphasizing that constitutes the best “real-world” approach. It also defended the methodology it used.

The reports have led to a state of uncertainty about the use of BP products.

“Right now, we have more unknowns than anything else,” John Barbieri, MD, MBA, assistant professor of dermatology at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, said in a video posted on X and YouTube, summarizing the findings released by Valisure on March 6 and 14. He was not involved in the Valisure research.

Brigham and Women&#039;s Hospital

In a telephone interview, Dr. Barbieri said the report “needs to be taken seriously,” but he also believed the Valisure report is lacking information about testing under “real-world” conditions. He is calling for more information and more transparency about the data. What’s clear, Dr. Barbieri told this news organization, is that the findings about high benzene levels are not a manufacturing error. “It’s something to do with the molecule itself.”
 

Valisure’s Analyses

Valisure performed an initial analysis, using a method called gas chromatography-mass spectrometry, which is the FDA-preferred method for detecting benzene, Mr. Light said. It tested 175 acne products, 99 containing BP and 76 with other ingredients, such as salicylic acid. All the products without BP had no detectable benzene or values below 2 ppm, the FDA concentration limit for benzene.

Of the 99 BP products, 94 contained benzene without any elevated temperature incubation, according to Valisure. Using 50 °C (122 °F, the accepted pharmaceutical stability testing temperature) on 66 products, Valisure detected over 1500 ppm of benzene in two products, over 100 ppm in 17 products, and over 10 ppm in 42 products over an 18-day period.

The analysis confirmed, Valisure said in a press release and the petition, that a substantial amount of benzene can form in a BP product and leak outside the packaging into surrounding air.

The EHP paper, which includes authors from Valisure, reported that researchers took single lots of seven branded BP products, namely, Equate Beauty 2.5% BP cleansers, Neutrogena 10% BP cleanser, CVS Health 10% BP face wash, Walgreens 10% BP cream, Clean & Clear 10% cleanser, Equate Beauty 10% BP acne wash, and Proactiv 2.5% BP cleanser.

Using testing that involved gas chromatography-mass spectrometry, benzene was detected in all the BP products samples tested, and levels increased during incubation at body and shelf-life performance temperatures to more than 2 ppm. The authors concluded that the study “raises substantial concerns” about the safety of BP products currently on the market.
 

Methodology Debates

Two days after Valisure released its analysis on March 6, the USP reviewed the citizen’s petition filed by Valisure and called for more transparency around the testing methods.

“The petition referenced USP and indicated that modified USP methods and procedures were used in the study. The presence of unsafe levels of benzene should be taken seriously,” the statement said. The USP statement also noted that the Valisure analysis used modified USP methods and said that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

In its statement, USP took issue with a practice known as accelerated thermal degradation, which it said Valisure used. USP said the approach involves raising the storage temperature of a product to higher than the temperature indicated on the label for the purpose of simulating degradation over a longer period. While the approach may be acceptable, USP said, the temperatures chosen may not be what is expected to happen to the products.

In response, Mr. Light of Valisure referenced guidance issued in August, 2020, from the FDA, stating that the method it used in the BP analysis can be used to detect impurities in hand sanitizers, including benzene. (In 2021, Valisure detected high levels of benzene in some hand sanitizers and asked the FDA to take action.)
 

Company Response

Among the companies that took issue with the report was Reckitt, which makes Clearasil, which contains BP. In a statement, the company said, in part: “The products and their ingredients are stable over the storage conditions described on their packaging which represent all reasonable and foreseeable conditions.” It said the findings presented by Valisure reflect “unrealistic scenarios rather than real-world conditions.”

The Personal Care Products Council, a national trade association that represents cosmetic and personal care product manufacturers, also took issue with the findings and the approach used to evaluate the products.
 

FDA and the Citizen’s Petition

The FDA accepted the petition, Mr. Light said, and gave it a docket number. “We’ll hopefully hear more soon” because the FDA is required to respond to a citizen’s petition within 180 days, he said.

“We generally don’t comment on pending citizens’ petitions,” an FDA spokesperson said in an email. “When we respond, we will respond directly to the petitioner and post the response in the designated agency public docket.”
 

Valisure’s Patent Application

Mr. Light and others have applied for a patent on methods of producing shelf-stable formulations to prevent degradation of BP to benzene.

“We saw the problem long before we had any sort of application,” Mr. Light said. The issue has been “known for decades.”
 

Role of BP Products for Acne

In the midst of uncertainty, “the first discussion is, do we want to use it?” Dr. Barbieri said in the interview. Some patients may want to avoid it altogether, until more data are available, including more verification of the findings, while others may be comfortable accepting the potential risk, he said.

“Benzoyl peroxide is one of our foundational acne treatments,” Dr. Barbieri said. In the American Academy of Dermatology updated guidelines on acne, published in January, 2024, strong recommendations were made for BP products, as well as topical retinoids, topical antibiotics, and oral doxycycline.

