Spironolactone’s HFpEF benefit happens mostly in women

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– Just when the aldosterone receptor antagonists spironolactone and eplerenone received official recognition in the 2017 U.S. heart failure guidelines as the only drug class that benefits patients with heart failure with preserved ejection fraction (HFpEF), a new post-hoc analysis of the pivotal evidence suggests the benefit is mostly in women, with little benefit to men.

 

The new analysis used data collected from TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist), which randomized patients with HFpEF to treatment with spironolactone or placebo. Results from the overall study were neutral for the primary outcome of cardiovascular death, aborted cardiac arrest, and heart failure hospitalization (N Engl J Med. 2014 April 10;370[15]:1383-92). However, a series of post-hoc analyses showed that a high percentage of patients enrolled at centers in Russia or Georgia did not match the expected HFpEF profile, and these patients had poor responses to spironolactone. In contrast, patients enrolled at centers in the Americas more frequently matched the study’s target HFpEF profile, and they showed significant improvement for the primary endpoint (Circulation. 2015 Jan 6;131[1]:34-42).

Mitchel L. Zoler/Frontline Medical News
Dr. David Kao
The new analysis, focused on those patients from the Americas, shows that the primary efficacy outcome from the TOPCAT trial was a statistically significant 18% lower in women than in men, David Kao, MD, reported at a meeting of the Heart Failure Association of the ESC.

“The observation that most of the benefit [from spironolactone treatment] may have been in women is interesting, but I don’t think that it would stop me from using [an aldosterone receptor antagonist] in men,” said Dr. Kao while presenting his report. The outcomes in both men and women “head in the same direction. It’s just that the mortality benefit is much clearer in women,” said Dr. Kao, a cardiologist at the University of Colorado at Denver, Aurora.

Among the patients enrolled at centers in North and South America, 882 were women, and 885 were men. Dr. Kao used the data collected in TOPCAT to calculate the impact of spironolactone treatment relative to placebo on outcomes just among women in the Americas and just among men.

The difference in all-cause mortality associated with spironolactone treatment had an even sharper sex disparity that in the primary outcome. Overall, all-cause mortality was 28% less common among women, compared with men, in the Americas. Among women, spironolactone treatment linked with a 30% reduced all-cause mortality rate, compared with placebo. Among men, the survival curves of those on spironolactone or placebo superimposed.

Dr. Kao said that published study results in rats had suggested that eplerenone (Inspra), an aldosterone receptor antagonist like spironolactone, had a more potent effect in females rats, compared with male rats, for preserving left ventricular function and size following myocardial damage. In addition, women with HFpEF often have more left ventricular hypertrophy, while men often have more diastolic dysfunction, and prior findings had suggested that aldosterone plays a role in left ventricular hypertrophy.

TOPCAT received no commercial funding. Dr. Kao had no disclosures.

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– Just when the aldosterone receptor antagonists spironolactone and eplerenone received official recognition in the 2017 U.S. heart failure guidelines as the only drug class that benefits patients with heart failure with preserved ejection fraction (HFpEF), a new post-hoc analysis of the pivotal evidence suggests the benefit is mostly in women, with little benefit to men.

 

The new analysis used data collected from TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist), which randomized patients with HFpEF to treatment with spironolactone or placebo. Results from the overall study were neutral for the primary outcome of cardiovascular death, aborted cardiac arrest, and heart failure hospitalization (N Engl J Med. 2014 April 10;370[15]:1383-92). However, a series of post-hoc analyses showed that a high percentage of patients enrolled at centers in Russia or Georgia did not match the expected HFpEF profile, and these patients had poor responses to spironolactone. In contrast, patients enrolled at centers in the Americas more frequently matched the study’s target HFpEF profile, and they showed significant improvement for the primary endpoint (Circulation. 2015 Jan 6;131[1]:34-42).

Mitchel L. Zoler/Frontline Medical News
Dr. David Kao
The new analysis, focused on those patients from the Americas, shows that the primary efficacy outcome from the TOPCAT trial was a statistically significant 18% lower in women than in men, David Kao, MD, reported at a meeting of the Heart Failure Association of the ESC.

“The observation that most of the benefit [from spironolactone treatment] may have been in women is interesting, but I don’t think that it would stop me from using [an aldosterone receptor antagonist] in men,” said Dr. Kao while presenting his report. The outcomes in both men and women “head in the same direction. It’s just that the mortality benefit is much clearer in women,” said Dr. Kao, a cardiologist at the University of Colorado at Denver, Aurora.

Among the patients enrolled at centers in North and South America, 882 were women, and 885 were men. Dr. Kao used the data collected in TOPCAT to calculate the impact of spironolactone treatment relative to placebo on outcomes just among women in the Americas and just among men.

The difference in all-cause mortality associated with spironolactone treatment had an even sharper sex disparity that in the primary outcome. Overall, all-cause mortality was 28% less common among women, compared with men, in the Americas. Among women, spironolactone treatment linked with a 30% reduced all-cause mortality rate, compared with placebo. Among men, the survival curves of those on spironolactone or placebo superimposed.

Dr. Kao said that published study results in rats had suggested that eplerenone (Inspra), an aldosterone receptor antagonist like spironolactone, had a more potent effect in females rats, compared with male rats, for preserving left ventricular function and size following myocardial damage. In addition, women with HFpEF often have more left ventricular hypertrophy, while men often have more diastolic dysfunction, and prior findings had suggested that aldosterone plays a role in left ventricular hypertrophy.

TOPCAT received no commercial funding. Dr. Kao had no disclosures.

– Just when the aldosterone receptor antagonists spironolactone and eplerenone received official recognition in the 2017 U.S. heart failure guidelines as the only drug class that benefits patients with heart failure with preserved ejection fraction (HFpEF), a new post-hoc analysis of the pivotal evidence suggests the benefit is mostly in women, with little benefit to men.

 

The new analysis used data collected from TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist), which randomized patients with HFpEF to treatment with spironolactone or placebo. Results from the overall study were neutral for the primary outcome of cardiovascular death, aborted cardiac arrest, and heart failure hospitalization (N Engl J Med. 2014 April 10;370[15]:1383-92). However, a series of post-hoc analyses showed that a high percentage of patients enrolled at centers in Russia or Georgia did not match the expected HFpEF profile, and these patients had poor responses to spironolactone. In contrast, patients enrolled at centers in the Americas more frequently matched the study’s target HFpEF profile, and they showed significant improvement for the primary endpoint (Circulation. 2015 Jan 6;131[1]:34-42).

Mitchel L. Zoler/Frontline Medical News
Dr. David Kao
The new analysis, focused on those patients from the Americas, shows that the primary efficacy outcome from the TOPCAT trial was a statistically significant 18% lower in women than in men, David Kao, MD, reported at a meeting of the Heart Failure Association of the ESC.

“The observation that most of the benefit [from spironolactone treatment] may have been in women is interesting, but I don’t think that it would stop me from using [an aldosterone receptor antagonist] in men,” said Dr. Kao while presenting his report. The outcomes in both men and women “head in the same direction. It’s just that the mortality benefit is much clearer in women,” said Dr. Kao, a cardiologist at the University of Colorado at Denver, Aurora.

Among the patients enrolled at centers in North and South America, 882 were women, and 885 were men. Dr. Kao used the data collected in TOPCAT to calculate the impact of spironolactone treatment relative to placebo on outcomes just among women in the Americas and just among men.

The difference in all-cause mortality associated with spironolactone treatment had an even sharper sex disparity that in the primary outcome. Overall, all-cause mortality was 28% less common among women, compared with men, in the Americas. Among women, spironolactone treatment linked with a 30% reduced all-cause mortality rate, compared with placebo. Among men, the survival curves of those on spironolactone or placebo superimposed.

Dr. Kao said that published study results in rats had suggested that eplerenone (Inspra), an aldosterone receptor antagonist like spironolactone, had a more potent effect in females rats, compared with male rats, for preserving left ventricular function and size following myocardial damage. In addition, women with HFpEF often have more left ventricular hypertrophy, while men often have more diastolic dysfunction, and prior findings had suggested that aldosterone plays a role in left ventricular hypertrophy.

TOPCAT received no commercial funding. Dr. Kao had no disclosures.

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Key clinical point: A post-hoc TOPCAT analysis showed that spironolactone’s benefit for heart failure patients with preserved ejection fraction mostly occurred in women.

Major finding: Women from the Americas in TOPCAT had an 18% lower rate of primary endpoint events, compared with men in the trial.

Data source: TOPCAT, a multicenter, randomized study with 3,445 patients.

Disclosures: TOPCAT received no commercial funding. Dr. Kao had no disclosures.

Complicated grief treatment gets better results than interpersonal psychotherapy

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– The effectiveness of complicated grief treatment (CGT) rests, to a significant extent, on its capacity to reduce the grieving patient’s level of avoidance of reminders of the loss, Kim Glickman, PhD, said at the annual conference of the Anxiety and Depression Association of America.

Her psychotherapeutic mechanism-of-action study identified two other mediators of improvement in response to CGT: guilt related to the death and negative thoughts about the future. Patients who experienced significant reductions in levels of those variables during CGT were much more likely to ultimately be treatment responders.

The clinical implication of these findings is that psychotherapists should focus on reducing grief complications, such as avoidance behaviors and maladaptive thoughts, including blaming oneself or others for how the person died and seeing a hopeless future, according to Dr. Glickman, of City University of New York.

Complicated grief affects about 7% of bereaved individuals. It is characterized by prolonged emotional pain, intense sorrow, preoccupation with thoughts of the loved one, and persistent yearning. It is typically resistant to antidepressant therapy. In the DSM-5, it is called “persistent complex bereavement disorder” and is described in a chapter on provisional conditions for further study. Since it doesn’t have the status of a formal diagnostic entity, insurers typically will not pay for treatment of complicated grief reactions.

CGT has been shown to be effective in three randomized clinical trials. It is a manualized 16-session therapy that can be considered a form of cognitive-behavioral therapy with added elements of interpersonal psychotherapy and motivational interviewing. The focus is on encouraging adaptation to the loss by keeping grief center stage, honoring the person who died, and envisioning a future with possibilities for happiness, Dr. Glickman explained.

The mechanisms of action of CGT haven’t been well-characterized. This was the impetus for Dr. Glickman’s study, in which she analyzed data from the first randomized trial to demonstrate CGT’s effectiveness more than a decade ago (JAMA. 2005 Jun 1;293[21]:2601-8).

