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Four variables easily accessible at hospital discharge could predict the risk for rehospitalization at 90 days among patients with ulcerative colitis (UC), a preliminary modeling study suggests.

“Absence of a gastroenterologist consultation within the year prior to admission, male sex, shorter length of hospital stay, and narcotic prescription at the time of discharge were independently associated with the risk for 90-day rehospitalization for a UC-related indication,” study author Sanjay Murthy, MD, associate professor of gastroenterology at the University of Ottawa, Ontario, Canada, and staff gastroenterologist at the Inflammatory Bowel Disease Centre at The Ottawa Hospital, said in an interview.

“While some hospital readmissions are likely unavoidable, a subset of them, particularly readmissions that occur soon after discharge, may be preventable with early and intensive postdischarge outpatient management,” he said. “Identifying those who are at high risk for early readmission is a rational first step toward applying targeted outpatient interventions that reduce this risk.”

The study was published in The Journal of the Canadian Association of Gastroenterology.

 

Major Predictor Variables 

The researchers conducted a retrospective study in adults with UC who were admitted to The Ottawa Hospital between 2009 and 2016 for a UC flare or UC-related complication, excluding bowel cancer. Using medical records and administrative health databases, they derived and validated a multivariable logistic regression model of 90-day UC-related rehospitalization risk.

Participants’ mean age at UC diagnosis was 35.3 years and 50.4% were men. In the year before the index hospitalization, 138 (55.6%) participants had a gastroenterologist visit, whereas 41 (16.5%) were hospitalized.

During the index hospitalization, 42 (16.9%) patients were newly diagnosed with UC, and 25 (10.1%) underwent intra-abdominal surgery. At discharge, 34 (13.7%) patients were prescribed an outpatient narcotic. The mean length of hospital stay was 9.97 days. Twenty-seven individuals (10.9%) were rehospitalized within 90 days of discharge.

Out of 35 variables, the model identified the following four as significant predictors of 90-day rehospitalization: gastroenterologist consultation within the prior year (adjusted odds ratio [aOR], 0.09), male sex (aOR, 3.77), length of hospital stay (aOR, 0.93), and discharge with narcotics prescription (aOR, 5.94).

The model had 77.8% sensitivity, 80.9% specificity, 33% positive predictive value, and 96.7% negative predictive value for predicting high vs low risk for 90-day hospital readmission.

The researchers noted several study limitations. The cohort was relatively small, which limited the statistical power for model building and identifying variable associations with the outcome. In addition, the study was conducted in a single tertiary care center, which limits its generalizability. Retrospective data may have affected the accuracy of the measurements, and information on some relevant variables was not available.

Nevertheless, Murthy said, “optimally applying our prediction model at the point of hospital discharge would have classified only about a quarter of individuals in our cohort as being at high-risk for 90-day readmission and potentially needing targeted early outpatient intervention, and this would have captured close to 80% of individuals who were destined for early readmission.”

“However, our research is still preliminary and requires considerably more work to ensure that the findings are suitable for application to clinical practice,” he added. “In the meantime, practitioners may reflect on the potential importance of the major predictor variables identified in our study within their practices.”

 

Careful Follow-Up Key 

Rajiv Bhuta, MD, assistant professor of clinical gastroenterology and hepatology at Temple University and a gastroenterologist at Temple University Hospital, both in Philadelphia, Pennsylvania, commented on the study but was not involved in it.

“The model performed fairly well (c-statistic of 0.78) using four variables: Gastroenterologist consultation within the prior year (protective), male sex (higher risk), length of stay (marginally protective), and narcotic prescription at discharge (higher risk). These are intuitive predictors that align with prior literature on UC hospitalizations,” said Bhuta.

“From a clinical perspective, this type of tool could be useful for targeting high-risk patients for early outpatient interventions (eg, close gastroenterology follow-up and pain management strategies). The negative predictive value (96.7%) suggests that it is particularly good at identifying patients at low risk for rehospitalization, which may help prioritize resource allocation more efficiently. However, practical implementation will require external validation and integration into electronic medical records to automatically flag high-risk patients at discharge.”

In addition, Bhuta noted, “the study only examines patient data through 2016. Why have the last 8 years been excluded? Given the small sample size and the sea change in available inflammatory bowel disease therapies since 2016, there could be significantly different findings with more current data.”

Furthermore, there is a lack of specific data supporting the protective effect of a gastroenterology visit in the previous year, and the readmission rate was lower than that reported by others (10% vs 20%), which, he said “may skew their findings.”

“The strong protective effect of prior gastroenterologist visits underscores the importance of specialty proactive disease management in these complex patients,” Bhuta continued. “Narcotic prescriptions at discharge may indicate inadequate disease activity control, thus making these patients important targets for close follow-up. Narcotics are generally not required once successful disease control has been achieved with steroids or biologics.

“While promising, this tool should not yet replace clinical judgment until it undergoes external validation,” he concluded. “In the meantime, clinicians should focus on structured outpatient follow-up and careful discharge planning to minimize UC-related rehospitalizations.”

This study was funded by a grant provided to Murthy by the department of medicine at the University of Ottawa. Murthy and Bhuta declared having no relevant financial relationships.

A version of this article appeared on Medscape.com . 

Four variables easily accessible at hospital discharge could predict the risk for rehospitalization at 90 days among patients with ulcerative colitis (UC), a preliminary modeling study suggests.

“Absence of a gastroenterologist consultation within the year prior to admission, male sex, shorter length of hospital stay, and narcotic prescription at the time of discharge were independently associated with the risk for 90-day rehospitalization for a UC-related indication,” study author Sanjay Murthy, MD, associate professor of gastroenterology at the University of Ottawa, Ontario, Canada, and staff gastroenterologist at the Inflammatory Bowel Disease Centre at The Ottawa Hospital, said in an interview.

“While some hospital readmissions are likely unavoidable, a subset of them, particularly readmissions that occur soon after discharge, may be preventable with early and intensive postdischarge outpatient management,” he said. “Identifying those who are at high risk for early readmission is a rational first step toward applying targeted outpatient interventions that reduce this risk.”

The study was published in The Journal of the Canadian Association of Gastroenterology.

 

Major Predictor Variables 

The researchers conducted a retrospective study in adults with UC who were admitted to The Ottawa Hospital between 2009 and 2016 for a UC flare or UC-related complication, excluding bowel cancer. Using medical records and administrative health databases, they derived and validated a multivariable logistic regression model of 90-day UC-related rehospitalization risk.

Participants’ mean age at UC diagnosis was 35.3 years and 50.4% were men. In the year before the index hospitalization, 138 (55.6%) participants had a gastroenterologist visit, whereas 41 (16.5%) were hospitalized.

During the index hospitalization, 42 (16.9%) patients were newly diagnosed with UC, and 25 (10.1%) underwent intra-abdominal surgery. At discharge, 34 (13.7%) patients were prescribed an outpatient narcotic. The mean length of hospital stay was 9.97 days. Twenty-seven individuals (10.9%) were rehospitalized within 90 days of discharge.

Out of 35 variables, the model identified the following four as significant predictors of 90-day rehospitalization: gastroenterologist consultation within the prior year (adjusted odds ratio [aOR], 0.09), male sex (aOR, 3.77), length of hospital stay (aOR, 0.93), and discharge with narcotics prescription (aOR, 5.94).

The model had 77.8% sensitivity, 80.9% specificity, 33% positive predictive value, and 96.7% negative predictive value for predicting high vs low risk for 90-day hospital readmission.

The researchers noted several study limitations. The cohort was relatively small, which limited the statistical power for model building and identifying variable associations with the outcome. In addition, the study was conducted in a single tertiary care center, which limits its generalizability. Retrospective data may have affected the accuracy of the measurements, and information on some relevant variables was not available.

Nevertheless, Murthy said, “optimally applying our prediction model at the point of hospital discharge would have classified only about a quarter of individuals in our cohort as being at high-risk for 90-day readmission and potentially needing targeted early outpatient intervention, and this would have captured close to 80% of individuals who were destined for early readmission.”

“However, our research is still preliminary and requires considerably more work to ensure that the findings are suitable for application to clinical practice,” he added. “In the meantime, practitioners may reflect on the potential importance of the major predictor variables identified in our study within their practices.”

 

Careful Follow-Up Key 

Rajiv Bhuta, MD, assistant professor of clinical gastroenterology and hepatology at Temple University and a gastroenterologist at Temple University Hospital, both in Philadelphia, Pennsylvania, commented on the study but was not involved in it.

“The model performed fairly well (c-statistic of 0.78) using four variables: Gastroenterologist consultation within the prior year (protective), male sex (higher risk), length of stay (marginally protective), and narcotic prescription at discharge (higher risk). These are intuitive predictors that align with prior literature on UC hospitalizations,” said Bhuta.

“From a clinical perspective, this type of tool could be useful for targeting high-risk patients for early outpatient interventions (eg, close gastroenterology follow-up and pain management strategies). The negative predictive value (96.7%) suggests that it is particularly good at identifying patients at low risk for rehospitalization, which may help prioritize resource allocation more efficiently. However, practical implementation will require external validation and integration into electronic medical records to automatically flag high-risk patients at discharge.”

In addition, Bhuta noted, “the study only examines patient data through 2016. Why have the last 8 years been excluded? Given the small sample size and the sea change in available inflammatory bowel disease therapies since 2016, there could be significantly different findings with more current data.”

Furthermore, there is a lack of specific data supporting the protective effect of a gastroenterology visit in the previous year, and the readmission rate was lower than that reported by others (10% vs 20%), which, he said “may skew their findings.”

“The strong protective effect of prior gastroenterologist visits underscores the importance of specialty proactive disease management in these complex patients,” Bhuta continued. “Narcotic prescriptions at discharge may indicate inadequate disease activity control, thus making these patients important targets for close follow-up. Narcotics are generally not required once successful disease control has been achieved with steroids or biologics.

“While promising, this tool should not yet replace clinical judgment until it undergoes external validation,” he concluded. “In the meantime, clinicians should focus on structured outpatient follow-up and careful discharge planning to minimize UC-related rehospitalizations.”

This study was funded by a grant provided to Murthy by the department of medicine at the University of Ottawa. Murthy and Bhuta declared having no relevant financial relationships.

A version of this article appeared on Medscape.com . 

Four variables easily accessible at hospital discharge could predict the risk for rehospitalization at 90 days among patients with ulcerative colitis (UC), a preliminary modeling study suggests.

“Absence of a gastroenterologist consultation within the year prior to admission, male sex, shorter length of hospital stay, and narcotic prescription at the time of discharge were independently associated with the risk for 90-day rehospitalization for a UC-related indication,” study author Sanjay Murthy, MD, associate professor of gastroenterology at the University of Ottawa, Ontario, Canada, and staff gastroenterologist at the Inflammatory Bowel Disease Centre at The Ottawa Hospital, said in an interview.

“While some hospital readmissions are likely unavoidable, a subset of them, particularly readmissions that occur soon after discharge, may be preventable with early and intensive postdischarge outpatient management,” he said. “Identifying those who are at high risk for early readmission is a rational first step toward applying targeted outpatient interventions that reduce this risk.”

The study was published in The Journal of the Canadian Association of Gastroenterology.

 

Major Predictor Variables 

The researchers conducted a retrospective study in adults with UC who were admitted to The Ottawa Hospital between 2009 and 2016 for a UC flare or UC-related complication, excluding bowel cancer. Using medical records and administrative health databases, they derived and validated a multivariable logistic regression model of 90-day UC-related rehospitalization risk.

Participants’ mean age at UC diagnosis was 35.3 years and 50.4% were men. In the year before the index hospitalization, 138 (55.6%) participants had a gastroenterologist visit, whereas 41 (16.5%) were hospitalized.