“When you take away BP, there’s no substitute for it,” Dr. Barbieri said. And if patients don’t get improvement with topicals, oral medications might be needed, and “these all have their own risks.”
 

In the Interim

Until more information is available, Dr. Barbieri is advising patients not to store the products at high temperatures or for a long time. Don’t keep the products past their expiration date, and perhaps keep products for a shorter time, “something like a month,” he said.

Those living in a hot climate might consider storing the products in the refrigerator, he said.

“We need more data from Valisure, from other groups that confirm their findings, and we need to hear from the FDA,” Dr. Barbieri said. “There’s a lot of uncertainty right now. But it’s important not to overreact.”

Dr. Barbieri had no relevant disclosures.


 

A version of this article appeared on Medscape.com.

The European Medicines Agency (EMA) has granted a marketing authorization to Novartis Europharm for Fabhalta (iptacopan) for treating adults with paroxysmal nocturnal hemoglobinuria (PNH) who have hemolytic anemia.

The decision was hailed as a first step toward enabling patient access in European Union countries following a March 21 meeting of the Committee for Medicinal Products for Human Use (CHMP).

PNH is a rare, debilitating, and potentially life-threatening genetic disorder that causes hemolytic anemia. Symptoms of the disease include fatigue, body pain, blood clots, bleeding, and shortness of breath. The standard treatment is anti-C5 monoclonal antibodies (eculizumab or ravulizumab) via subcutaneous or intravenous infusion. However, a minority of patients with PNH who are treated with these complement inhibitors encounter residual hemolytic anemia and require red blood cell transfusions.

The active substance of Fabhalta is iptacopan, a proximal complement inhibitor. Iptacopan targets factor B to selectively inhibit the alternative complement pathway and control both C3-mediated extravascular hemolysis and terminal complement-mediated intravascular hemolysis.

Superior Results in Phase 3 Trials

The decision to grant a marketing authorization was taken following a review of two phase 3 trials. The main study was a randomized, open-label, active comparator trial involving 97 patients with PNH who had residual anemia despite receiving treatment with anti-C5 monoclonal antibodies for the previous 6 months. Of the trial participants, 62 received iptacopan monotherapy and 35 continued their anti-C5 regimen for 24 weeks.

Treatment with Fabhalta was found to be significantly superior to the anti-C5 regimen, with 51 of 60 patients who could be evaluated achieving hemoglobin improvement (≥ 2 g/dL) and 42 achieving sustained hemoglobin levels (≥ 12 g/dL) without transfusion, compared with no patients who continued treatment with anti-C5 monoclonal antibodies. Also, 59 of 62 patients treated with Fabhalta did not require blood transfusions between day 14 and day 168, compared with 14 of 35 patients in the anti-C5 group.

The second trial was a single-arm study involving 40 PNH patients who had not previously been treated with a complement inhibitor. Following treatment with Fabhalta, 31 of 33 patients who could be evaluated achieved hemoglobin improvement (≥ 2 g/dL) at week 24, whereas 19 achieved sustained hemoglobin levels (≥ 12 g/dL) without transfusion.

The most common side effects of Fabhalta are upper respiratory tract infection, headache, and diarrhea.

The CHMP stressed that Fabhalta should be prescribed by physicians who are experienced in the management of patients with hematologic disorders.

Fabhalta was supported through the EMA’s Priority Medicines (PRIME) scheme, which provides regulatory support for promising medicines with the potential to address unmet medical needs. The CHMP’s recommendation has been sent to the European Commission for a final decision.

Novartis said in a company statement on March 22 that, if approved, Fabhalta would be the first oral monotherapy available to PNH patients in Europe.

A version of this article appeared on Medscape.com.

The European Medicines Agency (EMA) has granted a marketing authorization to Novartis Europharm for Fabhalta (iptacopan) for treating adults with paroxysmal nocturnal hemoglobinuria (PNH) who have hemolytic anemia.

The decision was hailed as a first step toward enabling patient access in European Union countries following a March 21 meeting of the Committee for Medicinal Products for Human Use (CHMP).

PNH is a rare, debilitating, and potentially life-threatening genetic disorder that causes hemolytic anemia. Symptoms of the disease include fatigue, body pain, blood clots, bleeding, and shortness of breath. The standard treatment is anti-C5 monoclonal antibodies (eculizumab or ravulizumab) via subcutaneous or intravenous infusion. However, a minority of patients with PNH who are treated with these complement inhibitors encounter residual hemolytic anemia and require red blood cell transfusions.

The active substance of Fabhalta is iptacopan, a proximal complement inhibitor. Iptacopan targets factor B to selectively inhibit the alternative complement pathway and control both C3-mediated extravascular hemolysis and terminal complement-mediated intravascular hemolysis.