Among the 69 patients with complicated grief who completed 16 sessions of psychotherapy, the clinical response rate was 51% in the CGT group, compared with 28% in patients randomized to interpersonal psychotherapy. The number needed to treat with CGT was 4.3 in order to achieve a clinical response, defined as either a Clinical Global Impression–Improvement score of 1 or 2 or at least a 20-point improvement pre to post treatment on the self-rated Inventory of Complicated Grief.

In order to more closely examine potential mediators of clinical response, Dr. Glickman chose as her measure of change in feelings of guilt the study participants’ scores on the Structured Clinical Interview for Complicated Grief. To assess negative thoughts about the future, she relied on item two from the Beck Depression Inventory and, for avoidance behaviors, she used scores on the 15-item Grief-Related Avoidance Questionnaire.

CGT proved significantly more effective than interpersonal therapy at improving scores on all three of these instruments. The mediating effect was most robust for improvement in avoidance behaviors.

Dr. Glickman’s future research plans include looking at additional possible mediators of CGT’s efficacy, including change in emotion regulation, ideally assessed on a weekly basis during the course of treatment.

Complicated grief therapy was pioneered by therapists at Columbia University in New York. Dr. Glickman noted that more information about complicated grief and training in CGT is available at www.complicatedgrief.columbia.edu.

The randomized trial on which her analysis was based was funded by the National Institute of Mental Health. Dr. Glickman reported having no financial conflicts regarding her study.

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– The effectiveness of complicated grief treatment (CGT) rests, to a significant extent, on its capacity to reduce the grieving patient’s level of avoidance of reminders of the loss, Kim Glickman, PhD, said at the annual conference of the Anxiety and Depression Association of America.

Her psychotherapeutic mechanism-of-action study identified two other mediators of improvement in response to CGT: guilt related to the death and negative thoughts about the future. Patients who experienced significant reductions in levels of those variables during CGT were much more likely to ultimately be treatment responders.

The clinical implication of these findings is that psychotherapists should focus on reducing grief complications, such as avoidance behaviors and maladaptive thoughts, including blaming oneself or others for how the person died and seeing a hopeless future, according to Dr. Glickman, of City University of New York.

Complicated grief affects about 7% of bereaved individuals. It is characterized by prolonged emotional pain, intense sorrow, preoccupation with thoughts of the loved one, and persistent yearning. It is typically resistant to antidepressant therapy. In the DSM-5, it is called “persistent complex bereavement disorder” and is described in a chapter on provisional conditions for further study. Since it doesn’t have the status of a formal diagnostic entity, insurers typically will not pay for treatment of complicated grief reactions.

CGT has been shown to be effective in three randomized clinical trials. It is a manualized 16-session therapy that can be considered a form of cognitive-behavioral therapy with added elements of interpersonal psychotherapy and motivational interviewing. The focus is on encouraging adaptation to the loss by keeping grief center stage, honoring the person who died, and envisioning a future with possibilities for happiness, Dr. Glickman explained.

The mechanisms of action of CGT haven’t been well-characterized. This was the impetus for Dr. Glickman’s study, in which she analyzed data from the first randomized trial to demonstrate CGT’s effectiveness more than a decade ago (JAMA. 2005 Jun 1;293[21]:2601-8).

Among the 69 patients with complicated grief who completed 16 sessions of psychotherapy, the clinical response rate was 51% in the CGT group, compared with 28% in patients randomized to interpersonal psychotherapy. The number needed to treat with CGT was 4.3 in order to achieve a clinical response, defined as either a Clinical Global Impression–Improvement score of 1 or 2 or at least a 20-point improvement pre to post treatment on the self-rated Inventory of Complicated Grief.

In order to more closely examine potential mediators of clinical response, Dr. Glickman chose as her measure of change in feelings of guilt the study participants’ scores on the Structured Clinical Interview for Complicated Grief. To assess negative thoughts about the future, she relied on item two from the Beck Depression Inventory and, for avoidance behaviors, she used scores on the 15-item Grief-Related Avoidance Questionnaire.

CGT proved significantly more effective than interpersonal therapy at improving scores on all three of these instruments. The mediating effect was most robust for improvement in avoidance behaviors.

Dr. Glickman’s future research plans include looking at additional possible mediators of CGT’s efficacy, including change in emotion regulation, ideally assessed on a weekly basis during the course of treatment.

Complicated grief therapy was pioneered by therapists at Columbia University in New York. Dr. Glickman noted that more information about complicated grief and training in CGT is available at www.complicatedgrief.columbia.edu.

The randomized trial on which her analysis was based was funded by the National Institute of Mental Health. Dr. Glickman reported having no financial conflicts regarding her study.

 

– The effectiveness of complicated grief treatment (CGT) rests, to a significant extent, on its capacity to reduce the grieving patient’s level of avoidance of reminders of the loss, Kim Glickman, PhD, said at the annual conference of the Anxiety and Depression Association of America.

Her psychotherapeutic mechanism-of-action study identified two other mediators of improvement in response to CGT: guilt related to the death and negative thoughts about the future. Patients who experienced significant reductions in levels of those variables during CGT were much more likely to ultimately be treatment responders.

The clinical implication of these findings is that psychotherapists should focus on reducing grief complications, such as avoidance behaviors and maladaptive thoughts, including blaming oneself or others for how the person died and seeing a hopeless future, according to Dr. Glickman, of City University of New York.

Complicated grief affects about 7% of bereaved individuals. It is characterized by prolonged emotional pain, intense sorrow, preoccupation with thoughts of the loved one, and persistent yearning. It is typically resistant to antidepressant therapy. In the DSM-5, it is called “persistent complex bereavement disorder” and is described in a chapter on provisional conditions for further study. Since it doesn’t have the status of a formal diagnostic entity, insurers typically will not pay for treatment of complicated grief reactions.

CGT has been shown to be effective in three randomized clinical trials. It is a manualized 16-session therapy that can be considered a form of cognitive-behavioral therapy with added elements of interpersonal psychotherapy and motivational interviewing. The focus is on encouraging adaptation to the loss by keeping grief center stage, honoring the person who died, and envisioning a future with possibilities for happiness, Dr. Glickman explained.

The mechanisms of action of CGT haven’t been well-characterized. This was the impetus for Dr. Glickman’s study, in which she analyzed data from the first randomized trial to demonstrate CGT’s effectiveness more than a decade ago (JAMA. 2005 Jun 1;293[21]:2601-8).

Among the 69 patients with complicated grief who completed 16 sessions of psychotherapy, the clinical response rate was 51% in the CGT group, compared with 28% in patients randomized to interpersonal psychotherapy. The number needed to treat with CGT was 4.3 in order to achieve a clinical response, defined as either a Clinical Global Impression–Improvement score of 1 or 2 or at least a 20-point improvement pre to post treatment on the self-rated Inventory of Complicated Grief.

In order to more closely examine potential mediators of clinical response, Dr. Glickman chose as her measure of change in feelings of guilt the study participants’ scores on the Structured Clinical Interview for Complicated Grief. To assess negative thoughts about the future, she relied on item two from the Beck Depression Inventory and, for avoidance behaviors, she used scores on the 15-item Grief-Related Avoidance Questionnaire.

CGT proved significantly more effective than interpersonal therapy at improving scores on all three of these instruments. The mediating effect was most robust for improvement in avoidance behaviors.

Dr. Glickman’s future research plans include looking at additional possible mediators of CGT’s efficacy, including change in emotion regulation, ideally assessed on a weekly basis during the course of treatment.

Complicated grief therapy was pioneered by therapists at Columbia University in New York. Dr. Glickman noted that more information about complicated grief and training in CGT is available at www.complicatedgrief.columbia.edu.

The randomized trial on which her analysis was based was funded by the National Institute of Mental Health. Dr. Glickman reported having no financial conflicts regarding her study.

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AT THE ANXIETY AND DEPRESSION CONFERENCE 2017

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Key clinical point: Investigators are zeroing in on the mechanisms by which complicated grief treatment results in clinical benefit.

Major finding: A key mediator of clinical improvement in response to cognitive grief treatment is a reduction in avoidance behaviors.

Data source: A secondary analysis of a randomized trial of complicated grief treatment versus interpersonal psychotherapy in 69 patients with complicated grief.

Disclosures: The study presenter reported having no financial conflicts.

First trimester use of inactivated flu vaccine didn’t cause birth defects

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First-trimester maternal inactivated influenza vaccine (IIV) was not linked to an increased risk of major structural birth defects in singleton infants, said Elyse Olshen Kharbanda, MD, of HealthPartners Institute, Minneapolis, and her associates.

Data from seven participating Vaccine Safety Datalink sites in six states were used to identify 52,856 women who received IIV in the first trimester of pregnancy (12% of the study total) and 373,088 not exposed to the flu vaccine in the first trimester (88%). A total of 865 women in the IIV-exposed group had an infant with 1 of the 50 selected major structural defects (1.6 per 100 live births), versus 5,730 in the unexposed group (1.5 per 100 live births).

Piotr Marcinski/Thinkstock
The adjusted prevalence ratio for having one of the birth defects after being exposed to IIV in the first trimester was 1.02 (95% confidence interval, 0.94-1.10). There were no increased risks for any of the major structural birth defects after maternal first-trimester IIV, including cardiac defects, neural tube defects, microcephaly, or cleft lip and/or cleft palate.

Among the strengths of the study were the large population, which allowed the researchers to examine subgroups of major structural birth defects; their findings were consistent across all those subgroups. In addition, the investigators were able to exclude women at increased risk for major birth defects because of comorbidities such as diabetes, drug exposures, diagnosed chromosomal abnormalities, or congenital infections. Finally, the study authors were able to exclude women with potential exposure to teratogenic medications.

“Because IIV is currently recommended for all women who will be pregnant during periods of influenza circulation, these data should provide reassurance for women considering first trimester vaccination,” said Dr. Kharbanda and her associates.

Read more in the Journal of Pediatrics (2017 May 24. doi: 10.1016/j.jpeds.2017.04.039).

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First-trimester maternal inactivated influenza vaccine (IIV) was not linked to an increased risk of major structural birth defects in singleton infants, said Elyse Olshen Kharbanda, MD, of HealthPartners Institute, Minneapolis, and her associates.

Data from seven participating Vaccine Safety Datalink sites in six states were used to identify 52,856 women who received IIV in the first trimester of pregnancy (12% of the study total) and 373,088 not exposed to the flu vaccine in the first trimester (88%). A total of 865 women in the IIV-exposed group had an infant with 1 of the 50 selected major structural defects (1.6 per 100 live births), versus 5,730 in the unexposed group (1.5 per 100 live births).