During the index hospitalization, 42 (16.9%) patients were newly diagnosed with UC, and 25 (10.1%) underwent intra-abdominal surgery. At discharge, 34 (13.7%) patients were prescribed an outpatient narcotic. The mean length of hospital stay was 9.97 days. Twenty-seven individuals (10.9%) were rehospitalized within 90 days of discharge.

Out of 35 variables, the model identified the following four as significant predictors of 90-day rehospitalization: gastroenterologist consultation within the prior year (adjusted odds ratio [aOR], 0.09), male sex (aOR, 3.77), length of hospital stay (aOR, 0.93), and discharge with narcotics prescription (aOR, 5.94).

The model had 77.8% sensitivity, 80.9% specificity, 33% positive predictive value, and 96.7% negative predictive value for predicting high vs low risk for 90-day hospital readmission.

The researchers noted several study limitations. The cohort was relatively small, which limited the statistical power for model building and identifying variable associations with the outcome. In addition, the study was conducted in a single tertiary care center, which limits its generalizability. Retrospective data may have affected the accuracy of the measurements, and information on some relevant variables was not available.

Nevertheless, Murthy said, “optimally applying our prediction model at the point of hospital discharge would have classified only about a quarter of individuals in our cohort as being at high-risk for 90-day readmission and potentially needing targeted early outpatient intervention, and this would have captured close to 80% of individuals who were destined for early readmission.”

“However, our research is still preliminary and requires considerably more work to ensure that the findings are suitable for application to clinical practice,” he added. “In the meantime, practitioners may reflect on the potential importance of the major predictor variables identified in our study within their practices.”

 

Careful Follow-Up Key 

Rajiv Bhuta, MD, assistant professor of clinical gastroenterology and hepatology at Temple University and a gastroenterologist at Temple University Hospital, both in Philadelphia, Pennsylvania, commented on the study but was not involved in it.

“The model performed fairly well (c-statistic of 0.78) using four variables: Gastroenterologist consultation within the prior year (protective), male sex (higher risk), length of stay (marginally protective), and narcotic prescription at discharge (higher risk). These are intuitive predictors that align with prior literature on UC hospitalizations,” said Bhuta.

“From a clinical perspective, this type of tool could be useful for targeting high-risk patients for early outpatient interventions (eg, close gastroenterology follow-up and pain management strategies). The negative predictive value (96.7%) suggests that it is particularly good at identifying patients at low risk for rehospitalization, which may help prioritize resource allocation more efficiently. However, practical implementation will require external validation and integration into electronic medical records to automatically flag high-risk patients at discharge.”

In addition, Bhuta noted, “the study only examines patient data through 2016. Why have the last 8 years been excluded? Given the small sample size and the sea change in available inflammatory bowel disease therapies since 2016, there could be significantly different findings with more current data.”

Furthermore, there is a lack of specific data supporting the protective effect of a gastroenterology visit in the previous year, and the readmission rate was lower than that reported by others (10% vs 20%), which, he said “may skew their findings.”

“The strong protective effect of prior gastroenterologist visits underscores the importance of specialty proactive disease management in these complex patients,” Bhuta continued. “Narcotic prescriptions at discharge may indicate inadequate disease activity control, thus making these patients important targets for close follow-up. Narcotics are generally not required once successful disease control has been achieved with steroids or biologics.

“While promising, this tool should not yet replace clinical judgment until it undergoes external validation,” he concluded. “In the meantime, clinicians should focus on structured outpatient follow-up and careful discharge planning to minimize UC-related rehospitalizations.”

This study was funded by a grant provided to Murthy by the department of medicine at the University of Ottawa. Murthy and Bhuta declared having no relevant financial relationships.

A version of this article appeared on Medscape.com . 

The large-scale layoffs in the federal government that began in January continue, as the US Department of Veterans Affairs (VA) announced the dismissal of > 1400 employees in “non-mission critical roles,” including those “related to DEI” (diversity, equity, inclusion) on Feb. 24. According to VA, those fired are bargaining-unit probationary employees who have served > 1 year in a competitive service appointment or who have served > 2 years in an excepted service appointment.

The agency says the “personnel moves” will save > $83 million annually, which will be redirected back toward health care, benefits and services for VA beneficiaries.

Of the nearly 40,000 probationary employees in the department, the majority were exempt, the VA says, because they serve in mission-critical positions—primarily those supporting benefits and services for VA beneficiaries, such as Veterans Crisis Line responders. VA employees who elected to participate in the Office of Personnel Management’s (OPM) deferred resignation program are also exempt. As an “additional safeguard,” the VA says the first Senior Executive Service (SES) or SES-equivalent leader in a dismissed employee’s chain of command can request the employee be exempted from removal.

The latest cuts follow the dismissal of > 1000 employees announced Feb. 13. In that case, the VA expected to save > $98 million annually, also to be “redirected back” toward health care, benefits, and services. VA insists it continues to hire for mission-critical positions that are exempt from the federal hiring freeze.

Layoffs are also impacting other federal public health agencies. Although the White House has not released figures, a ProPublica investigation details the impact of the layoffs on organ transplant and maternal mortality programs. Other layoffs that have been reported include :

• About 750 workers at the Centers for Disease Control and Prevention
• More than 1000 staffers at the National Institutes of Health
• “Dozens” at the Centers for Medicare and Medicaid Services
• “Scores” at the US Food and Drug Administration
• Downsizing at the VA EHR Modernization Integration Office

“By gutting essential health staff, hiding vital public health data, and silencing health experts, these actions have left every American family more vulnerable to deadly disease outbreaks, unsafe food and water, and preventable deaths,” the American Public Health Association said in a press release. “This is also not just an attack on federal institutions – it's a direct attack on every parent trying to protect their child from disease, every worker relying on public health safeguards and every family depending on rapid responses to outbreaks and emergencies.” American Public Health Association also announced that is suing the Department of Government Efficiency for violating federal transparency laws. “It is unfathomable that anybody thinks these cuts have value and are doing anything other than being performative.”

In 2024, the VA had planned to trim its 458,000-member workforce by about 2%, or 10,000 employees, through attrition (with most of the reduction coming from VHA). VHA Chief Financial Officer Laura Duke told reporters in March 2024 that the reduction was needed because the agency had far exceeded its hiring goals last year, and was also seeing higher-than-expected retention rates.

“These and other recent personnel decisions are extraordinarily difficult, but VA is focused on allocating its resources to help as many veterans, families, caregivers, and survivors as possible,” VA Secretary Doug Collins said. “These moves will not hurt VA health care, benefits or beneficiaries. In fact, veterans are going to notice a change for the better. In the coming weeks and months, VA will be announcing plans to put these resources to work helping the department fulfill its core mission: providing the best possible care and benefits to veterans, their families, caregivers and survivors.”

Senate Veterans’ Affairs Committee Ranking Member Richard Blumenthal (D-CT) and a group of 35 Democratic senators signed a letter earlier in February calling for Sec. Collins to immediately reinstate the terminated VA employees. “[W]e were outraged,” the letter said, “by the Administration’s abrupt and indiscriminate termination of tens of thousands of workers across almost every government agency, including more than 1000 Department of Veterans Affairs (VA) employees. We were further disturbed by the manner in which you publicly celebrated this reprehensible announcement—a clear departure from the assurances provided throughout your confirmation process to never ‘balance budgets on the back of veterans’ benefits’ and to always ‘put the veteran first.’”

Blumenthal also notes that the “continued mass terminations” come at a time when the VA faces critical staffing shortages and increased demand for its services. The senators detailed the effects the cuts were having, including how openings for new clinics were delayed because the VA cannot hire the necessary staff to open their doors; service lines at VA hospitals and clinics halted; beds and operating rooms at VA facilities suspended; support lines for caregivers reduced; Veterans Crisis Line employees fired; and suicide prevention training sessions postponed or canceled.

The large-scale layoffs in the federal government that began in January continue, as the US Department of Veterans Affairs (VA) announced the dismissal of > 1400 employees in “non-mission critical roles,” including those “related to DEI” (diversity, equity, inclusion) on Feb. 24. According to VA, those fired are bargaining-unit probationary employees who have served > 1 year in a competitive service appointment or who have served > 2 years in an excepted service appointment.

The agency says the “personnel moves” will save > $83 million annually, which will be redirected back toward health care, benefits and services for VA beneficiaries.

Of the nearly 40,000 probationary employees in the department, the majority were exempt, the VA says, because they serve in mission-critical positions—primarily those supporting benefits and services for VA beneficiaries, such as Veterans Crisis Line responders. VA employees who elected to participate in the Office of Personnel Management’s (OPM) deferred resignation program are also exempt. As an “additional safeguard,” the VA says the first Senior Executive Service (SES) or SES-equivalent leader in a dismissed employee’s chain of command can request the employee be exempted from removal.

The latest cuts follow the dismissal of > 1000 employees announced Feb. 13. In that case, the VA expected to save > $98 million annually, also to be “redirected back” toward health care, benefits, and services. VA insists it continues to hire for mission-critical positions that are exempt from the federal hiring freeze.

Layoffs are also impacting other federal public health agencies. Although the White House has not released figures, a ProPublica investigation details the impact of the layoffs on organ transplant and maternal mortality programs. Other layoffs that have been reported include :

• About 750 workers at the Centers for Disease Control and Prevention
• More than 1000 staffers at the National Institutes of Health
• “Dozens” at the Centers for Medicare and Medicaid Services
• “Scores” at the US Food and Drug Administration
• Downsizing at the VA EHR Modernization Integration Office

“By gutting essential health staff, hiding vital public health data, and silencing health experts, these actions have left every American family more vulnerable to deadly disease outbreaks, unsafe food and water, and preventable deaths,” the American Public Health Association said in a press release. “This is also not just an attack on federal institutions – it's a direct attack on every parent trying to protect their child from disease, every worker relying on public health safeguards and every family depending on rapid responses to outbreaks and emergencies.” American Public Health Association also announced that is suing the Department of Government Efficiency for violating federal transparency laws. “It is unfathomable that anybody thinks these cuts have value and are doing anything other than being performative.”

In 2024, the VA had planned to trim its 458,000-member workforce by about 2%, or 10,000 employees, through attrition (with most of the reduction coming from VHA). VHA Chief Financial Officer Laura Duke told reporters in March 2024 that the reduction was needed because the agency had far exceeded its hiring goals last year, and was also seeing higher-than-expected retention rates.

“These and other recent personnel decisions are extraordinarily difficult, but VA is focused on allocating its resources to help as many veterans, families, caregivers, and survivors as possible,” VA Secretary Doug Collins said. “These moves will not hurt VA health care, benefits or beneficiaries. In fact, veterans are going to notice a change for the better. In the coming weeks and months, VA will be announcing plans to put these resources to work helping the department fulfill its core mission: providing the best possible care and benefits to veterans, their families, caregivers and survivors.”

Senate Veterans’ Affairs Committee Ranking Member Richard Blumenthal (D-CT) and a group of 35 Democratic senators signed a letter earlier in February calling for Sec. Collins to immediately reinstate the terminated VA employees. “[W]e were outraged,” the letter said, “by the Administration’s abrupt and indiscriminate termination of tens of thousands of workers across almost every government agency, including more than 1000 Department of Veterans Affairs (VA) employees. We were further disturbed by the manner in which you publicly celebrated this reprehensible announcement—a clear departure from the assurances provided throughout your confirmation process to never ‘balance budgets on the back of veterans’ benefits’ and to always ‘put the veteran first.’”

Blumenthal also notes that the “continued mass terminations” come at a time when the VA faces critical staffing shortages and increased demand for its services. The senators detailed the effects the cuts were having, including how openings for new clinics were delayed because the VA cannot hire the necessary staff to open their doors; service lines at VA hospitals and clinics halted; beds and operating rooms at VA facilities suspended; support lines for caregivers reduced; Veterans Crisis Line employees fired; and suicide prevention training sessions postponed or canceled.