Superior Results in Phase 3 Trials

The decision to grant a marketing authorization was taken following a review of two phase 3 trials. The main study was a randomized, open-label, active comparator trial involving 97 patients with PNH who had residual anemia despite receiving treatment with anti-C5 monoclonal antibodies for the previous 6 months. Of the trial participants, 62 received iptacopan monotherapy and 35 continued their anti-C5 regimen for 24 weeks.

Treatment with Fabhalta was found to be significantly superior to the anti-C5 regimen, with 51 of 60 patients who could be evaluated achieving hemoglobin improvement (≥ 2 g/dL) and 42 achieving sustained hemoglobin levels (≥ 12 g/dL) without transfusion, compared with no patients who continued treatment with anti-C5 monoclonal antibodies. Also, 59 of 62 patients treated with Fabhalta did not require blood transfusions between day 14 and day 168, compared with 14 of 35 patients in the anti-C5 group.

The second trial was a single-arm study involving 40 PNH patients who had not previously been treated with a complement inhibitor. Following treatment with Fabhalta, 31 of 33 patients who could be evaluated achieved hemoglobin improvement (≥ 2 g/dL) at week 24, whereas 19 achieved sustained hemoglobin levels (≥ 12 g/dL) without transfusion.

The most common side effects of Fabhalta are upper respiratory tract infection, headache, and diarrhea.

The CHMP stressed that Fabhalta should be prescribed by physicians who are experienced in the management of patients with hematologic disorders.

Fabhalta was supported through the EMA’s Priority Medicines (PRIME) scheme, which provides regulatory support for promising medicines with the potential to address unmet medical needs. The CHMP’s recommendation has been sent to the European Commission for a final decision.

Novartis said in a company statement on March 22 that, if approved, Fabhalta would be the first oral monotherapy available to PNH patients in Europe.

A version of this article appeared on Medscape.com.

The European Medicines Agency (EMA) has granted a marketing authorization to Novartis Europharm for Fabhalta (iptacopan) for treating adults with paroxysmal nocturnal hemoglobinuria (PNH) who have hemolytic anemia.

The decision was hailed as a first step toward enabling patient access in European Union countries following a March 21 meeting of the Committee for Medicinal Products for Human Use (CHMP).

PNH is a rare, debilitating, and potentially life-threatening genetic disorder that causes hemolytic anemia. Symptoms of the disease include fatigue, body pain, blood clots, bleeding, and shortness of breath. The standard treatment is anti-C5 monoclonal antibodies (eculizumab or ravulizumab) via subcutaneous or intravenous infusion. However, a minority of patients with PNH who are treated with these complement inhibitors encounter residual hemolytic anemia and require red blood cell transfusions.

The active substance of Fabhalta is iptacopan, a proximal complement inhibitor. Iptacopan targets factor B to selectively inhibit the alternative complement pathway and control both C3-mediated extravascular hemolysis and terminal complement-mediated intravascular hemolysis.

Superior Results in Phase 3 Trials

The decision to grant a marketing authorization was taken following a review of two phase 3 trials. The main study was a randomized, open-label, active comparator trial involving 97 patients with PNH who had residual anemia despite receiving treatment with anti-C5 monoclonal antibodies for the previous 6 months. Of the trial participants, 62 received iptacopan monotherapy and 35 continued their anti-C5 regimen for 24 weeks.

Treatment with Fabhalta was found to be significantly superior to the anti-C5 regimen, with 51 of 60 patients who could be evaluated achieving hemoglobin improvement (≥ 2 g/dL) and 42 achieving sustained hemoglobin levels (≥ 12 g/dL) without transfusion, compared with no patients who continued treatment with anti-C5 monoclonal antibodies. Also, 59 of 62 patients treated with Fabhalta did not require blood transfusions between day 14 and day 168, compared with 14 of 35 patients in the anti-C5 group.

The second trial was a single-arm study involving 40 PNH patients who had not previously been treated with a complement inhibitor. Following treatment with Fabhalta, 31 of 33 patients who could be evaluated achieved hemoglobin improvement (≥ 2 g/dL) at week 24, whereas 19 achieved sustained hemoglobin levels (≥ 12 g/dL) without transfusion.

The most common side effects of Fabhalta are upper respiratory tract infection, headache, and diarrhea.

The CHMP stressed that Fabhalta should be prescribed by physicians who are experienced in the management of patients with hematologic disorders.

Fabhalta was supported through the EMA’s Priority Medicines (PRIME) scheme, which provides regulatory support for promising medicines with the potential to address unmet medical needs. The CHMP’s recommendation has been sent to the European Commission for a final decision.

Novartis said in a company statement on March 22 that, if approved, Fabhalta would be the first oral monotherapy available to PNH patients in Europe.

A version of this article appeared on Medscape.com.