Piotr Marcinski/Thinkstock
The adjusted prevalence ratio for having one of the birth defects after being exposed to IIV in the first trimester was 1.02 (95% confidence interval, 0.94-1.10). There were no increased risks for any of the major structural birth defects after maternal first-trimester IIV, including cardiac defects, neural tube defects, microcephaly, or cleft lip and/or cleft palate.

Among the strengths of the study were the large population, which allowed the researchers to examine subgroups of major structural birth defects; their findings were consistent across all those subgroups. In addition, the investigators were able to exclude women at increased risk for major birth defects because of comorbidities such as diabetes, drug exposures, diagnosed chromosomal abnormalities, or congenital infections. Finally, the study authors were able to exclude women with potential exposure to teratogenic medications.

“Because IIV is currently recommended for all women who will be pregnant during periods of influenza circulation, these data should provide reassurance for women considering first trimester vaccination,” said Dr. Kharbanda and her associates.

Read more in the Journal of Pediatrics (2017 May 24. doi: 10.1016/j.jpeds.2017.04.039).

 

First-trimester maternal inactivated influenza vaccine (IIV) was not linked to an increased risk of major structural birth defects in singleton infants, said Elyse Olshen Kharbanda, MD, of HealthPartners Institute, Minneapolis, and her associates.

Data from seven participating Vaccine Safety Datalink sites in six states were used to identify 52,856 women who received IIV in the first trimester of pregnancy (12% of the study total) and 373,088 not exposed to the flu vaccine in the first trimester (88%). A total of 865 women in the IIV-exposed group had an infant with 1 of the 50 selected major structural defects (1.6 per 100 live births), versus 5,730 in the unexposed group (1.5 per 100 live births).

Piotr Marcinski/Thinkstock
The adjusted prevalence ratio for having one of the birth defects after being exposed to IIV in the first trimester was 1.02 (95% confidence interval, 0.94-1.10). There were no increased risks for any of the major structural birth defects after maternal first-trimester IIV, including cardiac defects, neural tube defects, microcephaly, or cleft lip and/or cleft palate.

Among the strengths of the study were the large population, which allowed the researchers to examine subgroups of major structural birth defects; their findings were consistent across all those subgroups. In addition, the investigators were able to exclude women at increased risk for major birth defects because of comorbidities such as diabetes, drug exposures, diagnosed chromosomal abnormalities, or congenital infections. Finally, the study authors were able to exclude women with potential exposure to teratogenic medications.

“Because IIV is currently recommended for all women who will be pregnant during periods of influenza circulation, these data should provide reassurance for women considering first trimester vaccination,” said Dr. Kharbanda and her associates.

Read more in the Journal of Pediatrics (2017 May 24. doi: 10.1016/j.jpeds.2017.04.039).

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Cervical cancer screening adherence drops after HPV vaccination

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– Young adult women who received the human papillomavirus (HPV) vaccination were less likely to adhere to the recommended screening schedule for cervical cancer, according to a recent study.

In looking at a cohort of women who received at least two Pap smears during a 4-year study period, Daniel Terk, MD, and his colleagues saw a significant drop-off in screening visits after women received their HPV vaccinations. The group of women who received their vaccine midstudy were significantly less likely to come in for annual screening after their vaccination than before (n = 140, adjusted odds ratio 0.19, 95% confidence interval, 0.08-0.49).

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“When following individual vaccinated women, they were five times less likely to be adherent to cervical cancer screening after HPV vaccination,” Dr. Terk said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. “This may represent an unintended consequence of HPV vaccination.”

The retrospective chart review looked at rates of cervical cancer screening and HPV vaccination across 943 patient charts, beginning in 2006 when the HPV vaccine was released and ending in 2010. The inclusion criteria ensured that “participants were old enough to obtain cervical cancer screening and young enough to receive the HPV vaccine,” Dr. Terk and his collaborators wrote in the research abstract.

The drop-off in adherence for the subgroup who received their vaccines midstudy was an isolated finding, said Dr. Terk, noting that vaccination status did not affect adherence to the recommended screening schedule for the group as a whole.

Billing data and medical records were used to track HPV vaccination status and dates of administration, as well as the dates of testing and results for cervical cancer screening. Patients were included if they were born from 1980 to 1988, if they had two or more Pap smears during the study period, and if their HPV vaccination status could be verified. Patients with an initial abnormal Pap smear or a prior loop electrosurgical excision procedure were excluded, as were patients whose HPV vaccination status could not be confirmed.

In all, 943 patient charts were included in the review; 448 patients had no documented vaccination, with further review showing that 418 of these had, in fact, not been vaccinated, while the remaining 30 had actually had at least one HPV vaccine dose during the study period. Of the 495 patients with at least one documented vaccination, 175 had at least one Pap smear done before they were vaccinated, while 320 had their HPV vaccine before any documented cervical cancer screening.

Thus, there were two patient groups: 593 “unvaccinated” patients, who had at least one cervical cancer screening before receiving the vaccine, and 350 “vaccinated” patients, who had their HPV vaccine before any documented Pap smears.

Dr. Terk and his colleagues considered a screening interval of 18 months or less appropriate, while a longer interval than that between Pap smears was considered inappropriate timing. Individual patients were considered adherent if 76%-100% of their Pap smears were appropriately timed, partially adherent if 50%-75% of their Pap smears were appropriately timed, and not adherent if less than 50% of their Pap smears were appropriately timed.

Of those receiving their vaccine midstudy, 116 (82.9%) were adherent before vaccination, while 69 (49.3%) were adherent after vaccination.

The HPV vaccine is highly effective at preventing infection with the strains of HPV that are primarily responsible for cervical cancer. At the same time, about 70% of the cervical cancer cases that occur are associated with missed screening or inappropriate screening intervals, so screening is still an important part of the strategy to prevent cervical cancers, said Dr. Terk, a 4th-year ob.gyn. resident at the University of Rochester, N.Y.

The ACOG guidelines for cervical cancer screening have shifted through the years. During the period from 2003 to 2009, annual Pap smears were recommended for women under the age of 30 years, beginning at age 21 or 3 years after first sexual intercourse. Women 30 years and older who were at low risk could have a less frequent screening interval. ACOG currently recommends Pap testing alone every 3 years for women aged 21-29 years; co-testing with a Pap test and an HPV test every 5 years in women aged 30-65 years, or a Pap test alone every 3 years.

The study had a large sample size, and adherence rates track with national data, Dr. Terk said. However, screening guidelines have shifted in recent years, and vaccinations are now happening at a much younger age, so the findings should be interpreted with some caution. Still, he said, clinicians should incorporate a strong message about the importance of cervical cancer screening in their HPV vaccination and well-woman counseling.

Dr. Terk reported having no relevant financial disclosures and reported no outside sources of funding.

 

 

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– Young adult women who received the human papillomavirus (HPV) vaccination were less likely to adhere to the recommended screening schedule for cervical cancer, according to a recent study.

In looking at a cohort of women who received at least two Pap smears during a 4-year study period, Daniel Terk, MD, and his colleagues saw a significant drop-off in screening visits after women received their HPV vaccinations. The group of women who received their vaccine midstudy were significantly less likely to come in for annual screening after their vaccination than before (n = 140, adjusted odds ratio 0.19, 95% confidence interval, 0.08-0.49).

dina2001/Thinkstock
“When following individual vaccinated women, they were five times less likely to be adherent to cervical cancer screening after HPV vaccination,” Dr. Terk said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. “This may represent an unintended consequence of HPV vaccination.”

The retrospective chart review looked at rates of cervical cancer screening and HPV vaccination across 943 patient charts, beginning in 2006 when the HPV vaccine was released and ending in 2010. The inclusion criteria ensured that “participants were old enough to obtain cervical cancer screening and young enough to receive the HPV vaccine,” Dr. Terk and his collaborators wrote in the research abstract.

The drop-off in adherence for the subgroup who received their vaccines midstudy was an isolated finding, said Dr. Terk, noting that vaccination status did not affect adherence to the recommended screening schedule for the group as a whole.

Billing data and medical records were used to track HPV vaccination status and dates of administration, as well as the dates of testing and results for cervical cancer screening. Patients were included if they were born from 1980 to 1988, if they had two or more Pap smears during the study period, and if their HPV vaccination status could be verified. Patients with an initial abnormal Pap smear or a prior loop electrosurgical excision procedure were excluded, as were patients whose HPV vaccination status could not be confirmed.

In all, 943 patient charts were included in the review; 448 patients had no documented vaccination, with further review showing that 418 of these had, in fact, not been vaccinated, while the remaining 30 had actually had at least one HPV vaccine dose during the study period. Of the 495 patients with at least one documented vaccination, 175 had at least one Pap smear done before they were vaccinated, while 320 had their HPV vaccine before any documented cervical cancer screening.

Thus, there were two patient groups: 593 “unvaccinated” patients, who had at least one cervical cancer screening before receiving the vaccine, and 350 “vaccinated” patients, who had their HPV vaccine before any documented Pap smears.

Dr. Terk and his colleagues considered a screening interval of 18 months or less appropriate, while a longer interval than that between Pap smears was considered inappropriate timing. Individual patients were considered adherent if 76%-100% of their Pap smears were appropriately timed, partially adherent if 50%-75% of their Pap smears were appropriately timed, and not adherent if less than 50% of their Pap smears were appropriately timed.

Of those receiving their vaccine midstudy, 116 (82.9%) were adherent before vaccination, while 69 (49.3%) were adherent after vaccination.

The HPV vaccine is highly effective at preventing infection with the strains of HPV that are primarily responsible for cervical cancer. At the same time, about 70% of the cervical cancer cases that occur are associated with missed screening or inappropriate screening intervals, so screening is still an important part of the strategy to prevent cervical cancers, said Dr. Terk, a 4th-year ob.gyn. resident at the University of Rochester, N.Y.

The ACOG guidelines for cervical cancer screening have shifted through the years. During the period from 2003 to 2009, annual Pap smears were recommended for women under the age of 30 years, beginning at age 21 or 3 years after first sexual intercourse. Women 30 years and older who were at low risk could have a less frequent screening interval. ACOG currently recommends Pap testing alone every 3 years for women aged 21-29 years; co-testing with a Pap test and an HPV test every 5 years in women aged 30-65 years, or a Pap test alone every 3 years.

The study had a large sample size, and adherence rates track with national data, Dr. Terk said. However, screening guidelines have shifted in recent years, and vaccinations are now happening at a much younger age, so the findings should be interpreted with some caution. Still, he said, clinicians should incorporate a strong message about the importance of cervical cancer screening in their HPV vaccination and well-woman counseling.

Dr. Terk reported having no relevant financial disclosures and reported no outside sources of funding.