The large-scale layoffs in the federal government that began in January continue, as the US Department of Veterans Affairs (VA) announced the dismissal of > 1400 employees in “non-mission critical roles,” including those “related to DEI” (diversity, equity, inclusion) on Feb. 24. According to VA, those fired are bargaining-unit probationary employees who have served > 1 year in a competitive service appointment or who have served > 2 years in an excepted service appointment.

The agency says the “personnel moves” will save > $83 million annually, which will be redirected back toward health care, benefits and services for VA beneficiaries.

Of the nearly 40,000 probationary employees in the department, the majority were exempt, the VA says, because they serve in mission-critical positions—primarily those supporting benefits and services for VA beneficiaries, such as Veterans Crisis Line responders. VA employees who elected to participate in the Office of Personnel Management’s (OPM) deferred resignation program are also exempt. As an “additional safeguard,” the VA says the first Senior Executive Service (SES) or SES-equivalent leader in a dismissed employee’s chain of command can request the employee be exempted from removal.

The latest cuts follow the dismissal of > 1000 employees announced Feb. 13. In that case, the VA expected to save > $98 million annually, also to be “redirected back” toward health care, benefits, and services. VA insists it continues to hire for mission-critical positions that are exempt from the federal hiring freeze.

Layoffs are also impacting other federal public health agencies. Although the White House has not released figures, a ProPublica investigation details the impact of the layoffs on organ transplant and maternal mortality programs. Other layoffs that have been reported include :

• About 750 workers at the Centers for Disease Control and Prevention
• More than 1000 staffers at the National Institutes of Health
• “Dozens” at the Centers for Medicare and Medicaid Services
• “Scores” at the US Food and Drug Administration
• Downsizing at the VA EHR Modernization Integration Office

“By gutting essential health staff, hiding vital public health data, and silencing health experts, these actions have left every American family more vulnerable to deadly disease outbreaks, unsafe food and water, and preventable deaths,” the American Public Health Association said in a press release. “This is also not just an attack on federal institutions – it's a direct attack on every parent trying to protect their child from disease, every worker relying on public health safeguards and every family depending on rapid responses to outbreaks and emergencies.” American Public Health Association also announced that is suing the Department of Government Efficiency for violating federal transparency laws. “It is unfathomable that anybody thinks these cuts have value and are doing anything other than being performative.”

In 2024, the VA had planned to trim its 458,000-member workforce by about 2%, or 10,000 employees, through attrition (with most of the reduction coming from VHA). VHA Chief Financial Officer Laura Duke told reporters in March 2024 that the reduction was needed because the agency had far exceeded its hiring goals last year, and was also seeing higher-than-expected retention rates.

“These and other recent personnel decisions are extraordinarily difficult, but VA is focused on allocating its resources to help as many veterans, families, caregivers, and survivors as possible,” VA Secretary Doug Collins said. “These moves will not hurt VA health care, benefits or beneficiaries. In fact, veterans are going to notice a change for the better. In the coming weeks and months, VA will be announcing plans to put these resources to work helping the department fulfill its core mission: providing the best possible care and benefits to veterans, their families, caregivers and survivors.”

Senate Veterans’ Affairs Committee Ranking Member Richard Blumenthal (D-CT) and a group of 35 Democratic senators signed a letter earlier in February calling for Sec. Collins to immediately reinstate the terminated VA employees. “[W]e were outraged,” the letter said, “by the Administration’s abrupt and indiscriminate termination of tens of thousands of workers across almost every government agency, including more than 1000 Department of Veterans Affairs (VA) employees. We were further disturbed by the manner in which you publicly celebrated this reprehensible announcement—a clear departure from the assurances provided throughout your confirmation process to never ‘balance budgets on the back of veterans’ benefits’ and to always ‘put the veteran first.’”

Blumenthal also notes that the “continued mass terminations” come at a time when the VA faces critical staffing shortages and increased demand for its services. The senators detailed the effects the cuts were having, including how openings for new clinics were delayed because the VA cannot hire the necessary staff to open their doors; service lines at VA hospitals and clinics halted; beds and operating rooms at VA facilities suspended; support lines for caregivers reduced; Veterans Crisis Line employees fired; and suicide prevention training sessions postponed or canceled.

Individuals with asthma and chronic obstructive pulmonary disease (COPD) were more vulnerable than healthy controls to epithelial cell changes caused by microplastics exposure, based on data from a new simulation study.

Microplastic fibers present in the ambient air can be inhaled into the lungs and promote a range of complications including oxidative stress, local injury, and cytotoxicity, but data on the effects of microplastic fibers on individuals with obstructive lung diseases are limited, wrote Magdalena Poplinska-Goryca, MD, of the Medical University of Warsaw, Warsaw, Poland, and colleagues. 

In a study published in Scientific Reports, the researchers identified 10 adults aged ≥ 18 years with asthma, eight adults aged ≥ 40 years with COPD, and 11 healthy adult controls. Individuals with more serious conditions such as severe asthma or COPD, unstable or uncontrolled disease, concomitant malignancies, or chronic or acute lung disease were excluded.

The researchers obtained nasal epithelial cells from all participants, and exposed these cells to microplastic fibers created by the researchers in a laboratory setting. Overall, asthmatic and COPD airway epithelial cells showed a different reaction to microplastic fibers stimulation compared to healthy epithelial cells. The most significant response was associated with Th2 inflammation, modulation of stress response, and carcinogenesis. No differences in cytotoxic or minor inflammatory effects on epithelial cells of patients with asthma or COPD were noted compared with healthy controls. 

In addition, flow cytometric analysis showed increased CD24+ epithelial cells in asthma patients compared to controls after microplastics exposure.

“Many of the gene candidates selected from RNA-Seq analysis are related to cancer (upregulated in many cancer types according to the literature), and the activation of CD24 on primarily ciliated asthmatic epithelial cells after microplastic stimulation further supports this theory,” the researchers wrote.

The findings were limited by several factors including the use of nasal rather than bronchial epithelial cells, which would have yielded more information, the researchers noted. Also, patients with severe asthma and COPD were excluded, they said, because of the impact of oral steroid and antibiotic use by this patient group on epithelial cell immunology that could bias the results of epithelial response to microplastic fiber exposure.

However, the results suggest that “the structural impairment of the airway epithelium in obstructive diseases enhances the impact of microplastic particles compared to healthy epithelium,” the researchers concluded.

 

Current and Future Implications

The current study is important in addressing the increasing environmental presence of microplastics and their potential impact on respiratory health, said Seyedmohammad Pourshahid, MD, assistant professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview.

“By examining how microplastics interact with airway epithelial cells, particularly in individuals with asthma and COPD, the research aims to elucidate mechanisms that could contribute to disease progression or exacerbation,” he said. 

“The study’s findings that microplastics did not induce a strong inflammatory response, unlike other pollutants such as PM2.5, were unexpected; instead, microplastics appeared to influence pathways related to airway remodeling and oxidative stress,” Pourshahid noted. “This suggests that microplastics may affect respiratory health through mechanisms distinct from traditional pollutants,” he said.

“While preliminary, this research highlights the potential role of environmental microplastic exposure in respiratory diseases,” Pourshahid told this news organization. “Clinicians should be aware of emerging environmental factors that could impact patient health, especially in individuals with asthma and COPD. This awareness may inform patient education and advocacy for reducing exposure to airborne microplastics,” he said.

More studies are needed to explore the long-term effects of microplastic exposure on respiratory health, particularly in vulnerable populations, said Pourshahid. Research with in vivo models is necessary to confirm the findings and assess potential clinical implications to confirm these findings and assess potential clinical implications, he said. “Understanding the prevalence and sources of daily microplastic exposure can inform public health strategies to mitigate risks,” he added.

The study was supported by the Jakub Potocki Foundation. Paplińska-Goryca and Pourshahid had no financial conflicts to disclose.

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

Individuals with asthma and chronic obstructive pulmonary disease (COPD) were more vulnerable than healthy controls to epithelial cell changes caused by microplastics exposure, based on data from a new simulation study.

Microplastic fibers present in the ambient air can be inhaled into the lungs and promote a range of complications including oxidative stress, local injury, and cytotoxicity, but data on the effects of microplastic fibers on individuals with obstructive lung diseases are limited, wrote Magdalena Poplinska-Goryca, MD, of the Medical University of Warsaw, Warsaw, Poland, and colleagues. 

In a study published in Scientific Reports, the researchers identified 10 adults aged ≥ 18 years with asthma, eight adults aged ≥ 40 years with COPD, and 11 healthy adult controls. Individuals with more serious conditions such as severe asthma or COPD, unstable or uncontrolled disease, concomitant malignancies, or chronic or acute lung disease were excluded.

The researchers obtained nasal epithelial cells from all participants, and exposed these cells to microplastic fibers created by the researchers in a laboratory setting. Overall, asthmatic and COPD airway epithelial cells showed a different reaction to microplastic fibers stimulation compared to healthy epithelial cells. The most significant response was associated with Th2 inflammation, modulation of stress response, and carcinogenesis. No differences in cytotoxic or minor inflammatory effects on epithelial cells of patients with asthma or COPD were noted compared with healthy controls. 

In addition, flow cytometric analysis showed increased CD24+ epithelial cells in asthma patients compared to controls after microplastics exposure.

“Many of the gene candidates selected from RNA-Seq analysis are related to cancer (upregulated in many cancer types according to the literature), and the activation of CD24 on primarily ciliated asthmatic epithelial cells after microplastic stimulation further supports this theory,” the researchers wrote.

The findings were limited by several factors including the use of nasal rather than bronchial epithelial cells, which would have yielded more information, the researchers noted. Also, patients with severe asthma and COPD were excluded, they said, because of the impact of oral steroid and antibiotic use by this patient group on epithelial cell immunology that could bias the results of epithelial response to microplastic fiber exposure.

However, the results suggest that “the structural impairment of the airway epithelium in obstructive diseases enhances the impact of microplastic particles compared to healthy epithelium,” the researchers concluded.

 

Current and Future Implications

The current study is important in addressing the increasing environmental presence of microplastics and their potential impact on respiratory health, said Seyedmohammad Pourshahid, MD, assistant professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview.

“By examining how microplastics interact with airway epithelial cells, particularly in individuals with asthma and COPD, the research aims to elucidate mechanisms that could contribute to disease progression or exacerbation,” he said. 

“The study’s findings that microplastics did not induce a strong inflammatory response, unlike other pollutants such as PM2.5, were unexpected; instead, microplastics appeared to influence pathways related to airway remodeling and oxidative stress,” Pourshahid noted. “This suggests that microplastics may affect respiratory health through mechanisms distinct from traditional pollutants,” he said.

“While preliminary, this research highlights the potential role of environmental microplastic exposure in respiratory diseases,” Pourshahid told this news organization. “Clinicians should be aware of emerging environmental factors that could impact patient health, especially in individuals with asthma and COPD. This awareness may inform patient education and advocacy for reducing exposure to airborne microplastics,” he said.

More studies are needed to explore the long-term effects of microplastic exposure on respiratory health, particularly in vulnerable populations, said Pourshahid. Research with in vivo models is necessary to confirm the findings and assess potential clinical implications to confirm these findings and assess potential clinical implications, he said. “Understanding the prevalence and sources of daily microplastic exposure can inform public health strategies to mitigate risks,” he added.

The study was supported by the Jakub Potocki Foundation. Paplińska-Goryca and Pourshahid had no financial conflicts to disclose.

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

Individuals with asthma and chronic obstructive pulmonary disease (COPD) were more vulnerable than healthy controls to epithelial cell changes caused by microplastics exposure, based on data from a new simulation study.