No matter how much we’d like to leave it in the dust, COVID-19 remains prevalent and potent. Tens of thousands of people still contract COVID per week in the United States. Hundreds die. And those who don’t may still develop long COVID.

Pleas from public health officials for people to get a COVID vaccine or booster shot have been ignored by many people. About 80% of eligible Americans haven’t taken any kind of COVID booster. Meantime, the virus continues to mutate, eroding the efficacy of the vaccine’s past versions.

How to get more people to get the jab? Vaccine hesitancy, said infectious disease specialist William Schaffner, MD, is likely rooted in a lack of trust in authority, whether it’s public health officials or politicians.

Dr. Schaffner, professor of infectious diseases at the Vanderbilt University School of Medicine, Nashville, Tennessee, and former medical director of the National Foundation for Infectious Diseases, recommended five strategies physicians can try when discussing the importance of staying up to date on COVID vaccines with patients.
 

#1: Be Patient With Your Patient

First and foremost, if doctors are feeling reluctance from their patients, they need to know “what they shouldn’t do,” Dr. Schaffner said.

When a patient initially doesn’t want the vaccine, doctors shouldn’t express surprise. “Do not scold or berate or belittle. Do not give the impression the patient is somehow wrong or has failed a test of some sort,” Dr. Schaffner said.

Step back and affirm that they understand what the patient is saying so they feel reassured, even if they don’t agree or it’s based on falsehoods about the vaccine.

He said patients need to feel “the doctor heard them; it’s okay to tell the doctor this.” When you affirm what the patient says, it puts them at ease and provides a smoother road to eventually getting them to say “yes.”

But if there’s still a roadblock, don’t bulldoze them. “You don’t want to punish the patient ... let them know you’ll continue to hear them,” Dr. Schaffner said.
 

#2: Always Acknowledge a Concern

Fear of side effects is great among some patients, even if the risks are low, Dr. Schaffner said. Patients may be hesitant because they’re afraid they’ll become one of the “two or three in a million” who suffer extremely rare side effects from the vaccine, Dr. Schaffner said.

In that case, doctors should acknowledge their concern is valid, he said. Never be dismissive. Ask the patients how they feel about the vaccine, listen to their responses, and let them know “I hear you. This is a new mRNA vaccine…you have concern about that,” Dr. Schaffner said.

Doctors can segue into how there’s little reason to wait for some elusive perfectly risk-free vaccine when they can help themselves right now.

“The adverse events that occur with vaccines occur within 2 months [and are typically mild]. I don’t know of a single vaccine that has genuinely long-term implications,” Dr. Schaffner said. “We should remember that old French philosopher Voltaire. He admonished us: Waiting for perfection is the great enemy of the current good.”
 

#3: Make a Strong Recommendation

Here’s something that may seem obvious: Don’t treat the vaccine as an afterthought. “Survey after survey tells us this ... it has everything to do with the strength of the recommendation,” Dr. Schaffner said.

Doctors typically make strong treatment recommendations such conditions as diabetes or high blood pressure, but “when it comes to vaccines, they’re often rather nonchalant,” he said.

If a patient is eligible for a vaccine, doctors should tell the patient they need to get it — not that you think they should get it. “Doctors have to make a firm recommendation: ‘You’re eligible for a vaccine ... and you need to get it ... you’ll receive it on your way out.’ It then becomes a distinct and strong recommendation,” he said.
 

#4: Appeal to Patients’ Hearts, Not Their Minds

In the opening of Charles Dickens’s novel “Hard Times,” the stern school superintendent, Mr. Gradgrind, scolds his students by beating their brow with the notion that, “Facts alone are wanted in life. Plant nothing else and root out everything else.”

The idea that facts alone can sway a vaccine-resistant patient is wrong. “It often doesn’t happen that way,” Dr. Schaffner said. “I don’t think facts do that. Psychologists tell us, yes, information is important, but it’s rarely sufficient to change behavior.”

Data and studies are foundational to medicine, but the key is to change how a patient feels about the data they’re presented with, not how they think about it. “Don’t attack their brain so much but their heart,” Dr. Schaffner said.

Dr. Schaffner has stressed with his patients that the COVID vaccine has become “the social norm,” suggesting virtually everyone he knows has received it and had no problem.

Once questions have been answered about whether the vaccine works and its various side effects, doctors could remind the patient, “You know, everyone in my office is getting the vaccine, and we’re trying to provide this protection to every patient,” he said.

You’re then delving deeper into their emotions and crossing a barrier that facts alone can’t breach.
 

#5: Make it Personal

Lead by example and personalize the fight against the virus. This allows doctors to act as if they’re building an alliance with their patients by framing the vaccine not as something that only affects them but can also confer benefits to a broader social circle.

Even after using these methods, patients may remain resistant, apprehensive, or even indifferent. In cases like these, Dr. Schaffner said it’s a good idea to let it go for the time being.