 

 

 

– Young adult women who received the human papillomavirus (HPV) vaccination were less likely to adhere to the recommended screening schedule for cervical cancer, according to a recent study.

In looking at a cohort of women who received at least two Pap smears during a 4-year study period, Daniel Terk, MD, and his colleagues saw a significant drop-off in screening visits after women received their HPV vaccinations. The group of women who received their vaccine midstudy were significantly less likely to come in for annual screening after their vaccination than before (n = 140, adjusted odds ratio 0.19, 95% confidence interval, 0.08-0.49).

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“When following individual vaccinated women, they were five times less likely to be adherent to cervical cancer screening after HPV vaccination,” Dr. Terk said at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. “This may represent an unintended consequence of HPV vaccination.”

The retrospective chart review looked at rates of cervical cancer screening and HPV vaccination across 943 patient charts, beginning in 2006 when the HPV vaccine was released and ending in 2010. The inclusion criteria ensured that “participants were old enough to obtain cervical cancer screening and young enough to receive the HPV vaccine,” Dr. Terk and his collaborators wrote in the research abstract.

The drop-off in adherence for the subgroup who received their vaccines midstudy was an isolated finding, said Dr. Terk, noting that vaccination status did not affect adherence to the recommended screening schedule for the group as a whole.

Billing data and medical records were used to track HPV vaccination status and dates of administration, as well as the dates of testing and results for cervical cancer screening. Patients were included if they were born from 1980 to 1988, if they had two or more Pap smears during the study period, and if their HPV vaccination status could be verified. Patients with an initial abnormal Pap smear or a prior loop electrosurgical excision procedure were excluded, as were patients whose HPV vaccination status could not be confirmed.

In all, 943 patient charts were included in the review; 448 patients had no documented vaccination, with further review showing that 418 of these had, in fact, not been vaccinated, while the remaining 30 had actually had at least one HPV vaccine dose during the study period. Of the 495 patients with at least one documented vaccination, 175 had at least one Pap smear done before they were vaccinated, while 320 had their HPV vaccine before any documented cervical cancer screening.

Thus, there were two patient groups: 593 “unvaccinated” patients, who had at least one cervical cancer screening before receiving the vaccine, and 350 “vaccinated” patients, who had their HPV vaccine before any documented Pap smears.

Dr. Terk and his colleagues considered a screening interval of 18 months or less appropriate, while a longer interval than that between Pap smears was considered inappropriate timing. Individual patients were considered adherent if 76%-100% of their Pap smears were appropriately timed, partially adherent if 50%-75% of their Pap smears were appropriately timed, and not adherent if less than 50% of their Pap smears were appropriately timed.

Of those receiving their vaccine midstudy, 116 (82.9%) were adherent before vaccination, while 69 (49.3%) were adherent after vaccination.

The HPV vaccine is highly effective at preventing infection with the strains of HPV that are primarily responsible for cervical cancer. At the same time, about 70% of the cervical cancer cases that occur are associated with missed screening or inappropriate screening intervals, so screening is still an important part of the strategy to prevent cervical cancers, said Dr. Terk, a 4th-year ob.gyn. resident at the University of Rochester, N.Y.

The ACOG guidelines for cervical cancer screening have shifted through the years. During the period from 2003 to 2009, annual Pap smears were recommended for women under the age of 30 years, beginning at age 21 or 3 years after first sexual intercourse. Women 30 years and older who were at low risk could have a less frequent screening interval. ACOG currently recommends Pap testing alone every 3 years for women aged 21-29 years; co-testing with a Pap test and an HPV test every 5 years in women aged 30-65 years, or a Pap test alone every 3 years.

The study had a large sample size, and adherence rates track with national data, Dr. Terk said. However, screening guidelines have shifted in recent years, and vaccinations are now happening at a much younger age, so the findings should be interpreted with some caution. Still, he said, clinicians should incorporate a strong message about the importance of cervical cancer screening in their HPV vaccination and well-woman counseling.

Dr. Terk reported having no relevant financial disclosures and reported no outside sources of funding.

 

 

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Key clinical point: Women who received HPV vaccination were five times less likely to adhere to cervical cancer screening recommendations.

Major finding: The odds ratio for adherence after immunization compared to before was 0.19 (95% confidence interval, 0.08-0.49).

Data source: Retrospective chart review of 495 women who received at least two Pap smears during the period from 2006 to 2010.

Disclosures: The study authors reported no outside sources of funding and no conflicts of interest.

VIDEO: School program aims to cut diagnostic delay in endometriosis

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– Although symptoms can start young in endometriosis – sometimes in adolescence – women often suffer for years from bowel problems, pain, dyspareunia, and other complications before the condition is recognized and addressed.

Endometriosis can be “a monster of a disease,” especially if it’s not recognized early, said Deborah Bush, cofounder and CEO of the patient advocacy group Endometriosis New Zealand.

To help, she and her colleagues started an education program in New Zealand to teach secondary school students how to recognize – and seek help – when menstrual symptoms fall outside the norm.

In an interview at the World Congress on Endometriosis, Ms. Bush explained the importance of such efforts, and the impact they’ve had in New Zealand over the past 20 years (Aust N Z J Obstet Gynaecol. 2017 Mar 28. doi: 10.1111/ajo.12614).

She also gave an example from her own endometriosis consulting practice of what it took to turn around a patient who had been suffering with the disease for 15 years. Treatment had to move far beyond pelvic lesions.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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– Although symptoms can start young in endometriosis – sometimes in adolescence – women often suffer for years from bowel problems, pain, dyspareunia, and other complications before the condition is recognized and addressed.

Endometriosis can be “a monster of a disease,” especially if it’s not recognized early, said Deborah Bush, cofounder and CEO of the patient advocacy group Endometriosis New Zealand.

To help, she and her colleagues started an education program in New Zealand to teach secondary school students how to recognize – and seek help – when menstrual symptoms fall outside the norm.

In an interview at the World Congress on Endometriosis, Ms. Bush explained the importance of such efforts, and the impact they’ve had in New Zealand over the past 20 years (Aust N Z J Obstet Gynaecol. 2017 Mar 28. doi: 10.1111/ajo.12614).

She also gave an example from her own endometriosis consulting practice of what it took to turn around a patient who had been suffering with the disease for 15 years. Treatment had to move far beyond pelvic lesions.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– Although symptoms can start young in endometriosis – sometimes in adolescence – women often suffer for years from bowel problems, pain, dyspareunia, and other complications before the condition is recognized and addressed.

Endometriosis can be “a monster of a disease,” especially if it’s not recognized early, said Deborah Bush, cofounder and CEO of the patient advocacy group Endometriosis New Zealand.

To help, she and her colleagues started an education program in New Zealand to teach secondary school students how to recognize – and seek help – when menstrual symptoms fall outside the norm.

In an interview at the World Congress on Endometriosis, Ms. Bush explained the importance of such efforts, and the impact they’ve had in New Zealand over the past 20 years (Aust N Z J Obstet Gynaecol. 2017 Mar 28. doi: 10.1111/ajo.12614).

She also gave an example from her own endometriosis consulting practice of what it took to turn around a patient who had been suffering with the disease for 15 years. Treatment had to move far beyond pelvic lesions.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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VIDEO: Endometriosis research: What women want

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– To define the top 10 research priorities in endometriosis, researchers at the University of Edinburgh, Scotland, and their colleagues did something unusual in the world of medical science. They asked the women who have the disease.

More than 70% of the 1,225 people initially surveyed to define what most needs to be figured out in endometriosis were patients, and most of the rest were clinicians who take care of them. Patients were involved throughout an exhaustive process that whittled down nearly 5,000 initial suggestions to a list of 10 priorities.

The first priority is to determine if endometriosis can be cured, and the second task is to find its cause (Lancet. 2017 May 18. doi: 10.1016/S0140-6736(17)31344-2).

Women who have endometriosis said they want a noninvasive diagnostic test. They also want help managing the emotional and physical impacts of living with the disease, not simply treatments that focus on lesions, according to Andrew Horne, MBChB, PhD, a professor of gynecology and reproductive sciences at the University of Edinburgh, who led the efforts.

In an interview at the World Congress on Endometriosis, Dr. Horne explained why it’s critical to define the top research priorities and what doing so could mean for patients and doctors. He also explained the importance of a recent insight into the pathogenesis of endometriosis: It behaves like cancer.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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– To define the top 10 research priorities in endometriosis, researchers at the University of Edinburgh, Scotland, and their colleagues did something unusual in the world of medical science. They asked the women who have the disease.

More than 70% of the 1,225 people initially surveyed to define what most needs to be figured out in endometriosis were patients, and most of the rest were clinicians who take care of them. Patients were involved throughout an exhaustive process that whittled down nearly 5,000 initial suggestions to a list of 10 priorities.

The first priority is to determine if endometriosis can be cured, and the second task is to find its cause (Lancet. 2017 May 18. doi: 10.1016/S0140-6736(17)31344-2).

Women who have endometriosis said they want a noninvasive diagnostic test. They also want help managing the emotional and physical impacts of living with the disease, not simply treatments that focus on lesions, according to Andrew Horne, MBChB, PhD, a professor of gynecology and reproductive sciences at the University of Edinburgh, who led the efforts.

In an interview at the World Congress on Endometriosis, Dr. Horne explained why it’s critical to define the top research priorities and what doing so could mean for patients and doctors. He also explained the importance of a recent insight into the pathogenesis of endometriosis: It behaves like cancer.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– To define the top 10 research priorities in endometriosis, researchers at the University of Edinburgh, Scotland, and their colleagues did something unusual in the world of medical science. They asked the women who have the disease.

More than 70% of the 1,225 people initially surveyed to define what most needs to be figured out in endometriosis were patients, and most of the rest were clinicians who take care of them. Patients were involved throughout an exhaustive process that whittled down nearly 5,000 initial suggestions to a list of 10 priorities.

The first priority is to determine if endometriosis can be cured, and the second task is to find its cause (Lancet. 2017 May 18. doi: 10.1016/S0140-6736(17)31344-2).

Women who have endometriosis said they want a noninvasive diagnostic test. They also want help managing the emotional and physical impacts of living with the disease, not simply treatments that focus on lesions, according to Andrew Horne, MBChB, PhD, a professor of gynecology and reproductive sciences at the University of Edinburgh, who led the efforts.

In an interview at the World Congress on Endometriosis, Dr. Horne explained why it’s critical to define the top research priorities and what doing so could mean for patients and doctors. He also explained the importance of a recent insight into the pathogenesis of endometriosis: It behaves like cancer.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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Should Patients on B Cell–Depleting Therapies Be Immunized Against Influenza?