Microplastic fibers present in the ambient air can be inhaled into the lungs and promote a range of complications including oxidative stress, local injury, and cytotoxicity, but data on the effects of microplastic fibers on individuals with obstructive lung diseases are limited, wrote Magdalena Poplinska-Goryca, MD, of the Medical University of Warsaw, Warsaw, Poland, and colleagues. 

In a study published in Scientific Reports, the researchers identified 10 adults aged ≥ 18 years with asthma, eight adults aged ≥ 40 years with COPD, and 11 healthy adult controls. Individuals with more serious conditions such as severe asthma or COPD, unstable or uncontrolled disease, concomitant malignancies, or chronic or acute lung disease were excluded.

The researchers obtained nasal epithelial cells from all participants, and exposed these cells to microplastic fibers created by the researchers in a laboratory setting. Overall, asthmatic and COPD airway epithelial cells showed a different reaction to microplastic fibers stimulation compared to healthy epithelial cells. The most significant response was associated with Th2 inflammation, modulation of stress response, and carcinogenesis. No differences in cytotoxic or minor inflammatory effects on epithelial cells of patients with asthma or COPD were noted compared with healthy controls. 

In addition, flow cytometric analysis showed increased CD24+ epithelial cells in asthma patients compared to controls after microplastics exposure.

“Many of the gene candidates selected from RNA-Seq analysis are related to cancer (upregulated in many cancer types according to the literature), and the activation of CD24 on primarily ciliated asthmatic epithelial cells after microplastic stimulation further supports this theory,” the researchers wrote.

The findings were limited by several factors including the use of nasal rather than bronchial epithelial cells, which would have yielded more information, the researchers noted. Also, patients with severe asthma and COPD were excluded, they said, because of the impact of oral steroid and antibiotic use by this patient group on epithelial cell immunology that could bias the results of epithelial response to microplastic fiber exposure.

However, the results suggest that “the structural impairment of the airway epithelium in obstructive diseases enhances the impact of microplastic particles compared to healthy epithelium,” the researchers concluded.

 

Current and Future Implications

The current study is important in addressing the increasing environmental presence of microplastics and their potential impact on respiratory health, said Seyedmohammad Pourshahid, MD, assistant professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview.

“By examining how microplastics interact with airway epithelial cells, particularly in individuals with asthma and COPD, the research aims to elucidate mechanisms that could contribute to disease progression or exacerbation,” he said. 

“The study’s findings that microplastics did not induce a strong inflammatory response, unlike other pollutants such as PM2.5, were unexpected; instead, microplastics appeared to influence pathways related to airway remodeling and oxidative stress,” Pourshahid noted. “This suggests that microplastics may affect respiratory health through mechanisms distinct from traditional pollutants,” he said.

“While preliminary, this research highlights the potential role of environmental microplastic exposure in respiratory diseases,” Pourshahid told this news organization. “Clinicians should be aware of emerging environmental factors that could impact patient health, especially in individuals with asthma and COPD. This awareness may inform patient education and advocacy for reducing exposure to airborne microplastics,” he said.

More studies are needed to explore the long-term effects of microplastic exposure on respiratory health, particularly in vulnerable populations, said Pourshahid. Research with in vivo models is necessary to confirm the findings and assess potential clinical implications to confirm these findings and assess potential clinical implications, he said. “Understanding the prevalence and sources of daily microplastic exposure can inform public health strategies to mitigate risks,” he added.

The study was supported by the Jakub Potocki Foundation. Paplińska-Goryca and Pourshahid had no financial conflicts to disclose.

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

The Trump administration’s plans to study the “threat” posed by psychiatric medications in children have medical societies and mental health professionals concerned that the administration may be considering restrictions on the use of psychotropic drugs in pediatric patients.

An executive order signed last week created the “Make American Healthy Again Commission” to investigate the nation’s “escalating health crisis,” particularly in child health. Recently confirmed Secretary of the US Department of Health and Human Services Robert F. Kennedy Jr. will chair the effort.

As part of its investigation, the executive order directed the commission to assess “the prevalence of and threat posed by the prescription of selective serotonin reuptake inhibitors (SSRIs), antipsychotics, mood stabilizers, stimulants, and weight-loss drugs.”

A report on the commission’s findings is due in a little less than 100 days. Eighty days later, the commission must submit recommendations for federal action.

Although who the commission members are and the scope of its work is unclear, the language in the executive order — namely the implication that the Trump administration views psychotropic medication as a “threat” to children — was enough to prompt psychiatrists from across the country to contact the American Psychiatric Association (APA) about possible limitations on the use of psychotropic medications in pediatric patients.

“It’s concerning and surprising that some of our nation’s most vulnerable children who need these treatments to participate fully in life would be under scrutiny in this way,” Marketa Wills, MD, MBA, chief executive officer and medical director for the APA, told this news organization.

“If these medications are under threat and children decompensate that would not be good from a public health perspective, for the healthcare system or for the families we serve,” Wills said.

 

Past Comments Fuel Distress

Past comments by the commission chair have only fueled distress over the commission’s goals. Kennedy has long expressed skepticism about antidepressants, especially (SSRIs), questioning their safety and suggesting they are as addictive as heroin. 

“I know people, including members of my family, who’ve had a much worse time getting off of SSRIs than they have getting off of heroin,” Kennedy said during his Senate confirmation hearing in late January.

But there is no evidence to suggest SSRIs or other antidepressants are addictive, Leslie A. Hulvershorn, MD, chair and associate professor of psychiatry at Indiana University School of Medicine, told this news organization.

“They don’t work in the systems of the brain that drive addiction. A large amount of research suggests that they are safe to take for a long time,” she said. “I suspect the confusion comes from the difference between it not being wise to come off of the medication, because of a concern for relapse of a psychiatric illness, and some transient discomfort from abruptly stopping SSRIs without tapering them off versus being addicted to it, like heroin.”

During the hearing, Kennedy was also asked to respond to comments he made during a 2023 livestream on X in which he claimed that the use of antidepressants have contributed to the increase in school shootings in the United States.

“I am also going to look very closely at the role of psychiatric drugs in these events and there are no good studies right now that should have been done years ago on this issue because there is a tremendous circumstantial evidence that SSRIs and benzos and other drugs are doing this,” he said in the livestream. 

Research has shown that there is no link between school shootings and antidepressant use.

In a 2024 interview on the Latino Capitalist podcast, Kennedy said that he wanted create “wellness farms” for adults addicted to illicit drugs and children who take antidepressants or stimulants for ADHD could be “reparented.”

“The views on those wellness farms are concerning for us here at the American Psychiatric Association. It remains to be seen if he brings that back up in his new role at HHS. There is currently no evidence of their efficacy,” Wills said.

 

Fear Is a ‘Real Concern’

These controversial comments, combined with the commission’s charge to investigate the potential “threat” psychotropic medications pose to children, worry clinicians and families fear that access to medication could be restricted.

“Psychiatrists and patients are very concerned about the risk these statements may pose,” Hulvershorn said.

“Certainly, there is evidence that psychotropic medications are overprescribed, particularly in children who are in state care — like wards of the state — and who are part of Medicaid programs, but there is tremendous overall benefit associated with psychotropic medications in youth and adults. They are lifesaving and game changing in many instances,” she added.

Psychiatrists who’ve contacted the APA since last week’s announcement echo Hulvershorn’s comments. 

“The fear is the real concern,” Wills said. “No parent takes the decision lightly to put their child on medication. With all interventions, particularly with children, there are risks and benefits that must be carefully weighed. The best person to weigh those risks and benefits is the child and adolescent psychiatrist, in conjunction with the child’s parents.”

The focus on medication also overlooks the fact that psychosocial interventions — not medication — are first-line treatment for children with mental health issues and that guidelines recommend medication be used alongside nonpharmacological therapy.

“Extensive research, including large national multi-site studies, have examined the most effective ways to reduce psychological symptoms among youth, including anxiety, depression, and ADHD. Results consistently reveal that both psychotropic medications and psychological interventions can offer significant improvements, often in combination,” Mitch Prinstein, PhD, chief of psychology strategy and integration at the American Psychological Association, told this news organization. 

“Given the substantial challenges for many in gaining access to psychotherapy and a national shortage of licensed psychologists, reducing access to medications would undoubtedly have a debilitating effect of the already concerning youth mental health crisis,” Prinstein said. 

 

A Seat at The Table

While the launch of the commission has left some feeling uneasy, experts agree that a national focus on children’s mental health is needed.

The APA would “welcome an opportunity to be part of this national conversation following the evidence base, following settled science that shows when and how these medications are effective and helpful for children and families,” said Wills. “We also think it’s very important that child and adolescent psychiatrists be at the table for this national conversation on behalf of the families they serve.” 

In a joint letter with the APA, officials with the American Academy of Child and Adolescent Psychiatry also expressed interest in playing a role in the commission’s work. 

“We are in the middle of a mental health crisis, with a record number of Americans struggling with mental health and substance use disorders. We strongly urge you to prioritize strengthening the ability to respond to an increasing demand for psychiatric services, especially for children,” the letter stated.

Indeed, looking beyond just the use of psychotropic medications is vital to the success of any strategy to address the youth mental health crisis, Hulvershorn noted. 

“There are already many programs underway to examine the overprescribing. In my view, the lack of supports by payors for behavioral interventions, such as evidence-based family interventions, psychotherapies, etc., is the major driver for overuse of medications,” she said.

“Every pediatrician and child psychiatrist I know would rather try a behavioral intervention with a family first, but those are services that our systems do not financially support well and are, thus, underdeveloped, and very difficult to access,” Hulvershorn added.

More funding for evidence-based interventions — both behavioral and pharmacological — is desperately needed, she said. Support for workforce development should also be a part of any proposed solution. 

“Adequate and responsible funding in all of those areas is needed, but we have some low hanging fruit in terms of figuring out how to just deliver the interventions that science has shown us do work,” Hulvershorn said. “Many of those interventions don’t involve medication and I think every expert in the field would be glad to see more effort put into system reform to better deliver interventions that work to youth and their families.”

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

The Trump administration’s plans to study the “threat” posed by psychiatric medications in children have medical societies and mental health professionals concerned that the administration may be considering restrictions on the use of psychotropic drugs in pediatric patients.

An executive order signed last week created the “Make American Healthy Again Commission” to investigate the nation’s “escalating health crisis,” particularly in child health. Recently confirmed Secretary of the US Department of Health and Human Services Robert F. Kennedy Jr. will chair the effort.

As part of its investigation, the executive order directed the commission to assess “the prevalence of and threat posed by the prescription of selective serotonin reuptake inhibitors (SSRIs), antipsychotics, mood stabilizers, stimulants, and weight-loss drugs.”

A report on the commission’s findings is due in a little less than 100 days. Eighty days later, the commission must submit recommendations for federal action.

Although who the commission members are and the scope of its work is unclear, the language in the executive order — namely the implication that the Trump administration views psychotropic medication as a “threat” to children — was enough to prompt psychiatrists from across the country to contact the American Psychiatric Association (APA) about possible limitations on the use of psychotropic medications in pediatric patients.

“It’s concerning and surprising that some of our nation’s most vulnerable children who need these treatments to participate fully in life would be under scrutiny in this way,” Marketa Wills, MD, MBA, chief executive officer and medical director for the APA, told this news organization.

“If these medications are under threat and children decompensate that would not be good from a public health perspective, for the healthcare system or for the families we serve,” Wills said.

 

Past Comments Fuel Distress

Past comments by the commission chair have only fueled distress over the commission’s goals. Kennedy has long expressed skepticism about antidepressants, especially (SSRIs), questioning their safety and suggesting they are as addictive as heroin. 