Let the patient know they “have access to you and can keep speaking with you about it” in the future, he said. “It takes more time, and you have to be cognizant of the nature of the conversation.”

Everybody is unique, but with trust, patience, and awareness of the patient’s feelings, doctors have a better shot at finding common ground with their patients and convincing them the vaccine is in their best interest, he said.

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

No matter how much we’d like to leave it in the dust, COVID-19 remains prevalent and potent. Tens of thousands of people still contract COVID per week in the United States. Hundreds die. And those who don’t may still develop long COVID.

Pleas from public health officials for people to get a COVID vaccine or booster shot have been ignored by many people. About 80% of eligible Americans haven’t taken any kind of COVID booster. Meantime, the virus continues to mutate, eroding the efficacy of the vaccine’s past versions.

How to get more people to get the jab? Vaccine hesitancy, said infectious disease specialist William Schaffner, MD, is likely rooted in a lack of trust in authority, whether it’s public health officials or politicians.

Dr. Schaffner, professor of infectious diseases at the Vanderbilt University School of Medicine, Nashville, Tennessee, and former medical director of the National Foundation for Infectious Diseases, recommended five strategies physicians can try when discussing the importance of staying up to date on COVID vaccines with patients.
 

#1: Be Patient With Your Patient

First and foremost, if doctors are feeling reluctance from their patients, they need to know “what they shouldn’t do,” Dr. Schaffner said.

When a patient initially doesn’t want the vaccine, doctors shouldn’t express surprise. “Do not scold or berate or belittle. Do not give the impression the patient is somehow wrong or has failed a test of some sort,” Dr. Schaffner said.

Step back and affirm that they understand what the patient is saying so they feel reassured, even if they don’t agree or it’s based on falsehoods about the vaccine.

He said patients need to feel “the doctor heard them; it’s okay to tell the doctor this.” When you affirm what the patient says, it puts them at ease and provides a smoother road to eventually getting them to say “yes.”

But if there’s still a roadblock, don’t bulldoze them. “You don’t want to punish the patient ... let them know you’ll continue to hear them,” Dr. Schaffner said.
 

#2: Always Acknowledge a Concern

Fear of side effects is great among some patients, even if the risks are low, Dr. Schaffner said. Patients may be hesitant because they’re afraid they’ll become one of the “two or three in a million” who suffer extremely rare side effects from the vaccine, Dr. Schaffner said.

In that case, doctors should acknowledge their concern is valid, he said. Never be dismissive. Ask the patients how they feel about the vaccine, listen to their responses, and let them know “I hear you. This is a new mRNA vaccine…you have concern about that,” Dr. Schaffner said.

Doctors can segue into how there’s little reason to wait for some elusive perfectly risk-free vaccine when they can help themselves right now.

“The adverse events that occur with vaccines occur within 2 months [and are typically mild]. I don’t know of a single vaccine that has genuinely long-term implications,” Dr. Schaffner said. “We should remember that old French philosopher Voltaire. He admonished us: Waiting for perfection is the great enemy of the current good.”
 

#3: Make a Strong Recommendation

Here’s something that may seem obvious: Don’t treat the vaccine as an afterthought. “Survey after survey tells us this ... it has everything to do with the strength of the recommendation,” Dr. Schaffner said.

Doctors typically make strong treatment recommendations such conditions as diabetes or high blood pressure, but “when it comes to vaccines, they’re often rather nonchalant,” he said.

If a patient is eligible for a vaccine, doctors should tell the patient they need to get it — not that you think they should get it. “Doctors have to make a firm recommendation: ‘You’re eligible for a vaccine ... and you need to get it ... you’ll receive it on your way out.’ It then becomes a distinct and strong recommendation,” he said.
 

#4: Appeal to Patients’ Hearts, Not Their Minds

In the opening of Charles Dickens’s novel “Hard Times,” the stern school superintendent, Mr. Gradgrind, scolds his students by beating their brow with the notion that, “Facts alone are wanted in life. Plant nothing else and root out everything else.”

The idea that facts alone can sway a vaccine-resistant patient is wrong. “It often doesn’t happen that way,” Dr. Schaffner said. “I don’t think facts do that. Psychologists tell us, yes, information is important, but it’s rarely sufficient to change behavior.”

Data and studies are foundational to medicine, but the key is to change how a patient feels about the data they’re presented with, not how they think about it. “Don’t attack their brain so much but their heart,” Dr. Schaffner said.

Dr. Schaffner has stressed with his patients that the COVID vaccine has become “the social norm,” suggesting virtually everyone he knows has received it and had no problem.

Once questions have been answered about whether the vaccine works and its various side effects, doctors could remind the patient, “You know, everyone in my office is getting the vaccine, and we’re trying to provide this protection to every patient,” he said.