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A literature review suggests that the practice may benefit patients with multiple sclerosis.

NEW ORLEANS—Immunizing patients on B cell–depleting therapies against influenza using the inactivated virus vaccine may be beneficial, according to a report presented at the 31st Annual Meeting of the Consortium of Multiple Sclerosis Centers. “Creating virus-specific T cell immunity and boosting highly cross-reactive memory T cells from prior exposures to influenza are valuable in reducing the severity of the infection,” said Elena Grebenciucova, MD, and Eric Williamson, MD, of the Multiple Sclerosis Division of the Perelman Center for Advanced Medicine at the University of Pennsylvania in Philadelphia.

The use of B cell–depleting therapies in patients with multiple sclerosis, neuromyelitis optica, and other inflammatory disorders raises a clinical dilemma. Given that the ability to generate an adequate protective antibody response is severely impaired due to B-cell depletion, is it still beneficial to immunize patients using the inactivated influenza vaccine? The practice of vaccinating patients on B cell–depleting therapies is not universal among neurologists. Many assume that the practice has no benefit and choose not to vaccinate their patients. However, antibody-mediated immune responses are not the only part of the immune system that helps control influenza infection. T cell–mediated immunity, although affected by the absence of B cells in many complex ways, is not abolished, and may offer protection, limit severity of the disease, and reduce influenza-associated morbidity.

Drs. Grebenciucova and Williamson conducted a literature review and analysis to provide a mechanistic rationale for immunizing against influenza in patients on B cell–depleting therapies.

In 2008, Stambas et al reported that virus-specific CD8+ T effector cells are important in clearing influenza infection. They also found that CD4+ T memory cells are critical in maintaining virus-specific CD8+ memory responses. Influenza vaccine helps prime naïve T cells and generates virus-specific T cells. Vaccinating also can boost pre-existent influenza-specific memory T cells, which, unlike the specific antibodies, are effective against various strains of the virus.

Dolphi et al. showed that memory T cell CD8+ and CD4+ epitopes cross-react with internal viral protein sequences (matrix [M] and nucleoprotein [NP]) that are highly conserved among various influenza strains, and thus may offer protection even when the antibody response is either inadequate or directed against the wrong strain of the virus.

A study by Sridhar et al conducted in the setting of the 2009 H1N1 pandemic highlighted the importance of cross-reactive cellular immunity by evaluating CD8+ T cell responses prior to, during, and after the influenza infection and showed that those with pre-existent CD8+ T cells specific for highly conserved internal viral proteins experienced a less severe illness, despite the absence of neutralizing antibodies.

Wilkinson et al and McElhaney et al also showed that even in the setting of inadequate antibody responses, virus-specific T cell–mediated immunity against influenza virus offers protection and may reduce morbidity.

Suggested Reading

McElhaney JE, Kuchel GA, Zhou X, et al. T-cell immunity to influenza in older adults: a pathophysiological framework for development of more effective vaccines. Front Immunol. 2016;7:41.

Sridhar S, Begom S, Bermingham A, et al. Cellular immune correlates of protection against symptomatic pandemic influenza. Nat Med. 2013;19(10):1305-1312.

Stambas J, Guillonneau C, Kedzierska K, et al. Killer T cells in influenza. Pharmacol Ther. 2008;120(2):186-196.

Wilkinson TM, Li CK, Chui CS, et al. Preexisting influenza-specific CD4+ T cells correlate with disease protection against influenza challenge in humans. Nat Med. 2012;18(2):274-280.

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A literature review suggests that the practice may benefit patients with multiple sclerosis.
A literature review suggests that the practice may benefit patients with multiple sclerosis.

NEW ORLEANS—Immunizing patients on B cell–depleting therapies against influenza using the inactivated virus vaccine may be beneficial, according to a report presented at the 31st Annual Meeting of the Consortium of Multiple Sclerosis Centers. “Creating virus-specific T cell immunity and boosting highly cross-reactive memory T cells from prior exposures to influenza are valuable in reducing the severity of the infection,” said Elena Grebenciucova, MD, and Eric Williamson, MD, of the Multiple Sclerosis Division of the Perelman Center for Advanced Medicine at the University of Pennsylvania in Philadelphia.

The use of B cell–depleting therapies in patients with multiple sclerosis, neuromyelitis optica, and other inflammatory disorders raises a clinical dilemma. Given that the ability to generate an adequate protective antibody response is severely impaired due to B-cell depletion, is it still beneficial to immunize patients using the inactivated influenza vaccine? The practice of vaccinating patients on B cell–depleting therapies is not universal among neurologists. Many assume that the practice has no benefit and choose not to vaccinate their patients. However, antibody-mediated immune responses are not the only part of the immune system that helps control influenza infection. T cell–mediated immunity, although affected by the absence of B cells in many complex ways, is not abolished, and may offer protection, limit severity of the disease, and reduce influenza-associated morbidity.

Drs. Grebenciucova and Williamson conducted a literature review and analysis to provide a mechanistic rationale for immunizing against influenza in patients on B cell–depleting therapies.

In 2008, Stambas et al reported that virus-specific CD8+ T effector cells are important in clearing influenza infection. They also found that CD4+ T memory cells are critical in maintaining virus-specific CD8+ memory responses. Influenza vaccine helps prime naïve T cells and generates virus-specific T cells. Vaccinating also can boost pre-existent influenza-specific memory T cells, which, unlike the specific antibodies, are effective against various strains of the virus.

Dolphi et al. showed that memory T cell CD8+ and CD4+ epitopes cross-react with internal viral protein sequences (matrix [M] and nucleoprotein [NP]) that are highly conserved among various influenza strains, and thus may offer protection even when the antibody response is either inadequate or directed against the wrong strain of the virus.

A study by Sridhar et al conducted in the setting of the 2009 H1N1 pandemic highlighted the importance of cross-reactive cellular immunity by evaluating CD8+ T cell responses prior to, during, and after the influenza infection and showed that those with pre-existent CD8+ T cells specific for highly conserved internal viral proteins experienced a less severe illness, despite the absence of neutralizing antibodies.

Wilkinson et al and McElhaney et al also showed that even in the setting of inadequate antibody responses, virus-specific T cell–mediated immunity against influenza virus offers protection and may reduce morbidity.

Suggested Reading

McElhaney JE, Kuchel GA, Zhou X, et al. T-cell immunity to influenza in older adults: a pathophysiological framework for development of more effective vaccines. Front Immunol. 2016;7:41.

Sridhar S, Begom S, Bermingham A, et al. Cellular immune correlates of protection against symptomatic pandemic influenza. Nat Med. 2013;19(10):1305-1312.

Stambas J, Guillonneau C, Kedzierska K, et al. Killer T cells in influenza. Pharmacol Ther. 2008;120(2):186-196.

Wilkinson TM, Li CK, Chui CS, et al. Preexisting influenza-specific CD4+ T cells correlate with disease protection against influenza challenge in humans. Nat Med. 2012;18(2):274-280.

NEW ORLEANS—Immunizing patients on B cell–depleting therapies against influenza using the inactivated virus vaccine may be beneficial, according to a report presented at the 31st Annual Meeting of the Consortium of Multiple Sclerosis Centers. “Creating virus-specific T cell immunity and boosting highly cross-reactive memory T cells from prior exposures to influenza are valuable in reducing the severity of the infection,” said Elena Grebenciucova, MD, and Eric Williamson, MD, of the Multiple Sclerosis Division of the Perelman Center for Advanced Medicine at the University of Pennsylvania in Philadelphia.

The use of B cell–depleting therapies in patients with multiple sclerosis, neuromyelitis optica, and other inflammatory disorders raises a clinical dilemma. Given that the ability to generate an adequate protective antibody response is severely impaired due to B-cell depletion, is it still beneficial to immunize patients using the inactivated influenza vaccine? The practice of vaccinating patients on B cell–depleting therapies is not universal among neurologists. Many assume that the practice has no benefit and choose not to vaccinate their patients. However, antibody-mediated immune responses are not the only part of the immune system that helps control influenza infection. T cell–mediated immunity, although affected by the absence of B cells in many complex ways, is not abolished, and may offer protection, limit severity of the disease, and reduce influenza-associated morbidity.

Drs. Grebenciucova and Williamson conducted a literature review and analysis to provide a mechanistic rationale for immunizing against influenza in patients on B cell–depleting therapies.

In 2008, Stambas et al reported that virus-specific CD8+ T effector cells are important in clearing influenza infection. They also found that CD4+ T memory cells are critical in maintaining virus-specific CD8+ memory responses. Influenza vaccine helps prime naïve T cells and generates virus-specific T cells. Vaccinating also can boost pre-existent influenza-specific memory T cells, which, unlike the specific antibodies, are effective against various strains of the virus.

Dolphi et al. showed that memory T cell CD8+ and CD4+ epitopes cross-react with internal viral protein sequences (matrix [M] and nucleoprotein [NP]) that are highly conserved among various influenza strains, and thus may offer protection even when the antibody response is either inadequate or directed against the wrong strain of the virus.

A study by Sridhar et al conducted in the setting of the 2009 H1N1 pandemic highlighted the importance of cross-reactive cellular immunity by evaluating CD8+ T cell responses prior to, during, and after the influenza infection and showed that those with pre-existent CD8+ T cells specific for highly conserved internal viral proteins experienced a less severe illness, despite the absence of neutralizing antibodies.

Wilkinson et al and McElhaney et al also showed that even in the setting of inadequate antibody responses, virus-specific T cell–mediated immunity against influenza virus offers protection and may reduce morbidity.

Suggested Reading

McElhaney JE, Kuchel GA, Zhou X, et al. T-cell immunity to influenza in older adults: a pathophysiological framework for development of more effective vaccines. Front Immunol. 2016;7:41.

Sridhar S, Begom S, Bermingham A, et al. Cellular immune correlates of protection against symptomatic pandemic influenza. Nat Med. 2013;19(10):1305-1312.

Stambas J, Guillonneau C, Kedzierska K, et al. Killer T cells in influenza. Pharmacol Ther. 2008;120(2):186-196.

Wilkinson TM, Li CK, Chui CS, et al. Preexisting influenza-specific CD4+ T cells correlate with disease protection against influenza challenge in humans. Nat Med. 2012;18(2):274-280.

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Health reform action shifts to Senate, exacerbated by poor AHCA CBO score

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With a highly anticipated impact analysis from the nonpartisan Congressional Budget Office, the much maligned American Health Care Act seems relegated to a Capitol Hill recycling bin and repeal/replace focus has moved to the Senate.