“I know people, including members of my family, who’ve had a much worse time getting off of SSRIs than they have getting off of heroin,” Kennedy said during his Senate confirmation hearing in late January.

But there is no evidence to suggest SSRIs or other antidepressants are addictive, Leslie A. Hulvershorn, MD, chair and associate professor of psychiatry at Indiana University School of Medicine, told this news organization.

“They don’t work in the systems of the brain that drive addiction. A large amount of research suggests that they are safe to take for a long time,” she said. “I suspect the confusion comes from the difference between it not being wise to come off of the medication, because of a concern for relapse of a psychiatric illness, and some transient discomfort from abruptly stopping SSRIs without tapering them off versus being addicted to it, like heroin.”

During the hearing, Kennedy was also asked to respond to comments he made during a 2023 livestream on X in which he claimed that the use of antidepressants have contributed to the increase in school shootings in the United States.

“I am also going to look very closely at the role of psychiatric drugs in these events and there are no good studies right now that should have been done years ago on this issue because there is a tremendous circumstantial evidence that SSRIs and benzos and other drugs are doing this,” he said in the livestream. 

Research has shown that there is no link between school shootings and antidepressant use.

In a 2024 interview on the Latino Capitalist podcast, Kennedy said that he wanted create “wellness farms” for adults addicted to illicit drugs and children who take antidepressants or stimulants for ADHD could be “reparented.”

“The views on those wellness farms are concerning for us here at the American Psychiatric Association. It remains to be seen if he brings that back up in his new role at HHS. There is currently no evidence of their efficacy,” Wills said.

 

Fear Is a ‘Real Concern’

These controversial comments, combined with the commission’s charge to investigate the potential “threat” psychotropic medications pose to children, worry clinicians and families fear that access to medication could be restricted.

“Psychiatrists and patients are very concerned about the risk these statements may pose,” Hulvershorn said.

“Certainly, there is evidence that psychotropic medications are overprescribed, particularly in children who are in state care — like wards of the state — and who are part of Medicaid programs, but there is tremendous overall benefit associated with psychotropic medications in youth and adults. They are lifesaving and game changing in many instances,” she added.

Psychiatrists who’ve contacted the APA since last week’s announcement echo Hulvershorn’s comments. 

“The fear is the real concern,” Wills said. “No parent takes the decision lightly to put their child on medication. With all interventions, particularly with children, there are risks and benefits that must be carefully weighed. The best person to weigh those risks and benefits is the child and adolescent psychiatrist, in conjunction with the child’s parents.”

The focus on medication also overlooks the fact that psychosocial interventions — not medication — are first-line treatment for children with mental health issues and that guidelines recommend medication be used alongside nonpharmacological therapy.

“Extensive research, including large national multi-site studies, have examined the most effective ways to reduce psychological symptoms among youth, including anxiety, depression, and ADHD. Results consistently reveal that both psychotropic medications and psychological interventions can offer significant improvements, often in combination,” Mitch Prinstein, PhD, chief of psychology strategy and integration at the American Psychological Association, told this news organization. 

“Given the substantial challenges for many in gaining access to psychotherapy and a national shortage of licensed psychologists, reducing access to medications would undoubtedly have a debilitating effect of the already concerning youth mental health crisis,” Prinstein said. 

 

A Seat at The Table

While the launch of the commission has left some feeling uneasy, experts agree that a national focus on children’s mental health is needed.

The APA would “welcome an opportunity to be part of this national conversation following the evidence base, following settled science that shows when and how these medications are effective and helpful for children and families,” said Wills. “We also think it’s very important that child and adolescent psychiatrists be at the table for this national conversation on behalf of the families they serve.” 

In a joint letter with the APA, officials with the American Academy of Child and Adolescent Psychiatry also expressed interest in playing a role in the commission’s work. 

“We are in the middle of a mental health crisis, with a record number of Americans struggling with mental health and substance use disorders. We strongly urge you to prioritize strengthening the ability to respond to an increasing demand for psychiatric services, especially for children,” the letter stated.

Indeed, looking beyond just the use of psychotropic medications is vital to the success of any strategy to address the youth mental health crisis, Hulvershorn noted. 

“There are already many programs underway to examine the overprescribing. In my view, the lack of supports by payors for behavioral interventions, such as evidence-based family interventions, psychotherapies, etc., is the major driver for overuse of medications,” she said.

“Every pediatrician and child psychiatrist I know would rather try a behavioral intervention with a family first, but those are services that our systems do not financially support well and are, thus, underdeveloped, and very difficult to access,” Hulvershorn added.

More funding for evidence-based interventions — both behavioral and pharmacological — is desperately needed, she said. Support for workforce development should also be a part of any proposed solution. 

“Adequate and responsible funding in all of those areas is needed, but we have some low hanging fruit in terms of figuring out how to just deliver the interventions that science has shown us do work,” Hulvershorn said. “Many of those interventions don’t involve medication and I think every expert in the field would be glad to see more effort put into system reform to better deliver interventions that work to youth and their families.”

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

The Trump administration’s plans to study the “threat” posed by psychiatric medications in children have medical societies and mental health professionals concerned that the administration may be considering restrictions on the use of psychotropic drugs in pediatric patients.

An executive order signed last week created the “Make American Healthy Again Commission” to investigate the nation’s “escalating health crisis,” particularly in child health. Recently confirmed Secretary of the US Department of Health and Human Services Robert F. Kennedy Jr. will chair the effort.

As part of its investigation, the executive order directed the commission to assess “the prevalence of and threat posed by the prescription of selective serotonin reuptake inhibitors (SSRIs), antipsychotics, mood stabilizers, stimulants, and weight-loss drugs.”

A report on the commission’s findings is due in a little less than 100 days. Eighty days later, the commission must submit recommendations for federal action.

Although who the commission members are and the scope of its work is unclear, the language in the executive order — namely the implication that the Trump administration views psychotropic medication as a “threat” to children — was enough to prompt psychiatrists from across the country to contact the American Psychiatric Association (APA) about possible limitations on the use of psychotropic medications in pediatric patients.

“It’s concerning and surprising that some of our nation’s most vulnerable children who need these treatments to participate fully in life would be under scrutiny in this way,” Marketa Wills, MD, MBA, chief executive officer and medical director for the APA, told this news organization.

“If these medications are under threat and children decompensate that would not be good from a public health perspective, for the healthcare system or for the families we serve,” Wills said.

 

Past Comments Fuel Distress

Past comments by the commission chair have only fueled distress over the commission’s goals. Kennedy has long expressed skepticism about antidepressants, especially (SSRIs), questioning their safety and suggesting they are as addictive as heroin. 

“I know people, including members of my family, who’ve had a much worse time getting off of SSRIs than they have getting off of heroin,” Kennedy said during his Senate confirmation hearing in late January.

But there is no evidence to suggest SSRIs or other antidepressants are addictive, Leslie A. Hulvershorn, MD, chair and associate professor of psychiatry at Indiana University School of Medicine, told this news organization.

“They don’t work in the systems of the brain that drive addiction. A large amount of research suggests that they are safe to take for a long time,” she said. “I suspect the confusion comes from the difference between it not being wise to come off of the medication, because of a concern for relapse of a psychiatric illness, and some transient discomfort from abruptly stopping SSRIs without tapering them off versus being addicted to it, like heroin.”

During the hearing, Kennedy was also asked to respond to comments he made during a 2023 livestream on X in which he claimed that the use of antidepressants have contributed to the increase in school shootings in the United States.

“I am also going to look very closely at the role of psychiatric drugs in these events and there are no good studies right now that should have been done years ago on this issue because there is a tremendous circumstantial evidence that SSRIs and benzos and other drugs are doing this,” he said in the livestream. 

Research has shown that there is no link between school shootings and antidepressant use.

In a 2024 interview on the Latino Capitalist podcast, Kennedy said that he wanted create “wellness farms” for adults addicted to illicit drugs and children who take antidepressants or stimulants for ADHD could be “reparented.”

“The views on those wellness farms are concerning for us here at the American Psychiatric Association. It remains to be seen if he brings that back up in his new role at HHS. There is currently no evidence of their efficacy,” Wills said.

 

Fear Is a ‘Real Concern’

These controversial comments, combined with the commission’s charge to investigate the potential “threat” psychotropic medications pose to children, worry clinicians and families fear that access to medication could be restricted.

“Psychiatrists and patients are very concerned about the risk these statements may pose,” Hulvershorn said.

“Certainly, there is evidence that psychotropic medications are overprescribed, particularly in children who are in state care — like wards of the state — and who are part of Medicaid programs, but there is tremendous overall benefit associated with psychotropic medications in youth and adults. They are lifesaving and game changing in many instances,” she added.

Psychiatrists who’ve contacted the APA since last week’s announcement echo Hulvershorn’s comments. 

“The fear is the real concern,” Wills said. “No parent takes the decision lightly to put their child on medication. With all interventions, particularly with children, there are risks and benefits that must be carefully weighed. The best person to weigh those risks and benefits is the child and adolescent psychiatrist, in conjunction with the child’s parents.”

The focus on medication also overlooks the fact that psychosocial interventions — not medication — are first-line treatment for children with mental health issues and that guidelines recommend medication be used alongside nonpharmacological therapy.

“Extensive research, including large national multi-site studies, have examined the most effective ways to reduce psychological symptoms among youth, including anxiety, depression, and ADHD. Results consistently reveal that both psychotropic medications and psychological interventions can offer significant improvements, often in combination,” Mitch Prinstein, PhD, chief of psychology strategy and integration at the American Psychological Association, told this news organization. 

“Given the substantial challenges for many in gaining access to psychotherapy and a national shortage of licensed psychologists, reducing access to medications would undoubtedly have a debilitating effect of the already concerning youth mental health crisis,” Prinstein said. 

 

A Seat at The Table

While the launch of the commission has left some feeling uneasy, experts agree that a national focus on children’s mental health is needed.

The APA would “welcome an opportunity to be part of this national conversation following the evidence base, following settled science that shows when and how these medications are effective and helpful for children and families,” said Wills. “We also think it’s very important that child and adolescent psychiatrists be at the table for this national conversation on behalf of the families they serve.” 

In a joint letter with the APA, officials with the American Academy of Child and Adolescent Psychiatry also expressed interest in playing a role in the commission’s work. 

“We are in the middle of a mental health crisis, with a record number of Americans struggling with mental health and substance use disorders. We strongly urge you to prioritize strengthening the ability to respond to an increasing demand for psychiatric services, especially for children,” the letter stated.

Indeed, looking beyond just the use of psychotropic medications is vital to the success of any strategy to address the youth mental health crisis, Hulvershorn noted. 

“There are already many programs underway to examine the overprescribing. In my view, the lack of supports by payors for behavioral interventions, such as evidence-based family interventions, psychotherapies, etc., is the major driver for overuse of medications,” she said.

“Every pediatrician and child psychiatrist I know would rather try a behavioral intervention with a family first, but those are services that our systems do not financially support well and are, thus, underdeveloped, and very difficult to access,” Hulvershorn added.

More funding for evidence-based interventions — both behavioral and pharmacological — is desperately needed, she said. Support for workforce development should also be a part of any proposed solution. 

“Adequate and responsible funding in all of those areas is needed, but we have some low hanging fruit in terms of figuring out how to just deliver the interventions that science has shown us do work,” Hulvershorn said. “Many of those interventions don’t involve medication and I think every expert in the field would be glad to see more effort put into system reform to better deliver interventions that work to youth and their families.”

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

A diet high in omega-3 and low in omega-6 fatty acids, alongside fish oil supplements, may curb the growth of prostate cancer cells in men with early-stage disease, new data showed.

Among men on active surveillance for prostate cancer, consuming this diet for a year led to a significant decrease in the prostate cancer tissue Ki-67 index, a biomarker for prostate cancer progression, metastasis, and death, according to findings from the phase 2 CAPFISH-3 study presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium.