You’re then delving deeper into their emotions and crossing a barrier that facts alone can’t breach.
 

#5: Make it Personal

Lead by example and personalize the fight against the virus. This allows doctors to act as if they’re building an alliance with their patients by framing the vaccine not as something that only affects them but can also confer benefits to a broader social circle.

Even after using these methods, patients may remain resistant, apprehensive, or even indifferent. In cases like these, Dr. Schaffner said it’s a good idea to let it go for the time being.

Let the patient know they “have access to you and can keep speaking with you about it” in the future, he said. “It takes more time, and you have to be cognizant of the nature of the conversation.”

Everybody is unique, but with trust, patience, and awareness of the patient’s feelings, doctors have a better shot at finding common ground with their patients and convincing them the vaccine is in their best interest, he said.

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

No matter how much we’d like to leave it in the dust, COVID-19 remains prevalent and potent. Tens of thousands of people still contract COVID per week in the United States. Hundreds die. And those who don’t may still develop long COVID.

Pleas from public health officials for people to get a COVID vaccine or booster shot have been ignored by many people. About 80% of eligible Americans haven’t taken any kind of COVID booster. Meantime, the virus continues to mutate, eroding the efficacy of the vaccine’s past versions.

How to get more people to get the jab? Vaccine hesitancy, said infectious disease specialist William Schaffner, MD, is likely rooted in a lack of trust in authority, whether it’s public health officials or politicians.

Dr. Schaffner, professor of infectious diseases at the Vanderbilt University School of Medicine, Nashville, Tennessee, and former medical director of the National Foundation for Infectious Diseases, recommended five strategies physicians can try when discussing the importance of staying up to date on COVID vaccines with patients.
 

#1: Be Patient With Your Patient

First and foremost, if doctors are feeling reluctance from their patients, they need to know “what they shouldn’t do,” Dr. Schaffner said.

When a patient initially doesn’t want the vaccine, doctors shouldn’t express surprise. “Do not scold or berate or belittle. Do not give the impression the patient is somehow wrong or has failed a test of some sort,” Dr. Schaffner said.

Step back and affirm that they understand what the patient is saying so they feel reassured, even if they don’t agree or it’s based on falsehoods about the vaccine.

He said patients need to feel “the doctor heard them; it’s okay to tell the doctor this.” When you affirm what the patient says, it puts them at ease and provides a smoother road to eventually getting them to say “yes.”

But if there’s still a roadblock, don’t bulldoze them. “You don’t want to punish the patient ... let them know you’ll continue to hear them,” Dr. Schaffner said.
 

#2: Always Acknowledge a Concern

Fear of side effects is great among some patients, even if the risks are low, Dr. Schaffner said. Patients may be hesitant because they’re afraid they’ll become one of the “two or three in a million” who suffer extremely rare side effects from the vaccine, Dr. Schaffner said.

In that case, doctors should acknowledge their concern is valid, he said. Never be dismissive. Ask the patients how they feel about the vaccine, listen to their responses, and let them know “I hear you. This is a new mRNA vaccine…you have concern about that,” Dr. Schaffner said.

Doctors can segue into how there’s little reason to wait for some elusive perfectly risk-free vaccine when they can help themselves right now.

“The adverse events that occur with vaccines occur within 2 months [and are typically mild]. I don’t know of a single vaccine that has genuinely long-term implications,” Dr. Schaffner said. “We should remember that old French philosopher Voltaire. He admonished us: Waiting for perfection is the great enemy of the current good.”
 

#3: Make a Strong Recommendation

Here’s something that may seem obvious: Don’t treat the vaccine as an afterthought. “Survey after survey tells us this ... it has everything to do with the strength of the recommendation,” Dr. Schaffner said.

Doctors typically make strong treatment recommendations such conditions as diabetes or high blood pressure, but “when it comes to vaccines, they’re often rather nonchalant,” he said.

If a patient is eligible for a vaccine, doctors should tell the patient they need to get it — not that you think they should get it. “Doctors have to make a firm recommendation: ‘You’re eligible for a vaccine ... and you need to get it ... you’ll receive it on your way out.’ It then becomes a distinct and strong recommendation,” he said.
 

#4: Appeal to Patients’ Hearts, Not Their Minds

In the opening of Charles Dickens’s novel “Hard Times,” the stern school superintendent, Mr. Gradgrind, scolds his students by beating their brow with the notion that, “Facts alone are wanted in life. Plant nothing else and root out everything else.”

The idea that facts alone can sway a vaccine-resistant patient is wrong. “It often doesn’t happen that way,” Dr. Schaffner said. “I don’t think facts do that. Psychologists tell us, yes, information is important, but it’s rarely sufficient to change behavior.”

Data and studies are foundational to medicine, but the key is to change how a patient feels about the data they’re presented with, not how they think about it. “Don’t attack their brain so much but their heart,” Dr. Schaffner said.