Sen. Orrin Hatch (R-Utah), chairman of the Senate Finance Committee, has reached out to physicians’ organizations to learn their priorities.

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Any reform legislation “should maintain key insurance market reforms, such as coverage for pre-existing conditions, guaranteed issue, and parental coverage for young adults, as well as stabilize and strengthen the individual insurance market, ensure that low- and moderate-income patients are able to secure affordable and meaningful coverage, and guarantee that Medicaid, the Children’s Health Insurance Program, and other safety net programs are adequately funded,” James Madara, MD, executive vice president and CEO of the American Medical Association wrote in a May 23 letter to the chairman. AMA has “consistently recommended that any proposals to replace portions of the current law should pay special attention to ensure that individuals currently covered do not become uninsured.”

The organization also called for the reduction of regulatory burdens and increased cost transparency.

Additional recommendations include

• Support for advanceable, refundable tax credits to help individuals purchase private health care coverage, with the current tax credit structure in the ACA maintained.

• Maintenance of the ACA cost-sharing reductions for 2017 and 2018.

• Enhanced tax credits for young adults aged 19-30 years and modest funding of health savings accounts to help counter high deductibles.

The AMA also supports maintenance of the current Medicaid expansion while offering states even more flexibility for innovation.

Similarly, the American Osteopathic Association noted that any policy changes “should be to expand or at least maintain access to comprehensive, affordable coverage and care. With that said, we are also concerned about the growing potential for market instability and the deleterious effect that a collapse would have on patients’ access to insurance coverage and health care services,” according to a May 23 letter from Boyd Buser, DO, president of AOA.

The organization called for continued coverage of preventive care services with no copayment and expressed concern that “the changes being considered for the Medicaid program as part of health reform discussions will significantly impact coverage for these Americans.”

The House-passed American Health Care Act (H.R. 1628) would repeal the ACA’s Medicaid expansion provisions and implement a per-capita funding scheme for state Medicaid programs. “The AOA is concerned that this will leave states with insufficient funds to provide care to the most vulnerable in our society,” Dr. Buser wrote.

AOA recommended a number of consumer protections, including adequate funding of an invisible risk-sharing program that is maintained by an organization outside of the government; efforts to improve health literacy, and other cost-containment recommendations, particularly the maintenance of the cost-sharing reduction payments.

Even if the Senate were able to incorporate these recommendations, its leaders face an uphill battle to get enough support for passage.

“If, on the Republican side, they can come to an agreement on the bill, I think they have a chance of passing it,” Julius Hobson, senior policy analyst at the Washington law firm Polsinelli, said in an interview. “The GOP is not taking up the House-passed AHCA but is proceeding with writing its own reform legislation.

However, he pointed out that there is very little margin for error because the party only holds a two-seat majority and moderates Republican senators have expressed concerns about cuts to Medicaid.

If Senate Republicans do pass a bill that appeals to its more moderate members, that legislation is likely to face stiff opposition in the House.

“Given what we just saw the House go through, I don’t know” if a more moderate bill could pass in that chamber, he said, adding that, if “they don’t do this by the end of the calendar year, you can forget it.”

The potential death blow to the AHCA came in the form of a financial impact “score” from the Congressional Budget Office (CBO).

The government budget watchdog estimated the AHCA would reduce the budget deficit by $119 billion from 2017 to 2026, with the largest savings coming from “reductions in outlays for Medicaid and from the replacement of the Affordable Care Act’s subsidies for nongroup health insurance with new tax credits for nongroup health insurance. Those savings would be partially offset by other changes in coverage provisions – spending for a new Patient and State Stability Fund, designed to reduce premiums, and a reduction in revenues from repealing penalties on employers who do not offer insurance and on people who do not purchase insurance.”

The CBO score also predicted that an additional 23 million patients would be uninsured by 2026 – for a total of 51 million – compared with a total of 28 million uninsured under the ACA.

CBO analysts predicted that nongroup health insurance markets would stabilize before 2020 under the AHCA, but instability could increased if states seek waivers to modify the essential health benefits and community rating requirements.

Although premiums overall would decrease under the AHCA, certain subpopulations could see substantial increases under state waivers.

Additionally, the waivers could also impact the provision of care.

Analysis of the impact of the waiving of essential health benefits is the part doctors should be paying most attention to, Laura Wooster, AOA senior vice president of public policy, said in an interview.

“They would start seeing patients who potentially would have insurance plans that only cover certain benefits,” she said. That would “prevent them from providing certain services or care for their patients under the patients’ coverage. Even a more immediate administrative aspect of it that things would become more complicated if there isn’t a uniform standard, then it is going to be even more complicated for patients to navigate what’s covered, what’s not, and, if the physician takes the insurance, which services are they able to provide.”

She added that, if states waive any or all of the essential health benefits, those benefits would no longer be subject to lifetime and annual caps on spending.

Mr. Hobson suggested that the biggest part of the CBO score that doctors should be worried about is the spike in uninsured that could result from any reform effort.

“The concern for physicians will be that they are more likely to see more patients who don’t have insurance depending on the specialty,” Mr. Hobson said. “Primary care will certainly see a lot of that. Physicians in emergency departments will see more of them because, as you well know, when people don’t have insurance, that’s where they show up when they are at their sickest.”

He added that a “patient can come in, a physician can diagnose the problem, but, if the patient doesn’t have the insurance, he or she may not have the ability to spend the money to do what they need to do, which means they will be back.”

 

 

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With a highly anticipated impact analysis from the nonpartisan Congressional Budget Office, the much maligned American Health Care Act seems relegated to a Capitol Hill recycling bin and repeal/replace focus has moved to the Senate.

Sen. Orrin Hatch (R-Utah), chairman of the Senate Finance Committee, has reached out to physicians’ organizations to learn their priorities.

Graffoto8/Thinkstock
Any reform legislation “should maintain key insurance market reforms, such as coverage for pre-existing conditions, guaranteed issue, and parental coverage for young adults, as well as stabilize and strengthen the individual insurance market, ensure that low- and moderate-income patients are able to secure affordable and meaningful coverage, and guarantee that Medicaid, the Children’s Health Insurance Program, and other safety net programs are adequately funded,” James Madara, MD, executive vice president and CEO of the American Medical Association wrote in a May 23 letter to the chairman. AMA has “consistently recommended that any proposals to replace portions of the current law should pay special attention to ensure that individuals currently covered do not become uninsured.”

The organization also called for the reduction of regulatory burdens and increased cost transparency.

Additional recommendations include

• Support for advanceable, refundable tax credits to help individuals purchase private health care coverage, with the current tax credit structure in the ACA maintained.

• Maintenance of the ACA cost-sharing reductions for 2017 and 2018.

• Enhanced tax credits for young adults aged 19-30 years and modest funding of health savings accounts to help counter high deductibles.

The AMA also supports maintenance of the current Medicaid expansion while offering states even more flexibility for innovation.

Similarly, the American Osteopathic Association noted that any policy changes “should be to expand or at least maintain access to comprehensive, affordable coverage and care. With that said, we are also concerned about the growing potential for market instability and the deleterious effect that a collapse would have on patients’ access to insurance coverage and health care services,” according to a May 23 letter from Boyd Buser, DO, president of AOA.

The organization called for continued coverage of preventive care services with no copayment and expressed concern that “the changes being considered for the Medicaid program as part of health reform discussions will significantly impact coverage for these Americans.”

The House-passed American Health Care Act (H.R. 1628) would repeal the ACA’s Medicaid expansion provisions and implement a per-capita funding scheme for state Medicaid programs. “The AOA is concerned that this will leave states with insufficient funds to provide care to the most vulnerable in our society,” Dr. Buser wrote.

AOA recommended a number of consumer protections, including adequate funding of an invisible risk-sharing program that is maintained by an organization outside of the government; efforts to improve health literacy, and other cost-containment recommendations, particularly the maintenance of the cost-sharing reduction payments.

Even if the Senate were able to incorporate these recommendations, its leaders face an uphill battle to get enough support for passage.

“If, on the Republican side, they can come to an agreement on the bill, I think they have a chance of passing it,” Julius Hobson, senior policy analyst at the Washington law firm Polsinelli, said in an interview. “The GOP is not taking up the House-passed AHCA but is proceeding with writing its own reform legislation.

However, he pointed out that there is very little margin for error because the party only holds a two-seat majority and moderates Republican senators have expressed concerns about cuts to Medicaid.

If Senate Republicans do pass a bill that appeals to its more moderate members, that legislation is likely to face stiff opposition in the House.

“Given what we just saw the House go through, I don’t know” if a more moderate bill could pass in that chamber, he said, adding that, if “they don’t do this by the end of the calendar year, you can forget it.”

The potential death blow to the AHCA came in the form of a financial impact “score” from the Congressional Budget Office (CBO).

The government budget watchdog estimated the AHCA would reduce the budget deficit by $119 billion from 2017 to 2026, with the largest savings coming from “reductions in outlays for Medicaid and from the replacement of the Affordable Care Act’s subsidies for nongroup health insurance with new tax credits for nongroup health insurance. Those savings would be partially offset by other changes in coverage provisions – spending for a new Patient and State Stability Fund, designed to reduce premiums, and a reduction in revenues from repealing penalties on employers who do not offer insurance and on people who do not purchase insurance.”

The CBO score also predicted that an additional 23 million patients would be uninsured by 2026 – for a total of 51 million – compared with a total of 28 million uninsured under the ACA.

CBO analysts predicted that nongroup health insurance markets would stabilize before 2020 under the AHCA, but instability could increased if states seek waivers to modify the essential health benefits and community rating requirements.

Although premiums overall would decrease under the AHCA, certain subpopulations could see substantial increases under state waivers.

Additionally, the waivers could also impact the provision of care.

Analysis of the impact of the waiving of essential health benefits is the part doctors should be paying most attention to, Laura Wooster, AOA senior vice president of public policy, said in an interview.

“They would start seeing patients who potentially would have insurance plans that only cover certain benefits,” she said. That would “prevent them from providing certain services or care for their patients under the patients’ coverage. Even a more immediate administrative aspect of it that things would become more complicated if there isn’t a uniform standard, then it is going to be even more complicated for patients to navigate what’s covered, what’s not, and, if the physician takes the insurance, which services are they able to provide.”

She added that, if states waive any or all of the essential health benefits, those benefits would no longer be subject to lifetime and annual caps on spending.

Mr. Hobson suggested that the biggest part of the CBO score that doctors should be worried about is the spike in uninsured that could result from any reform effort.