“This data is certainly intriguing and supports studies looking at this further in prostate cancer,” Bradley Alexander McGregor, MD, from Dana-Farber Cancer Institute, Boston, Massachusetts, who wasn’t involved in the study, told this news organization. But, McGregor noted, patients were on the diet for 1 year, and the long-term implications of this diet are not known.

 

Growing Evidence on Diet

Diets that include fried and processed foods tend to be high in omega 6s, while those that include salmon and tuna are higher in omega 3s.

Research has shown that consuming more omega-3 fatty acids is associated with a lower risk for mortality from prostate cancer, explained study investigator William Aronson, MD, with David Geffen School of Medicine at University of California, Los Angeles (UCLA). Research suggests that ingesting more omega-6 accelerates the growth of human tumors in mice, while raising omega-3 levels lowers it. High omega-3 and low omega-6 are also known to have an inhibitory effect on M2-like macrophages, which are the predominant immune cell type in prostate cancer metastasis.

To investigate the impact of these fatty acids on early-stage prostate cancer, Aronson and colleagues conducted a single-center, phase 2, randomized, open-label study in 100 men with grade 1/2 prostate cancer who elected active surveillance.

Patients were randomly allocated 1:1 to a control group that continued their normal diet (minus fish oil) or to an intervention group that followed a low omega-6/high omega-3 diet, supplemented with fish oil (2.2 g/d), for 1 year.

The primary endpoint was the change in Ki-67 index from baseline to 1 year from same-site biopsies between the groups.

For the primary endpoint, the Ki-67 index decreased in the intervention group by 15% from baseline to 1 year and increased in the control group by 24%. The difference between groups was statistically significant (P = .043).

For the secondary endpoints, the intervention led to a reduction in triglyceride levels and macrophage colony stimulating factor but no change in tumor volume grade group, PSA level, or Decipher 22 gene score.

Aronson said the findings support future phase 3 trials incorporating this intervention among men on active surveillance for prostate cancer.

McGregor said it’s important to note that this was “an aggressive intervention with dietary changes and addition of fish oil and patients need to be highly motivated.” Four men discontinued due to adverse effects — primarily gastrointestinal adverse effects such as diarrhea and nausea — larger sample sizes will be key to better understand the tolerability.

Bottom line, said McGregor, “based on this data alone, it should not be recommended but can be considered for highly motivated patients after discussion of the limitations of available data and side effects.”

The study was funded in part by the National Cancer Institute, the UCLA Health Jonsson Comprehensive Cancer Center, Howard B. Klein, and the Seafood Industry Research Fund. Aronson disclosed relationships with AstraZeneca, Bayer, Blue Earth Diagnostics, Janssen Oncology, and Pfizer/Astellas. McGregor disclosed relationships with Arcus Biosciences, Astellas Pharma, Bristol Myers Squibb, Daiichi Sankyo/AstraZeneca, Eisai, Exelixis, Genmab, Gilead Sciences, Loxo/Lilly, Pfizer, and Seattle Genetics/Astellas.

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

A diet high in omega-3 and low in omega-6 fatty acids, alongside fish oil supplements, may curb the growth of prostate cancer cells in men with early-stage disease, new data showed.

Among men on active surveillance for prostate cancer, consuming this diet for a year led to a significant decrease in the prostate cancer tissue Ki-67 index, a biomarker for prostate cancer progression, metastasis, and death, according to findings from the phase 2 CAPFISH-3 study presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium.

“This data is certainly intriguing and supports studies looking at this further in prostate cancer,” Bradley Alexander McGregor, MD, from Dana-Farber Cancer Institute, Boston, Massachusetts, who wasn’t involved in the study, told this news organization. But, McGregor noted, patients were on the diet for 1 year, and the long-term implications of this diet are not known.

 

Growing Evidence on Diet

Diets that include fried and processed foods tend to be high in omega 6s, while those that include salmon and tuna are higher in omega 3s.

Research has shown that consuming more omega-3 fatty acids is associated with a lower risk for mortality from prostate cancer, explained study investigator William Aronson, MD, with David Geffen School of Medicine at University of California, Los Angeles (UCLA). Research suggests that ingesting more omega-6 accelerates the growth of human tumors in mice, while raising omega-3 levels lowers it. High omega-3 and low omega-6 are also known to have an inhibitory effect on M2-like macrophages, which are the predominant immune cell type in prostate cancer metastasis.

To investigate the impact of these fatty acids on early-stage prostate cancer, Aronson and colleagues conducted a single-center, phase 2, randomized, open-label study in 100 men with grade 1/2 prostate cancer who elected active surveillance.

Patients were randomly allocated 1:1 to a control group that continued their normal diet (minus fish oil) or to an intervention group that followed a low omega-6/high omega-3 diet, supplemented with fish oil (2.2 g/d), for 1 year.

The primary endpoint was the change in Ki-67 index from baseline to 1 year from same-site biopsies between the groups.

For the primary endpoint, the Ki-67 index decreased in the intervention group by 15% from baseline to 1 year and increased in the control group by 24%. The difference between groups was statistically significant (P = .043).

For the secondary endpoints, the intervention led to a reduction in triglyceride levels and macrophage colony stimulating factor but no change in tumor volume grade group, PSA level, or Decipher 22 gene score.

Aronson said the findings support future phase 3 trials incorporating this intervention among men on active surveillance for prostate cancer.

McGregor said it’s important to note that this was “an aggressive intervention with dietary changes and addition of fish oil and patients need to be highly motivated.” Four men discontinued due to adverse effects — primarily gastrointestinal adverse effects such as diarrhea and nausea — larger sample sizes will be key to better understand the tolerability.

Bottom line, said McGregor, “based on this data alone, it should not be recommended but can be considered for highly motivated patients after discussion of the limitations of available data and side effects.”

The study was funded in part by the National Cancer Institute, the UCLA Health Jonsson Comprehensive Cancer Center, Howard B. Klein, and the Seafood Industry Research Fund. Aronson disclosed relationships with AstraZeneca, Bayer, Blue Earth Diagnostics, Janssen Oncology, and Pfizer/Astellas. McGregor disclosed relationships with Arcus Biosciences, Astellas Pharma, Bristol Myers Squibb, Daiichi Sankyo/AstraZeneca, Eisai, Exelixis, Genmab, Gilead Sciences, Loxo/Lilly, Pfizer, and Seattle Genetics/Astellas.

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

A diet high in omega-3 and low in omega-6 fatty acids, alongside fish oil supplements, may curb the growth of prostate cancer cells in men with early-stage disease, new data showed.

Among men on active surveillance for prostate cancer, consuming this diet for a year led to a significant decrease in the prostate cancer tissue Ki-67 index, a biomarker for prostate cancer progression, metastasis, and death, according to findings from the phase 2 CAPFISH-3 study presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium.

“This data is certainly intriguing and supports studies looking at this further in prostate cancer,” Bradley Alexander McGregor, MD, from Dana-Farber Cancer Institute, Boston, Massachusetts, who wasn’t involved in the study, told this news organization. But, McGregor noted, patients were on the diet for 1 year, and the long-term implications of this diet are not known.

 

Growing Evidence on Diet

Diets that include fried and processed foods tend to be high in omega 6s, while those that include salmon and tuna are higher in omega 3s.

Research has shown that consuming more omega-3 fatty acids is associated with a lower risk for mortality from prostate cancer, explained study investigator William Aronson, MD, with David Geffen School of Medicine at University of California, Los Angeles (UCLA). Research suggests that ingesting more omega-6 accelerates the growth of human tumors in mice, while raising omega-3 levels lowers it. High omega-3 and low omega-6 are also known to have an inhibitory effect on M2-like macrophages, which are the predominant immune cell type in prostate cancer metastasis.

To investigate the impact of these fatty acids on early-stage prostate cancer, Aronson and colleagues conducted a single-center, phase 2, randomized, open-label study in 100 men with grade 1/2 prostate cancer who elected active surveillance.

Patients were randomly allocated 1:1 to a control group that continued their normal diet (minus fish oil) or to an intervention group that followed a low omega-6/high omega-3 diet, supplemented with fish oil (2.2 g/d), for 1 year.

The primary endpoint was the change in Ki-67 index from baseline to 1 year from same-site biopsies between the groups.

For the primary endpoint, the Ki-67 index decreased in the intervention group by 15% from baseline to 1 year and increased in the control group by 24%. The difference between groups was statistically significant (P = .043).

For the secondary endpoints, the intervention led to a reduction in triglyceride levels and macrophage colony stimulating factor but no change in tumor volume grade group, PSA level, or Decipher 22 gene score.

Aronson said the findings support future phase 3 trials incorporating this intervention among men on active surveillance for prostate cancer.

McGregor said it’s important to note that this was “an aggressive intervention with dietary changes and addition of fish oil and patients need to be highly motivated.” Four men discontinued due to adverse effects — primarily gastrointestinal adverse effects such as diarrhea and nausea — larger sample sizes will be key to better understand the tolerability.

Bottom line, said McGregor, “based on this data alone, it should not be recommended but can be considered for highly motivated patients after discussion of the limitations of available data and side effects.”

The study was funded in part by the National Cancer Institute, the UCLA Health Jonsson Comprehensive Cancer Center, Howard B. Klein, and the Seafood Industry Research Fund. Aronson disclosed relationships with AstraZeneca, Bayer, Blue Earth Diagnostics, Janssen Oncology, and Pfizer/Astellas. McGregor disclosed relationships with Arcus Biosciences, Astellas Pharma, Bristol Myers Squibb, Daiichi Sankyo/AstraZeneca, Eisai, Exelixis, Genmab, Gilead Sciences, Loxo/Lilly, Pfizer, and Seattle Genetics/Astellas.

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

TOPLINE: Gulf War Illness (GWI) symptom severity shows negative correlation with predicted binding affinity of anthrax vaccine antigen to Human Leukocyte Antigen (HLA) Class II molecules. Stronger binding affinity is associated with weaker symptoms, with correlation coefficient r = -0.356 (P < .001).

METHODOLOGY: 

•      Researchers analyzed 458 Gulf War veterans: 397 men, 61 women, mean (SD) age 56.3 (0.5) years.
•      The aim was to determine the association between GWI symptom severity and binding affinity of anthrax Protective Antigen to HLA Class II molecules.
•      Analysis included in silico estimation of predicted binding affinity between 750 15-amino acid length subsequences of protective antigen and specific HLA Class II alleles carried by each participant.
•      Investigators assessed GWI symptom severity across 6 domains: fatigue, pain, neurological/cognitive/mood, respiratory, gastrointestinal, and dermatologic symptoms that began during or after Gulf War and lasted > 6 months. 

TAKEAWAY:

•      GWI symptom severity demonstrated significant negative correlation with strength of predicted binding affinity of protective antigen peptides to HLA-II molecules (correlation coefficient [r], −0.356; P < .001), independent of age (partial correlation, −0.376; P < .001).
•      Researchers identified 180 of 750 (24%) 15-mer epitopes with strong binding affinities to HLA-II molecules, suggesting good potential for CD4+ lymphocyte engagement.
•      Analysis revealed that DPB1 (15/31, 48%) and DRB1 (13/44, 30%) alleles showed strong binding affinity with Protective Antigen epitopes, while all DQB1 alleles (18/18, 100%) showed no strong binding.
•      The number of strong binding hits per individual ranged from 3 to 168, indicating wide variability in potential antibody production capability across participants.

IN PRACTICE: "The current findings, demonstrating a robust negative association between HLAanthrax vaccine PA binding and GWI symptom severity, strongly support the hypothesized role of reduced antibody production against anthrax vaccine PA in GWI that most probably underlies the findings supporting anthrax antigen persistence in GWI, in the broader context of antigen persistence in other diseases," Lisa M. James and Apostolos P. Georgopoulos write. 