Dr. Schaffner has stressed with his patients that the COVID vaccine has become “the social norm,” suggesting virtually everyone he knows has received it and had no problem.

Once questions have been answered about whether the vaccine works and its various side effects, doctors could remind the patient, “You know, everyone in my office is getting the vaccine, and we’re trying to provide this protection to every patient,” he said.

You’re then delving deeper into their emotions and crossing a barrier that facts alone can’t breach.
 

#5: Make it Personal

Lead by example and personalize the fight against the virus. This allows doctors to act as if they’re building an alliance with their patients by framing the vaccine not as something that only affects them but can also confer benefits to a broader social circle.

Even after using these methods, patients may remain resistant, apprehensive, or even indifferent. In cases like these, Dr. Schaffner said it’s a good idea to let it go for the time being.

Let the patient know they “have access to you and can keep speaking with you about it” in the future, he said. “It takes more time, and you have to be cognizant of the nature of the conversation.”

Everybody is unique, but with trust, patience, and awareness of the patient’s feelings, doctors have a better shot at finding common ground with their patients and convincing them the vaccine is in their best interest, he said.

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

Remote cognitive behavioral therapy (CBT) is just as effective as in-person CBT for a range of mental health and somatic disorders, a new review of more than 50 randomized clinical trials (RCTs) showed.

The RCTs included more than 5000 patients receiving CBT for conditions such as mood, anxiety, and body dysmorphic disorders, as well as chronic pain, insomnia, and alcohol use disorder.

“The World Health Organization has designated CBT as essential healthcare, but access remains an important barrier for many people in Canada. Our findings suggest that therapist-guided, remotely delivered CBT can be used to facilitate greater access to evidence-based care,” lead investigator Jason Busse, PhD, McMaster University, Hamilton, Ontario, Canada, said in a press release.

The findings were published online on March 18 in CMAJ.
 

Access Problematic

In Canada, CBT may be provided within existing government-funded healthcare services and by private providers such as registered psychotherapists, social worker, and psychologists who require out-of-pocket expenses.

Access to evidence-based mental healthcare such as CBT can be challenging in a country as geographically large, and as sparsely populated, as Canada. To increase access, some of the provinces have funded Internet-based CBT, but the efficacy of in-person vs remote CBT remains uncertain.

The investigators searched the medical literature for RCTs that enrolled adult patients randomized to receive either therapist-guided remote or in-person CBT.

The study included 52 RCTs with 5463 participants with a mean age of 43 years, and 3354 (61%) were female.

A total of 17 studies focused on the treatment of anxiety and related disorders, 14 on depression and mood disorders, seven on insomnia, six on chronic pain or fatigue syndromes, five on body image or eating disorders, three on tinnitus, and one on alcohol use disorder.

CBT was provided on an individual and group basis. Treatment duration ranged from 5 to 21 sessions, with the median follow-up of 180 days.

Investigators found little to no difference in effectiveness between in-person and therapist-guided remote CBT on primary outcomes (standardized mean difference [SMD], −0.02; 95% CI, −0.11 to 0.07).

Analysis using end scores also showed little to no difference in efficacy between in-person and remote CBT (SMD, −0.01; 95% CI, −0.11 to 0.08).
 

Policy Implications

The authors noted that remote CBT can potentially expand access to care as it is more convenient for patients and potentially more cost-effective.

“Our finding that remote CBT is an effective alternative to in-person delivery has potential policy implications,” they wrote.

The researchers recommended Canadian provinces and territories increase funding to boost access to therapist-guided remote CBT, thereby expanding access to evidence-based care.

Study limitations included the fact that most of the eligible RCTs reviewed in the analysis were conducted in high-income countries with middle-aged patients and followed them for a median 180 days, so generalizability of the findings to older patients living in lower-income patients or for longer follow-up periods was uncertain.

The study was partially funded by the Canadian Institutes of Health Research. Disclosures were noted in the original article.

A version of this article appeared on Medscape.com .

Remote cognitive behavioral therapy (CBT) is just as effective as in-person CBT for a range of mental health and somatic disorders, a new review of more than 50 randomized clinical trials (RCTs) showed.

The RCTs included more than 5000 patients receiving CBT for conditions such as mood, anxiety, and body dysmorphic disorders, as well as chronic pain, insomnia, and alcohol use disorder.

“The World Health Organization has designated CBT as essential healthcare, but access remains an important barrier for many people in Canada. Our findings suggest that therapist-guided, remotely delivered CBT can be used to facilitate greater access to evidence-based care,” lead investigator Jason Busse, PhD, McMaster University, Hamilton, Ontario, Canada, said in a press release.

The findings were published online on March 18 in CMAJ.
 

Access Problematic

In Canada, CBT may be provided within existing government-funded healthcare services and by private providers such as registered psychotherapists, social worker, and psychologists who require out-of-pocket expenses.