“The concern for physicians will be that they are more likely to see more patients who don’t have insurance depending on the specialty,” Mr. Hobson said. “Primary care will certainly see a lot of that. Physicians in emergency departments will see more of them because, as you well know, when people don’t have insurance, that’s where they show up when they are at their sickest.”

He added that a “patient can come in, a physician can diagnose the problem, but, if the patient doesn’t have the insurance, he or she may not have the ability to spend the money to do what they need to do, which means they will be back.”

 

 

 

With a highly anticipated impact analysis from the nonpartisan Congressional Budget Office, the much maligned American Health Care Act seems relegated to a Capitol Hill recycling bin and repeal/replace focus has moved to the Senate.

Sen. Orrin Hatch (R-Utah), chairman of the Senate Finance Committee, has reached out to physicians’ organizations to learn their priorities.

Graffoto8/Thinkstock
Any reform legislation “should maintain key insurance market reforms, such as coverage for pre-existing conditions, guaranteed issue, and parental coverage for young adults, as well as stabilize and strengthen the individual insurance market, ensure that low- and moderate-income patients are able to secure affordable and meaningful coverage, and guarantee that Medicaid, the Children’s Health Insurance Program, and other safety net programs are adequately funded,” James Madara, MD, executive vice president and CEO of the American Medical Association wrote in a May 23 letter to the chairman. AMA has “consistently recommended that any proposals to replace portions of the current law should pay special attention to ensure that individuals currently covered do not become uninsured.”

The organization also called for the reduction of regulatory burdens and increased cost transparency.

Additional recommendations include

• Support for advanceable, refundable tax credits to help individuals purchase private health care coverage, with the current tax credit structure in the ACA maintained.

• Maintenance of the ACA cost-sharing reductions for 2017 and 2018.

• Enhanced tax credits for young adults aged 19-30 years and modest funding of health savings accounts to help counter high deductibles.

The AMA also supports maintenance of the current Medicaid expansion while offering states even more flexibility for innovation.

Similarly, the American Osteopathic Association noted that any policy changes “should be to expand or at least maintain access to comprehensive, affordable coverage and care. With that said, we are also concerned about the growing potential for market instability and the deleterious effect that a collapse would have on patients’ access to insurance coverage and health care services,” according to a May 23 letter from Boyd Buser, DO, president of AOA.

The organization called for continued coverage of preventive care services with no copayment and expressed concern that “the changes being considered for the Medicaid program as part of health reform discussions will significantly impact coverage for these Americans.”

The House-passed American Health Care Act (H.R. 1628) would repeal the ACA’s Medicaid expansion provisions and implement a per-capita funding scheme for state Medicaid programs. “The AOA is concerned that this will leave states with insufficient funds to provide care to the most vulnerable in our society,” Dr. Buser wrote.

AOA recommended a number of consumer protections, including adequate funding of an invisible risk-sharing program that is maintained by an organization outside of the government; efforts to improve health literacy, and other cost-containment recommendations, particularly the maintenance of the cost-sharing reduction payments.

Even if the Senate were able to incorporate these recommendations, its leaders face an uphill battle to get enough support for passage.

“If, on the Republican side, they can come to an agreement on the bill, I think they have a chance of passing it,” Julius Hobson, senior policy analyst at the Washington law firm Polsinelli, said in an interview. “The GOP is not taking up the House-passed AHCA but is proceeding with writing its own reform legislation.

However, he pointed out that there is very little margin for error because the party only holds a two-seat majority and moderates Republican senators have expressed concerns about cuts to Medicaid.

If Senate Republicans do pass a bill that appeals to its more moderate members, that legislation is likely to face stiff opposition in the House.

“Given what we just saw the House go through, I don’t know” if a more moderate bill could pass in that chamber, he said, adding that, if “they don’t do this by the end of the calendar year, you can forget it.”

The potential death blow to the AHCA came in the form of a financial impact “score” from the Congressional Budget Office (CBO).

The government budget watchdog estimated the AHCA would reduce the budget deficit by $119 billion from 2017 to 2026, with the largest savings coming from “reductions in outlays for Medicaid and from the replacement of the Affordable Care Act’s subsidies for nongroup health insurance with new tax credits for nongroup health insurance. Those savings would be partially offset by other changes in coverage provisions – spending for a new Patient and State Stability Fund, designed to reduce premiums, and a reduction in revenues from repealing penalties on employers who do not offer insurance and on people who do not purchase insurance.”

The CBO score also predicted that an additional 23 million patients would be uninsured by 2026 – for a total of 51 million – compared with a total of 28 million uninsured under the ACA.

CBO analysts predicted that nongroup health insurance markets would stabilize before 2020 under the AHCA, but instability could increased if states seek waivers to modify the essential health benefits and community rating requirements.

Although premiums overall would decrease under the AHCA, certain subpopulations could see substantial increases under state waivers.

Additionally, the waivers could also impact the provision of care.

Analysis of the impact of the waiving of essential health benefits is the part doctors should be paying most attention to, Laura Wooster, AOA senior vice president of public policy, said in an interview.

“They would start seeing patients who potentially would have insurance plans that only cover certain benefits,” she said. That would “prevent them from providing certain services or care for their patients under the patients’ coverage. Even a more immediate administrative aspect of it that things would become more complicated if there isn’t a uniform standard, then it is going to be even more complicated for patients to navigate what’s covered, what’s not, and, if the physician takes the insurance, which services are they able to provide.”

She added that, if states waive any or all of the essential health benefits, those benefits would no longer be subject to lifetime and annual caps on spending.

Mr. Hobson suggested that the biggest part of the CBO score that doctors should be worried about is the spike in uninsured that could result from any reform effort.

“The concern for physicians will be that they are more likely to see more patients who don’t have insurance depending on the specialty,” Mr. Hobson said. “Primary care will certainly see a lot of that. Physicians in emergency departments will see more of them because, as you well know, when people don’t have insurance, that’s where they show up when they are at their sickest.”

He added that a “patient can come in, a physician can diagnose the problem, but, if the patient doesn’t have the insurance, he or she may not have the ability to spend the money to do what they need to do, which means they will be back.”

 

 

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ATS conference participants shout for science

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– A group of about 60 individuals in lab coats marched through the rain from buses to Upper Senate Park on the evening of May 23, gathering in front of a raised podium in the park shadowed by the Capitol Building.

The demonstrators were trying to bring attention to recent policies that threaten to undermine research funding, tobacco regulation, affordable health care, clean air, and other advocacy priorities of the American Thoracic Society. The ATS had organized this rally – “Lab Coats for Lungs” – in conjunction with its international conference, which took place in Washington May 19-24.

“We rally today because we share growing anxiety that science in general, and our field in particular, is being dismissed in the halls of power,” ATS Vice President Polly Parsons, MD, announced from the podium.

Other speakers condemned the Trump administration’s proposals to scale down on environmental, health, and safety regulations, as well as proposed cuts to federal funding for scientific research, including an 18% reduction to National Institutes of Health funding.

Some speakers, including Gary Ewart, ATS chief of advocacy and government relations, and the event’s organizer, encouraged the crowd to raise their voices.

“Tell me what democracy looks like,” he yelled several times.

“This is what democracy looked like,” his fellow marchers shouted.

Mollie Kalaycio/Frontline Medical News
Dr. Marc Moss, ATS president, speaks at the "Lab Coats for Lungs" rally in Washington.
ATS President Marc Moss, MD, also engaged the crowd.

“What brought us the ability to transplant a lung and save a patient’s life who is dying of respiratory failure? What will cause the next breakthrough discovery? When our elected officials are looking for answers to challenging questions, what should they use for their guiding light?”

“Science!” bellowed the demonstrators, following each of Dr. Moss’s inquiries.

Some of the marchers wore pink lab coats rather than white, as a demonstration of women’s rights and gender equality in the field of science and medicine.

“The idea to wear pink coats was a result of discussions that mentioned that women’s rights were an integral part of the campaign for science, health, and clean air,” said ATS member Naftali Kaminski, MD. “Access to health care is critical to women, as is clean air. This why we chose to wear pink instead of white coats.”

Other speakers included Sen. Tom Carper (D-DE), Sen. Ed Markey (D-MA), pulmonary fibrosis patient advocate Teresa Barnes, and past ATS President David Gozal, MD.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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– A group of about 60 individuals in lab coats marched through the rain from buses to Upper Senate Park on the evening of May 23, gathering in front of a raised podium in the park shadowed by the Capitol Building.

The demonstrators were trying to bring attention to recent policies that threaten to undermine research funding, tobacco regulation, affordable health care, clean air, and other advocacy priorities of the American Thoracic Society. The ATS had organized this rally – “Lab Coats for Lungs” – in conjunction with its international conference, which took place in Washington May 19-24.

“We rally today because we share growing anxiety that science in general, and our field in particular, is being dismissed in the halls of power,” ATS Vice President Polly Parsons, MD, announced from the podium.

Other speakers condemned the Trump administration’s proposals to scale down on environmental, health, and safety regulations, as well as proposed cuts to federal funding for scientific research, including an 18% reduction to National Institutes of Health funding.

Some speakers, including Gary Ewart, ATS chief of advocacy and government relations, and the event’s organizer, encouraged the crowd to raise their voices.

“Tell me what democracy looks like,” he yelled several times.

“This is what democracy looked like,” his fellow marchers shouted.

Mollie Kalaycio/Frontline Medical News
Dr. Marc Moss, ATS president, speaks at the "Lab Coats for Lungs" rally in Washington.
ATS President Marc Moss, MD, also engaged the crowd.

“What brought us the ability to transplant a lung and save a patient’s life who is dying of respiratory failure? What will cause the next breakthrough discovery? When our elected officials are looking for answers to challenging questions, what should they use for their guiding light?”

“Science!” bellowed the demonstrators, following each of Dr. Moss’s inquiries.

Some of the marchers wore pink lab coats rather than white, as a demonstration of women’s rights and gender equality in the field of science and medicine.

“The idea to wear pink coats was a result of discussions that mentioned that women’s rights were an integral part of the campaign for science, health, and clean air,” said ATS member Naftali Kaminski, MD. “Access to health care is critical to women, as is clean air. This why we chose to wear pink instead of white coats.”

Other speakers included Sen. Tom Carper (D-DE), Sen. Ed Markey (D-MA), pulmonary fibrosis patient advocate Teresa Barnes, and past ATS President David Gozal, MD.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

 

– A group of about 60 individuals in lab coats marched through the rain from buses to Upper Senate Park on the evening of May 23, gathering in front of a raised podium in the park shadowed by the Capitol Building.