SOURCE: The study was led by Lisa M. James and Apostolos P. Georgopoulos of the Brain Sciences Center at the Minneapolis Veterans Affairs Health Care System. It was published online on January 18 in Vaccines.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

TOPLINE: Gulf War Illness (GWI) symptom severity shows negative correlation with predicted binding affinity of anthrax vaccine antigen to Human Leukocyte Antigen (HLA) Class II molecules. Stronger binding affinity is associated with weaker symptoms, with correlation coefficient r = -0.356 (P < .001).

METHODOLOGY: 

•      Researchers analyzed 458 Gulf War veterans: 397 men, 61 women, mean (SD) age 56.3 (0.5) years.
•      The aim was to determine the association between GWI symptom severity and binding affinity of anthrax Protective Antigen to HLA Class II molecules.
•      Analysis included in silico estimation of predicted binding affinity between 750 15-amino acid length subsequences of protective antigen and specific HLA Class II alleles carried by each participant.
•      Investigators assessed GWI symptom severity across 6 domains: fatigue, pain, neurological/cognitive/mood, respiratory, gastrointestinal, and dermatologic symptoms that began during or after Gulf War and lasted > 6 months. 

TAKEAWAY:

•      GWI symptom severity demonstrated significant negative correlation with strength of predicted binding affinity of protective antigen peptides to HLA-II molecules (correlation coefficient [r], −0.356; P < .001), independent of age (partial correlation, −0.376; P < .001).
•      Researchers identified 180 of 750 (24%) 15-mer epitopes with strong binding affinities to HLA-II molecules, suggesting good potential for CD4+ lymphocyte engagement.
•      Analysis revealed that DPB1 (15/31, 48%) and DRB1 (13/44, 30%) alleles showed strong binding affinity with Protective Antigen epitopes, while all DQB1 alleles (18/18, 100%) showed no strong binding.
•      The number of strong binding hits per individual ranged from 3 to 168, indicating wide variability in potential antibody production capability across participants.

IN PRACTICE: "The current findings, demonstrating a robust negative association between HLAanthrax vaccine PA binding and GWI symptom severity, strongly support the hypothesized role of reduced antibody production against anthrax vaccine PA in GWI that most probably underlies the findings supporting anthrax antigen persistence in GWI, in the broader context of antigen persistence in other diseases," Lisa M. James and Apostolos P. Georgopoulos write. 

SOURCE: The study was led by Lisa M. James and Apostolos P. Georgopoulos of the Brain Sciences Center at the Minneapolis Veterans Affairs Health Care System. It was published online on January 18 in Vaccines.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

TOPLINE: Gulf War Illness (GWI) symptom severity shows negative correlation with predicted binding affinity of anthrax vaccine antigen to Human Leukocyte Antigen (HLA) Class II molecules. Stronger binding affinity is associated with weaker symptoms, with correlation coefficient r = -0.356 (P < .001).

METHODOLOGY: 

•      Researchers analyzed 458 Gulf War veterans: 397 men, 61 women, mean (SD) age 56.3 (0.5) years.
•      The aim was to determine the association between GWI symptom severity and binding affinity of anthrax Protective Antigen to HLA Class II molecules.
•      Analysis included in silico estimation of predicted binding affinity between 750 15-amino acid length subsequences of protective antigen and specific HLA Class II alleles carried by each participant.
•      Investigators assessed GWI symptom severity across 6 domains: fatigue, pain, neurological/cognitive/mood, respiratory, gastrointestinal, and dermatologic symptoms that began during or after Gulf War and lasted > 6 months. 

TAKEAWAY:

•      GWI symptom severity demonstrated significant negative correlation with strength of predicted binding affinity of protective antigen peptides to HLA-II molecules (correlation coefficient [r], −0.356; P < .001), independent of age (partial correlation, −0.376; P < .001).
•      Researchers identified 180 of 750 (24%) 15-mer epitopes with strong binding affinities to HLA-II molecules, suggesting good potential for CD4+ lymphocyte engagement.
•      Analysis revealed that DPB1 (15/31, 48%) and DRB1 (13/44, 30%) alleles showed strong binding affinity with Protective Antigen epitopes, while all DQB1 alleles (18/18, 100%) showed no strong binding.
•      The number of strong binding hits per individual ranged from 3 to 168, indicating wide variability in potential antibody production capability across participants.

IN PRACTICE: "The current findings, demonstrating a robust negative association between HLAanthrax vaccine PA binding and GWI symptom severity, strongly support the hypothesized role of reduced antibody production against anthrax vaccine PA in GWI that most probably underlies the findings supporting anthrax antigen persistence in GWI, in the broader context of antigen persistence in other diseases," Lisa M. James and Apostolos P. Georgopoulos write. 

SOURCE: The study was led by Lisa M. James and Apostolos P. Georgopoulos of the Brain Sciences Center at the Minneapolis Veterans Affairs Health Care System. It was published online on January 18 in Vaccines.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

People with vasculitis may need at least three or four vaccinations for COVID-19 before they start to show an immune response against SARS-CoV-2 infection, new research has suggested.

In a longitudinal retrospective study, serum antibody neutralization against the Omicron variant of the virus and its descendants was found to be “largely absent” after the first two doses of COVID-19 vaccine had been given to patients. But increasing neutralizing antibody titers were seen after both the third and fourth vaccine boosters had been administered.

Results also showed that the more recently people had been treated with the B cell–depleting therapy rituximab, the lower the levels of immunogenicity that were achieved, and thus protection against SARS-CoV-2.

“Our results have significant implications for individuals treated with rituximab in the post-Omicron era, highlighting the value of additive boosters in affirming increasing protection in clinically vulnerable populations,” the team behind the work at the University of Cambridge in England, has reported in Science Advances.

Moreover, because the use of rituximab reduced the neutralization of not just wild-type (WT) Omicron but also the Omicron-descendant variants BA.1, BA.2, BA.4, and XBB, this highlights “the urgent need for additional adjunctive strategies to enhance vaccine-induced immunity as well as preferential access for such patients to updated vaccines using spike from now circulating Omicron lineages,” the team added.

 

Studying Humoral Responses to SARS-CoV-2 Vaccines

Corresponding author Ravindra K. Gupta, BMBCh, MA, MPH, PhD, told this news organization that studying humoral responses to SARS-CoV-2 vaccines in immunocompromised individuals such as those with vasculitis was important for two main reasons.

“It is really important at individual level for their own health, of course, but also because we know that variants of concern have often evolved and developed within patients and can then spread in wider populations,” he said.

Gupta, who is professor of clinical microbiology at the Cambridge Institute for Therapeutic Immunology & Infectious Disease added: “We believe that the variants of concern that we’re having to deal with right now, including Omicron, have come from such [immunocompromised] individuals.”

Omicron “was a big shift,” Gupta noted. “It had a lot of new mutations on it, so it was almost like a new strain of the virus.” Few studies have looked at the longitudinal immunogenicity proffered by COVID vaccines in the post-Omicron era, particularly in those with vasculitis who are often treated with immunosuppressive drugs, including rituximab.

 

Two-Pronged Study Approach

For the study, a population of immunocompromised individuals diagnosed with vasculitis who had been treated with rituximab in the past 5 years was identified. Just over half (58%) had received adenovirus-based AZD1222/ChAdOx1 nCoV-19 (AstraZeneca-Oxford; AZN) and 37% BNT162b2 (Pfizer-BioNTech; mRNA) as their primary vaccines. Patients with antineutrophil cytoplasmic antibody–associated vasculitis comprised the majority of those who received rituximab (83%), compared with less than half of those who did not take rituximab (48%).

A two-pronged approach was taken with the researchers first measuring neutralizing antibody titers before and 30 days after four successive COVID vaccinations in a group of 32 individuals with available samples. They then performed a cross-sectional, case-control study in 95 individuals to look at neutralizing antibody titers and antibody-dependent cell-mediated cytotoxicity (ADCC) in individuals who had (n = 64) and had not (n = 31) been treated with rituximab in the past 5 years and had samples available after their third and fourth COVID vaccinations.

The first analysis was done to see how people were responding to vaccination over time. “That told us that there was a problem with the first two doses and that we got some response after doses three and four, but the response was uniformly quite poor against the new variants of concern,” Gupta said.

A human embryonic kidney cell model had been used to determine individuals’ neutralizing antibody titers in response to WT, BA.1, BA.2, BA.4, and XBB pseudotyped viruses. After the first and second COVID vaccinations, the geometric mean titer (GMT) against each variant barely increased from a baseline of 40.0. The greatest increases in GMT was seen with the WT virus, at 43.7, 90.7, 256.3, and 394.2, after the first, second, third and fourth doses, respectively. The lowest increases in GMT were seen with the XBB variant, with respective values of 40.0, 40.8, 45.7, and 53.9.

 

Incremental Benefit Offers Some ‘Reassurance’

Vasculitis specialist Rona Smith, MA, MB BChir, MD, who was one of the authors of the paper, told this news organization separately that the results showed there was “an incremental benefit of having COVID vaccinations,” which “offers a little bit of reassurance” that there can be an immune response in people with vasculitis.

Although results of the cross-sectional study showed that there was a significant dampening effect of rituximab treatment on the immune response, “I don’t think it’s an isolated effect in our [vasculitis] patients,” Smith suggested, adding the results were “probably still relevant to patients who receive routine dosing of rituximab for other conditions.”

Neutralizing antibody titers were consistently lower among individuals who had been treated with rituximab vs those who had not, with treatment in the past 18 months found to significantly impair immunogenicity.

The ADCC response was better preserved than the neutralizing antibody response, Gupta said, although it was still significantly lower in the rituximab-treated than in the non–rituximab-treated patients.

 

When to Vaccinate in Vasculitis?

Regarding when to give vaccines to people with vasculitis, Smith said: “Current recommendations are that patients should receive any vaccines that they’re offered routinely, whether that be COVID vaccines, flu vaccines, pneumococcal vaccines.”

As for the timing of those vaccinations, she observed that the current thinking was that vaccinations should “ideally be at least 1 month before a rituximab treatment, and ideally 3-4 [months] after their last dose. However, as many patients are on a 6-month dosing cycle, it can be difficult for some of them to find a suitable time window to have the COVID vaccine when it is offered.”

Additional precautions, such as wearing masks in crowded places and avoiding visits to acutely unwell friends or relatives, may still be prudent, Smith acknowledged, but he was clear that people should not be locking themselves away as they did during the COVID-19 pandemic.

When advising patients, “our general recommendation is that it is better to have a vaccine than not, but we can’t guarantee how well you will respond to it, but some response is better than none,” Smith said.

The study was independently supported. Gupta had no relevant financial relationships to disclose. Smith was a coauthor of the paper and has received research grant funding from Union Therapeutics, GlaxoSmithKline/Vir Biotechnology, Addenbrooke’s Charitable Trust, and Vasculitis UK. Another coauthor reported receiving research grants from CSL Vifor, Roche, and GlaxoSmithKline and advisory board, consultancy, and lecture fees from Roche and CSL Vifor.

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

People with vasculitis may need at least three or four vaccinations for COVID-19 before they start to show an immune response against SARS-CoV-2 infection, new research has suggested.

In a longitudinal retrospective study, serum antibody neutralization against the Omicron variant of the virus and its descendants was found to be “largely absent” after the first two doses of COVID-19 vaccine had been given to patients. But increasing neutralizing antibody titers were seen after both the third and fourth vaccine boosters had been administered.

Results also showed that the more recently people had been treated with the B cell–depleting therapy rituximab, the lower the levels of immunogenicity that were achieved, and thus protection against SARS-CoV-2.