Access to evidence-based mental healthcare such as CBT can be challenging in a country as geographically large, and as sparsely populated, as Canada. To increase access, some of the provinces have funded Internet-based CBT, but the efficacy of in-person vs remote CBT remains uncertain.

The investigators searched the medical literature for RCTs that enrolled adult patients randomized to receive either therapist-guided remote or in-person CBT.

The study included 52 RCTs with 5463 participants with a mean age of 43 years, and 3354 (61%) were female.

A total of 17 studies focused on the treatment of anxiety and related disorders, 14 on depression and mood disorders, seven on insomnia, six on chronic pain or fatigue syndromes, five on body image or eating disorders, three on tinnitus, and one on alcohol use disorder.

CBT was provided on an individual and group basis. Treatment duration ranged from 5 to 21 sessions, with the median follow-up of 180 days.

Investigators found little to no difference in effectiveness between in-person and therapist-guided remote CBT on primary outcomes (standardized mean difference [SMD], −0.02; 95% CI, −0.11 to 0.07).

Analysis using end scores also showed little to no difference in efficacy between in-person and remote CBT (SMD, −0.01; 95% CI, −0.11 to 0.08).
 

Policy Implications

The authors noted that remote CBT can potentially expand access to care as it is more convenient for patients and potentially more cost-effective.

“Our finding that remote CBT is an effective alternative to in-person delivery has potential policy implications,” they wrote.

The researchers recommended Canadian provinces and territories increase funding to boost access to therapist-guided remote CBT, thereby expanding access to evidence-based care.

Study limitations included the fact that most of the eligible RCTs reviewed in the analysis were conducted in high-income countries with middle-aged patients and followed them for a median 180 days, so generalizability of the findings to older patients living in lower-income patients or for longer follow-up periods was uncertain.

The study was partially funded by the Canadian Institutes of Health Research. Disclosures were noted in the original article.

A version of this article appeared on Medscape.com .

Remote cognitive behavioral therapy (CBT) is just as effective as in-person CBT for a range of mental health and somatic disorders, a new review of more than 50 randomized clinical trials (RCTs) showed.

The RCTs included more than 5000 patients receiving CBT for conditions such as mood, anxiety, and body dysmorphic disorders, as well as chronic pain, insomnia, and alcohol use disorder.

“The World Health Organization has designated CBT as essential healthcare, but access remains an important barrier for many people in Canada. Our findings suggest that therapist-guided, remotely delivered CBT can be used to facilitate greater access to evidence-based care,” lead investigator Jason Busse, PhD, McMaster University, Hamilton, Ontario, Canada, said in a press release.

The findings were published online on March 18 in CMAJ.
 

Access Problematic

In Canada, CBT may be provided within existing government-funded healthcare services and by private providers such as registered psychotherapists, social worker, and psychologists who require out-of-pocket expenses.

Access to evidence-based mental healthcare such as CBT can be challenging in a country as geographically large, and as sparsely populated, as Canada. To increase access, some of the provinces have funded Internet-based CBT, but the efficacy of in-person vs remote CBT remains uncertain.

The investigators searched the medical literature for RCTs that enrolled adult patients randomized to receive either therapist-guided remote or in-person CBT.

The study included 52 RCTs with 5463 participants with a mean age of 43 years, and 3354 (61%) were female.

A total of 17 studies focused on the treatment of anxiety and related disorders, 14 on depression and mood disorders, seven on insomnia, six on chronic pain or fatigue syndromes, five on body image or eating disorders, three on tinnitus, and one on alcohol use disorder.

CBT was provided on an individual and group basis. Treatment duration ranged from 5 to 21 sessions, with the median follow-up of 180 days.

Investigators found little to no difference in effectiveness between in-person and therapist-guided remote CBT on primary outcomes (standardized mean difference [SMD], −0.02; 95% CI, −0.11 to 0.07).

Analysis using end scores also showed little to no difference in efficacy between in-person and remote CBT (SMD, −0.01; 95% CI, −0.11 to 0.08).
 

Policy Implications

The authors noted that remote CBT can potentially expand access to care as it is more convenient for patients and potentially more cost-effective.

“Our finding that remote CBT is an effective alternative to in-person delivery has potential policy implications,” they wrote.

The researchers recommended Canadian provinces and territories increase funding to boost access to therapist-guided remote CBT, thereby expanding access to evidence-based care.

Study limitations included the fact that most of the eligible RCTs reviewed in the analysis were conducted in high-income countries with middle-aged patients and followed them for a median 180 days, so generalizability of the findings to older patients living in lower-income patients or for longer follow-up periods was uncertain.

The study was partially funded by the Canadian Institutes of Health Research. Disclosures were noted in the original article.

A version of this article appeared on Medscape.com .