The demonstrators were trying to bring attention to recent policies that threaten to undermine research funding, tobacco regulation, affordable health care, clean air, and other advocacy priorities of the American Thoracic Society. The ATS had organized this rally – “Lab Coats for Lungs” – in conjunction with its international conference, which took place in Washington May 19-24.

“We rally today because we share growing anxiety that science in general, and our field in particular, is being dismissed in the halls of power,” ATS Vice President Polly Parsons, MD, announced from the podium.

Other speakers condemned the Trump administration’s proposals to scale down on environmental, health, and safety regulations, as well as proposed cuts to federal funding for scientific research, including an 18% reduction to National Institutes of Health funding.

Some speakers, including Gary Ewart, ATS chief of advocacy and government relations, and the event’s organizer, encouraged the crowd to raise their voices.

“Tell me what democracy looks like,” he yelled several times.

“This is what democracy looked like,” his fellow marchers shouted.

Mollie Kalaycio/Frontline Medical News
Dr. Marc Moss, ATS president, speaks at the "Lab Coats for Lungs" rally in Washington.
ATS President Marc Moss, MD, also engaged the crowd.

“What brought us the ability to transplant a lung and save a patient’s life who is dying of respiratory failure? What will cause the next breakthrough discovery? When our elected officials are looking for answers to challenging questions, what should they use for their guiding light?”

“Science!” bellowed the demonstrators, following each of Dr. Moss’s inquiries.

Some of the marchers wore pink lab coats rather than white, as a demonstration of women’s rights and gender equality in the field of science and medicine.

“The idea to wear pink coats was a result of discussions that mentioned that women’s rights were an integral part of the campaign for science, health, and clean air,” said ATS member Naftali Kaminski, MD. “Access to health care is critical to women, as is clean air. This why we chose to wear pink instead of white coats.”

Other speakers included Sen. Tom Carper (D-DE), Sen. Ed Markey (D-MA), pulmonary fibrosis patient advocate Teresa Barnes, and past ATS President David Gozal, MD.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
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Does a High-Quality Diet Affect Disability Status in Patients With MS?

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Patients with diet quality scores in the top quintile had lower levels of disability and depression.

NEW ORLEANS—A diet high in fruits, vegetables, legumes, and whole grains and low in sugar and red meat is associated with less disability and fewer depressive symptoms in patients with multiple sclerosis (MS), according to research presented at the 31st Annual Meeting of the Consortium of MS Centers.

Ruth Ann Marrie, MD, PhD

“Our findings suggest that people with MS who have a healthier diet have less disability, and that a generally healthy lifestyle is associated with a lower burden of severe depression, pain, fatigue, and cognitive problems. Therefore, modifying diet may offer a way of improving symptoms,” said Ruth Ann Marrie, MD, PhD, Associate Professor of Neurology and Director of the MS Clinic at the University of Manitoba in Winnipeg, Canada.

Many patients with MS ask whether their diet could influence their disease status. To address this question, Dr. Marrie and colleagues assessed the association between overall diet quality and disability and physical and mental functioning in a large cohort of people with MS. They conducted a cross-sectional study of North American Research Committee on MS (NARCOMS) registry participants who had completed a dietary screener questionnaire. The questionnaire, created by the National Health and Nutrition Examination Survey, provides an assessment of diet composition when full information on diet is unavailable. The survey estimates intake of fruits, vegetables and legumes, whole grains, added sugars, and red and processed meats.

The researchers constructed an overall diet-quality score based on responses to the questionnaire and assigned participants to sex-specific quintiles of each of the questionnaire’s five food groups. They then assigned scores for fruits, vegetables, legumes, and whole grains based on the patient’s quintile ranking. The investigators inverted scores for red and processed meats and added sugar. The researchers summed individual food-group scores to obtain an overall diet score, ranging from 4 (poor quality) to 20 (high quality).

Dr. Marrie and colleagues assessed the association between diet quality and disability status (using the Patient-Determined Disease Steps) and mental and physical functioning (ie, depression, fatigue, cognition, mobility, vision, pain, spasticity, tremor, and sensory function) using proportional odds models adjusting for age, gender, income, BMI, smoking status, and disease duration.

In all, 7,418 responders had an average quality-diet score of 11.9. Patients with higher scores tended to be older, leaner, and nonsmokers. People with diet-quality scores in the top quintile had lower levels of disability and lower depression scores. Diet-quality scores were not associated with other physical or mental functioning scores, however.

A lack of details about potentially important dietary factors, such as types of fat, is one limitation of the study, said Dr. Marrie.

“While our study does not prove that diet change will improve symptoms, a high-quality diet that emphasizes intake of fruits, vegetables, and whole grains, and lower intake of red meat, can be encouraged, given the known benefits for general health,” said Dr. Marrie. “Future studies should look at the relationship between diet and disability, as well as symptoms over time, so that we can establish whether changing diet will improve outcomes in MS. These studies should also look at diet in more detail.”

The National MS Society supported this study.

Erica Tricarico

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Patients with diet quality scores in the top quintile had lower levels of disability and depression.
Patients with diet quality scores in the top quintile had lower levels of disability and depression.

NEW ORLEANS—A diet high in fruits, vegetables, legumes, and whole grains and low in sugar and red meat is associated with less disability and fewer depressive symptoms in patients with multiple sclerosis (MS), according to research presented at the 31st Annual Meeting of the Consortium of MS Centers.

Ruth Ann Marrie, MD, PhD

“Our findings suggest that people with MS who have a healthier diet have less disability, and that a generally healthy lifestyle is associated with a lower burden of severe depression, pain, fatigue, and cognitive problems. Therefore, modifying diet may offer a way of improving symptoms,” said Ruth Ann Marrie, MD, PhD, Associate Professor of Neurology and Director of the MS Clinic at the University of Manitoba in Winnipeg, Canada.

Many patients with MS ask whether their diet could influence their disease status. To address this question, Dr. Marrie and colleagues assessed the association between overall diet quality and disability and physical and mental functioning in a large cohort of people with MS. They conducted a cross-sectional study of North American Research Committee on MS (NARCOMS) registry participants who had completed a dietary screener questionnaire. The questionnaire, created by the National Health and Nutrition Examination Survey, provides an assessment of diet composition when full information on diet is unavailable. The survey estimates intake of fruits, vegetables and legumes, whole grains, added sugars, and red and processed meats.

The researchers constructed an overall diet-quality score based on responses to the questionnaire and assigned participants to sex-specific quintiles of each of the questionnaire’s five food groups. They then assigned scores for fruits, vegetables, legumes, and whole grains based on the patient’s quintile ranking. The investigators inverted scores for red and processed meats and added sugar. The researchers summed individual food-group scores to obtain an overall diet score, ranging from 4 (poor quality) to 20 (high quality).

Dr. Marrie and colleagues assessed the association between diet quality and disability status (using the Patient-Determined Disease Steps) and mental and physical functioning (ie, depression, fatigue, cognition, mobility, vision, pain, spasticity, tremor, and sensory function) using proportional odds models adjusting for age, gender, income, BMI, smoking status, and disease duration.

In all, 7,418 responders had an average quality-diet score of 11.9. Patients with higher scores tended to be older, leaner, and nonsmokers. People with diet-quality scores in the top quintile had lower levels of disability and lower depression scores. Diet-quality scores were not associated with other physical or mental functioning scores, however.

A lack of details about potentially important dietary factors, such as types of fat, is one limitation of the study, said Dr. Marrie.

“While our study does not prove that diet change will improve symptoms, a high-quality diet that emphasizes intake of fruits, vegetables, and whole grains, and lower intake of red meat, can be encouraged, given the known benefits for general health,” said Dr. Marrie. “Future studies should look at the relationship between diet and disability, as well as symptoms over time, so that we can establish whether changing diet will improve outcomes in MS. These studies should also look at diet in more detail.”

The National MS Society supported this study.

Erica Tricarico

NEW ORLEANS—A diet high in fruits, vegetables, legumes, and whole grains and low in sugar and red meat is associated with less disability and fewer depressive symptoms in patients with multiple sclerosis (MS), according to research presented at the 31st Annual Meeting of the Consortium of MS Centers.

Ruth Ann Marrie, MD, PhD

“Our findings suggest that people with MS who have a healthier diet have less disability, and that a generally healthy lifestyle is associated with a lower burden of severe depression, pain, fatigue, and cognitive problems. Therefore, modifying diet may offer a way of improving symptoms,” said Ruth Ann Marrie, MD, PhD, Associate Professor of Neurology and Director of the MS Clinic at the University of Manitoba in Winnipeg, Canada.

Many patients with MS ask whether their diet could influence their disease status. To address this question, Dr. Marrie and colleagues assessed the association between overall diet quality and disability and physical and mental functioning in a large cohort of people with MS. They conducted a cross-sectional study of North American Research Committee on MS (NARCOMS) registry participants who had completed a dietary screener questionnaire. The questionnaire, created by the National Health and Nutrition Examination Survey, provides an assessment of diet composition when full information on diet is unavailable. The survey estimates intake of fruits, vegetables and legumes, whole grains, added sugars, and red and processed meats.

The researchers constructed an overall diet-quality score based on responses to the questionnaire and assigned participants to sex-specific quintiles of each of the questionnaire’s five food groups. They then assigned scores for fruits, vegetables, legumes, and whole grains based on the patient’s quintile ranking. The investigators inverted scores for red and processed meats and added sugar. The researchers summed individual food-group scores to obtain an overall diet score, ranging from 4 (poor quality) to 20 (high quality).

Dr. Marrie and colleagues assessed the association between diet quality and disability status (using the Patient-Determined Disease Steps) and mental and physical functioning (ie, depression, fatigue, cognition, mobility, vision, pain, spasticity, tremor, and sensory function) using proportional odds models adjusting for age, gender, income, BMI, smoking status, and disease duration.

In all, 7,418 responders had an average quality-diet score of 11.9. Patients with higher scores tended to be older, leaner, and nonsmokers. People with diet-quality scores in the top quintile had lower levels of disability and lower depression scores. Diet-quality scores were not associated with other physical or mental functioning scores, however.

A lack of details about potentially important dietary factors, such as types of fat, is one limitation of the study, said Dr. Marrie.

“While our study does not prove that diet change will improve symptoms, a high-quality diet that emphasizes intake of fruits, vegetables, and whole grains, and lower intake of red meat, can be encouraged, given the known benefits for general health,” said Dr. Marrie. “Future studies should look at the relationship between diet and disability, as well as symptoms over time, so that we can establish whether changing diet will improve outcomes in MS. These studies should also look at diet in more detail.”

The National MS Society supported this study.

Erica Tricarico

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