“Our results have significant implications for individuals treated with rituximab in the post-Omicron era, highlighting the value of additive boosters in affirming increasing protection in clinically vulnerable populations,” the team behind the work at the University of Cambridge in England, has reported in Science Advances.

Moreover, because the use of rituximab reduced the neutralization of not just wild-type (WT) Omicron but also the Omicron-descendant variants BA.1, BA.2, BA.4, and XBB, this highlights “the urgent need for additional adjunctive strategies to enhance vaccine-induced immunity as well as preferential access for such patients to updated vaccines using spike from now circulating Omicron lineages,” the team added.

 

Studying Humoral Responses to SARS-CoV-2 Vaccines

Corresponding author Ravindra K. Gupta, BMBCh, MA, MPH, PhD, told this news organization that studying humoral responses to SARS-CoV-2 vaccines in immunocompromised individuals such as those with vasculitis was important for two main reasons.

“It is really important at individual level for their own health, of course, but also because we know that variants of concern have often evolved and developed within patients and can then spread in wider populations,” he said.

Gupta, who is professor of clinical microbiology at the Cambridge Institute for Therapeutic Immunology & Infectious Disease added: “We believe that the variants of concern that we’re having to deal with right now, including Omicron, have come from such [immunocompromised] individuals.”

Omicron “was a big shift,” Gupta noted. “It had a lot of new mutations on it, so it was almost like a new strain of the virus.” Few studies have looked at the longitudinal immunogenicity proffered by COVID vaccines in the post-Omicron era, particularly in those with vasculitis who are often treated with immunosuppressive drugs, including rituximab.

 

Two-Pronged Study Approach

For the study, a population of immunocompromised individuals diagnosed with vasculitis who had been treated with rituximab in the past 5 years was identified. Just over half (58%) had received adenovirus-based AZD1222/ChAdOx1 nCoV-19 (AstraZeneca-Oxford; AZN) and 37% BNT162b2 (Pfizer-BioNTech; mRNA) as their primary vaccines. Patients with antineutrophil cytoplasmic antibody–associated vasculitis comprised the majority of those who received rituximab (83%), compared with less than half of those who did not take rituximab (48%).

A two-pronged approach was taken with the researchers first measuring neutralizing antibody titers before and 30 days after four successive COVID vaccinations in a group of 32 individuals with available samples. They then performed a cross-sectional, case-control study in 95 individuals to look at neutralizing antibody titers and antibody-dependent cell-mediated cytotoxicity (ADCC) in individuals who had (n = 64) and had not (n = 31) been treated with rituximab in the past 5 years and had samples available after their third and fourth COVID vaccinations.

The first analysis was done to see how people were responding to vaccination over time. “That told us that there was a problem with the first two doses and that we got some response after doses three and four, but the response was uniformly quite poor against the new variants of concern,” Gupta said.

A human embryonic kidney cell model had been used to determine individuals’ neutralizing antibody titers in response to WT, BA.1, BA.2, BA.4, and XBB pseudotyped viruses. After the first and second COVID vaccinations, the geometric mean titer (GMT) against each variant barely increased from a baseline of 40.0. The greatest increases in GMT was seen with the WT virus, at 43.7, 90.7, 256.3, and 394.2, after the first, second, third and fourth doses, respectively. The lowest increases in GMT were seen with the XBB variant, with respective values of 40.0, 40.8, 45.7, and 53.9.

 

Incremental Benefit Offers Some ‘Reassurance’

Vasculitis specialist Rona Smith, MA, MB BChir, MD, who was one of the authors of the paper, told this news organization separately that the results showed there was “an incremental benefit of having COVID vaccinations,” which “offers a little bit of reassurance” that there can be an immune response in people with vasculitis.

Although results of the cross-sectional study showed that there was a significant dampening effect of rituximab treatment on the immune response, “I don’t think it’s an isolated effect in our [vasculitis] patients,” Smith suggested, adding the results were “probably still relevant to patients who receive routine dosing of rituximab for other conditions.”

Neutralizing antibody titers were consistently lower among individuals who had been treated with rituximab vs those who had not, with treatment in the past 18 months found to significantly impair immunogenicity.

The ADCC response was better preserved than the neutralizing antibody response, Gupta said, although it was still significantly lower in the rituximab-treated than in the non–rituximab-treated patients.

 

When to Vaccinate in Vasculitis?

Regarding when to give vaccines to people with vasculitis, Smith said: “Current recommendations are that patients should receive any vaccines that they’re offered routinely, whether that be COVID vaccines, flu vaccines, pneumococcal vaccines.”

As for the timing of those vaccinations, she observed that the current thinking was that vaccinations should “ideally be at least 1 month before a rituximab treatment, and ideally 3-4 [months] after their last dose. However, as many patients are on a 6-month dosing cycle, it can be difficult for some of them to find a suitable time window to have the COVID vaccine when it is offered.”

Additional precautions, such as wearing masks in crowded places and avoiding visits to acutely unwell friends or relatives, may still be prudent, Smith acknowledged, but he was clear that people should not be locking themselves away as they did during the COVID-19 pandemic.

When advising patients, “our general recommendation is that it is better to have a vaccine than not, but we can’t guarantee how well you will respond to it, but some response is better than none,” Smith said.

The study was independently supported. Gupta had no relevant financial relationships to disclose. Smith was a coauthor of the paper and has received research grant funding from Union Therapeutics, GlaxoSmithKline/Vir Biotechnology, Addenbrooke’s Charitable Trust, and Vasculitis UK. Another coauthor reported receiving research grants from CSL Vifor, Roche, and GlaxoSmithKline and advisory board, consultancy, and lecture fees from Roche and CSL Vifor.

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

People with vasculitis may need at least three or four vaccinations for COVID-19 before they start to show an immune response against SARS-CoV-2 infection, new research has suggested.

In a longitudinal retrospective study, serum antibody neutralization against the Omicron variant of the virus and its descendants was found to be “largely absent” after the first two doses of COVID-19 vaccine had been given to patients. But increasing neutralizing antibody titers were seen after both the third and fourth vaccine boosters had been administered.

Results also showed that the more recently people had been treated with the B cell–depleting therapy rituximab, the lower the levels of immunogenicity that were achieved, and thus protection against SARS-CoV-2.

“Our results have significant implications for individuals treated with rituximab in the post-Omicron era, highlighting the value of additive boosters in affirming increasing protection in clinically vulnerable populations,” the team behind the work at the University of Cambridge in England, has reported in Science Advances.

Moreover, because the use of rituximab reduced the neutralization of not just wild-type (WT) Omicron but also the Omicron-descendant variants BA.1, BA.2, BA.4, and XBB, this highlights “the urgent need for additional adjunctive strategies to enhance vaccine-induced immunity as well as preferential access for such patients to updated vaccines using spike from now circulating Omicron lineages,” the team added.

 

Studying Humoral Responses to SARS-CoV-2 Vaccines

Corresponding author Ravindra K. Gupta, BMBCh, MA, MPH, PhD, told this news organization that studying humoral responses to SARS-CoV-2 vaccines in immunocompromised individuals such as those with vasculitis was important for two main reasons.

“It is really important at individual level for their own health, of course, but also because we know that variants of concern have often evolved and developed within patients and can then spread in wider populations,” he said.

Gupta, who is professor of clinical microbiology at the Cambridge Institute for Therapeutic Immunology & Infectious Disease added: “We believe that the variants of concern that we’re having to deal with right now, including Omicron, have come from such [immunocompromised] individuals.”

Omicron “was a big shift,” Gupta noted. “It had a lot of new mutations on it, so it was almost like a new strain of the virus.” Few studies have looked at the longitudinal immunogenicity proffered by COVID vaccines in the post-Omicron era, particularly in those with vasculitis who are often treated with immunosuppressive drugs, including rituximab.

 

Two-Pronged Study Approach

For the study, a population of immunocompromised individuals diagnosed with vasculitis who had been treated with rituximab in the past 5 years was identified. Just over half (58%) had received adenovirus-based AZD1222/ChAdOx1 nCoV-19 (AstraZeneca-Oxford; AZN) and 37% BNT162b2 (Pfizer-BioNTech; mRNA) as their primary vaccines. Patients with antineutrophil cytoplasmic antibody–associated vasculitis comprised the majority of those who received rituximab (83%), compared with less than half of those who did not take rituximab (48%).

A two-pronged approach was taken with the researchers first measuring neutralizing antibody titers before and 30 days after four successive COVID vaccinations in a group of 32 individuals with available samples. They then performed a cross-sectional, case-control study in 95 individuals to look at neutralizing antibody titers and antibody-dependent cell-mediated cytotoxicity (ADCC) in individuals who had (n = 64) and had not (n = 31) been treated with rituximab in the past 5 years and had samples available after their third and fourth COVID vaccinations.

The first analysis was done to see how people were responding to vaccination over time. “That told us that there was a problem with the first two doses and that we got some response after doses three and four, but the response was uniformly quite poor against the new variants of concern,” Gupta said.

A human embryonic kidney cell model had been used to determine individuals’ neutralizing antibody titers in response to WT, BA.1, BA.2, BA.4, and XBB pseudotyped viruses. After the first and second COVID vaccinations, the geometric mean titer (GMT) against each variant barely increased from a baseline of 40.0. The greatest increases in GMT was seen with the WT virus, at 43.7, 90.7, 256.3, and 394.2, after the first, second, third and fourth doses, respectively. The lowest increases in GMT were seen with the XBB variant, with respective values of 40.0, 40.8, 45.7, and 53.9.

 

Incremental Benefit Offers Some ‘Reassurance’

Vasculitis specialist Rona Smith, MA, MB BChir, MD, who was one of the authors of the paper, told this news organization separately that the results showed there was “an incremental benefit of having COVID vaccinations,” which “offers a little bit of reassurance” that there can be an immune response in people with vasculitis.

Although results of the cross-sectional study showed that there was a significant dampening effect of rituximab treatment on the immune response, “I don’t think it’s an isolated effect in our [vasculitis] patients,” Smith suggested, adding the results were “probably still relevant to patients who receive routine dosing of rituximab for other conditions.”

Neutralizing antibody titers were consistently lower among individuals who had been treated with rituximab vs those who had not, with treatment in the past 18 months found to significantly impair immunogenicity.

The ADCC response was better preserved than the neutralizing antibody response, Gupta said, although it was still significantly lower in the rituximab-treated than in the non–rituximab-treated patients.

 

When to Vaccinate in Vasculitis?

Regarding when to give vaccines to people with vasculitis, Smith said: “Current recommendations are that patients should receive any vaccines that they’re offered routinely, whether that be COVID vaccines, flu vaccines, pneumococcal vaccines.”

As for the timing of those vaccinations, she observed that the current thinking was that vaccinations should “ideally be at least 1 month before a rituximab treatment, and ideally 3-4 [months] after their last dose. However, as many patients are on a 6-month dosing cycle, it can be difficult for some of them to find a suitable time window to have the COVID vaccine when it is offered.”

Additional precautions, such as wearing masks in crowded places and avoiding visits to acutely unwell friends or relatives, may still be prudent, Smith acknowledged, but he was clear that people should not be locking themselves away as they did during the COVID-19 pandemic.

When advising patients, “our general recommendation is that it is better to have a vaccine than not, but we can’t guarantee how well you will respond to it, but some response is better than none,” Smith said.

The study was independently supported. Gupta had no relevant financial relationships to disclose. Smith was a coauthor of the paper and has received research grant funding from Union Therapeutics, GlaxoSmithKline/Vir Biotechnology, Addenbrooke’s Charitable Trust, and Vasculitis UK. Another coauthor reported receiving research grants from CSL Vifor, Roche, and GlaxoSmithKline and advisory board, consultancy, and lecture fees from Roche and CSL Vifor.

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